NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 25424 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 868-8 | 2018-12 | Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods More |
| EN 868-9 | 2018-12 | Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods More |
| EUV 2017/746 | 2017-04-05 | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More |
| IEC 61010-2-040 | 2020-05 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials More |
| ISO 11139 | 2018-08 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More |
| ISO 11607-1 | 2019-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More |
| ISO 11607-2 | 2019-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes 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 |
