EN 868-6-2009 2500 Packaging for terminally sterilized medical devices - Part 6 Paper for low temperature sterilization processes - Requirements and test methods《灭菌医疗装置的包装 第6部分 低温灭.pdf

1、BS EN 868-6:2009ICS 11.080.30; 55.040NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging materialsfor terminallysterilized medicaldevicesPart 6: Paper for low temperaturesterilization processes Requirements and test methodsCopyright European Committee for

2、Standardization Provided by IHS 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 55006 5Amendments/corri

3、genda issued since publicationDate CommentsBS EN 868-6:2009National forewordThis British Standard is the UK implementation of EN 868-6:2009. Itsupersedes BS EN 868-6:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves an

4、d disinfectors.A list of organizations 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 i

5、mmunityfrom legal obligations.Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-6:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-6May 2009ICS 11.080.30 Superse

6、des EN 868-6:1999 English VersionPackaging for terminally sterilized medical devices - Part 6:Paper for low temperature sterilization processes -Requirements and test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 6: Papier pour lafabrication de systmes de

7、 barrire strile destins lastrilisation basse temprature ou par irradiation -Exigences et mthodes dessaiVerpackungen fr in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 6: Papier fr Niedertemperatur-Sterilisationsverfahren - Anforderungen und PrfverfahrenThis European Standard was approv

8、ed 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 a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstand

9、ards 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 version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to

10、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, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Nether

11、lands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any

12、 form and by any means reservedworldwide for CEN national Members.Ref. No. EN 868-6:2009: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-6:2009EN 868-6:2009 (E) 2 Con

13、tents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 Requirements .65 Information to be supplied by the manufacturer 7Annex A (informative) Details of significant technical changes between this European Standard and the previous edition .8Annex B (normativ

14、e) Method for the determination of fluorescence 9Annex C (normative) Method for the determination of water repellency . 10Annex D (normative) Method for the determination of pore size 11Bibliography . 16Copyright European Committee for Standardization Provided by IHS under license with CENNot for Re

15、saleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-6:2009EN 868-6:2009 (E) 3 Foreword This document (EN 868-6:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which is held by DIN. This European Standard

16、shall be given the status of a national standard, either by publication of an identical text or by endorsement, at 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 thi

17、s document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 868-6:1999. Annex A provides details of significant technical changes between this European Standard and the previous edition. E

18、N 868 consists of the following parts, under 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 (sp

19、ecified 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 construction Requirements and test methods; Part 6: Paper for low temperature sterilization processes Requirements and test me

20、thods; Part 7: Adhesive coated paper for low 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 te

21、st methods; Part 10: Adhesive coated nonwoven materials of polyolefines Requirements and test methods. In addition, ISO/TC 198 “Sterilization of health care products“ in collaboration with CEN/TC 102 “Sterilizers for medical purposes“ has prepared the EN ISO 11607 series “Packaging for terminally st

22、erilized 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 st

23、andards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,

24、 Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-6:2009EN 868-6:2009 (E) 4 Int

25、roduction 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 barrier systems, sterile barrier systems and packaging systems

26、 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. Every sterile barrier system shall fulfil the requirements of EN ISO 11607-1. The EN 868 series

27、can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1. During the 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 th

28、is Resolution and the corresponding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods needed 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 t

29、o 10 during one of their next revisions. 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 basi

30、c reference for all parts of the series EN 868. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-6:2009EN 868-6:2009 (E) 5 1 Scope This part of EN 868 provides test meth

31、ods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain 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 th

32、e user. 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 to 4.3 can be used to de

33、monstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs. NOTE 2 The paper specified in this part of

34、 the series EN 868 is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 3 Paper according to EN 868-3 can also be used for these steri

35、lization processes. The materials specified in this part of EN 868 are intended for single use only. NOTE 4 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 filters, indicators, packing

36、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, may apply. 2 Normative references The following referenced documents are

37、 indispensable for the application of this document. 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 p

38、rocedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990) EN 20535, Paper and board Determination of water absorptiveness Cobb method (ISO 535:1991) EN 21974, Paper Determination of tearing resistance (Elmendorf method) (ISO 1974:1990) EN ISO 536, Paper and board Determinatio

39、n 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 strength (ISO 2758:2001) EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices

40、Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) 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 Copyright European Committee

41、 for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-6:2009EN 868-6:2009 (E) 6 ISO 5636-3, Paper and board Determination of air permeance (medium range) Part 3: Bendtsen method ISO 6588-2:2005, Paper,

42、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, Paper, board and pulp Determina

43、tion of water-soluble sulfates 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 apply. 4 Requirements 4.1 General The requirements of EN ISO 11607-1 apply. NOTE EN ISO 11607-1:2006, 5.1.4 refers to conditions during production and hand

44、ling with respect to their impact on the product (e.g. electrostatic conductivity, bioburden if applicable). 4.2 Performance requirements and test methods 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 st

45、rength properties or any permeability to air, so 4.2.11, 4.2.12 and 4.2.15 need not apply. 4.2.2 No colour shall leach out of 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 m

46、 of the conditioned paper when tested in accordance with EN ISO 536 shall be within 5 % of the nominal value stated by the manufacturer. 4.2.4 The pH of an aqueous extract of the paper shall be not less than 5 nor greater than 8 when tested in accordance with ISO 6588-2, hot extraction method. 4.2.5

47、 The chloride content of the paper, 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. 4.2.6 The sulphate content of the pape

48、r, calculated as sodium sulphate, shall not exceed 0,25 % when tested in accordance with ISO 9198, 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. 4.2.7 When tested in accordance with Annex B the paper shall neither exhibit an increase in brightness due to the optical brightener of more than 1 % nor have more than five fluorescent spots, each having an axis greater than 1 mm per 0,01 m. 4.2.8 The internal tearing resistance of the conditioned paper shall be not less than 300 mN in