Standard Svensk standard · SS-EN 868-8:2019

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: Gällande

Omfattning
This document specifies 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 manufacturers and users. Other than the general requirements as specified in EN ISO 11607 1 and EN ISO 11607 2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document. NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance 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 The use of additional materials and/or accessories inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) is not covered in this part of EN 868. However, other requirements, including the determination of the acceptability of these materials and/or accessories during validation activities, can 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-80009250

Utgåva: 3

Fastställd: 2019-01-07

Antal sidor: 32

Ersätter: SS-EN 868-8:2009