Including sterilization methods, air quality of surgery rooms, etc.
Items to be displayed:
| Standard and/or project | Stage | TC |
|---|---|---|
| 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 | ISO/TC 198 |
| ISO 11135-1:2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | 90.92 | ISO/TC 198 |
| ISO/TS 11135-2:2008 Sterilization of health care products -- Ethylene oxide -- Part 2: Guidance on the application of ISO 11135-1 | 90.92 | ISO/TC 198 |
| ISO/TS 11135-2:2008/Cor 1:2009 | 60.60 | ISO/TC 198 |
| ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | 90.92 | ISO/TC 198 |
| ISO 11137-1:2006/FDAmd 1 | 50.20 | ISO/TC 198 |
| ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose | 60.60 | ISO/TC 198 |
| ISO 11137-3:2006 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects | 90.92 | ISO/TC 198 |
| ISO/CD 11137-3 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects | 30.20 | ISO/TC 198 |
| ISO 11138-1:2006 Sterilization of health care products -- Biological indicators -- Part 1: General requirements | 90.93 | ISO/TC 198 |
| ISO 11138-2:2006 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes | 90.93 | ISO/TC 198 |
| ISO 11138-3:2006 Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes | 90.93 | ISO/TC 198 |
| ISO 11138-4:2006 Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes | 90.93 | ISO/TC 198 |
| ISO 11138-5:2006 Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes | 90.93 | ISO/TC 198 |
| ISO/NP 11138-6 Sterilization of health care products -- Biological Indicators -- Part 6: Biological indicators for hydrogen peroxide vapour sterilization processes | 10.99 | ISO/TC 198 |
| ISO/TS 11139:2006 Sterilization of health care products -- Vocabulary | 90.93 | ISO/TC 198 |
| ISO/DIS 11140-1 Sterilization of health care products -- Chemical indicators -- Part 1: General requirements | 40.60 | ISO/TC 198 |
| ISO 11140-1:2005 Sterilization of health care products -- Chemical indicators -- Part 1: General requirements | 90.92 | ISO/TC 198 |
| ISO 11140-3:2007 Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test | 90.93 | ISO/TC 198 |
| ISO 11140-3:2007/Cor 1:2007 | 60.60 | ISO/TC 198 |
| ISO 11140-4:2007 Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration | 90.93 | ISO/TC 198 |
| ISO 11140-5:2007 Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests | 90.93 | ISO/TC 198 |
| 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 | ISO/TC 198 |
| ISO 11737-1:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products | 90.93 | ISO/TC 198 |
| ISO 11737-1:2006/Cor 1:2007 | 60.60 | ISO/TC 198 |
| ISO 11737-2:2009 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | 60.60 | ISO/TC 198 |
| ISO/TS 13004:2013 Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSD | 60.60 | ISO/TC 198 |
| ISO 13408-1:2008 Aseptic processing of health care products -- Part 1: General requirements | 90.93 | ISO/TC 198 |
| ISO 13408-1:2008/Amd 1:2013 | 60.60 | ISO/TC 198 |
| ISO 13408-2:2003 Aseptic processing of health care products -- Part 2: Filtration | 90.93 | ISO/TC 198 |
| ISO 13408-3:2006 Aseptic processing of health care products -- Part 3: Lyophilization | 90.93 | ISO/TC 198 |
| ISO 13408-4:2005 Aseptic processing of health care products -- Part 4: Clean-in-place technologies | 90.93 | ISO/TC 198 |
| ISO 13408-5:2006 Aseptic processing of health care products -- Part 5: Sterilization in place | 90.93 | ISO/TC 198 |
| ISO 13408-6:2005 Aseptic processing of health care products -- Part 6: Isolator systems | 90.93 | ISO/TC 198 |
| ISO 13408-6:2005/Amd 1:2013 | 60.60 | ISO/TC 198 |
| ISO 13408-7:2012 Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products | 60.60 | ISO/TC 198 |
| ISO 14160:2011 Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices | 60.60 | ISO/TC 198 |
| ISO 14161:2009 Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results | 60.60 | ISO/TC 198 |
| ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | 60.60 | ISO/TC 198 |
| ISO 15882:2008 Sterilization of health care products -- Chemical indicators -- Guidance for selection, use and interpretation of results | 90.60 | ISO/TC 198 |
| ISO/AWI 17210 Test method to demonstrate the suitability of a medical device simulator during steam sterilization -- Medical device simulator testing | 20.00 | ISO/TC 198 |
| ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices | 90.92 | ISO/TC 198 |
| ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | 90.93 | ISO/TC 198 |
| ISO/TS 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1 | 60.60 | ISO/TC 198 |
| ISO/TS 17665-3:2013 Sterilization of health care products -- Moist heat -- Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization | 60.60 | ISO/TC 198 |
| ISO/CD 18362 Processing of cell-based health care products | 30.20 | ISO/TC 198 |
| ISO 18472:2006 Sterilization of health care products -- Biological and chemical indicators -- Test equipment | 90.93 | ISO/TC 198 |
| ISO 20857:2010 Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices | 60.60 | ISO/TC 198 |
| ISO 25424:2009 Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices | 60.60 | ISO/TC 198 |
