1、BS EN 868-3:2009ICS 11.080.30; 55.040NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging forterminally sterilizedmedical devicesPart 3: Paper for use in themanufacture of paper bags (specifiedin EN 868-4) and in the manufactureof pouches and reels (specifi
2、ed inEN 868-5) Requirements and testmethodsCopyright European Committee 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 Strate
3、gyCommittee on 31 October2009. BSI 2009ISBN 978 0 580 54955 7Amendments/corrigenda issued since publicationDate CommentsBS EN 868-3:2009National forewordThis British Standard is the UK implementation of EN 868-3:2009. Itsupersedes BS EN 868-3:1999 which is withdrawn.The UK participation in its prepa
4、ration was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves 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 f
5、or its correct application.Compliance with a British Standard cannot 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 868-3:2009EUROPEA
6、N STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-3May 2009ICS 11.080.30 Supersedes EN 868-3:1999 English VersionPackaging for terminally sterilized medical devices - Part 3:Paper for use in the manufacture of paper bags (specified in EN868-4) and in the manufacture of pouches and reels (specified inEN
7、 868-5) - Requirements and test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 3: Papier utilis dans lafabrication de sacs en papier (spcifis dans lEN 868-4) etdans la fabrication de sachets et gaines (spcifis danslEN 868-5) - Exigences et mthodes dessaiVe
8、rpackungen fr in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 3: Papier zur Herstellung vonPapierbeuteln (festgelegt in EN 868-4) und zur Herstellungvon Klarsichtbeuteln und -schluchen (festgelegt in EN868-5) - Anforderungen und PrfverfahrenThis European Standard was approved by CEN on
9、 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 nationalstandards may be
10、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 the CEN Mana
11、gement 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, Netherlands, Norwa
12、y, 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 form and by
13、 any means reservedworldwide for CEN national Members.Ref. No. EN 868-3:2009: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 868-3:2009EN 868-3:2009 (E) 2 Contents Page F
14、oreword 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 (normative) Method fo
15、r 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 ResaleNo repro
16、duction or networking permitted without license from IHS-,-,-BS EN 868-3:2009EN 868-3:2009 (E) 3 Foreword This document (EN 868-3:2009) 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 giv
17、en 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 this document m
18、ay 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 868-3:1999. Annex A provides details of significant technical changes between this European Standard and the previous edition. EN 868 consis
19、ts 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 (specified in E
20、N 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 methods; Part
21、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 test methods;
22、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 sterilized med
23、ical 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 standards orga
24、nizations 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, Portugal, R
25、omania, 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 868-3:2009EN 868-3:2009 (E) 4 Introduction Th
26、e 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 that are in
27、tended 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 can be used
28、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 this Resolutio
29、n 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 to 10 during
30、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 basic reference
31、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 license from IHS-,-,-BS EN 868-3:2009EN 868-3:2009 (E) 5 1 Scope This part of EN 868 provides test methods and valu
32、es for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of us
33、e. 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 of EN 868 but does not add or modify the general requirements specifi
34、ed 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 sterile barrier system in order to ease the organization, drying or aseptic
35、 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 the acceptability of these materials during validation activities, may
36、 apply. The materials specified in this part of EN 868 are intended for single use only. NOTE 3 Applicable sterilization methods are specified by the manufacturer. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references,
37、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 procedure for monitoring the atmosphere and conditioning of samples (ISO 187
38、: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 Determination of grammage (ISO 536:1995) EN ISO 1924-2, Paper and board Determination o
39、f 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 Part 1: Requirements for materials, sterile barrier systems and packaging s
40、ystems (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 5636-3, Paper and board Determination of air permeance (medium range) Part 3: Bendtsen method ISO 6
41、588-2:2005, 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 reproduction or networking permitted without license from IHS-,-,-BS EN 868-3:2009EN 868-3:2009 (E
42、) 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, board and pulp Determination of water-soluble sulfates 3 Terms and definitions For the purposes of
43、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 handling with respect to their impact on the product (e.g. electrostatic conduc
44、tivity, bioburden if applicable). 4.2 Performance requirements and test methods 4.2.1 The requirements of 4.2.11 and 4.2.15 do not apply to materials solely used in irradiation sterilization packaging. 4.2.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of
45、a hot aqueous extract prepared in accordance with the method given in ISO 6588-2. 4.2.3 The average mass of 1 m 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 shal
46、l be not less than 5 nor greater than 8 when tested in accordance with ISO 6588-2. 4.2.5 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
47、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 a hot extract prepared in accordance with ISO 6588-2:2005, 7.2 except that 2 ml of potassium chloride solut
48、ion 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 550 mN in both machine and cross direction when tested in accordance with EN 21974. 4.2.9 The air permeance of the conditioned paper shall be not less than 3,4 m/Pa s at an air pressure of 1,47 kPa when tested in accordan
