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EVS-EN 868-7:2017

Pakendatult steriliseeritud meditsiiniseadme pakendamine. Osa 7: Madaltemperatuursel steriliseerimisel kasutatav liimpaber. Nõuded ja katsemeetodid

Üldinfo
Kehtiv alates 02.03.2017
Alusdokumendid
EN 868-7:2017
Tegevusala (ICS grupid)
11.080.30 Steriilne pakendamine
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
02.03.2017
Põhitekst
07.08.2009
Põhitekst
This draft European Standard provides test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. The need for a protective packaging may be determined by the manufacturer and the user. 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 or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. 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. The materials specified in this part of EN 868 are intended for single use only.
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EVS-EN ISO 8536-4:2020

Meditsiinis kasutatavad infusioonisüsteemid. Osa 4: Ühekordseks kasutamiseks mõeldud raskusjõul toimivad infusioonikomplektid
Uusim versioon Kehtiv alates 17.02.2020