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BSI - BS EN 868-8 - TC

Tracked Changes (Redline) - Packaging for terminally sterilized medical devices Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 – Requirements and test methods

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Organization: BSI
Publication Date: 24 February 2020
Status: active
Page Count: 44
ICS Code (Sterilized packaging): 11.080.30
ICS Code (Cans. Tins. Tubes): 55.120

Document History

BS EN 868-8 - TC
February 24, 2020
Tracked Changes (Redline) - Packaging for terminally sterilized medical devices Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 – Requirements and test methods
A description is not available for this item.

References

This document references:
EN ISO 4017 - Fasteners - Hexagon head screws - Product grades A and B
Published by CEN on July 1, 2022
This document specifies the characteristics of hexagon head screws, in steel and stainless steel, with metric coarse pitch threads M1,6 to M64, and with product grades A and B. If in certain cases...
This document references:
ISO 4582 - Plastics - Determination of changes in colour and variations in properties after exposure to glass-filtered solar radiation, natural weathering or laboratory radiation sources
Published by ISO on August 1, 2017
This document specifies methods to determine changes in colour and other appearance properties, and variations in mechanical or other properties, of plastics that have been exposed to glass-filtered...
This document references:
90/385/EEC - Commission Communication in the Framework of the Implementation of Council Directive in Relation to Active Implantable Medical Devices (1), and Council Directive 93/42/EEC of 14 June 1993 in Relation to Medical Devices (2)
Published by EU on June 20, 1990
A description is not available for this item.
This document references:
EN 285 - Sterilization - Steam sterilizers - Large sterilizers
Published by CEN on December 1, 2015
This document specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one...
This document references:
EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Published by CEN on January 1, 2020
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of...
This document references:
EN 285 - Sterilization - Steam sterilizers - Large sterilizers
Published by CEN on December 1, 2015
This document specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one...
This document references:
EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Published by CEN on January 1, 2020
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of...
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