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

This draft European Standard provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) 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 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.
NOTE   Applicable sterilization methods are specified by the manufacturer.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3: Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5) - Anforderungen und Prüfverfahren

Dieser europäische Norm-Entwurf enthält Prüfverfahren und Werte für Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868 4) und zur Herstellung von Klarsichtbeuteln und  schläuchen (festgelegt in EN 868 5), die dazu vorgesehen sind, als Sterilbarrieresysteme und/oder Verpackungssysteme die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Die Erfordernis für eine Schutzverpackung darf durch den Hersteller und den Anwender bestimmt werden.
Dieser Teil von EN 868 enthält lediglich Leistungsanforderungen und Prüfverfahren, die spezifisch für die Produkte nach diesem Teil von EN 868 sind, ergänzt oder modifiziert jedoch nicht die in EN ISO 11607 1 festgelegten allgemeinen Anforderungen.
Die besonderen Anforderungen nach 4.2 können daher verwendet werden, um Übereinstimmung mit einer oder mehreren Anforderung(en) - aber nicht mit allen Anforderungen - der EN ISO 11607 1 nachzuweisen.
Werden zusätzliche Materialien im Sterilbarrieresystem verwendet, um die Organisation, die Trocknung oder die aseptische Präsentation zu erleichtern (z. B. Innenverpackung, Filter für Sterilisier¬behälter, Indikatoren, Verpackungslisten, Unterlagen, Einsätze für Instrumente, Fächer oder eine zusätzliche Umhüllung für das Medizinprodukt), dann können andere Anforderungen, einschließlich der Bestimmung der Eignung dieser Materialien im Rahmen von Validierungstätigkeiten, gelten.
Die nach diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.
ANMERKUNG   Anwendbare Sterilisationsverfahren werden durch den Hersteller festgelegt.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 3: Papier utilisé dans la fabrication des sacs en papier (spécifiés dans l'EN 868-4) et dans la fabrication de sachets et gaines (spécifiés dans l'EN 868-5) - Exigences et méthodes d'essai

Le présent projet de Norme européenne fournit des méthodes d’essai et des valeurs applicables au papier utilisé dans la fabrication des sacs en papier (spécifiés dans l’EN 868-4) et des sachets et gaines (spécifiés dans l’EN 868-5) utilisés comme systèmes de barrière stérile et/ou comme systèmes d’emballage destinés à maintenir l’état de stérilité des dispositifs médicaux, stérilisés au stade terminal, jusqu’à leur utilisation.
La nécessité d’un emballage de protection peut être déterminée par le fabricant et l’utilisateur.
La présente partie de l’EN 868 présente uniquement les exigences de performance et les méthodes d’essai spécifiques aux produits couverts par la présente partie de l’EN 868, mais elle n'ajoute pas ou ne modifie pas les exigences générales spécifiées dans l’EN ISO 11607-1.
En conséquence, les exigences particulières mentionnées en 4.2 peuvent être utilisées pour démontrer la conformité à une ou plusieurs exigences de l’EN ISO 11607-1, mais pas à la totalité de ces exigences.
En cas d'utilisation de matériaux complémentaires à l’intérieur du système de barrière stérile de manière à faciliter le rangement, le séchage ou la présentation aseptique (par exemple, enveloppe interne, filtre de conteneur, indicateurs, inventaires d’emballage, matelas de support silicone ou autres plastiques, kits d’organisation des instruments médicaux, fonds de protection de panier ou une enveloppe supplémentaire contenant le dispositif médical), d’autres exigences peuvent alors s’appliquer, y compris la détermination de l’acceptabilité de ces matériaux lors des activités de validation.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.
NOTE   Les méthodes de stérilisation applicables sont spécifiées par le fabricant.

Embalaža za končno sterilizirane medicinske pripomočke - 3. del: Papir za izdelavo papirnatih vrečk (specifikacija EN 868-4) in papir za izdelavo vrečk in zvitkov (specifikacija EN 868-5) - Zahteve in preskusne metode

Ta osnutek evropskega standarda podaja preskusne metode in vrednosti za papir za izdelavo papirnatih vrečk (specifikacija EN 868-4) ter papir za izdelavo vrečk in zvitkov (specifikacija EN 868-5), ki se uporablja kot sterilni pregradni sistemi in/ali sistemi embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
Potrebo po zaščitni embalaži lahko določita proizvajalec in uporabnik.
Ta del standarda EN 868 le uvaja zahteve delovanja in preskusne metode, ki se uporabljajo za proizvode, zajete v tem delu standarda EN 868, vendar ne dodaja ali spreminja splošnih zahtev, podanih v standardu EN ISO 11607-1.
Posebne zahteve iz točke 4.2 se lahko uporabljajo za dokazovanje skladnosti z eno ali več zahtevami, vendar ne z vsemi zahtevami standarda EN ISO 11607-1.
Ko se znotraj sterilnega pregradnega sistema uporabljajo dodatni materiali za lažjo organizacijo, sušenje ali aseptičnost (npr. notranji ovoj, filtrirni vsebniki, kazalniki, embalažni listi, podloge, kompleti organizatorjev za inštrumente, obloge za pladnje ali dodatni ovoj okoli medicinskega pripomočka), se lahko uporabljajo druge zahteve, vključno z ugotavljanjem sprejemljivosti teh materialov med preverjanjem.
Materiali, določeni v tem delu standarda ISO 868, so namenjeni le enkratni uporabi.

General Information

Status
Published
Publication Date
07-Feb-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
08-Feb-2017
Completion Date
08-Feb-2017

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SLOVENSKI STANDARD
SIST EN 868-3:2017
01-april-2017
1DGRPHãþD
SIST EN 868-3:2009

(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO3DSLU]DL]GHODYR

SDSLUQDWLKYUHþN VSHFLILNDFLMD(1 LQSDSLU]DL]GHODYRYUHþNLQ]YLWNRY
VSHFLILNDFLMD(1 =DKWHYHLQSUHVNXVQHPHWRGH

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

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3:

Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung

von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5) - Anforderungen und

Prüfverfahren

Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade

terminal - Partie 3 : Papier utilisé dans la fabrication des sacs en papier (spécifiés dans

l'EN 868-4) et dans la fabrication de sachets et gaines (spécifiés dans l'EN 868-5) -

Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-3:2017
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.080 9UHþH9UHþNH Sacks. Bags
SIST EN 868-3:2017 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 868-3:2017
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SIST EN 868-3:2017
EN 868-3
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-3:2009
English Version
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

Emballages des dispositifs médicaux stérilisés au stade Verpackungsmaterialien für in der Endverpackung zu

terminal - Partie 3: Papier utilisé dans la fabrication sterilisierende Medizinprodukte - Teil 3: Papier zur

des sacs en papier (spécifiés dans l'EN 868-4) et dans Herstellung von Papierbeuteln (festgelegt in EN 868-4)

la fabrication de sachets et gaines (spécifiés dans l'EN und zur Herstellung von Klarsichtbeuteln und -

868-5) - Exigences et méthodes d'essai schläuchen (festgelegt in EN 868-5) - Anforderungen

und Prüfverfahren
This European Standard was approved by CEN on 4 December 2016.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 868-3:2017 E

worldwide for CEN national Members.
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SIST EN 868-3:2017
EN 868-3:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 6

4 Requirements ................................................................................................................................................... 6

Annex A (informative) Details of significant technical changes between this European

Standard and the previous edition ........................................................................................................... 9

Annex B (normative) Method for the determination of water repellency ............................................. 10

B.1 Apparatus ........................................................................................................................................................ 10

B.2 Reagent ............................................................................................................................................................ 10

B.3 Procedure........................................................................................................................................................ 10

B.4 Repeatability and reproducibility.......................................................................................................... 11

B.5 Test report ...................................................................................................................................................... 11

Annex C (normative) Method for the determination of pore size ............................................................. 12

C.1 Principle .......................................................................................................................................................... 12

C.2 Test liquid ....................................................................................................................................................... 12

C.3 Apparatus ........................................................................................................................................................ 12

C.4 Preparation of test specimens ................................................................................................................. 14

C.5 Procedure........................................................................................................................................................ 14

C.6 Result ................................................................................................................................................................ 15

C.6.1 Calculation and expression of results ................................................................................................... 15

C.6.2 Derivation of formula for calculation of equivalent pore radius ................................................ 15

C.7 Repeatability and reproducibility.......................................................................................................... 16

C.8 Test report ...................................................................................................................................................... 16

Annex D (informative) Repeatability and reproducibility of test methods ........................................... 17

Bibliography ................................................................................................................................................................. 19

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SIST EN 868-3:2017
EN 868-3:2017 (E)
European foreword

This document (EN 868-3:2017) has been prepared by Technical Committee CEN/TC 102 “Sterilizers

and associated equipment for processing of medical devices”, the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by August 2017, and conflicting national standards shall

be withdrawn at the latest by August 2017.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 868-3:2009.

Annex A provides details of significant technical changes between this European Standard and the

previous edition.

EN 868 consists of the following parts, under the general title Packaging for terminally sterilized medical

devices:
— Part 2: Sterilization wrap — Requirements and test methods;

— 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;
— Part 4: Paper bags — Requirements and test methods;

— Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements

and test methods;

— Part 6: Paper for low temperature sterilization processes — Requirements and test methods;

— Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test

methods;

— Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements

and test methods;

— Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods;

— Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods.

In addition, ISO/TC 198 “Sterilization of health care products” in collaboration with CEN/TC 102

“Sterilizers and associated equipment for processing of medical devices” has prepared the

EN ISO 11607 series “Packaging for terminally sterilized medical devices”. The EN ISO 11607 series

specifies general requirements for materials, sterile barrier systems and packaging systems (Part 1)

and validation requirements for forming, sealing and assembly processes (Part 2).

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
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SIST EN 868-3:2017
EN 868-3:2017 (E)
Introduction

The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally

sterilized medical devices”. Part 1 of this series specifies general 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 to the point of use. Part 2 of this

series specifies validation requirements for forming, sealing and assembly processes.

General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1.

The EN 868 series can be used to demonstrate compliance with one or more of the requirements

specified in EN ISO 11607-1.

CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse

environmental impacts by standards. It was agreed that this subject should be given priority during the

next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series.

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SIST EN 868-3:2017
EN 868-3:2017 (E)
1 Scope

This European Standard specifies test methods and values for paper, used in the manufacture of paper

bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) 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

European Standard.
The materials specified in this part of EN 868 are intended for single use only.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

EN 20187, Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for

monitoring the atmosphere and conditioning of samples (ISO 187)

EN ISO 535, Paper and board - Determination of water absorptiveness - Cobb method (ISO 535)

EN ISO 536, Paper and board - Determination of grammage (ISO 536)

EN ISO 1924-2, Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation

method (20 mm/min) (ISO 1924-2)

EN ISO 1974, Paper - Determination of tearing resistance - Elmendorf method (ISO 1974)

EN ISO 2758, Paper - Determination of bursting strength (ISO 2758)

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+AMD1:2014)

ISO 2470-2, Paper, board and pulps — Measurement of diffuse blue reflectance factor — Part 2: Outdoor

daylight conditions (D65 brightness)

ISO 3689, Paper and board — Determination of bursting strength after immersion in water

ISO 3781, Paper and board — Determination of tensile strength after immersion in water

ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen

method

ISO 6588-2:2012, Paper, board and pulps — Determination of pH of aqueous extracts — Part 2: Hot

extraction

ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates

and times
ISO 9197, Paper, board and pulps — Determination of water-soluble chlorides
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SIST EN 868-3:2017
EN 868-3:2017 (E)
ISO 9198, Paper, board and pulp — Determination of water-soluble sulfates
3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2009+A1:2014

apply.
4 Requirements
4.1 General

For any material, preformed sterile barrier system or sterile barrier system, the requirements of

EN ISO 11607-1 shall apply.

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.

NOTE 1 Compliance to EN 868–3 does not automatically mean compliance to EN ISO 11607-1.

A confirmation of compliance to EN 868-3 shall contain a statement whether EN ISO 11607-1 is

covered.

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, can apply.

4.2 Performance requirements and test methods

NOTE See Annex D for repeatability and reproducibility of the test methods: pore diameters, sulphate

content, chloride content and water repellency. For information on statement of precision and/or bias,

repeatability and reproducibility of other test methods, see EN ISO 11607-1:2009+A1:2014, Table B.1.

4.2.1 The requirements of 4.2.11 and 4.2.15 do not apply to materials solely used in irradiation

sterilization packaging.

4.2.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of a hot

aqueous extract prepared in accordance with the method given in ISO 6588-2.

4.2.3 The average mass of 1 m of the conditioned paper when tested in accordance with EN ISO 536

shall be within ± 5 % of the nominal value stated by the manufacturer.

4.2.4 The pH of an aqueous extract of the paper shall be not less than 5 or greater than 8 when tested

in accordance with ISO 6588-2, hot extraction method.

4.2.5 The chloride content of the paper, calculated as sodium chloride, shall not exceed 0,05 % when

tested in accordance with ISO 9197 using a hot extract prepared in accordance with ISO 6588-2:2012,

7.2 except that 2 ml of potassium chloride solution is not added.
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SIST EN 868-3:2017
EN 868-3:2017 (E)

4.2.6 The sulphate content of the paper, calculated as sodium sulphate, shall not exceed 0,25 % when

tested in accordance with ISO 9198, using a hot extract prepared in accordance with ISO 6588-2:2012,

7.2 except that 2 ml of potassium chloride solution is not added.

4.2.7 When tested in accordance with ISO 2470-2 the material shall not exhibit an increase in D65

brightness, due to the optical brightener agents, of more than 1 %; calculated as the ratio of the D65

brightness measured with the 420 nm UV-cut-off filter in place to the D65 brightness measured without

420 nm UV-cut-off filter.

4.2.8 When exposed at 25 cm from a UV light source, the material shall not have per 0,01 m more than

five fluorescent spots, each having an axi
...

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