$81
CEI UNI EN ISO 20417
2021
Medical devices – Information to be supplied by the manufacturer
- Format:
- Language(s) :
- Published :
- English
- 11/01/2021
ENGLISH
NOTE 1 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.
NOTE 2 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.
| CEI UNI EN ISO 20417 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | CEI UNI EN ISO 20417 |
| Scope | Medical devices - Information to be supplied by the manufacturer |
| Publisher | CEI - Comitato Elettrotecnico Italiano |
| Languages | English |
| State | [ Active ] |
| Publication Year | 2021 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| Edition | 21 |
| File Size | 1 file , 5.8 MB |
| Number of Pages | 86 |
| Published | 11/01/2021 |
| CEI UNI EN ISO 20417 | ||
|---|---|---|
| History | Publisher Year | |
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