NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11135 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-6 | 2016-12 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation More |
| ISO 10993-7 AMD 1 | 2019-12 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants More |
| ISO 10993-7 Technical Corrigendum 1 | 2009-11 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1 More |
| ISO 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 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 14001 | 2015-09 | Environmental management systems - Requirements with guidance for use More |
| ISO 14040 | 2006-07 | Environmental management - Life cycle assessment - Principles and framework 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 |
