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Scope

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

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64
published ISO standards *

under the direct responsibility of ISO/TC 198

19
ISO standards under development *

under the direct responsibility of ISO/TC 198

35
Participating members
20
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 15   Assurance of sterility Working group
ISO/TC 198/WG 16   Vaporized hydrogen peroxide sterilization Working group
Liaison Committees to ISO/TC 198

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 medical devices ISO
ISO/TC 304 Healthcare organization management ISO

 

Liaison Committees from ISO/TC 198

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 medical devices ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 304 Healthcare organization management ISO

 

Organizations in liaison (Category A and B)
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

Date Month Location TC/SC Note
5-9 December 2022 Arlington (United States) ISO/TC 198  

* Information definite but meeting not yet formally convened
** Provisional

ISO/TC 198 - Secretariat

ANSI [United States]

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