STN EN ISO 10993-2
| Name: | STN EN ISO 10993-2 |
| Validity: | Valid |
| Number of pages: | 28 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Biologické hodnotenie zdravotníckych pomôcok. Časť 2: Požiadavky na dobré podmienky pre zvieratá (ISO 10993-2: 2022) |
| English title | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022) |
| Release Date: | 01. 02. 2023 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6511 |
| Level of incorporation: | idt EN ISO 10993-2:2022, idt ISO 10993-2:2022 |
| Official Journal | 01/23 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 10993-2:2006-12 (85 6511) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. |
| Preview: | Náhľad normy (PDF) |