Verkkokauppa
SFS-EN 868-4:2017:en
Packaging for terminally sterilized medical devices. Part 4: Paper bags. Requirements and test methods
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
This draft European Standard provides test methods and values for paper bags manufactured from paper specified in EN 868-3, 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 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 4.6 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
The materials specified in this part of EN 868 are intended for single use only.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
This draft European Standard provides test methods and values for paper bags manufactured from paper specified in EN 868-3, 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 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 4.6 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
The materials specified in this part of EN 868 are intended for single use only.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
EN ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
Tekninen komitea
Direktiivi
Vahvistuspäivä
17.02.2017
Julkaisupäivä
21.02.2017
Painos
3
Sivumäärä
15
Julkaisun kieli
englanti