DIN EN 868-4-2017 Packaging for terminally sterilized medical devices - Part 4 Paper bags - Requirements and test methods German version EN 868-4 2017《最终灭菌医疗器械的包装 第4部分 纸袋 试验方法和要求 德.pdf

1、May 2017 English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.30!%e)l“2660673www.din.deDIN

2、EN 868-4Packaging for terminally sterilized medical devices Part 4: Paper bags Requirements and test methods;English version EN 8684:2017,English translation of DIN EN 868-4:2017-05Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte Teil 4: Papierbeutel Anforderungen und Prfverfa

3、hren;Englische Fassung EN 8684:2017,Englische bersetzung von DIN EN 868-4:2017-05Emballages des dispositifs mdicaux striliss au stade terminal Partie 4: Sacs en papier Exigences et mthodes dessai;Version anglaise EN 8684:2017,Traduction anglaise de DIN EN 868-4:2017-05SupersedesDIN EN 8684:200909www

4、.beuth.deDocument comprises 18 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.17DIN EN 868-4:2017-05 2 A comma is used as the decimal marker. National foreword This document (EN 868-4:2017) has been prepared by Technical Co

5、mmittee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-04 AA “Sterile supply”. The

6、 DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 5725-2 DIN ISO 5725-2 ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN EN 868-4:2009-09 as follows: a) this European Standard has been amended to be in line with the standard s

7、eries EN ISO 11607; in particular, the following changes have been made: 1) EN ISO 11607-2 has been included as normative reference; 2) the requirements according to EN ISO 11607-1 and -2 have been declared general requirements for this standard; 3) significance and limits of the requirements of thi

8、s standard have been specified with regard to requirements according to EN ISO 11607-1; 4) the test methods with regard to information on statement on precision and bias, repeatability and reproducibility have been linked to those in EN ISO 11607-1:2009 + A1:2014, Table B.1; 5) the test method for t

9、he determination of tensile strength according to Annex C has been amended; b) informative data on repeatability and reproducibility for test methods has been provided in Annex D for the following test methods: chloride content; sulphate content; c) the Bibliography has been updated. Previous editio

10、ns DIN 58953-3: 1981-11, 1987-01 DIN EN 868-4: 1999-08, 2009-09 DIN EN 868-4:2017-05 3 National Annex NA (informative) Bibliography DIN ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of

11、a standard measurement method DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN EN 868-4:2017-05 4 Page intentionally left blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-4 February 2017 ICS 11.080.30 Supersedes EN 868-4:

12、2009English Version Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods Emballages des dispositifs mdicaux striliss au stade terminal - Partie 4: Sacs en papier - Exigences et mthodes dessai Verpackungsmaterialien fr in der Endverpackung zu steril

13、isierende Medizinprodukte - Teil 4: Papierbeutel -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 n

14、ational standard without any alteration. 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

15、version in any other language made by translation 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, Cypru

16、s, Czech Republic, Denmark, Estonia, Finland, 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 Uni

17、ted Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION 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

18、 868-4:2017 EEN 868-4:2017 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 5 4 Requirements . 6 5 Information to be supplied by the manufacturer 8 Annex A (informative) Details of significant technical changes between this Europea

19、n Standard and the previous edition 10 Annex B (normative) Method for the determination of pH value, chloride and sulphate in paper bags . 11 B.1 Preparation of test pieces . 11 B.2 pH value . 11 B.3 Chloride . 11 B.4 Sulphate . 11 B.5 Test report 11 Annex C (normative) Method for the determination

20、of the tensile strength of the back seam joint in paper bags (see 4.5.4) . 12 C.1 Preparation of the test pieces 12 C.2 Procedure 12 C.3 Test report 12 Annex D (informative) Repeatability and Reproducibility of test methods 13 Bibliography . 14 DIN EN 868-4:2017-05 EN 868-4:2017 (E) 3 European forew

21、ord This document (EN 868-4:2017) 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 given the status of a national standard, either by publication of a

22、n 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 may be the subject of patent rights. CEN shall not be held responsibl

23、e for identifying any or all such patent rights. This document supersedes EN 868-4:2009. Annex A provides 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 sterili

24、zed 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) Requirements and test methods; Part 4: Paper bags Requirements and test me

25、thods; 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 coated paper for low temperature sterilization processes Requirements a

26、nd 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: Adhesive coated nonwoven materials of polyolefines Requirements and test m

27、ethods. 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 series EN ISO 11607 “Packaging for terminally sterilized medical devices”. The EN ISO 11607- series speci

28、fies 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 organisations of the following countries are bou

29、nd 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portuga

30、l, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 868-4:2017-05 EN 868-4:2017 (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

31、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 of use. Part 2 of this series specifies validation requirement

32、s for forming, sealing and assembly processes. General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1 and EN ISO 11607-2. The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1. CEN/TC 102/WG 4 al

33、so 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 all parts of the EN 868 series. DIN EN 868-

34、4:2017-05 EN 868-4:2017 (E) 5 1 Scope This European Standard specifies test methods and values for paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to th

35、e 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 to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for

36、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 references, only the edition cited applies. For undated references, the latest edition of the referenced document (in

37、cluding any amendments) applies. EN 868-3, Packaging for terminally sterilized medical devices - 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) - Requirements and test methods EN ISO 1924-2, Paper and

38、 board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2) EN ISO 11140-1, Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1) EN ISO 11607-1:2009+A1:2014, Packaging for terminally sterilized

39、 medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006+AMD1:2014) EN ISO 11607-2, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2) ISO 6588-2

40、:2012, Paper, 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

41、pulp Determination of water-soluble sulfates 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2009+A1:2014 apply. DIN EN 868-4:2017-05 EN 868-4:2017 (E) 6 4 Requirements 4.1 General For any preformed sterile barrier system or sterile barrie

42、r system, the requirements of EN ISO 11607-1 and EN ISO 11607-2 shall apply. 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.

43、 As such, the particular requirements in 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 1 Compliance to EN 8684 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-4 shall contain a state

44、ment whether EN ISO 11607-1 and EN ISO 11607-2 are covered. 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, tr

45、ay liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, can apply. 4.2 Construction and design 4.2.1 General 4.2.1.1 The bags shall be manufactured from single web paper

46、specified in EN 868-3. 4.2.1.2 The following terms shall be used to describe the design of the bag: a) back the surface of the bag with a longitudinal seam; b) front the surface of the bag with no longitudinal seam; c) unlipped where the length of both the front and back surfaces are the same and th

47、e front surface has a thumb cut (9 3) mm deep and not less than 15 mm wide; d) lipped where the length of the back surface is greater than the length of the front surface by not less than 10 mm and not more than 25 mm; e) gusseted where the construction of the bag includes side panels; f) ungusseted

48、 where the longitudinal edges of the front and back surfaces are contiguous; g) seal top where there is a continuous strip of seal adhesive on the inner surface of the front, back and gussets (if gusseted) of the top of the bag; h) plain top where there is no seal adhesive. 4.2.1.3 The adhesive(s) u

49、sed in the construction of the bag shall be water resistant and non-corrosive, subsequently referred to as “construction adhesive(s)”. DIN EN 868-4:2017-05 EN 868-4:2017 (E) 7 4.2.2 Bottom seal formation The bottom seal shall be formed by using one of the following methods: a) the bottom shall be double folded with each fold bonded with “construction adhesive”, or b) the bottom shall be sealed across the entire width with a “construction adhesive” or with a seal not less than 6,5 m