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ČSN P CEN ISO/TS 16775 (855281)
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Translate name
STANDARD published on 1.11.2022
The information about the standard:
Designation standards: ČSN P CEN ISO/TS 16775
Classification mark: 855281
Catalog number: 515607
Publication date standards: 1.11.2022
SKU: NS-1088428
The number of pages: 160
Approximate weight : 511 g (1.13 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text 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
Preview of the standard ČSN P CEN ISO/TS 16775 (855281)
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