iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN 868-7:2000

(Main)

Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods

Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods

This Part of the series of EN 868 provides examples of particular requirements and test methods for heat sealable adhesive coated paper manufactured from paper complying with prEN 868-6, for use as packaging of medical devices which are to be terminally sterilized with ethylene oxide or irradiation. It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards.

Verpackungsmaterialien und -systeme für zu sterilisierende Medizinprodukte - Teil 7: Klebemittelbeschichtetes Papier für die Herstellung von heißsiegelfähigen Verpackungen für medizinische Zwecke zur Sterilisation mit Ethylenoxid oder Strahlen - Anforderungen und Prüfverfahren

Dieser Teil der Reihe EN 868 enthält Beispiele von besonderen Anforderungen und Prüfverfahren für heißsiegelfähiges, klebemittelbeschichtetes Papier, hergestellt aus Papier nach prEN 868-6, das für die Herstellung von Verpackungen für Medizinprodukte verwendet werden wird, die in der Endpackung mit Ethylenoxid oder Strahlen sterilisiert werden. In diesem Teil wurden keine zusätzlichen Anforderungen zu den im Teil 1 enthaltenen allgemeinen Anforderungen aufgenommen. Er stellt einen Leitfaden dar, der auf verschiedenen Bestandteilen entsprechender früher nationaler Normen basiert.

Matériaux et systemes d'emballages pour les dispositifs médicaux devant etre stérilisés - Partie 7: Papier enduit d'adhésif pour la fabrication d'emballages thermoscellables a usage médical pour stérilisation a l'oxyde d'éthylene ou par irradiation - Exigences et méthodes d'essai

Cette partie de la série de normes EN 868 donne des exemples d'exigences particulieres et de méthodes d'essai pour le papier enduit adhésif thermoscellable, fabriqué a partir de papier conforme au prEN 868-6, pour utilisation comme emballage des dispositifs médicaux devant etre stérilisés au stade terminal par l'oxyde d'éthylene ou par irradiation. Cette partie n'ajoute pas de nouvelles exigences aux exigences générales de la partie 1 mais propose un guide basé sur divers éléments des anciennes normes nationales applicables.

Embalažni materiali in sistemi za medicinske pripomočke, ki jih je treba sterilizirati - 7. del. Papir, oplemeniten z lepilom, za izdelavo embalažnih enot pri toplotnem lepljenju za uporabo v medicini pri sterilizaciji z etilenoksidom ali obsevanjem - Zahteve in preskusne metode

General Information

Status
Withdrawn
Publication Date
30-Jun-2000
Withdrawal Date
06-Jul-2009
ICS
11.080.30 - Sterilized packaging
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
07-Jul-2009
Due Date
30-Jul-2009
Completion Date
07-Jul-2009
Ref Project
EN 868-7:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods

Relations

Replaced By
SIST EN 868-7:2009 - Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
Effective Date
01-Oct-2009
Parent
SIST EN 868-1:2000 - Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods
Effective Date
22-Dec-2008

Buy Standard

EN 868-7:2000EN 868-7:2000
PreviousNext
Standard
EN 868-7:2000
English language
19 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 868-7:2000
01-julij-2000
(PEDODåQLPDWHULDOLLQVLVWHPL]DPHGLFLQVNHSULSRPRþNHNLMLKMHWUHEDVWHULOL]LUDWL
GHO3DSLURSOHPHQLWHQ]OHSLORP]DL]GHODYRHPEDODåQLKHQRWSULWRSORWQHP
OHSOMHQMX]DXSRUDERYPHGLFLQLSULVWHULOL]DFLML]HWLOHQRNVLGRPDOLREVHYDQMHP
=DKWHYHLQSUHVNXVQHPHWRGH
Packaging materials and systems for medical devices which are to be sterilized - Part 7:
Adhesive coated paper for the manufacture of heat sealable packs for medical use for
sterilization by ethylene oxide or irradiation - Requirements and test methods
Verpackungsmaterialien und -systeme für zu sterilisierende Medizinprodukte - Teil 7:
Klebemittelbeschichtetes Papier für die Herstellung von heißsiegelfähigen Verpackungen
für medizinische Zwecke zur Sterilisation mit Ethylenoxid oder Strahlen - Anforderungen
und Prüfverfahren
Matériaux et systemes d'emballages pour les dispositifs médicaux devant etre stérilisés -
Partie 7: Papier enduit d'adhésif pour la fabrication d'emballages thermoscellables a
usage médical pour stérilisation a l'oxyde d'éthylene ou par irradiation - Exigences et
méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-7:1999
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN 868-7:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 868-7:2000

---------------------- Page: 2 ---------------
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

SIST
SIST EN ISO 11607-2:2020/A11:2022(Amendment)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
EN ISO 11607-2:2020/A11:2022

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

  • Amendment
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11607-1:2020/A11:2022(Amendment)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 11607-1:2020/A11:2022

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

  • Amendment
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST-TS CEN ISO/TS 16775:2022(Main)
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
CEN ISO/TS 16775:2021

This document provides guidance for the application of the requirements contained in ISO 11607-1 and
ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2.
This is an informative document, not normative. It does not include requirements to be used as basis of
regulatory inspection or certification assessment activities.
The guidance can be used to better understand the requirements of ISO 11607-1 and ISO 11607-2 and
illustrates the variety of methods and approaches available for meeting the requirements of those
International Standards. It is not required that this document be used to demonstrate conformity with
them.
Guidance is given for evaluation, selection and use of packaging materials, preformed sterile barrier
systems, sterile barrier systems and packaging systems. Guidance on validation requirements for
forming, sealing and assembly processes is also given.
This document provides information for both healthcare facilities and the medical devices industry for
terminally sterilized medical devices.
This document does not provide guidance for applications of packaging materials and systems after
their opening. In the use of packaging for other purposes such as a “sterile field” or transport of
contaminated items, other regulatory standards will apply

  • Technical specification
    154 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11607-1:2020(Main)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 11607-1:2020

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

  • Standard
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    52 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11607-2:2020(Main)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
EN ISO 11607-2:2020

This document specifies requirements for thedevelopment and validation of processes for packaging medical devices that areterminally sterilized. These processes include forming, sealing and assembly ofpreformed sterile barrier systems, sterile barrier systems and packagingsystems. It is applicable to industry, to health care facilities, and towherever medical devices are packaged and sterilized. It does not cover allrequirements for packaging medical devices that are manufactured aseptically.Additional requirements can be necessary for drug/device combinations   .

  • Standard
    21 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    26 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 868-5:2019(Main)
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-5:2018

This part of EN 868 provides 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 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.
NOTE 1 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 4.5 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.
NOTE 2 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.

  • Standard
    21 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    19 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 868-10:2019(Main)
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
EN 868-10:2018

This document specifies test methods and values for sealable adhesive coated nonwoven materials of
polyolefines, manufactured from nonwovens complying with EN 868-9 used for 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.

  • Standard
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 868-9:2019(Main)
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
EN 868-9:2018

This document specifies test methods and values for uncoated nonwoven materials of polyolefines used
for 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.

  • Standard
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    9 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 868-8:2019(Main)
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
EN 868-8:2018

This part of EN 868 provides 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 manufactures and users.
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 nor modify the general requirements specified in EN ISO 11607-1.
As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
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 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.

  • Standard
    21 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    20 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 868-2:2017(Main)
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-2:2017

This draft European Standard provides test methods and values for materials for 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 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 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.

  • Standard
    23 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day