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17/30360915 DC : 0

NA
NA

Status of Standard is Unknown

BS EN 868-8 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
Available format(s)

Hardcopy , PDF

Language(s)

English

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) - Details of significant technical
        changes between this European Standard and the
        previous edition
Annex B (informative) - Guidance on dimensions
Annex C (normative) - Carrying device strength test
Annex D (normative) - Stacking test - Procedure
Annex E (normative) - Stacking device capability test
Annex F (normative) - Determination of sterilization
        performance
Annex G (normative) - Load dryness tests
Annex H (informative) - Guidance on determination
        of useful life with respect tO sterilization
Bibliography

BS EN 868-8.

Committee
CH/198
DocumentType
Draft
Pages
22
PublisherName
British Standards Institution
Status
NA
Supersedes

Standards Relationship
PREN 868-8 : DRAFT 2017 Identical

ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
ISO 4582:2017 Plastics — Determination of changes in colour and variations in properties after exposure to glass-filtered solar radiation, natural weathering or laboratory radiation sources
EN ISO 4017:2014 Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014)
PREN ISO 17664 : DRAFT 2001 STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels

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