ČSN P CEN ISO/TS 16775 (855281)

Obaly pro závěrečně sterilizované zdravotnické prostředky - Návod pro použití ISO 11607-1 a ISO 11607-2

Cena: 945 Kč
včetně 15 % DPH
tisk na počkání

Anotace obsahu normy

This Technical Specification 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/or 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/or ISO 11607-2 and illustrates some of 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 compliance with them.
Guidelines are 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 Technical Specification provides information for health care facilities (see Clause 3) and for the medical devices industry (see Clause 4).
It 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.

Označení ČSN P CEN ISO/TS 16775 (855281)
Katalogové číslo 95729
Cena 945 Kč945
Datum schválení 1. 10. 2014
Datum účinnosti 1. 11. 2014
Jazyk angličtina (obsahuje pouze anglický originál)
Počet stran 130 stran formátu A4
EAN kód 8590963957296
Dostupnost skladem (tisk na počkání)