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ISO/TC 198  - Стерилизация продукции медицинского назначения

Темы (или пункты), которые надо показать:


Стандарты и проекты под прямой ответственностью ISO/TC 198 Секретариат

Стандарт и/или проектСтадияМКС
ISO/FDIS 11135
Sterilization of health-care products -- Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
50.20 11.080.01
ISO/CD 11137-3
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects
30.60 11.080.01
ISO/NP 11138-1
Sterilization of health care products -- Biological indicators -- Part 1: General requirements
10.99 11.080.01
ISO/NP 11138-2
Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
10.99 11.080.01
ISO/NP 11138-3
Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes
10.99 11.080.01
ISO/NP 11138-4
Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes
10.99 11.080.01
ISO/NP 11138-5
Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
10.99 11.080.01
ISO/FDIS 11140-1
Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
50.00 11.080.01
ISO 11607-1:2006/FDAmd 1
50.20 11.080.30
ISO 11607-2:2006/FDAmd 1
50.20 11.080.30
ISO/NP 11737-1
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
10.99 11.080.01
07.100.10
ISO/NP 13408-2
Aseptic processing of health care products -- Part 2: Filtration
10.99 11.080.01
ISO/NP 14161
Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
10.99 11.080.01
ISO 15883-1:2006/FDAmd 1
50.20 11.080.10
ISO/CD 15883-4
Washer-disinfectors -- Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
30.00 11.080.10
ISO/DIS 15883-7
Washer-disinfectors -- Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO/DIS 15883-7:2014)
40.20 11.080.10
ISO/TS 16775
Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2
60.00 11.080.30
ISO/CD 17664
Sterilization of medical devices -- Information to be provided by the device manufacturer for the processing of reusable medical devices
30.00
ISO/CD 18362
Processing of cell-based health care products
30.60 11.080.01
ISO/NP 18472
Sterilization of health care products -- Biological and chemical indicators -- Test equipment
10.99 11.080.01