1、May 2017 English price group 13No 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)j“2660671www.din.deDIN
2、EN 868-2Packaging for terminally sterilized medical devices Part 2: Sterilization wrap Requirements and test methods;English version EN 8682:2017,English translation of DIN EN 868-2:2017-05Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte Teil 2: Sterilisierverpackung Anforderu
3、ngen und Prfverfahren;Englische Fassung EN 8682:2017,Englische bersetzung von DIN EN 868-2:2017-05Emballages des dispositifs mdicaux striliss au stade terminal Partie 2: Enveloppe de strilisation Exigences et mthodes dessai;Version anglaise EN 8682:2017,Traduction anglaise de DIN EN 868-2:2017-05Sup
4、ersedesDIN EN 8682:200909www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.Document comprises 27 pages 04.17 2 A comma is used as the decimal marker. National foreword This document (EN 868-2:2017) has been prepared ty Tec
5、hnical 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 DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-04 AA “Sterile sup
6、ply”. 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 DIN ISO 8601 Amendments This standard differs from DIN EN 868-2:2009-09 as follows: a) this European Standa
7、rd has been amended to be in line with the standard series EN ISO 11607; in particular, the following changes have been made: 1) terms of EN ISO 11607 have been adopted without additional elements, i.e. the terms “sterile field” and “surgical drape” which are covered by the EN 13795 series have been
8、 deleted; 2) the requirements according to EN ISO 11607-1 have been declared general requirements for this standard; 3) significance and limits of the requirements of this standard have been specified with regard to requirements according to EN ISO 11607-1; 4) the test methods with regard to informa
9、tion on statement of precision and bias, repeatability and reproducibility have been linked to those in EN ISO 11607-1:2009 + A1:2014, Table B.1; b) the test method on fluorescence is in accordance with ISO 2470-2; the test method according to Annex B has been deleted; c) the following test methods
10、have been updated by a statement on repeatability and reproducibility: 1) method for the determination of water repellency according to Annex C; 2) method for the determination of pore size according to Annex D; d) informative data on repeatability and reproducibility for test methods has been provi
11、ded for the determination of water repellency according to Annex C as well as for the method for the determination of pore size according to Annex D, the chloride content and the sulphate content; e) the Bibliography has been updated. Previous editions DIN 58953-5: 1982-11, 1987-05 DIN EN 868-2: 199
12、9-08, 2009-09 DIN EN 868-2:2017-05 3National Annex NA (informative) 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 p
13、recision) of measurement methods and results Part 2: Basic method 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 868-2:2017-05 4 This page
14、 is intentionally blank DIN EN 868-2:2017-05 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-2 February 2017 ICS 11.080.30 Supersedes EN 868-2:2009English Version Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods Emballages des
15、dispositifs mdicaux striliss au stade terminal - Partie 2: Enveloppe de strilisation - Exigences et mthodes dessai Verpackungsmaterialien fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Sterilisierverpackung - 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 868-2:2017 EEN 868-2:2017 (E) 2Contents Page European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3
21、 Terms and definitions . 7 4 Requirements . 7 5 Information to be supplied by the manufacturer . 11 Annex A (informative) Details of significant technical changes between this European Standard and the previous edition 12 Annex B (informative) Method for the determination of drape . 13 B.1 Apparatus
22、 13 B.1.1 Softness tester . 13 B.1.2 Rule . 13 B.2 Procedure 13 B.3 Test report 13 Annex C (normative) Method for the determination of water repellency 14 C.1 Apparatus 14 C.2 Reagent 14 C.3 Procedure 14 C.4 Repeatability and reproducibility 14 C.5 Test report 15 Annex D (normative) Method for the d
23、etermination of pore size . 16 D.1 Principle 16 D.2 Test liquid . 16 D.3 Apparatus 16 D.4 Preparation of test specimens . 18 D.5 Procedure 18 D.6 Result 19 D.6.1 Calculation and expression of results . 19 D.6.2 Derivation of formula for calculation of equivalent pore radius 19 D.7 Repeatability and
24、reproducibility 20 D.8 Test report 20 DIN EN 868-2:2017-05 EN 868-2:2017 (E) 3Annex E (informative) Repeatability and reproducibility of test methods 21 Bibliography . 23 DIN EN 868-2:2017-05 EN 868-2:2017 (E) 4European foreword This document (EN 868-2:2017) has been prepared by Technical Committee
25、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 confl
26、icting 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 E
27、N 868-2:2009. 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 metho
28、ds; 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 f
29、ilm 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 steri
30、lizers 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
31、collaboration with CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” has prepared the series EN ISO 11607 “Packaging for terminally sterilized medical devices”. The EN ISO 11607- series specifies general requirements for materials, sterile barrier systems and packag
32、ing 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
33、, 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
34、and the United Kingdom. DIN EN 868-2:2017-05 EN 868-2:2017 (E) 5Introduction 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 st
35、erile 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
36、 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
37、 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 868-2:2017-05 EN 868-2:2017 (E) 61 Scope This European Standard specifies test methods and values
38、 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. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, tes
39、t methods and values that are specific to the products covered by this European Standard. While 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. 2 Normative references The following documents, in
40、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 St
41、andard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187) EN 20811, Textiles Determination of resistance to water penetration Hydrostatic pressure test (ISO 811) EN 29073-3, Textiles Test methods for nonwovens Part 3: Determinati
42、on of tensile strength and elongation (ISO 9073-3) 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 elong
43、ation 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 9237, Textiles Determination of permeability of fabrics to air (ISO 9237) EN ISO 11607-1:2009+A1:2014, Pack
44、aging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006+AMD1:2014) EN ISO 13937-1, Textiles Tear properties of fabrics Part 1: Determination of tear force using ballistic pendulum method (Elmendorf) (ISO 1393
45、7-1) EN ISO 13938-1, Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1) ISO 2470-2, Paper, board and pulps Measurement of diffuse blue reflectance factor Part 2: Outdoor daylight conditions (D65 brightness) DI
46、N EN 868-2:2017-05 EN 868-2:2017 (E) 7 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
47、 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 ISO 9198,
48、 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
49、 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
