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Hlavní stránka>ČSN P CEN ISO/TS 16775 - Obaly pro zdravotnické prostředky sterilizované v konečném obalu - Návod pro použití ISO 11607-1 a ISO 11607-2
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Vydáno: 01.11.2022
ČSN P CEN ISO/TS 16775 - Obaly pro zdravotnické prostředky sterilizované v konečném obalu - Návod pro použití ISO 11607-1 a ISO 11607-2

ČSN P CEN ISO/TS 16775

Obaly pro zdravotnické prostředky sterilizované v konečném obalu - Návod pro použití ISO 11607-1 a ISO 11607-2

Formát
Dostupnost
Cena a měna
Anglicky Tisk
Skladem
1200 Kč
Označení normy:ČSN P CEN ISO/TS 16775
Třídící znak:855281
Počet stran:160
Vydáno:01.11.2022
Harmonizace:Norma není harmonizována
Katalogové číslo:515607
Popis

ČSN P CEN ISO/TS 16775

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. Guidance is given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given. This document provides information for both healthcare facilities and the medical devices industry for terminally sterilized medical devices. This document does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a "sterile field" or transport of contaminated items, other regulatory standards will apply.