EN 868-7-2017 en Packaging for terminally sterilized medical devices - Part 7 Adhesive coated paper for low temperature sterilization processes - Requirements and test methods《最终灭菌.pdf

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1、BS EN 868-7:2017Packaging for terminallysterilized medical devicesPart 7: Adhesive coated paper for lowtemperature sterilization processes Requirements and test methodsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 868-7:2017 BRITISH STANDARDNational forewordT

2、his British Standard is the UK implementation of EN 868-7:2017. It supersedes BS EN 868-7:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represented on this comm

3、ittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 90659 6 ICS 11.08

4、0.30; 55.040 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 868

5、-7:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-7 February 2017 ICS 11.080.30 Supersedes EN 868-7:2009English Version Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods Emball

6、ages des dispositifs mdicaux striliss au stade terminal - Partie 7: Papier enduit dadhsif pour des procds de strilisation basse temprature - Exigences et mthodes dessai Verpackungsmaterialien fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 7: Klebemittelbeschichtetes Papier fr Nied

7、ertemperatur-Sterilisationsverfahren - Anforderungen und Prfverfahren 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 sta

8、ndard 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

9、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 Re

10、public, 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

11、. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 worldwide for CEN national Members. Ref. No. EN 868-7:2017

12、 EBS EN 868-7:2017EN 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 Information to be supplied by the manufacturer 9 Annex A (informative) Details of significant technical changes between this Eu

13、ropean 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 Repeatability and reproducibility 11 B.5 Test report 12 Annex C (normative) Method for the determination of pore size . 13 C.1 Pr

14、inciple 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 Derivation of formula for calculation of equivalent pore radius 16 C.7 Repeatability and reproducibility 17 C.8 Test report 17

15、 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 Test report 18 BS EN 868-7:2017EN 868-7:2017(E) 3 Annex E (normative) Method for the determination of mass per unit area of u

16、ncoated 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) Method for the determination of seal strength and mode of specimen failure 21 F.1 Principle of the method 21 F.2 Test method 2

17、1 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 BS EN 868-7:2017EN 868-7:2017 (E) 4 European foreword This document (EN 868-7:2017) has been prepared by Technical Committee CEN/TC

18、 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

19、 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-

20、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 the general title Packaging for terminally sterilized medical devices: Part 2: Sterilization wrap Requirements and test methods; Pa

21、rt 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 co

22、nstruction 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

23、 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 collab

24、oration 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 s

25、ystems (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, Cyp

26、rus, 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 t

27、he United Kingdom. BS EN 868-7:2017EN 868-7:2017(E) 5 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 barri

28、er 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 s

29、terile 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

30、 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. BS EN 868-7:2017EN 868-7:2017 (E) 6 1 Scope This European Standard specifies test methods and values for sealable ad

31、hesive coated paper manufactured from paper complying with EN 868-6, 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 materials specified in this part are intended to be used for ethylen

32、e 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 materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN

33、 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 r

34、eferenced 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 meth

35、od (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 1

36、974) 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

37、 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

38、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, boar

39、d and pulps Determination of water-soluble chlorides BS EN 868-7:2017EN 868-7:2017(E) 7 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 Requireme

40、nts 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 ad

41、d or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.3 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 8687 does not automatically mean compliance to EN ISO 11607-

42、1. A confirmation of compliance to EN 868-7 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, packi

43、ng 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 1 See A

44、nnex G 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. NOTE

45、2 Test methods included in Annex D “regularity of seal adhesive coatings on paper”, Annex E “Determination of mass per unit area of uncoated paper and adhesive coating” and Annex F “Determination of seal strength and visual inspection of adhesive coating” have no statement of precision and bias or r

46、epeatability and reproducibility, yet. 4.2.1 When the paper is to be used to manufacture packaging intended to be irradiation sterilized only, it is not necessary for it to have wet strength properties or any permeability to air, so 4.2.12 and 4.2.17 need not apply. 4.2.2 No colour shall leach out o

47、f 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 m2of the conditioned coated paper when tested in accordance with EN ISO 536 shall be within 7,5 % of the nominal value stated

48、 by the manufacturer. 4.2.4 The pH of an aqueous extract of the coated paper shall be not less than 5 or greater than 8 when tested in accordance with ISO 6588-2, hot extraction method. BS EN 868-7:2017EN 868-7:2017 (E) 8 4.2.5 The chloride content of the paper, calculated as sodium chloride, shall

49、not exceed 0,05 % when tested in accordance with ISO 9197 using an hot extract prepared in accordance with ISO 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added. 4.2.6 The sulphate content of the paper, calculated as sodium sulphate, shall not exceed 0,25 % when tested in accordance with ISO 9198, using an 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 th