STN EN ISO 20417
| Name: | STN EN ISO 20417 |
| Validity: | Withdrawn |
| Number of pages: | 84 |
| Language: |
EN
|
| Hard copy: | 28,80€ |
| Electronic version |
a) Only read (without ability to print and copy)
25,92€ b) Without ability to print, with ability to copy (printscreen) 28,80€ c) With ability to print and copy (printscreen) 37,44€ |
| Slovak title | Zdravotnícke pomôcky. Informácie poskytované výrobcom (ISO 20417: 2021) |
| English title | Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021) |
| Release Date: | 01. 09. 2021 |
| Date of withdrawal: | 01. 03. 2022 |
| ICS: | 11.040.01 |
| Sorting character/National clasification code | 85 5201 |
| Level of incorporation: | idt EN ISO 20417:2021, idt ISO 20417:2021 |
| Official Journal | 08/21 |
| Amendments | |
| Replaced by: | STN EN ISO 20417:2022-03 (85 5201) |
| Repleces: | STN EN 1041+A1:2014-01 (85 5201) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |