Verkkokauppa
SFS-EN 868-6:2017:en
Packaging for terminally sterilized medical devices. Part 6: Paper for low temperature sterilization processes. Requirements and test methods
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
This draft European Standard provides test methods and values for paper used in the manufacture of preformed 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 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs.
NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7.
NOTE 2 Paper according to EN 868-3 can also be used for these sterilization processes.
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 filters, 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 used in the manufacture of preformed 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 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs.
NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7.
NOTE 2 Paper according to EN 868-3 can also be used for these sterilization processes.
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 filters, 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 20187:1993 Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
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 11607-1:2009/A1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/Amd 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 11607-1:2009/A1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/Amd 1:2014)
Tekninen komitea
Direktiivi
Vahvistuspäivä
17.02.2017
Julkaisupäivä
21.02.2017
Painos
3
Sivumäärä
20
Julkaisun kieli
englanti