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1、BRITISH STANDARDPackaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methodsThe European Standard EN 868-2:1999 has the status of aBritish StandardICS 11.080.30; 55.040;| BS EN868-2:1999|Licensed Copy: London South Bank Unive
2、rsity, London South Bank University, Wed Jul 12 21:50:13 BST 2006, Uncontrolled Copy, (c) BSI|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 868-2:1999National forewordThis British Standard is the English language version of EN 868-2:1999. It supersedesBS 6254:1989 and B
3、S 6255:1989, which are withdrawn.The UK participation in its preparation was entrusted by Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, to Subcommittee LBI/35/9, Sterilization packaging materials, which has the responsibility to: aid enquirers to understand the text; present
4、to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK.A list of organizations represented on this subcommittee can be obtained on re
5、quest to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using theFind facility of the BS
6、I Standards Electronic Catalogue.Sterilization packaging materials falling within the scope of EN 868-1 are considered to be medical devices under Directive 93/42/EEC and compliance with the requirements of EN 868-1 is a means of ensuring that particular essential requirements of the Directive are m
7、et (see Annex ZA of EN 868-1). This Part ofEN 868 may be used to demonstrate compliance with some of the requirements of Part 1. However, compliance with this Part of EN 868 alone may not necessarily be considered to ensure that the essential requirements of the Directive have been met.A British Sta
8、ndard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application.Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover, a
9、n inside front cover, the EN title page, pages 2 to 11 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:13 BST 2006, Uncontrolled Copy, (c) BSIA
10、md. No.DateCommentsThis British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the StandardsCommittee and comes into effect on 15 November 1999BSI 11-1999ISBN 0 580 35311 7Amendments issued since publicatio
11、nEUROPEAN STANDARDEN 868-2NORME EUROPE ENNEEUROPA ISCHE NORMJune 1999ICS 11.080.30; 55.040English versionPackaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methodsMate riaux et syste mes demballages pour les dispositifs me
12、dicaux devant e tre ste rilise s Partie 2: Enveloppes de ste rilisation Exigences et me thodes dessaiVerpackungsmaterialien und -systeme fu r zu sterilisierende Medizinprodukte Teil 2: Sterilisierverpackung Anforderungen und Pru fverfahrenLicensed Copy: London South Bank University, London South Ban
13、k University, Wed Jul 12 21:50:13 BST 2006, Uncontrolled Copy, (c) BSIThis European Standard was approved by CEN on 13 May 1999.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
14、 without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other langua
15、ge made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ice
16、land, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.CENEuropean Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r NormungCentral Secretariat: rue de Stassart 36, B-1050 Brussels1999 CEN All rights of
17、exploitation in any form and by any means reserved worldwide for CEN nationalMembers.Ref. No. EN 868-2:1999 EPage 9EN 868-2:1999BSI 11-1999ForewordThis European Standard has been prepared byTechnical Committee CEN/TC 102, Sterilizers forContentsPageLicensed Copy: London South Bank University, London
18、 South Bank University, Wed Jul 12 21:50:13 BST 2006, Uncontrolled Copy, (c) BSImedical purposes, the Secretariat of which is held byDIN.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 byDecember 199
19、9, and conflicting national standards shall be withdrawn at the latest by December 1999.This standard is one of a series of European Standards concerned with packaging materials and systems for medical devices which are to be sterilized. This series of European Standards consists of the following pa
20、rts:EN 868-1, Packaging materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods. EN 868-2, Packaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methods.EN 868-3, Pack
21、aging materials and systems for medical devices which are to be sterilized 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 inEN 868-5) Requirements and test methods.EN 868-4, Packaging materials and systems for med
22、ical devices which are to be sterilized Part 4: Paper bags Requirements and test methods.EN 868-5, Packaging materials and systems for medical devices which are to be sterilized Part 5: Heat and self sealable pouches and reels of paper and plastic film construction Requirements and test methods.EN 8
23、68-6, Packaging materials and systems for medical devices which are to be sterilized Part 6: Paper for the manufacture of packs formedical use for sterilization by ethylene oxide or irradiation Requirements and test methods.EN 868-7, Packaging materials and systems for medical devices which are to b
24、e sterilized Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation Requirements and test methods.EN 868-8, Packaging materials and systems for medical devices which are to be sterilized Part 8: Re-usable sterilizat
25、ion containers for steam sterilizers conforming to EN 285 Requirements and test methods.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland
26、, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.Foreword 2Introduction 31Scope 32Normative references 33Definitions 34Requirements 3Annex A (normative) Method for the determination of repellency to low s
27、urfacetension liquids 6Annex B (normative) Method for thedetermination of water repellency 6Annex C (normative) Method for thedetermination of pore size 7Annex D (normative) Method for thedetermination of drape 9Annex E (normative) Method for thedetermination of saline repellency 10Annex F (normativ
28、e) Method for thedetermination of air penetration porosity 10Annex G (informative) Dimensions andtolerances 11Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:13 BST 2006, Uncontrolled Copy, (c) BSIIntroductionPart 1 of this series of European Standards spe
29、cifies general requirements and test methods for all packaging materials and systems intended for use as packaging for medical devices which are to be terminally sterilized in their packaging.1 ScopeThis part of the series of EN 868 provides examples of particular requirements and test methods for s
30、terilization wrap suitable for use as packaging of medical devices which are to be terminally sterilized.It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards.As such, the particular req
31、uirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1.NOTE If the intended use as specified by the manufacturer includes the possibility of the material being used for other applications (e.g. sterile field, container filter or as an
32、 inner wrap for containers), then additional and/or other requirements can apply.2 Normative referencesThis European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publicatio
33、ns are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard onlywhen incorporated in it by amendment or revision. For undated references, the latest edition of the publication referred to applies.EN 868-1, Packagin
34、g materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods. EN 20187, Paper, board and pulps Standard atmosphere for conditioning and testing andprocedure for monitoring the atmosphere and conditioning of samples(ISO 187:1990).EN 20535, Paper
35、 and board Determination of water absorptiveness Cobb method(ISO 535:1991).EN 21974, Paper Determination of tearing resistance (Elmendorf method)(ISO 1974:1990).EN 28601, Data elements and interchange formats Information interchange Representation of dates and times(ISO 8601:1988 and technical corri
36、gendum 1:1991).EN ISO 1924-2, Paper and board Determination of tensile properties Part 2: Constant rate of elongation method(ISO 1924-2:1994).ISO 536, Paper and board Determination of grammage.ISO 2758, Paper Determination of bursting strength. ISO 3689, Paper and board Determination of bursting str
37、ength after immersion in water(Revision of ISO 3689:1976).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, Paper, board and pulps Determination of pH of aqu
38、eous extracts.ISO 9073-9, Textiles Test methods for nonwovens Part 9: Determination of drape coefficient.ISO 9197-1, Paper, board and pulps Determination of water-soluble chlorides Part 1: General method. ISO 9198, Paper, board and pulps Determination ofwater-soluble sulfates Titrimetric method.DIN
39、58953-6:1987, Sterilization Sterile supply Sterilization paper for bags and tube packaging Test.BS 6524:1984, Method for determination of the surface resistivity of a textile fabric.3 DefinitionsFor the purposes of this European Standard, the definitions of EN 868-1 apply.4 Requirements4.1 GeneralTh
40、e requirements of EN 868-1 apply.NOTE The following particular requirements and test methods can be used to demonstrate compliance with one or more, but not all, of the requirements of EN 868-1.4.2 MaterialsRaw materials used for the manufacture of packaging materials may be virgin or reclaimed mate
41、rials, provided the source, history and traceability of all raw materials, especially recycled materials, are known and controlled to ensure that the finished product will consistently meet the requirements of this standard.NOTE With current commercial technologies it is unlikely that reclaimed mate
42、rial other than manufacturing waste will be sufficiently controlled to allow its safe use for medical device packaging.4.3 ConditioningWhere reference is made in the following performance requirements to conditioned wrap or to the need for conditioning prior to carrying out a test the wrap shall be
43、conditioned in accordance with the method given in EN 20187.4.4 Performance requirements and test methods4.4.1 General4.4.1.1 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the wrap shall be free from tears, creases or localized thickenin
44、g sufficient to impair its functioning.Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:13 BST 2006, Uncontrolled Copy, (c) BSI4.4.1.2 No colour shall leach out of the wrap. Compliance shall be tested by visual examination of a hot aqueous extract prepared
45、in accordance with the method given in ISO 6588.4.4.1.3 NOTE The paper can be printed.Whether printed or not, no substance known to be toxic shall leach out of the wrap in sufficient quantity to cause a health hazard.Until relevant European or International Standards are published national regulations can apply.4.4.1.4 The average mass of 1
