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Scope

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

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54

published ISO standards *

under the direct responsibility of ISO/TC 198

29

ISO standards under development *

under the direct responsibility of ISO/TC 198

28

Participating members

24

Observing members

* number includes updates

Reference Title Type
ISO/TC 198/TG 1 Assurance of sterility Working group
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 10 Liquid chemical sterilization Working group
ISO/TC 198/WG 11 General criteria for sterilization processes and sterilizing equipement 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 electrical equipment used in medical practice IEC
IEC/TC 62 Electrical equipment in medical practice 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 194/SC 1 Tissue product safety 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 194/SC 1 Tissue product safety 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
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

ISO/TC 198 - Secretariat

ANSI United States
Association for the Advancement of Medical Instrumentation
4301 N. Fairfax Drive, Suite 301
Arlington, VA 22203-1633
United States

Tel: +1 703 525 48 90
Fax: +1 703 276 07 93

Secretariat direct:
Ms Amanda Benedict
Tel: +1-703-253-8284