Standard Svensk standard · SS-EN 868-8:2009

Förpackningsmaterial för medicintekniska produkter avsedda för sterilisering i sluten förpackning - Del 8: Återanvändbara steriliseringsbehållare för ångautoklaver som överensstämmer med EN 285 - Krav och provningsmetoder

Status: Upphävd · Ersätts av: SS-EN 868-8:2019

Omfattning
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.

Ämnesområden

Sterilisering vid förpackning Förpackningsmaterial och tillbehör


Produktinformation

Språk: Engelska

Framtagen av: Rengöring, desinfektion och sterilisering, SIS/TK 349

Internationell titel: Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

Artikelnummer: STD-69919

Utgåva: 2

Fastställd: 2009-05-28

Antal sidor: 28

Ersätter: SS-EN 868-8

Ersätts av: SS-EN 868-8:2019