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ČSN P CEN ISO/TS 16775 (855281)
Obaly pro zdravotnické prostředky sterilizované v konečném obalu - Návod pro použití ISO 11607-1 a ISO 11607-2 (Norma k přímému použití jako ČSN).
NORMA vydaná dňa 1.11.2022
Informácie o norme:
Označenie normy: ČSN P CEN ISO/TS 16775
Rozlišovací znak: 855281
Katalógové číslo: 515607
Dátum vydania normy: 1.11.2022
Kód tovaru: NS-1088428
Počet strán: 160
Približná hmotnosť: 511 g (1.13 libier)
Krajina: Česká technická norma
Kategória: Technické normy ČSN
Kategórie - podobné normy:
Anotácia textu normy ČSN P CEN ISO/TS 16775 (855281):
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
Náhľad normy ČSN P CEN ISO/TS 16775 (855281)
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