EN 868-7-2009 7500 Packaging for terminally sterilized medical devices - Part 7 Adhesive coated paper for low temperature sterilization processes - Requirements and test methods《灭菌.pdf

1、BS EN 868-7:2009ICS 11.080.30; 55.040NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging forterminally sterilizedmedical devicesPart 7: Adhesive coated paper for lowtemperature sterilization processes Requirements and test methodsCopyright European Committ

2、ee for 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 59166 2Amendmen

3、ts/corrigenda issued since publicationDate CommentsBS EN 868-7:2009National forewordThis British Standard is the UK implementation of EN 868-7:2009. Itsupersedes BS EN 868-7:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoc

4、laves and 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

5、confer immunityfrom 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 868-7:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-7May 2009ICS 11.080.30

6、 Supersedes EN 868-7:1999 English VersionPackaging for terminally sterilized medical devices - Part 7:Adhesive coated paper for low temperature sterilizationprocesses - Requirements and test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 7: Papier enduitda

7、dhsif pour la fabrication demballages thermoscellables usage mdical pour strilisation loxyde dthylne oupar irradiation - Exigences et mthodes dessaiVerpackungen fr in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 7: Klebemittelbeschichtetes Papierfr Niedertemperatur-Sterilisationsverfah

8、ren -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 a national standard without any alteration. Up-to-dat

9、e 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 version in any other language made by translationunder the r

10、esponsibility 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, Estonia, Finland,France, Germany, Greece, Hungary, I

11、celand, 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 NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue M

12、arnix 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 868-7:2009: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted

13、without license from IHS-,-,-BS EN 868-7:2009EN 868-7:2009 (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 8Annex A (informative) Details of significant technical changes between

14、 this European Standard and the previous edition .9Annex B (normative) Method for the determination of fluorescence . 10Annex C (normative) Method for the determination of water repellency . 11Annex D (normative) Method for the determination of pore size 12Annex E (normative) Method for the determin

15、ation of regularity of seal adhesive coatings on paper 17Annex F (normative) Method for the determination of mass per unit area of uncoated paper and adhesive coating . 18Annex G (normative) Method for the determination of seal strength and visual inspection of the adhesive coating . 20Bibliography

16、. 22Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-7:2009EN 868-7:2009 (E) 3 Foreword This document (EN 868-7:2009) has been prepared by Technical Committee CEN/TC 102

17、 “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, at the latest by November 2009, and conflicting national standards shall be withdrawn a

18、t 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 any or all such patent rights. This document supersedes EN 868-7:1999. Annex A provide

19、s 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; Part 3: Paper for use in

20、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 construction Requirements

21、 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 conforming to EN 285 R

22、equirements 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 collaboration with CEN/TC 102

23、 “Sterilizers for medical purposes“ 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 systems (Part 1) and validation requirements for forming, sealin

24、g 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, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,

25、 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, 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 repr

26、oduction or networking permitted without license from IHS-,-,-BS EN 868-7:2009EN 868-7:2009 (E) 4 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 me

27、thods 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 this series specifies validation requirements for forming, sealing and assembly proces

28、ses. 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 the revision of EN 868 parts 2 to 10 CEN/TC 102/WG 4 recognized Resolution CEN/BT 21/200

29、3 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 to show compliance with the requirements specified in EN 868 parts 2 to 10 with the int

30、ention 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 the minimization of adverse environmental impacts by standards. It was agreed that this

31、 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 under license with CENNot for ResaleNo reproduction or networking permitted without li

32、cense from IHS-,-,-BS EN 868-7:2009EN 868-7:2009 (E) 5 1 Scope This part of EN 868 provides 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 sterility of

33、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. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces

34、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 demonstrate compliance with one or more but no

35、t all of the requirements of EN ISO 11607-1. 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, packing lists, mats, instrument organizer sets, tray liners or an

36、 additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. The materials specified in this part of EN 868 are intended for single use only. 2 Normative references The following

37、referenced documents are 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 condit

38、ioning and testing and procedure 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, Pape

39、r 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 strength (ISO 2758:2001) EN ISO 11607-1:2006, Packaging for terminally ste

40、rilized medical devices 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 ISO

41、5636-3, 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 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo

42、 reproduction or networking permitted without license from IHS-,-,-BS EN 868-7:2009EN 868-7:2009 (E) 6 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,

43、board and pulps Determination of water-soluble sulfates 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 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 d

44、uring production and handling with respect to their impact on the product (e.g. electrostatic conductivity, bioburden if applicable). 4.2 Materials The adhesive coating shall not react with, contaminate, transfer to or adversely affect the product packed in it, before, during or after sterilization.

45、 4.3 Performance requirements and test methods 4.3.1 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 4.3.11 and 4.3.16 need not apply. 4.3.2 No colour shall lea

46、ch 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 6588-2. 4.3.3 The average mass of 1 m of the conditioned coated paper when tested in accordance with EN ISO 536 shall be within 7,5 % of the nominal value

47、 stated by the manufacturer. 4.3.4 The pH of an aqueous extract of the coated paper shall be not less than 5 nor greater than 8 when tested in accordance with ISO 6588-2. 4.3.5 The chloride content of the paper, calculated as sodium chloride, shall not exceed 0,05 % when tested in accordance with IS

48、O 9197 using an hot extract prepared in accordance with ISO 6588-2:2005, 7.2 except that 2 ml of potassium chloride solution is not added. 4.3.6 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 6588-2:2005, 7.2 except that 2 ml of potassium chloride solution is not added. 4.3.7 The uncoated paper shall neither exhibit an increase in brightness due to the optical brightener of more than 1 % nor have more than five fluorescen