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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/DIS 11135.2
Sterilization of health-care products -- Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
40.60 11.080.01
ISO 11137-1:2006/Amd 1
60.00 11.080.01
ISO/CD 11137-3
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects
30.20 11.080.01
ISO/NP 11138-6
Sterilization of health care products -- Biological Indicators -- Part 6: Biological indicators for hydrogen peroxide vapour sterilization processes
10.99 11.080.01
ISO/DIS 11140-1
Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
40.60 11.080.01
ISO/NP 11140-6
Sterilization of health care products -- Chemical indicators -- Part 6: Class 2 indicators and process challenge devices for use in performance testing of steam sterilizers
10.99 11.080.01
ISO 11607-1:2006/DAmd 1
40.20 11.080.30
ISO 11607-2:2006/DAmd 1
40.20 11.080.30
ISO 15883-1:2006/DAmd 1
40.60 11.080.10
ISO/WD 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
20.20 11.080.10
ISO/DTS 16775
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
30.99 11.080.30
ISO/AWI 17210
Test method to demonstrate the suitability of a medical device simulator during steam sterilization -- Medical device simulator testing
20.00 11.080.01
ISO/WD 17664
Sterilization of medical devices -- Information to be provided by the device manufacturer for the processing of reusable medical devices
20.20
ISO/CD 18362
Processing of cell-based health care products
30.20 11.080.01