Le dernier examen de cette norme date de 2018. Cette édition reste donc d’actualité.
Résumé Preview
ISO/TS 16775:2014 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. It is an informative document, not normative, and 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 to 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.
ISO/TS 16775:2014 provides information for health care facilities and for the medical devices industry. 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.
Informations générales
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État actuel : PubliéeDate de publication : 2014-05
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Edition : 1
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- ICS :
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Emballage stérile
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Cycle de vie
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Actuellement
PubliéeISO/TS 16775:2014
Les normes ISO sont réexaminées tous les cinq ans
Stade: 90.92 (Sera révisée) -
Sera remplacée par
ProjetISO/PRF TS 16775
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