BS EN ISO 20417:2021
Medical devices. Information to be supplied by the manufacturer
| Označení normy: | BS EN ISO 20417:2021 |
| Počet stran: | 86 |
| Vydáno: | 2022-05-27 |
| ISBN: | 978 0 539 22260 9 |
| Status: | Corrigendum |
BS EN ISO 20417:2021
This standard BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer is classified in these ICS categories:
- 11.040.01 Medical equipment in general
- 11.120.01 Pharmaceutics in general
- 01.110 Technical product documentation
There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.