ISO 20417:2021
Current
The latest, up-to-date edition.
Medical devices — Information to be supplied by the manufacturer
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
13-04-2021
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NOTE1 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.
NOTE2 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.
| Committee |
ISO/TC 210
|
| DocumentType |
Standard
|
| Pages |
72
|
| ProductNote |
This standard also refers to IEC 60417, IMDRF/GRRP WG/N472018, IMDRF/GRRP WG/N52 2019, IMDRF/UDI WG/N7 2013, Council directive 90/385/EEC, Council directive 93/42/EEC, Council directive 98/79/EC
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| ÖVE/ÖNORM EN ISO 20417:2021 11 15 | Identical |
| PN-EN ISO 20417:2021 | Identical |
| UNI CEI EN ISO 20417:2021 | Identical |
| ÖVE/ÖNORM EN ISO 20417:2022 09 01 | Identical |
| SN EN ISO 20417:2021 | Identical |
| NF EN ISO 20417:2021 | Identical |
| SS-ISO 20417:2021 | Identical |
| I.S. EN ISO 20417:2021 | Identical |
| EN ISO 20417:2021 | Identical |
| I.S. EN ISO 20417:2021&LC:2021 | Identical |
| BS EN ISO 20417:2021 | Identical |
| UNE-EN ISO 20417:2021 | Identical |
| IS/ISO 20417 : 2021 | Identical |
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