NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11607-2 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11607-1 | 2019-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More |
| ISO 11607-1 AMD 1 | 2023-09 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management More |
| DIN CEN ISO/TS 16775 | 2022-04 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021); German version CEN ISO/TS 16775:2021 More |
| DIN EN ISO 11607-1 | 2024-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023 More |
| DIN EN ISO 13485 | 2021-12 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021 More |
| DIN EN ISO 14971 | 2022-04 | Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More |
| DIN EN ISO 186 | 2002-08 | Paper and board - Sampling to determine average quality (ISO 186:2002); German version EN ISO 186:2002 More |
| DIN EN ISO 9001 | 2015-11 | Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More |
| DIN ISO 2859-1 | 2014-08 | Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999 + Cor. 1:2001 + Amd.1:2011); Text in German and English More |
| DIN 58953-7 | 2020-11 | Sterilization - Sterile supply - Part 7: Use of sterilization paper, nonwoven wrapping material, paper bags and sealable pouches and reels More |
