Norm

NPR-CEN-ISO/TS 16775:2014 en

Verpakkingsmateriaal ten behoeve van steriele medische hulpmiddelen die gesteriliseerd worden in de verpakking - Richtlijn betreffende de toepassing van ISO 11607-1 en ISO 11607-2

179,33

Over deze norm

Status Definitief
Aantal pagina's 115
Gepubliceerd op 01-06-2014
Taal Engels
NPR-CEN-ISO/TS 16775 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.

Details

ICS-code 11.080.30
Nederlandse titel Verpakkingsmateriaal ten behoeve van steriele medische hulpmiddelen die gesteriliseerd worden in de verpakking - Richtlijn betreffende de toepassing van ISO 11607-1 en ISO 11607-2
Engelse titel Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Normatieve verwijzingen
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