BS EN 868-3-2017 Packaging for terminally sterilized medical devices Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and re.pdf

1、BS EN 868-3:2017Packaging for terminallysterilized medical devicesPart 3: Paper for use in the manufactureof paper bags (specified in EN 868-4) andin the manufacture of pouches and reels(specified in EN 868-5) Requirementsand test methodsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd

2、 1 15/05/2013 15:06BS EN 868-3:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 868-3:2017. Itsupersedes BS EN 868-3:2009 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/198, Sterilization and Associated Equi

3、pment andProcesses.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2017. Publis

4、hed by BSI Standards Limited 2017ISBN 978 0 580 90660 2ICS 11.080.30; 55.040Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 28 February 2017.Amendments/Corrigenda

5、issued since publicationDate Text affectedBS EN 868-3:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-3 February 2017 ICS 11.080.30 Supersedes EN 868-3:2009English Version Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (speci

6、fied in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods Emballages des dispositifs mdicaux striliss au stade terminal - Partie 3: Papier utilis dans la fabrication des sacs en papier (spcifis dans lEN 868-4) et dans la fabrication de sach

7、ets et gaines (spcifis dans lEN 868-5) - Exigences et mthodes dessai Verpackungsmaterialien fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3: Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schluchen (festgelegt in EN

8、 868-5) - Anforderungen und Prfverfahren This European Standard was approved by CEN on 4 December 2016. 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 without any alteration.

9、 Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 tr

10、anslation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Fin

11、land, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STAN

12、DARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 868-3:2017 EBS EN 868-3:2017EN 868-3:20

13、17 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 6 4 Requirements . 6 Annex A (informative) Details of significant technical changes between this European Standard and the previous edition . 9 Annex B (normative) Method for the

14、determination of water repellency . 10 B.1 Apparatus 10 B.2 Reagent 10 B.3 Procedure 10 B.4 Repeatability and reproducibility 11 B.5 Test report 11 Annex C (normative) Method for the determination of pore size . 12 C.1 Principle 12 C.2 Test liquid . 12 C.3 Apparatus 12 C.4 Preparation of test specim

15、ens . 14 C.5 Procedure 14 C.6 Result 15 C.6.1 Calculation and expression of results . 15 C.6.2 Derivation of formula for calculation of equivalent pore radius 15 C.7 Repeatability and reproducibility 16 C.8 Test report 16 Annex D (informative) Repeatability and reproducibility of test methods . 17 B

16、ibliography . 19 BS EN 868-3:2017EN 868-3:2017 (E) 3 European foreword This document (EN 868-3:2017) has been prepared by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is held by DIN. This European Standard shall be

17、given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2017, and conflicting national standards shall be withdrawn at the latest by August 2017. Attention is drawn to the possibility that some of the elements of this document ma

18、y be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 868-3:2009. Annex A provides details of significant technical changes between this European Standard and the previous edition. EN 868 consists of the follow

19、ing 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 EN 868-5) Require

20、ments 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 7: Adhesive coat

21、ed 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; Part 10: Adhesiv

22、e 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 and associated equipment for processing of medical devices” has prepared the EN ISO 11607 series “Packaging for ter

23、minally 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, sealing and assembly processes (Part 2). According to the CEN-CENELEC Internal Regulations, the n

24、ational standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

25、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 868-3:2017EN 868-3:2017 (E) 4 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for t

26、erminally 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 intended to maintain sterility of terminally sterilized medical devices to the point o

27、f use. Part 2 of this series specifies validation requirements for forming, sealing and assembly processes. General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1. The EN 868 series can be used to demonstrate compliance with one or more of the requirements speci

28、fied in EN ISO 11607-1. 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 for a

29、ll parts of the EN 868 series. BS EN 868-3:2017EN 868-3:2017 (E) 5 1 Scope This European Standard specifies test methods and values 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 sys

30、tems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific

31、 to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated r

32、eferences, 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 sam

33、ples (ISO 187) EN ISO 535, Paper and board - Determination of water absorptiveness - Cobb method (ISO 535) EN ISO 536, Paper and board - Determination of grammage (ISO 536) EN ISO 1924-2, Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (

34、ISO 1924-2) EN ISO 1974, Paper - Determination of tearing resistance - Elmendorf method (ISO 1974) EN ISO 2758, Paper - Determination of bursting strength (ISO 2758) EN ISO 11607-1:2009+A1:2014, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier

35、 systems and packaging systems (ISO 11607-1:2006+AMD1:2014) ISO 2470-2, Paper, board and pulps Measurement of diffuse blue reflectance factor Part 2: Outdoor daylight conditions (D65 brightness) ISO 3689, Paper and board Determination of bursting strength after immersion in water ISO 3781, Paper and

36、 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 6588-2:2012, Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction ISO 8601, Data elements and inter

37、change formats Information interchange Representation of dates and times ISO 9197, Paper, board and pulps Determination of water-soluble chlorides BS EN 868-3:2017EN 868-3:2017 (E) 6 ISO 9198, Paper, board and pulp Determination of water-soluble sulfates 3 Terms and definitions For the purposes of t

38、his document, the terms and definitions given in EN ISO 11607-1:2009+A1:2014 apply. 4 Requirements 4.1 General For any material, preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607-1 shall apply. This part of EN 868 only introduces performance requirements an

39、d 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 can be used to demonstrate compliance with one or more but not all of the requirements of EN IS

40、O 11607-1. NOTE 1 Compliance to EN 8683 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-3 shall contain a statement whether EN ISO 11607-1 is covered. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the org

41、anization, 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 the acceptability of these materials duri

42、ng validation activities, can apply. 4.2 Performance requirements and test methods NOTE See Annex D for repeatability and reproducibility of the test methods: pore diameters, sulphate content, chloride content and water repellency. For information on statement of precision and/or bias, repeatability

43、 and reproducibility of other test methods, see EN ISO 11607-1:2009+A1:2014, Table B.1. 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 examina

44、tion of a hot aqueous extract prepared in accordance with the method given in ISO 6588-2. 4.2.3 The average mass of 1 m2of 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 pa

45、per shall be not less than 5 or greater than 8 when tested in accordance with ISO 6588-2, hot extraction method. 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

46、 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added. BS EN 868-3:2017EN 868-3:2017 (E) 7 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

47、 ISO 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added. 4.2.7 When tested in accordance with ISO 2470-2 the material shall not exhibit an increase in D65 brightness, due to the optical brightener agents, of more than 1 %; calculated as the ratio of the D65 brightness meas

48、ured with the 420 nm UV-cut-off filter in place to the D65 brightness measured without 420 nm UV-cut-off filter. 4.2.8 When exposed at 25 cm from a UV light source, the material shall not have per 0,01 m2more than five fluorescent spots, each having an axis greater than 1 mm. NOTE The UV light to be

49、 used is the one described as per Annex B. 4.2.9 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 ISO 1974. 4.2.10 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 accordance with ISO 5636-3. 4.2.11 The bursting strength of the conditioned paper shall be not less than 230 kPa when tested in accordance with EN ISO 2758. 4.2