NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11737-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11137-3 | 2017-06 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control More |
| ISO 11138-2 | 2017-03 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes More |
| ISO 11139 | 2018-08 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More |
| ISO 11737-2 | 2019-12 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process More |
| ISO 13022 | 2012-04 | Medical products containing viable human cells - Application of risk management and requirements for processing practices More |
| ISO 14160 | 2020-09 | 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 More |
| ISO 14937 | 2009-10 | 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 More |
| ISO 20857 | 2010-08 | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices More |
| ISO 22442-3 | 2007-12 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
