Verkkokauppa
SFS-EN 868-5:2019:en
Packaging for terminally sterilized medical devices. Part 5: Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are 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.
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.
The materials specified in this part of EN 868 are intended for single use only.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are 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.
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.
The materials specified in this part of EN 868 are intended for single use only.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ASTM D 882:2012 Standard Test Method for Tensile Properties of Thin Plastic Sheeting
ASTM F 88/F 88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
EN 868-10:2018 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
ASTM F 88/F 88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
EN 868-10:2018 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
Tekninen komitea
Vahvistuspäivä
04.01.2019
Julkaisupäivä
08.01.2019
Painos
3
Sivumäärä
21
Julkaisun kieli
englanti