STN EN ISO 22442-1
| Name: | STN EN ISO 22442-1 |
| Validity: | Valid |
| Number of pages: | 40 |
| Language: |
EN
|
| Hard copy: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Zdravotnícke pomôcky využívajúce živočíšne tkanivá a ich deriváty. Časť 1: Aplikácia manažérstva rizika (ISO 22442-1: 2020) |
| English title | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020) |
| 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 22442-1:2020, idt ISO 22442-1:2020 |
| Official Journal | 05/21 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 22442-1:2016-04 (85 6570) |
| Note in Official Journal: | |
| Subject of the standard: | This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. |
| Preview: | Náhľad normy (PDF) |