EN 868-2-2009 1875 Packaging for terminally sterilized medical devices - Part 2 Sterilization wrap - Requirements and test methods《灭菌医疗装置的包装 第2部分 灭菌套要求和测试方法》.pdf

1、BS EN 868-2:2009ICS 11.080.30; 55.040NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging materialsfor terminallysterilized medicaldevicesPart 2: Sterilization wrap Requirements and test methodsCopyright European Committee for Standardization Provided by IH

2、S under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 54954 0Amendments/corrigenda issued since publication

3、Date CommentsBS EN 868-2:2009National forewordThis British Standard is the UK implementation of EN 868-2:2009. Itsupersedes BS EN 868-2:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organ

4、izations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.

5、Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-2:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-2May 2009ICS 11.080.30 Supersedes EN 868-2:1999 English Vers

6、ionPackaging for terminally sterilized medical devices - Part 2:Sterilization wrap - Requirements and test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 2: Enveloppe destrilisation - Exigences et mthodes dessaiVerpackungen fr in der Endverpackung zu steri

7、lisierendeMedizinprodukte - Teil 2: Sterilisierverpackung -Anforderungen und PrfverfahrenThis European Standard was approved by CEN on 23 April 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of

8、 a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A versio

9、n in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark

10、, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUR

11、OPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 868-2:2009: ECopyright European Committee for Standardization Provided by IHS under license with CEN

12、Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-2:2009EN 868-2:2009 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 Requirements .65 Information to be supplied by the manufacturer 9Annex A (informa

13、tive) Details of significant technical changes between this European Standard and the previous edition 10Annex B (normative) Method for the determination of fluorescence . 12Annex C (informative) Method for the determination of drape 13Annex D (normative) Method for the determination of water repell

14、ency . 14Annex E (normative) Method for the determination of pore size 15Bibliography . 20Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-2:2009EN 868-2:2009 (E) 3 Fore

15、word This document (EN 868-2:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, 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, a

16、t the latest by November 2009, and conflicting national standards shall be withdrawn at the latest by November 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying

17、any or all such patent rights. This document supersedes EN 868-2:1999. 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 device

18、s: 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: Sea

19、lable 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; P

20、art 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 additio

21、n, ISO/TC 198 “Sterilization of health care products“ in collaboration with CEN/TC 102 “Sterilizers for medical purposes“ 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

22、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 organizations of the following countries are bound to implement this European Standard: Austria, Belgium,

23、 Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Copyright European Com

24、mittee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-2:2009EN 868-2:2009 (E) 4 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterili

25、zed 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

26、this series specifies validation requirements for forming, sealing and assembly processes. Every sterile barrier system shall fulfil the requirements of 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. During th

27、e revision of EN 868 parts 2 to 10, CEN/TC 102/WG 4 recognized Resolution CEN/BT 21/2003 relating to the implementation of the uncertainty of measurement concept in standards. Following this Resolution and the corresponding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods needed

28、to show compliance with the requirements specified in EN 868 parts 2 to 10 with the intention that the information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts 2 to 10 during one of their next revisions. CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to

29、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. Copyright European Committee for Standardization Provided by IHS

30、 under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-2:2009EN 868-2:2009 (E) 5 1 Scope This part of EN 868 provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain

31、sterility of terminally sterilized medical devices to the point of use. NOTE 1 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

32、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 2 When additional materials are used inside the steril

33、e 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

34、the acceptability of these materials during validation activities, may apply. The 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. NOTE 3 If the intended purpose according to the manufacturer of t

35、he material for sterile barrier system specifies the use as sterile field, then the additional requirements of the EN 13795 series apply. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited app

36、lies. 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 187:1990) EN 20535, Paper and

37、 board Determination of water absorptiveness Cobb method (ISO 535:1991) EN 20811, Textiles Determination of resistance to water penetration Hydrostatic pressure test EN 21974, Paper Determination of tearing resistance (Elmendorf method) (ISO 1974:1990) EN 29073-3, Textiles Test methods for nonwovens

38、 Part 3: Determination of tensile strength and elongation EN ISO 536, Paper and board Determination of grammage (ISO 536:1995) EN ISO 1924-2, Paper and board Determination of tensile properties Part 2: Constant rate of elongation method (ISO 1924-2:1994) EN ISO 2758, Paper Determination of bursting

39、strength (ISO 2758:2001) EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) EN ISO 13937-1, Textiles Tear properties of fabrics Part 1: Determination of tear force using ballist

40、ic pendulum method (Elmendorf) (ISO 13937-1:2000) Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-2:2009EN 868-2:2009 (E) 6 EN ISO 13938-1, Textiles Bursting properties

41、 of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999) 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

42、, Paper and board Determination of air permeance (medium range) Part 3: Bendtsen method ISO 6588-2:2005, 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

43、 9197, Paper, board and pulps Determination of water-soluble chlorides ISO 9198, Paper, board and pulp Determination of water-soluble sulfates ISO 9237, Textiles Determination of the permeability of fabrics to air 3 Terms and definitions For the purposes of this document, the terms and definitions g

44、iven in EN ISO 11607-1:2006 and the following apply. 3.1 sterile field area created by sterile drape material where aseptic technique is practised NOTE A sterile field can be practised e.g. on a back table. 3.2 surgical drape drape covering a patient or equipment to prevent transfer of infective age

45、nts see also EN 137951:2002 4 Requirements 4.1 General The requirements of EN ISO 116071 apply. NOTE EN ISO 116071:2006, 5.1.4 refers to conditions during production and handling with respect to their impact on the product (e.g. electrostatic conductivity, bioburden if applicable). 4.2 Performance r

46、equirements and test methods 4.2.1 General 4.2.1.1 No colour shall leach out of the wrap. Compliance shall be tested by visual examination of a hot aqueous extract prepared in accordance with the method given in ISO 65882. Copyright European Committee for Standardization Provided by IHS under licens

47、e with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-2:2009EN 868-2:2009 (E) 7 4.2.1.2 The average mass of 1 m of the conditioned wrap when tested in accordance with EN ISO 536 shall be within 5 % of the nominal value stated by the manufacturer. 4.2.

48、1.3 The pH of an aqueous extract of the wraps shall be not less than 5 nor greater than 8 when tested in accordance with ISO 6588-2, hot extraction method. 4.2.1.4 The chloride content of the wrap, 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 6588-2:2005, 7.2 except that 2 ml of potassium chloride solution is not added. 4.2.1.5 The sulphate content of the wrap, calculated as sodium sulphate, shall not exceed 0,25 % when