STN EN ISO 22442-2
| Name: | STN EN ISO 22442-2 |
| 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 | Zdravotnícke pomôcky využívajúce živočíšne tkanivá a ich deriváty. Časť 2: Kontroly pôvodu, odberu a manipulácie (ISO 22442-2: 2020) |
| English title | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020) |
| Release Date: | 01. 06. 2021 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6570 |
| Level of incorporation: | idt EN ISO 22442-2:2020, idt ISO 22442-2:2020 |
| Official Journal | 05/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 22442-2:2016-04 (85 6570) |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1. NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats. This document does not cover the utilization of human tissues in medical devices. |
| Preview: | Náhľad normy (PDF) |