ISO/TC 198 - Sterilization of health care products

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

Work programme

Drafts and new work items
Business plans

TC Business plans for public review
Working area

Working documents (user account required)
ISO Electronic applications

IT Tools that help support the standards development process
Public material

Browse documents made available by this group

This committee contributes with 63 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

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

901 N. Glebe Road, Suite 300
Arlington 22203 VA
United States

Tel: +1 703 525 48 90

Fax: +1 703 276 07 93