DIN EN 868-8:2009
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; English version of DIN EN 868-8:2009-09

Standard No.

DIN EN 868-8:2009

Release Date

2009

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN 868-8 E:2017

Latest

DIN EN 868-8:2019-03

Replace

DIN EN 868-8:1999 DIN EN 868-8:2007

Scope

This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285. NOTE 1 The need for a packaging material inside the container is determined by the manufactures and users. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add nor modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization per- formance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature. NOTE 3 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.

DIN EN 868-8:2009 Referenced Document

• EN 10088-1 Stainless steels - Part 1: List of stainless steels*， 2023-12-20 Update
• EN 285:2006 Sterilization - Steam sterilizers - Large sterilizers (Incorporates Amendment A2: 2009)
• EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials@ sterile barrier systems and packaging systems
• EN ISO 4017 Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2022)*， 2022-07-20 Update
• 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*， 2017-08-17 Update

DIN EN 868-8:2009 history

• 2019 DIN EN 868-8:2019-03 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018
• 2019 DIN EN 868-8:2019 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
• 1970 DIN EN 868-8 E:2017-08 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
• 2017 DIN EN 868-8 E:2017 Draft Document - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German and English version prEN 868-8:2017
• 2009 DIN EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; English version of DIN EN 868-8:2009-09
• 0000 DIN EN 868-8:2007
• 0000 DIN EN 868-8:1999