NA 176
DIN Standards Committee Health Technologies
DIN EN 13060 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| EN 868-4 | 2025-04 | Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods More |
| EN 868-5 | 2018-12 | Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods More |
| EN IEC 62061 | 2021-07 | Safety of machinery - Functional safety of safety-related control systems (IEC 62061:2021) More |
| EN IEC 80001-1 | 2021-10 | Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (IEC 80001-1:2021) More |
| EN ISO 11139 | 2018-09 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018) More |
| EN ISO 11139/A1 | 2024-01 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions (ISO 11139:2018/Amd 1:2024) More |
| EN ISO 12100 | 2010-11 | Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010) More |
| EN ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) More |
| EN 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 (ISO 14937:2009) More |
| EN ISO 15223-1 | 2021-09 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) More |
