NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 5840-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 |
| ISO 5840-2 | 2021-01 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes More |
| ISO 5840-3 | 2021-01 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques More |
| ASTM F 1830 | 2019 | Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps More |
| ASTM F 2182 | 2019 | Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging More |
| ASTM F 2213 | 2017 | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment 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 10993-4 | 2017-12 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017 More |
| DIN EN ISO 11135 | 2020-04 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More |
