Product Certification
PC 044
Zenith Quality Assessors Private Limited
Address Visionnaire, 03rd Floor, Plot No. 121 & 122, Sakore Nagar, Viman Nagar, Pune – 411014, Maharashtra, India
Contact Person Mr. Pradyut Bera
Designation Director Sr Inspection & Product Assurance Manager
Mobile – –
Tel +91 9607006692 / 9607006823 / 9607006973 / 9607006945 / 9607004749
Email ID certification@zenith-worldwide.com
Website www.zenith-worldwide.com
Valid From 21 February 2025
Valid Upto 20 February 2028
Accreditation Standards ISO/IEC 17065:2012
IAF Scope Products/ Processes / Services covered under the scope Description of Scheme Normative document(s) [Standard(s)/ Regulation(s) etc]

IAF Scope 14

Rubber and plastic

Products

A.1.1 Non-active Medical

Devices;

General non- active,

non- implantable medical

devices;

Non-active devices

for injection, infusion,

transfusion and dialysis

Intravenous Cannula

Blood Collection Set

 ICMED 13485 Plus

ISO 10555-1:2023, ISO 10555-5:2013

ISO 6710:2017, ISO 7864:2016

A.1.1 Non-active Medical

Devices;

General non- active,

non- implantable medical

devices;

Non-active

Instruments

 Negative Pressure Wound Therapy Canister ICMED 13485 Plus No standards available

IAF Scope 17

Basic metals and

fabricated metal products

A.1.1 Non-active Medical

Devices

General non- active,

non- implantable medical

devices;

Non-active devices for injection, infusion,

transfusion and dialysis

 Blood Collection Needle ICMED 13485 Plus ISO 7864:2016

IAF Scope 19

Electrical & optical

Equipment

A.1.2 Active Medical Devices (Non-implantable); General active medical devices (non-

implantable);

 Negative Pressure Wound Therapy Device ICMED 13485 Plus

IEC 60601-1:2005+AMD1:2012+AMD2:2020

IEC 60601-1-2:2014+AMD1:2020

Devices for

stimulation or inhibition

 Electronic Tourniquet IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020
Surgical Navigation System IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020

IAF Scope 19

Electrical & optical

Equipment

A.1.4 In Vitro Diagnostic

Medical Devices (IVD);

In Vitro Diagnostic Instruments and software

 Immunoturbidimetric Analyzer ICMED 13485 Plus IEC 61010-1:2010/AMD1:2016, IEC 61010-2-101:2018, IEC 61326-2-6:2025
A.1.1 Non-active medical devices
General non-active, non-implantable medical devices
Non-active devices for anaesthesia, emergency and intensive care		 Drug Coated Balloon Catheter/PTCA Balloon Dilatation Catheters ICMED 13485 Plus ISO 10555 – Intravascular catheters — Sterile and single-use catheters
Respiratory Masks ICMED 13485 Plus ISO 22609 – Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
Breathing Circuits ICMED 13485 Plus ISO 5367 Anaesthetic and respiratory equipment – Breathing sets and connectors
Laryngeal Tubes ICMED 13485 Plus ISO 11712 – Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
Tracheal Tubes ICMED 13485 Plus ISO 5361 – Anaesthetic and respiratory
equipment — Tracheal tubes and connectors
Thoracic T-Tubes ICMED 13485 Plus ISO 5361 – Anaesthetic and respiratory equipment — Tracheal tubes and connectors
Airway Accessing
Catheters		 ICMED 13485 Plus ISO 8836:2019 – Suction catheters for use in the respiratory tract
A.1.1 Non-active medical devices
General non-active, non-implantable medical devices

Non-active devices
for injection, infusion,
transfusion and
dialysis 		Perfusion Sets ICMED 13485 Plus ISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus
Infusion Sets ICMED 13485 Plus ISO 8536 Infusion equipment for medical use
Transfusion Sets ICMED 13485 Plus ISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus
Blood Transfusion
Therapy Sets		 ICMED 13485 Plus ISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus
Thrombus Aspiration Catheter ICMED 13485 Plus ISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus
Surgical Tubing
Products		 ICMED 13485 Plus ISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion
sets for single use with pressure infusion apparatus
Urine Collecting
Bags		 ICMED 13485 Plus ISO 8669-2 Urine collection bags Requirements and test methods
Disposable Syringes
and Needles		 ICMED 13485 Plus ISO 7886-1 Sterile hypodermic syringes for single use Part 1: Syringes for manual use
Hypodermic Syringe ICMED 13485 Plus ISO 7886-1 Sterile hypodermic syringes for single use Part 1: Syringes for manual use
lnsulin Syringe ICMED 13485 Plus ISO 8537 Sterile single-use syringes, with or without needle, for insulin
Auto Disable
Syringe		 ICMED 13485 Plus ISO 7886-3 Sterile hypodermic syringes for single use Part 3: Auto-disabled syringes for fixed-dose immunization
Closed Wound
Drainage Tube		 ICMED 13485 Plus ISO 10079-4 Medical suction equipment Part 4: General requirements
Suction Tubes ICMED 13485 Plus IS 9073 Specification for neuro – Suction tubes
ICMED 13485 Plus IS 9183 Suction Tube, Magill’s Pattern
ICMED 13485 Plus IS 8837 Specification for suction tubes with stylet microlaryngeal surgery
A.1.1 Non-active medical devices

General non-active, non-implantable medical devices

Non-active orthopedic and rehabilitation
devices 		External Fixators ICMED 13485 Plus ISO 8615 Implants for surgery Fixation devices for use in the ends of the femur in adults
Artificial Limbs ICMED 13485 Plus ISO 13405 (Series) Prosthetics and orthotics —
Classification and description of prosthetic components
ICMED 13485 Plus ISO 10328 Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods
A.1.1 Non-active medical devices

General non-active, non-implantable medical devices

Non-active medical
devices with
measuring function

Mercury
Thermometer

Sphygmomanometer

 ISO 81060 (Series) Non-invasive
sphygmomanometers

ICMED 13485 Plus

ICMED 13485 Plus
A.1.1 Non-active medical devices

General non-active, non-implantable medical devices

Non-active medical
devices with
measuring function 		Opthalmic Surgical
Instruments		 ICMED 13485 Plus ISO 15004-1 – Ophthalmic instruments — Fundamental requirements and test methods
— Part 1: General requirements applicable to all ophthalmic instruments
ICMED 13485 Plus ISO 15004-2 – Ophthalmic instruments Fundamental requirements and test
methods — Part 2: Light hazard protection
methods — Part 2: Light hazard protection
requirements and test methods — Part 2: Light hazard protection
Tonometer ICMED 13485 Plus ISO 8612 Ophthalmic instruments – Tonometers
Refractor Head/Refractor
Arm		 ICMED 13485 Plus ISO 10341 Ophthalmic instruments — Refractor heads
Ophthalmic Cryo
Surgical System		 ICMED 13485 Plus ISO 15004-1 Ophthalmic instruments — Fundamental requirements and test methods
— Part 1: General
requirements applicable to all ophthalmic instruments
Eye ointment ICMED 13485 Plus
A.1.1 Non-active medical devices

General non-active, non-implantable medical devices

Non-active instruments 		Rectal Catheters ICMED 13485 Plus EVS-EN 12439 Sterile rectal
catheters for single use
Urological
Catheters		 ICMED 13485 Plus ISO 20696 Sterile urethral catheters for single use
ENT Instruments ICMED 13485 Plus ISO 16061 Instruments for use in association with non-active surgical implants General requirements
Orthopedic Surgical
Instruments		 ICMED 13485 Plus ISO 8319 Orthopaedic instruments Drive connections
General Surgical
Instruments		 ICMED 13485 Plus ISO 7740 Instruments for surgery – Scalpels with
detachable blades – Fitting dimensions
ICMED 13485 Plus ISO 7741 Instruments for surgery — Scissors and shears — General requirements and
test methods
ICMED 13485 Plus ISO 7151 Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
ICMED 13485 Plus ISO 7153 Surgical instruments — Materials — Part 1: Metals
ICMED 13485 Plus ISO 13402 Surgical and dental hand instruments — Determination of resistance
against autoclaving, corrosion and thermal exposure
Ambidextrous
Gloves Powdered
and Powder Free
(Natural Latex and
Synthetic Latex)		 ICMED 13485 Plus EN 455 Medical gloves for single use (Series)

ISO 21420 Protective gloves — General
requirements and test methods
Examination Gloves
Powdered and
Powder Free
(Natural Latex and
Synthetic Latex)		 ICMED 13485 Plus EN 455 Medical gloves for single use (Series)
ICMED 13485 Plus ISO 11193-1 Single-use medical examination gloves — Part 1: Specification for gloves made
from rubber latex or rubber solution
Drapes and Gowns ICMED 13485 Plus EN 13795-1 Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns
ICMED 13485 Plus ISO 22610 Surgical drapes, gowns and clean air suits, used as medical devices, for patients,
clinical staff and equipment — Test method to determine the resistance to wet bacterial
penetration
Disposable Caps
and Masks		 ICMED 13485 Plus ISO 19918 Protective clothing Protection against chemicals Measurement of cumulative
permeation of chemicals with low vapour pressure through materials
Gynaecological
Gloves in
Powdered and
Powder Free Form		 ICMED 13485 Plus EN 455 Medical gloves for single
use (Series)
Operation Theatre
Furniture		 ICMED 13485 Plus IS 8346 Dentistry — Operator’s Stool ( Second Revision )
ICMED 13485 Plus IS 7378 Bed, Fowler’s, Hospital
Skin staplers
(without pins) and
staple remover		 ICMED 13485 Plus
A.1.1 Non-active medical devices

General non-active, non-implantable medical devices

Contraceptive medical devices 		Condom ICMED 13485 Plus ISO 4074 Natural rubber latex male condoms – Requirements and test methods
ICMED 13485 Plus ISO 23409 Male condoms — Requirements and test methods for condoms made from
synthetic materials
A.1.1 Non-active medical devices

General non-active, non-implantable medical devices

Non-active medical devices for disinfecting, cleaning, rinsing 		Solutions for
disinfecting
medical devices		 ICMED 13485 Plus ISO 15883-1 Washerdisinfectors Part 1: General requirements, terms and definitions and tests
Disinfectant wipes ICMED 13485 Plus EN 16615 Chemical disinfectants and antiseptics – Quantitative test method for
the evaluation of bactericidal and yeasticidal activity on nonporous surfaces with mechanical action employing wipes in the medical area (4-
field test) – Test method and requirements (phase 2, step 2)
A.1.1 Non-active medical devices

General non-active, non-implantable medical devices

Non-active devices
for in vitro fertilisation (IVF) and assisted
reproductive
technologies (ART) 		Media (e.g., Sperm
density gradient
media, Sperm
preparation media,
Oocyte vitrification
media, Blastocyst
vitrification media,
Embryo vitrification
media, etc.)		 ICMED 13485 Plus ISO 10993 Biological evaluation of medical device
Sperm DNA
fragmentation
detection kit		 ICMED 13485 Plus ISO 10993 Biological evaluation of medical device
Cryolife ICMED 13485 Plus ISO 10993 Biological evaluation of medical device
Cryoloop ICMED 13485 Plus ISO 10993 Biological evaluation of medical device
Thawing kit ICMED 13485 Plus ISO 10993 Biological evaluation of medical device
Reagents (e.g.,
WBC reagent,
Fructose reagent,
HOS reagent
(Hypo-osmotic
swelling test), etc.)		 ICMED 13485 Plus ISO 10993 Biological evaluationof medical device
Stains (e.g., Diffquick
stain, Eosinnigrosin
stain, etc.)		 ICMED 13485 Plus ISO 10993 Biological evaluation of medical device
A.1.1 Non-active medical devices

General non-active, non-implantable medical devices

Non-active medical
devices for ingestion

Gastroenteric
Feeding Tubes

Feeding Tube

ICMED 13485 Plus

ICMED 13485 Plus

ISO 20695 Enteral feeding systems — Design and testing

ISO 20695 Enteral feeding systems — Design and testing
Ryles Tube ICMED 13485 Plus ISO 20695 Enteral feeding systems — Design and testing
A.1.1 Non-active medical devices

Non-active implants 		Cardiac vascular
stent (DES and Bare
Metal)		 ICMED 13485 Plus ISO 25539-2 Cardiovascular implants, endovascular devices- Part 2: Vascular stents
Non-active cardiovascular
implants		 Cardiac Valve
Prostheses		 ICMED 13485 Plus ISO 5840-1:2021 Cardiovascular implants –
Cardiac valve prostheses Part 1: General requirements
ICMED 13485 Plus

ISO 5840-2 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically

implanted
heart valve substitutes
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
A.1.1 Non-active medical devices

Non-active implants

Non-active orthopedic
implants 		Orthopaedic Bone
screws		 ICMED 13485 Plus ISO 5835 Implants for surgery – Metal bone screws with hexagonal drive connection,
spherical under-surface of head, asymmetrical thread – Dimensions
ICMED 13485 Plus ISO 14630 Non-active surgical implants – General requirements
ICMED 13485 Plus ISO 6475 Implants for surgery — Metal bone screws with asymmetrical thread and
spherical under-surface — Mechanical requirements and test methods
Spinal Implants ICMED 13485 Plus ISO 23089-2 Implants for surgery Pre-clinical mechanical assessment of spinal implants
and particular requirements – Part 2: Spinal intervertebral body fusion devices
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Orthopaedic Plates ICMED 13485 Plus ISO 5836 Implants for surgery – Metal bone plates – Holes corresponding to screws with
asymmetrical thread and spherical under-surface
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants
General requirements
Intramedullary
Nails		 ICMED 13485 Plus ISO 15142 Implants for surgery Metal intramedullary nailing systems – Part 1: Intramedullary nails
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants
General requirements
Knee Implants ICMED 13485 Plus ISO 21536 Non-active surgical implants – Joint replacement implants -Specific requirements
for knee-joint replacement implants
ICMED 13485 Plus EN ISO 14630 non-active surgical implants
General requirements
ICMED 13485 Plus ISO 14879-1 Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays
Hip Implants ICMED 13485 Plus ISO 7206 (Series) Implants for surgery — Partial and total hipjoint prostheses
ICMED 13485 Plus EN ISO 14630 Non-activesurgical implants
General requirements
Shoulder Implants ICMED 13485 Plus ISO 21534 Non-active surgical implants — Joint replacement implants — Particular
requirements
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Elbow Implants ICMED 13485 Plus ISO 21534 Non-active surgical implants — Joint replacement implants — Particular
requirements
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants
General requirements
R CAN Limb Salvage
System Implants		 ICMED 13485 Plus ISO 7206 Implants for surgery — Partial and total hip-joint prostheses
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Arthroscopy
Implants		 ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
A.1.1 Non-active medical devices

Non-active implants

Non-active orthopedic
implants 		Orthopaedic Bone
screws		 ICMED 13485 Plus ISO 5835 Implants for surgery – Metal bone screws with hexagonal drive connection,
spherical under-surface of head, asymmetrical thread – Dimensions
ICMED 13485 Plus ISO 14630 Non-active surgical implants – General requirements
ICMED 13485 Plus ISO 6475 Implants for surgery — Metal bone screws with asymmetrical thread and
spherical under-surface — Mechanical requirements and test methods
Spinal Implants ICMED 13485 Plus ISO 23089-2 Implants for surgery Pre-clinical mechanical assessment of spinal implants
and particular requirements – Part 2: Spinal intervertebral body fusion devices
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Orthopaedic Plates ICMED 13485 Plus ISO 5836 Implants for surgery – Metal bone plates – Holes corresponding to screws with
asymmetrical thread and spherical under-surface
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants
General requirements
Intramedullary
Nails		 ICMED 13485 Plus ISO 15142 Implants for surgery Metal intramedullary nailing systems – Part 1: Intramedullary nails
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants
General requirements
Knee Implants ICMED 13485 Plus ISO 21536 Non-active surgical implants – Joint replacement implants -Specific requirements
for knee-joint replacement implants
ICMED 13485 Plus EN ISO 14630 non-active surgical implants
General requirements
ICMED 13485 Plus ISO 14879-1 Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays
Hip Implants ICMED 13485 Plus ISO 7206 (Series) Implants for surgery — Partial and total hipjoint prostheses
ICMED 13485 Plus EN ISO 14630 Non-activesurgical implants
General requirements
Shoulder Implants ICMED 13485 Plus ISO 21534 Non-active surgical implants — Joint replacement implants — Particular
requirements
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Elbow Implants ICMED 13485 Plus ISO 21534 Non-active surgical implants — Joint replacement implants — Particular
requirements
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants
General requirements
R CAN Limb Salvage
System Implants		 ICMED 13485 Plus ISO 7206 Implants for surgery — Partial and total hip-joint prostheses
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Arthroscopy
Implants		 ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Endoprosthesis ICMED 13485 Plus ISO 21536 Non-active surgical implants – Joint replacement implants – Specific requirements
for knee-joint replacement implants
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Cranio-
Maxillofacial
Implants		 ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirement
Joint Prosthesis ICMED 13485 Plus ISO 14879-1 Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial trays
ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
A.1.1 Non-active medical devices

Non-active implants

Non-active functional implants 		Intraocular lenses ICMED 13485 Plus ISO 15798 Ophthalmic implants — Ophthalmic viscosurgical devices
ICMED 13485 Plus ISO 11979 (Series) Ophthalmic implants—
Intraocular lenses
Speaking Valves ICMED 13485 Plus ISO 21917 Anaesthetic and respiratory equipment — Voice prostheses
Voice Prosthesis ICMED 13485 Plus ISO 21917 Anaesthetic and respiratory equipment — Voice prostheses
Urethral stent
implants		 ICMED 13485 Plus EN ISO 14630 Non-active surgical implants
General requirements
Renal Stent System ICMED 13485 Plus EN ISO 14630 Non-active surgical implant – General requirements
Biliary Stent
System		 ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
Otology Implants ICMED 13485 Plus EN ISO 14630 Non-active surgical implants – General requirements
A.1.1 Non-active medical devices

Non-active implants

Non-active soft tissue implants 		Implantable
medical device
indicated to treat
degenerative Joint
abnormality
Maxillofacial
Implants		 ICMED 13485 Plus EN ISO 14630 Non-active surgical implants
General requirements
ICMED 13485 Plus ISO 22794 Dentistry – Implantable materials for bone filling and augmentation in oral and
maxillofacial surgery – Contents of a technical file
A.1.1 Non-active medical devices

Devices for wound care

Bandages and wound dressings 		Medical PVA
Dressings		 ICMED 13485 Plus EN 13726 Test methods for wound dressings – Aspects of absorption, moisture vapour
transmission, waterproofness and extensibility
Gelatin Sponges ICMED 13485 Plus IS 10829 X-Ray Detectable Gauze Swabs and Laparotomy Sponges
Surgical
Dressings/Absorbent dressing		 ICMED 13485 Plus EN 13726 Test methods for wound dressings – Aspects of absorption, moisture vapour
transmission, waterproofness and extensibility
ICMED 13485 Plus

EN 14079 Non-active medical devices – Performance

requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

Corrugated
Drainage Sheet		 ICMED 13485 Plus EN 1644-1 Test methods for nonwoven compresses for medical use – Part 1: Nonwovens used in the manufacture of compresses
Alcohol Prep Pad ICMED 13485 Plus EN 1644-1 Test methods for nonwoven compresses for medical use – Part 1:
Nonwovens used in the manufacture of compresses
Dressing for Burn
Wound
Management		 ICMED 13485 Plus IS 863 Handloom Cotton Bandage Cloth, Non-Sterilized
First Aid Bandage ICMED 13485 Plus IS 863 Handloom Cotton Bandage Cloth, Non-Sterilized
A.1.1 Non-active medical devices

Devices for wound care

Suture material and clamps 		Sterile Umbilical
Cord Clamp		 ICMED 13485 Plus
Disposable Skin
Staplers		 ICMED 13485 Plus IS 14228 Implants for surgery – Staples with parallel legs for orthopaedic use – General
requirements
Sutures
(Absorbable and
Non-Absorbable)		 ICMED 13485 Plus IS 9165-1 Surgical instruments – Needles, suture: Part 1 specification (First Revision)
A.1.1 Non-active medical devices

Non-active dental devices and accessories

Non-active dental
devices/equipment
and instruments 		Dental Aligners Kit ICMED 13485 Plus EN 1641 Dentistry – Medical devices for dentistry – Materials
ICMED 13485 Plus ISO 27020 – Dentistry -Brackets and tubes for use in orthodontics
Aligner Chewie ICMED 13485 Plus EN 1641 Dentistry – Medical devices for dentistry – Materials
Cheek Retractor ICMED 13485 Plus ISO 21850-1 Dentistry- Materials for dental instruments Part 1: Stainless steel
Aligner Retriever ICMED 13485 Plus ISO 21850-1 Dentistry – Materials for dental instruments Part 1: Stainless steel
Acrylic Teeth ICMED 13485 Plus ISO 22112- Dentistry -Artificial teeth for dental prostheses IS 863 Handloom Cotton Bandage Cloth, Non-Sterilized
Dental Prothesis ICMED 13485 Plus ISO 22112- Dentistry- Artificial teeth for dental prostheses
A.1.1 Non-active medical devices

Non-active dental devices and accessories

Dental materials 		Impression Kit ICMED 13485 Plus SO 4823 Dentistry — Elastomeric impression and bite registration materials
Dental Materials ICMED 13485 Plus EN 1641 Dentistry – Medical devices for dentistry – Materials
A.1.1 Non-active medical devices

Non-active dental devices and accessories

Dental implants 		Dental implant ICMED 13485 Plus ISO 14801 Dentistry — Implants — Dynamic loading test for endosseous dental implants
A.1.1 Non-active medical devices

Non-active medical devices other than
specified above 		ICMED 13485 Plus
A.1.2 Active medical device (Non-implantable)

General active medical devices (non- implantable)
Devices for extra-corporal circulation, infusion and haemopheresis 		Infusion Pumps ICMED 13485 Plus

IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements,
tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-24 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
Perfusion Pump ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-24 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
Syringe Pump ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-24 Medical electrical equipment – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
A.1.2 Active medical device (Non-implantable)

General active medical devices (non-implantable)

Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia 		Nebulizer

IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

ICMED 13485 Plus

ICMED 13485 Plus
IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ICMED 13485 Plus
ISO 27427 Anaesthetic and respiratory equipment Nebulizing systems and components ICMED 13485 Plus
Respirators IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance ICMED 13485 Plus
ISO 16900-7 Respiratory protective devices
Methods of test and test equipment
Part 7: Practical performance test methods		 ICMED 13485 Plus
Ventilator (Neonates, Paediatric, Adult) IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance ICMED 13485 Plus
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests ICMED 13485 Plus
IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ICMED 13485 Plus
ISO 80601-2-84 Medical electrical equipment
Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment		 ICMED 13485 Plus
ISO 80601-2-12 Medical electrical equipment
Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators		 ICMED 13485 Plus
Oxygen Concentrator IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance ICMED 13485 Plus
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – ICMED 13485 Plus
Requirements and tests
IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ICMED 13485 Plus
ISO 80601-2-69 Medical electrical equipment
Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment		 ICMED 13485 Plus
Anaesthesia machines IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance ICMED 13485 Plus
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests ICMED 13485 Plus
IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: ICMED 13485 Plus
General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ISO 80601-2-13 Medical electrical equipment- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation ICMED 13485 Plus
Infant CPAP IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance ICMED 13485 Plus
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for  ICMED 13485 Plus
basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems  ICMED 13485 Plus
Stress test treadmill IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and  ICMED 13485 Plus
essential performance
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests  ICMED 13485 Plus
A.1.2 Active medical device (Non-implantable)

General active medical devices (non-implantable)

Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia 		Cardiac defibrillators (AED) ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements,
tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-4 Medical electrical equipment – Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Diagnostic Muscular Simulator ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Muscles Stimulator (For Diagnostic and Therapy), ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral
Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-10 Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Ultrasonic Physiotherapy Equipment ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-5 Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
A.1.2 Active medical device (Non-implantable)

General active medical devices (non-implantable) 		High frequency surgical equipment and high frequency surgical accessories/ Diathermy/ Surgical diathermy ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Active surgical devices ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-2 Medical electrical equipment – Part 2-2: Particular
requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Robot Assisted surgical equipment ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral
Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 80601-2-77 Medical electrical equipment
Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Surgical luminaries and luminaries for diagnosis ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-2-41 Medical electrical equipment – Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
Bone cutting, drilling, Reaming Equipment ICMED 13485 Plus ISO 9714-1 Orthopaedic drilling instruments
Part 1: Drill bits, taps and countersink cutters
ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
Surgical Electrodes ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-2-2 Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories
Lithotripters ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
A.1.2 Active medical device (Non-implantable)

General active medical devices (non- implantable)

Active ophthalmologic devices 		Auto Refractometer ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 15004-1 Ophthalmic instruments
Fundamental requirements and test methods
Part 1: General requirements
applicable to all ophthalmic instruments
ICMED 13485 Plus ISO 10342 Ophthalmic instruments Eye refractometers
Binocular Indirect Ophthalmoscope ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
ICMED 13485 Plus ISO 15004-1 Ophthalmic instruments
Fundamental requirements and test methods
Part 1: General requirements applicable to all ophthalmic instruments
Ophthalmic Microscope (Visualization System for Ophthalmic Micro Surgery) ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 15004-1 Ophthalmic instruments
Fundamental requirements and test methods
Part 1: General requirements applicable to all ophthalmic instruments
Slit Lamp Digital Imaging System ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 10939 Ophthalmic instruments Slit-lamp microscopes
Video Indirect Ophthalmoscope ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 10943 Ophthalmic instruments – Indirect ophthalmoscopes
Keratometer ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 15004-1 Ophthalmic instruments
Fundamental requirements and test methods
Part 1: General requirements applicable to all ophthalmic instruments
ICMED 13485 Plus ISO 10343 Ophthalmic instruments
Ophthalmometers
Fundus Camera/ Retinal Camera ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 10940 Ophthalmic instruments Fundus cameras
Slit Lamp with Ophthalmoscope ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
ICMED 13485 Plus ISO 10939 Ophthalmic instruments
Slit-lamp microscopes
Focimeters ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 8598-1 Optics and optical instruments -Focimeters – Part 1: General purpose instruments
Tonometers ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 8612 Ophthalmic instruments – Tonometers
A.1.2 Active medical device (Non-implantable)

General active medical devices (non-implantable)

Active dental devices 		Powered dental surgical unit and hand pieces ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral
Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 14457 Dentistry Handpieces and motors
Mobile dental unit and patient chairs ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 5467-1 Dentistry Mobile dental units and dental patient chairs – Part 1: General requirements
Mobile dental unit and patient chairs – Air, water, suction and waste water systems ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 5467-2 Dentistry Mobile dental units and dental patient chairs – Part 2: Air, water, suction and wastewater systems
Stationary dental unit and patient chairs ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 7494-1 Dentistry Stationary dental units and dental patient chairs – Part 1: General requirements
Stationary dental unit and patient chairs – Air, water, ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General
suction and waste water systems requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 7494-2 Dentistry Stationary dental units and dental patient chairs – Part 2: Air, water, suction and wastewater systems
Powered Scaler
(Ultrasonic)		 ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
ICMED 13485 Plus ISO 18397 Dentistry Powered scaler
A.1.2 Active medical device (Non-implantable)

General active medical devices (non-implantable)

Active rehabilitation devices and active prostheses 		Electric Wheelchairs ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 7176 (Series) Wheelchairs
Medical Robots for Rehabilitation ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General
requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 80601-2-78 Medical electrical equipment
Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
External limb prostheses ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 22523 External limb prostheses and external orthoses – Requirements and test methods
ICMED 13485 Plus ISO 22523 External limb prostheses and external orthoses – Requirements and test methods
A.1.2 Active medical device (Non-implantable)

General active medical devices (non-implantable)

Active devices for patient positioning and transport 		Medical beds (Electrical) ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-52 Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
Dialysis Chairs (Electrical) ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
A.1.2 Active medical device (Non-implantable)

General active medical devices (non-implantable)

Software, íncluding software design for medical devices 		Radiology imaging software ICMED 13485 Plus IEC 62304 Medical device software – Software life cycle processes
ICMED 13485 Plus IEC 82304-1 Health software Part 1: General requirements for product safety
ICMED 13485 Plus IEC 62304 Medical device software Software life cycle processes
ICMED 13485 Plus IEC 82304-1 Health software Part 1: General requirements for product safety
ICMED 13485 Plus IEC 62304 Medical device software Software life cycle processes
ICMED 13485 Plus IEC 82304-1 Health software Part 1: General requirements for product safety
ICMED 13485 Plus IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security – Part 5-1: Security Activities in the product life cycle
A.1.2 Active medical device (Non-implantable)

General active medical devices (non-implantable)

Medical gas supply systems and parts thereof 		Medical Gas Flow and Purity Analyzer ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 7396-1 Medical gas pipeline systems
Part 1: Pipeline systems for compressed medical gases and vacuum
ICMED 13485 Plus ISO 8573-1 Compressed air Part 1: Contaminants and purity classes
Respiratory gas monitors ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 80601-2-55 Medical electrical equipment
Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Gas manifold and line pressure regulator ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus ISO 10524 (Series) Pressure regulators for use with medical gases
A.1.2 Active medical device (Non-implantable)

Devices for imaging

Devices utilizing ionizing radiation 		Diagnostic X-ray Equipment ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-1-3 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
ICMED 13485 Plus IEC 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X- ray equipment for radiography and radioscopy
ICMED 13485 Plus IS 7620 SPECIFICATION FOR DIAGNOSTIC MEDICAL X-RAY EQUIPMENT
Mobile X-Ray device ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-3 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
C-Arm ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-3 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
ICMED 13485 Plus ISO 15708-2 Non-destructive testing
Radiation methods for computed tomography Part 2: Principles, equipment and samples
A.1.2 Active medical device (Non-implantable)

Devices for imaging

Devices utilizing non-ionizing radiation 		Ultrasound Diagnostic Device ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-37 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Endoscopy ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-18 Medical electrical equipment –
Part 2-18: Particular requirements for the basic
safety and essential performance of endoscopic
equipment
ICMED 13485 Plus ISO 8600-1 Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements
Vascular Doppler ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
A.1.2 Active medical device (Non-implantable)

Devices for monitoring

Monitoring devices of non-vital physiological parameters 		Uroflow meter ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
Urodynamic system ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
BMI meter ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
A.1.2 Active medical device (Non-implantable)

Devices for monitoring
Monitoring devices of vital physiological parameters 		Electrocardiographic monitoring equipment ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-27 Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Multiparameter Monitor ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus performance of multifunction patient monitoring equipment IEC 80601-2-49 Medical electrical equipment
Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
Capnography ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements,
tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 80601-2-55 Medical electrical equipment
Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Automated non-invasive sphygmomanometers/ Noninvasive Blood Pressure ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 80601-2-30 Medical electrical equipment
Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
Invasive Blood Pressure Monitoring Device ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-34 Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of
invasive blood pressure monitoring equipment
Spirometry Devices ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 26782 Anaesthetic and respiratory equipment – Spirometers intended for the measurement of time forced expired volumes in humans
Pulse Oximeter ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 80601-2-61 Medical electrical equipment
Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Infant Cardiorespiratory Monitor/ Fetal Monitor ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus ISO 18778 Respiratory equipment – Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
Digital Stethoscope ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
A.1.2 Active medical device (Non-implantable)

Devices for radiation therapy and thermo therapy

Devices utilising non-ionizing radiation 		Infant phototherapy equipment ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-50 Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Surgical laser used in ophthalmic procedures ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60825-1 Safety of laser products – Part 1: Equipment classification and requirements
Laser Surgery Equipment ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-22 Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical,
cosmetic, therapeutic and diagnostic laser equipment
A.1.2 Active medical device (Non-implantable)

Devices for radiation therapy and thermo therapy

Devices for hyperthermia / hypothermia 		Infant radiant warmers ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-21 Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Radiant Heat Warmer ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-35 Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
Infant transport incubators ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-20 Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
Infant Incubators ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-19 Medical electrical equipment – Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Neonatal Hypothermia Treatment device ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
ICMED 13485 Plus IEC 60601-2-21 Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
A.1.2 Active medical device (Non-implantable)

Devices for radiation therapy and thermo therapy

Devices for (extracorporal) shock-wave therapy (lithotripsy) 		Extracorporeal shock wave lithotripsy device ICMED 13485 Plus IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 60601-1-8 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
A.1.4 In Vitro Diagnostic medical device (IVD)

Reagents and
reagent products,
calibrators and
control materials

Reagents and
reagent products, 		Rapid test kits,
Calibrators , control
and Reagents		 ICMED 13485 Plus ISO 20916 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
ICMED 13485 Plus ISO 15193- In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for content and presentation of reference measurement
procedures
ICMED 13485 Plus ISO 15194 – In vitro diagnostic medical devices – Measurement
calibrators and control materials for: Clinical
Chemistry		 of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation
A.1.4 In Vitro Diagnostic medical device (IVD)

Reagents and
reagent products,
calibrators and
control materials

Reagents and
reagent products,
calibrators and
control materials
for:
Immunochemistr-y
(Immunology) 		Rapid test kits,
Calibrators , control
and Reagents		 ICMED 13485 Plus ISO 20916 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
ICMED 13485 Plus ISO 15193- In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for content and presentation of reference measurement
procedures
ICMED 13485 Plus ISO 15194 – In vitro diagnostic medical devices
Measurement of quantities in samples of biological origin – Requirements for certified
reference materials and the content of supporting documentation
A.1.4 In Vitro Diagnostic medical device (IVD)

Reagents and
reagent products,
calibrators and
control materials

Reagents and
reagent products,
calibrators and
control materials
for:
Haematology/Hae
mostasis/
Immunohematol-ogy 		Rapid test kits,
Calibrators , control
and Reagents		 ICMED 13485 Plus ISO 20916 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
ICMED 13485 Plus ISO 15193- In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for content and presentation of reference measurement
procedures
ICMED 13485 Plus ISO 15194 – In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for certified reference materials and the content of supporting documentation
A.1.4 In Vitro Diagnostic medical device (IVD)

Reagents and
reagent products,
calibrators and
control materials

Reagents and
reagent products, 		Rapid test kits,
Calibrators , control
and Reagents		 ICMED 13485 Plus ISO 20916 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
ICMED 13485 Plus ISO 15193- In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for content and presentation of reference measurement
procedures
ICMED 13485 Plus ISO 15194:2009 – In vitro diagnostic medical devices
calibrators and control materials
for: Microbiology		 Measurement of quantities in
samples of biological origin – Requirements for certified reference materials and the content of supporting documentation
A.1.4 In Vitro Diagnostic medical device (IVD)

Reagents and
reagent products,
calibrators and
control materials

Reagents and
reagent products,
calibrators and
control materials
for: Infectious
Immunology 		Rapid test kits,
Calibrators , control
and Reagents		 ICMED 13485 Plus ISO 20916 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
ICMED 13485 Plus ISO 15193- In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements
for content and presentation of reference measurement
procedures
ICMED 13485 Plus ISO 15194 – In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for certified reference materials and the content of supporting documentation
A.1.4 In Vitro Diagnostic medical device (IVD)

Reagents and
reagent products,
calibrators and
control materials

Reagents and
reagent products,
calibrators and
control materials
for:
Histology/Cytology 		Rapid test kits,
Calibrators , control
and Reagents		 ICMED 13485 Plus ISO 20916 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
ICMED 13485 Plus ISO 15193- In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for content and presentation of reference measurement
procedures
ICMED 13485 Plus ISO 15194 – In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for certified reference materials and the content of supporting documentation
A.1.4 In Vitro Diagnostic medical device (IVD)

Reagents and
reagent products,
calibrators and
control materials

Reagents and
reagent products,
calibrators and
control materials
for: Genetic Testing 		Rapid test kits,
Calibrators , control
and Reagents		 ICMED 13485 Plus ISO 20916 – In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
ICMED 13485 Plus ISO 15193- In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for content and presentation of reference measurement
procedures
ICMED 13485 Plus ISO 15194 – In vitro diagnostic medical devices – Measurement of quantities in samples of
biological origin – Requirements for certified reference materials
and the content of supporting documentation
A.1.4 In Vitro Diagnostic medical device (IVD)

In Vitro Diagnostic
Instruments and
software 		ACT Machine ICMED 13485 Plus IEC 60601-1 AMD2 – Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
ICMED 13485 Plus EVS-EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 61010-1:2010 – Safety requirements for electrical equipment for measurement,
control, and laboratory use – Part 1: General requirements
ICMED 13485 Plus IEC 61010-2-101 – Safety requirements for electrical equipment for measurement,
control, and laboratory use – Part 2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment
ICMED 13485 Plus ISO 18113-1- In vitro Diagnostic Medical Devices -Information supplied by Manufacturer (labelling)-Part 1 : Terms, Definition and general Requirements
Coagulation
Analyzer		 ICMED 13485 Plus IEC 60601-1 AMD2 – Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
ICMED 13485 Plus EVS-EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 61010-1- Safety requirements for electrical
equipment for measurement, control, and laboratory use – Part 1: General requirements
ICMED 13485 Plus IEC 61010-2-101 – Safety requirements for electrical equipment for measurement, control, and laboratory use -Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
ICMED 13485 Plus ISO 17593 – Clinical laboratory testing and in vitro medical devices – Requirements for in
vitro monitoring systems for self- testing of oral anticoagulant therapy
Glucometer ICMED 13485 Plus IEC 60601-1- Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus ISO 15197 In vitro diagnostic test systems –
Requirements for blood-glucose monitoring systems for self testing in managing diabetes
mellitus requirements for in vitro diagnostic (IVD) medical equipment
ICMED 13485 Plus EVS-EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral
Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 61010-1 Safety requirements for electrical
equipment for measurement, control, and laboratory use – Part 1: General requirements
ICMED 13485 Plus IEC 61010-2-101- Safety requirements for electrical
equipment for measurement,control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Urine Analyzer ICMED 13485 Plus IEC 60601-1 AMD2 – Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
ICMED 13485 Plus EVS-EN 60601-1-2- Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard:
Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 61010-1- Safety requirements for electrical
equipment for measurement, control, and laboratory use – Part 1: General requirements
ICMED 13485 Plus IEC 61010-2-101 – Safety requirements for electrical equipment for measurement,
control, and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
RT-PCR ICMED 13485 Plus IEC 60601-1- Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus EVS-EN 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 61010-1- Safety requirements for electrical
equipment for measurement, control, and laboratory use – Part 1: General requirements
ICMED 13485 Plus IEC 61010-2-101 – Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular
requirements for in vitro diagnostic (IVD) medical equipment
Hemetology
Analyzer		 ICMED 13485 Plus IEC 60601-1 Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus EVS-EN 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 61010-1 Safety requirements for electrical
equipment for measurement, control, and laboratory use – Part 1: General requirements
ICMED 13485 Plus IEC 61010-2-101 Safety requirements for electrical equipment for measurement,
control, and laboratory use – Part 2-101: Particular requirements for
in vitro diagnostic (IVD) medical equipment
Biochemistry
Analyzer		 ICMED 13485 Plus IEC 60601-1Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
ICMED 13485 Plus EVS-EN 60601-1-2 1 – Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
ICMED 13485 Plus IEC 61010-1 Safety requirements for electrical
equipment for measurement, control, and laboratory use – Part 1: General requirements
ICMED 13485 Plus IEC 61010-2-101 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular
requirements for in vitro diagnostic (IVD) medical equipment
A.1.5 Sterilization methods for medical devices

Ethylene oxide gas sterilization (EOG) 		For the devices listed in the A.1.1 category (Sterilization Method as per applicability) ICMED 13485 Plus EN ISO 11135:2014 – Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

A.1.5 Sterilization methods for medical devices

Moist heat

 For the devices listed in the A.1.1 category (Sterilization Method as per applicability) ICMED 13485 Plus EN ISO 17665-1:2006 – Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization
process for medical devices (ISO 17665-1:2006

A.1.5 Sterilization methods for medical devices

Aseptic Techniques

 For the devices listed in the A.1.1 category (Sterilization Method as per applicability) ICMED 13485 Plus EN ISO 13408-1:2015 – Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
A.1.5 Sterilization methods for medical devices For the devices listed in the A.1.1 category (Sterilization Method as per applicability) ICMED 13485 Plus

EN ISO 11137-1:2015(MAIN)

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
Radiation sterilization (e.g. gamma, x-ray, electron beam)
A.1.6 Devices Incorporating/Utilizing Specific Substances/Technologies

Medical devices incorporating medicinal substances 		For the devices listed in the A.1.1 category (Sterilization Method as per applicability) ICMED 13485 Plus
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