NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 22442-1 [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 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 22442-2 | 2020-09 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling More |
| ISO 22442-3 | 2007-12 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents More |
| DIN EN ISO 10993-1 | 2021-05 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More |
| DIN EN ISO 10993-11 | 2018-09 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018 More |
| DIN EN ISO 10993-12 | 2021-08 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021 More |
| DIN EN ISO 10993-13 | 2010-11 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010 More |
| DIN EN ISO 10993-14 | 2009-08 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 More |
| DIN EN ISO 10993-16 | 2018-02 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017 More |
