STN P CEN ISO/TS 16775
| Name: | STN P CEN ISO/TS 16775 |
| Validity: | Valid |
| Number of pages: | 156 |
| Language: |
EN
|
| Hard copy: | 36,30€ |
| Electronic version |
a) Only read (without ability to print and copy)
32,67€ b) Without ability to print, with ability to copy (printscreen) 36,30€ c) With ability to print and copy (printscreen) 47,19€ |
| Slovak title | Obaly na zdravotnícke pomôcky sterilizované v konečnom obale. Návod na používanie ISO 11607-1 a ISO 11607-2 (ISO/TS 16775: 2021) |
| English title | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021) |
| Release Date: | 01. 02. 2022 |
| Date of withdrawal: | |
| ICS: | 11.080.30 |
| Sorting character/National clasification code | 85 6544 |
| Level of incorporation: | idt ISO/TS 16775:2021, idt CEN ISO/TS 16775:2021 |
| Official Journal | 01/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN P CEN ISO/TS 16775:2014-10 (85 6544) |
| Note in Official Journal: | Táto predbežná STN je určená na overenie. Pripomienky zasielajte ÚNMS SR najneskôr do 22. 8. 2023. |
| Subject of the standard: | This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2. This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities. The guidance can be used to better understand the requirements of ISO 11607-1 and ISO 11607-2 and illustrates the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate conformity with them. |
| Preview: | Náhľad normy (PDF) |