NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 16061 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 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 11137-3 | 2017-06 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control 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 14155 | 2020-07 | Clinical investigation of medical devices for human subjects - Good clinical practice 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 |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 25424 | 2018-10 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices More |
