DS/CEN ISO/TS 16775:2014

Emballage til slutsteriliseret medicinsk udstyr - Vejledning om anvendelse af ISO 11607-1 og ISO 11607-2


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Kategori:
Pris fra:
kr. 1.015,00

Beskrivelse

This document will provide guidance on the application of ISO11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes. Possible options for compliance with the requirements of Parts 1 and 2 will be addressed as special concerns than may require attention due to regional or local conditions,
practices or regulations. Additional guidance on important packaging issues will also be included (see attached outline).

Antal sider: 132

Udgivet: 2014-07-11

Godkendelsesdato: 2014-06-18

Internationale relationer : CEN ISO/TS 16775:2014 IDT ISO/TS 16775:2014 IDT

ICS: 11.080.30 - Sterilemballage

Varenummer: M273629


Udvalg og komiteer

Komite

  • CEN/TC 102
  • CEN/TC 102/WG 4
  • ISO/TC 198
  • ISO/TC 198

Dansk udvalg

DS/S-259