1、May 2017 English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.30!%e)k“2660672www.din.deDIN
2、EN 868-6Packaging for terminally sterilized medical devices Part 6: Paper for low temperature sterilization processes Requirements and test methods;English version EN 8686:2017,English translation of DIN EN 868-6:2017-05Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte Teil 6:
3、Papier fr NiedertemperaturSterilisationsverfahren Anforderungen und Prfverfahren;Englische Fassung EN 8686:2017,Englische bersetzung von DIN EN 868-6:2017-05Emballages des dispositifs mdicaux striliss au stade terminal Partie 6: Papier pour des procds de strilisation basse temprature Exigences et mt
4、hodes dessai;Version anglaise EN 8686:2017,Traduction anglaise de DIN EN 868-6:2017-05SupersedesDIN EN 8686:200909www.beuth.deDocument comprises 23 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.17DIN EN 868-6:2017-05 2 A c
5、omma is used as the decimal marker. National foreword This document (EN 868-6:2017) has been prepared by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DI
6、N-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-04 AA “Sterile supply”. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 3689 DIN ISO 3689 ISO 3781 DIN ISO 3781 ISO 5725-2 DIN ISO 5725-2 ISO 8601
7、 DIN ISO 8601 Amendments This standard differs from DIN EN 868-6:2009-09 as follows: a) this European Standard has been amended to be in line with the standard series EN ISO 11607; in particular, the following changes have been made: 1) the requirements according to EN ISO 11607-1 have been declared
8、 general requirements for this standard; 2) significance and limits of the requirements of this standard have been specified with regard to requirements according to EN ISO 11607-1; 3) the test methods with regard to information on statement on precision and bias, repeatability and reproducibility h
9、ave been linked to those in EN ISO 11607-1:2009 + A1:2014, Table B.1; b) the test method on fluorescence is in line with ISO 2470-2:2008; the test method according to Annex B has been deleted; c) the following test methods have been updated by a statement on repeatability and reproducibility: 1) met
10、hod for the determination of water repellency according to Annex B; 2) method for the determination of pore size according to Annex C; 3) informative data on repeatability and reproducibility for test methods has been provided in Annex D for the following test methods: the method for the determinati
11、on of water repellency according to Annex B; the method for the determination of pore size according to Annex B, the chloride content and the sulphate content; d) the Bibliography has been updated. Previous editions DIN EN 868-6: 1999-08, 2009-09 DIN EN 868-6:2017-05 3 National Annex NA (informative
12、) Bibliography DIN ISO 3689, Paper and board Determination of bursting strength after immersion in water DIN ISO 3781, Paper and board Determination of tensile strength after immersion in water DIN ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method
13、for the determination of repeatability and reproducibility of a standard measurement method DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN EN 868-6:2017-05 4 Page intentionally left blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE
14、NORM EN 868-6 February 2017 ICS 11.080.30 Supersedes EN 868-6:2009English Version Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods Emballages des dispositifs mdicaux striliss au stade terminal - Partie 6:
15、Papier pour des procds de strilisation basse temprature - Exigences et mthodes dessai Verpackungsmaterialien fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 6: Papier fr Niedertemperatur-Sterilisationsverfahren - Anforderungen und Prfverfahren This European Standard was approved by
16、 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 stand
17、ards 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 no
18、tified 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,
19、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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-C
20、ENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 868-6:2017 EEN 868-6:2017 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 5 2 Normative references 5
21、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 Rep
22、eatability and reproducibility 10 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
23、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 DIN EN 868-6:2017-05 EN 868-6:2017 (E) 3 European foreword This document (EN 8
24、68-6:2017) 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
25、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 o
26、r all such patent rights. This document supersedes EN 868-6:2009. 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: Pa
27、rt 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
28、 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
29、: 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, IS
30、O/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 requireme
31、nts 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 E
32、uropean 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, Sl
33、ovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 868-6:2017-05 EN 868-6:2017 (E) 4 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 requ
34、irements 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
35、 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 wit
36、h 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. DIN EN 868-6:2017-05 EN 868-6:2017 (E) 5 1 Scope Thi
37、s European Standard specifies 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. Other than the general requirements as specified
38、 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. Paper specified in this European Standard is intended for use in part or complete manufacture of pouches and form and fill packs
39、 and lidding material for trays. 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
40、 8687. NOTE 2 Paper according to EN 8683 can also be used for these sterilization processes. 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 indis
41、pensable 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 monitori
42、ng 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: Constan
43、t 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: Re
44、quirements 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 aft
45、er 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 DIN EN 868-6:2017-05 EN 868-6:2017 (E) 6 ISO 6588-2:2012, Paper, board and pulps Determination
46、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 ISO 9198, Paper, board and pulp Determination of water-soluble sulfates
47、 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 8
48、68 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
49、 more but not all of the requirements of EN ISO 11607-1. NOTE 1 Compliance to EN 8686 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-6 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 org
