DIN EN 868-7-2017 Packaging for terminally sterilized medical devices - Part 7 Adhesive coated paper for low temperature sterilization processes - Requirements and test methods Ger.pdf

1、May 2017 English price group 14No 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!%eAs“2663080www.din.deDIN

2、EN 868-7Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterilization processes Requirements and test methods;English version EN 8687:2017,English translation of DIN EN 868-7:2017-05Verpackungen fr in der Endverpackung zu sterilisierende Medizinp

3、rodukte Teil 7: Klebemittelbeschichtetes Papier fr NiedertemperaturSterilisationsverfahren Anforderungen und Prfverfahren;Englische Fassung EN 8687:2017,Englische bersetzung von DIN EN 868-7:2017-05Emballages des dispositifs mdicaux striliss au stade terminal Partie 7: Papier enduit dadhsif pour des

4、 procds de strilisation basse temprature Exigences et mthodes dessai;Version anglaise EN 8687:2017,Traduction anglaise de DIN EN 868-7:2017-05SupersedesDIN EN 8687:200909www.beuth.deDocument comprises 29 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be

5、considered authoritative.05.17 DIN EN 868-7:2017-05 2 A comma is used as the decimal marker. National foreword This document (EN 868-7:2017) has been prepared by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” (Secretariat: DIN, Germany). The r

6、esponsible German body involved in its preparation was DIN-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

7、 ISO 3781 DIN ISO 3781 ISO 5725-2 DIN ISO 5725-2 ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN EN 868-7:2009-09 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 re

8、quirements according to EN ISO 11607-1 have been declared general requirements for this standard; 2) the 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 the sta

9、tement 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 line with ISO 2470-2:2008; the test method according to Annex B has been deleted; c) the test method for determining the sea

10、l strength and mode of specimen failure according to Annex F has been modified; d) the following test methods have been updated by a statement on repeatability and reproducibility: 1) method for the determination of water repellency according to Annex B; 2) method for the determination of pore size

11、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 determination of water repellency according to Annex B; the method for the determination of pore size according to Annex C,

12、the chloride content and the sulphate content; e) the Bibliography has been updated. DIN EN 868-7:2017-05 3 Previous editions DIN EN 868-7: 1999-08, 2009-09 National Annex NA (informative) Bibliography DIN ISO 3689, Paper and board Determination of bursting strength after immersion in water DIN ISO

13、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 for the determination of repeatability and reproducibility of a standard measurement method DIN ISO 8601, Data el

14、ements and interchange formats Information interchange Representation of dates and times DIN EN 868-7:2017-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-7 February 2017 ICS 11.080.30 Supersedes EN 868-7:2009English Version Packaging for terminally ste

15、rilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods Emballages des dispositifs mdicaux striliss au stade terminal - Partie 7: Papier enduit dadhsif pour des procds de strilisation basse temprature - Exigences et mthodes

16、dessai Verpackungsmaterialien fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 7: Klebemittelbeschichtetes Papier fr Niedertemperatur-Sterilisationsverfahren - Anforderungen und Prfverfahren This European Standard was approved by CEN on 4 December 2016. CEN members are bound to comp

17、ly 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

18、 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 sa

19、me 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

20、, 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-CENELEC Management Centre: Avenue Marnix 17, B-1000 Bru

21、ssels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 868-7:2017 EEN 868-7:2017 (E) 2 Contents Page European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 7 4 Requirements . 7 5 Infor

22、mation to be supplied by the manufacturer 9 Annex A (informative) Details of significant technical changes between this European Standard and the previous edition 10 Annex B (normative) Method for the determination of water repellency . 11 B.1 Apparatus 11 B.2 Reagent 11 B.3 Procedure 11 B.4 Repeata

23、bility and reproducibility 11 B.5 Test report 12 Annex C (normative) Method for the determination of pore size . 13 C.1 Principle 13 C.2 Test liquid . 13 C.3 Apparatus 13 C.4 Preparation of test specimens . 15 C.5 Procedure 15 C.6 Result 16 C.6.1 Calculation and expression of results . 16 C.6.2 Deri

24、vation of formula for calculation of equivalent pore radius 16 C.7 Repeatability and reproducibility 17 C.8 Test report 17 Annex D (normative) Method for the determination of regularity of seal adhesive coatings on paper . 18 D.1 Principle of the method . 18 D.2 Apparatus 18 D.3 Procedure 18 D.4 Tes

25、t report 18 DIN EN 868-7:2017-05 EN 868-7:2017(E) 3 Annex E (normative) Method for the determination of mass per unit area of uncoated paper and adhesive coating . 19 E.1 Units . 19 E.2 Principle of the method 19 E.3 Apparatus 19 E.4 Procedure 19 E.5 Results 20 E.6 Test report 20 Annex F (normative)

26、 Method for the determination of seal strength and mode of specimen failure 21 F.1 Principle of the method 21 F.2 Test method 21 F.3 Preparation of test-specimen . 21 F.4 Procedure 21 F.5 Test report 22 Annex G (informative) Repeatability and reproducibility of test methods 23 Bibliography . 25 DIN

27、EN 868-7:2017-05 EN 868-7:2017 (E) 4 European foreword This document (EN 868-7:2017) 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

28、 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

29、 of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 868-7:2009. Annex A provides details of significant technical changes between this European Standard and the previous edition. EN 868 consists of the following parts, under

30、 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 m

31、ethods; 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

32、 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 nonwove

33、n 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 sterili

34、zed 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 standa

35、rds 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, Lux

36、embourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 868-7:2017-05 EN 868-7:2017(E) 5 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally

37、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. Par

38、t 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

39、 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 o

40、f the EN 868 series. DIN EN 868-7:2017-05 EN 868-7:2017 (E) 6 1 Scope This European Standard specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain st

41、erility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies mate

42、rials, 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 ar

43、e 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 m

44、onitoring 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:

45、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 - Par

46、t 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 stren

47、gth 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:

48、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 DIN EN 868-7:2017-05 EN 868-7:2017(E) 7 ISO 9198, Paper, board and pulp Determination of water-soluble su

49、lfates 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