M00021164
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
British Standards Institution
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Availability date: 11/05/2021
European foreword <br>Introduction <br>1 Scope <br>2 Normative references <br>3 Terms and definitions <br>4 Requirements <br>5 Information to be supplied by the manufacturer <br>Annex A (informative) - Details of significant technical <br> changes between this European Standard and the <br> previous edition <br>Annex B (informative) - Method for the determination <br> of drape <br>Annex C (normative) - Method for the determination <br> of water repellency <br>Annex D (normative) - Method for the determination <br> of pore size <br>Annex E (informative) - Repeatability and reproducibility <br> of test methods <br>Bibliography
Defines test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Published | |
Document Type | Standard |
Status | Current |
Publisher | British Standards Institution |
Pages | |
ISBN | |
Committee | CH/198 |
Supersedes |
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