NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 21649 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60068-2-30 | 2005-08 | Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) More |
| IEC 60601-1 | 2005-12 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More |
| IEC/TR 60601-4-1 | 2017-05 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy More |
| ISO 11135 | 2014-07 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More |
| ISO 11137-2 | 2013-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More |
| ISO 11137-2 AMD 1 | 2022-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Amendment 1 More |
| 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 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14253-1 | 2017-10 | Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for verifying conformity or nonconformity with specifications More |
| ISO 15223-1 | 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements More |
