STN EN ISO 20417
| Name: | STN EN ISO 20417 |
| Validity: | Valid |
| Number of pages: | 64 |
| Language: |
EN
|
| Paper: | 24,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
21,96€ b) Without ability to print, with ability to copy (printscreen) 24,40€ c) With ability to print and copy (printscreen) 31,72€ |
| Slovak title | Zdravotnícke pomôcky. Informácie poskytované výrobcom (ISO 20417: 2026) |
| English title | Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026) |
| Release Date: | 01. 08. 2026 |
| Date of withdrawal: | |
| ICS: | 11.040.01 |
| Sorting character/National clasification code | 85 5201 |
| Level of incorporation: | idt EN ISO 20417:2026, idt ISO 20417:2026 |
| Official Journal | 07/26 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 20417:2022-03 (85 5201) |
| Note in Official Journal: | |
| Subject of the standard: | NOTE 1 There is guidance or rationale for this Clause in A.2.1. This document specifies the requirements for information supplied by the manufacturer for a medical device or 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) |