ISO/TC 198 - Sterilization of health care products

Standardization of processes and equipment for sterilization of health care products.

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This committee contributes with 65 standards to the following Sustainable Development Goals:

Published ISO standards *

ISO standards under development *

Participating members

Observing members

* number includes updates

Reference	Title	Type
ISO/TC 198/WG 1	Industrial ethylene oxide sterilization	Working group
ISO/TC 198/WG 2	Radiation sterilization	Working group
ISO/TC 198/WG 3	Moist heat sterilization	Working group
ISO/TC 198/WG 4	Biological indicators	Working group
ISO/TC 198/WG 5	Terminology	Working group
ISO/TC 198/WG 6	Chemical indicators	Working group
ISO/TC 198/WG 7	Packaging	Working group
ISO/TC 198/WG 8	Microbiological methods	Working group
ISO/TC 198/WG 9	Aseptic processing	Working group
ISO/TC 198/WG 12	Information for reprocessing of resterilizable devices	Working group
ISO/TC 198/WG 13	Washer-disinfectors	Working group
ISO/TC 198/WG 17	Cleaning	Working group

The committees below can access the documents of ISO/TC 198:

Reference	Title	ISO/IEC
IEC/SC 62A	Common aspects of medical equipment, software, and systems	IEC
IEC/TC 62	Medical equipment, software, and systems	IEC
IEC/TC 66	Safety of measuring, control and laboratory equipment	IEC
ISO/TC 76	Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use	ISO
ISO/TC 106/SC 4	Dental instruments	ISO
ISO/TC 121	Anaesthetic and respiratory equipment	ISO
ISO/TC 122	Packaging	ISO
ISO/TC 150	Implants for surgery	ISO
ISO/TC 150/SC 6	Active implants	ISO
ISO/TC 150/SC 7	Tissue-engineered medical products	ISO
ISO/TC 157	Non-systemic contraceptives and STI barrier prophylactics	ISO
ISO/TC 168	Prosthetics and orthotics	ISO
ISO/TC 170	Surgical instruments	ISO
ISO/TC 194	Biological and clinical evaluation of medical devices	ISO
ISO/TC 209	Cleanrooms and associated controlled environments	ISO
ISO/TC 210	Quality management and corresponding general aspects for products with a health purpose including medical devices	ISO
ISO/TC 304	Healthcare organization management	ISO

ISO/TC 198 can access the documents of the committees below:

Reference	Title	ISO/IEC
ISO/TC 76	Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use	ISO
ISO/TC 85	Nuclear energy, nuclear technologies, and radiological protection	ISO
ISO/TC 106/SC 4	Dental instruments	ISO
ISO/TC 121	Anaesthetic and respiratory equipment	ISO
ISO/TC 122	Packaging	ISO
ISO/TC 150	Implants for surgery	ISO
ISO/TC 150/SC 6	Active implants	ISO
ISO/TC 150/SC 7	Tissue-engineered medical products	ISO
ISO/TC 194	Biological and clinical evaluation of medical devices	ISO
ISO/TC 209	Cleanrooms and associated controlled environments	ISO
ISO/TC 210	Quality management and corresponding general aspects for products with a health purpose including medical devices	ISO
ISO/TC 276	Biotechnology	ISO
ISO/TC 304	Healthcare organization management	ISO

Acronym	Title	Category
IAEA	International Atomic Energy Agency	A
MedTech Europe	Alliance of European medical technology industry associations	A
WFHSS	World Federation for Hospital Sterilisation Sciences	A

Association for the Advancement of Medical Instrumentation

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