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

1、BS EN 868-4:2017Packaging for terminally sterilized medical devices -Part 4: Paper bags Requirements and test methodsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 868-4:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN

2、 868-4:2017. It supersedes BS EN 868-4:2009 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represented on this committee can be obtained on request to its secretary.

3、This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 90658 9 ICS 11.080.30; 55.040; 55.080 Compliance with a British Sta

4、ndard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 868-4:2017EUROPEAN STANDARD NORME EUROPENNE E

5、UROPISCHE NORM EN 868-4 February 2017 ICS 11.080.30 Supersedes EN 868-4:2009English 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

6、 mthodes dessai Verpackungsmaterialien fr in der Endverpackung zu sterilisierende 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 stip

7、ulate the conditions for giving this European Standard the status of a national 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

8、Standard exists in three official versions (English, French, German). A 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

9、 national standards bodies of 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, Portugal, Romania

10、, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United 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 a

11、nd by any means reserved worldwide for CEN national Members. Ref. No. EN 868-4:2017 EBS EN 868-4:2017EN 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 manufactur

12、er 8 Annex A (informative) Details of significant technical changes between this European 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 . 1

13、1 B.4 Sulphate . 11 B.5 Test report 11 Annex C (normative) Method for the determination 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 t

14、est methods 13 Bibliography . 14 BS EN 868-4:2017EN 868-4:2017 (E) 3 European foreword 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 St

15、andard shall be 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

16、this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 868-4:2009. Annex A provides details of significant technical changes between this European Standard and the previous edition. EN 868 consis

17、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

18、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

19、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;

20、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 and associated equipment for processing of medical devices” has prepared the series EN ISO 11607 “P

21、ackaging 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, sealing and assembly processes (Part 2). According to the CEN-CENELEC Internal R

22、egulations, the national 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

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

24、 “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 intended to maintain sterility of terminally sterilized medical devic

25、es to the point of 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 and EN ISO 11607-2. The EN 868 series can be used to demonstrate compliance with o

26、ne or more of the requirements specified 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 seri

27、es that is the basic reference for all parts of the EN 868 series. BS EN 868-4:2017EN 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 inte

28、nded 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 to the products covered by this European S

29、tandard. 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 references, only the edition cited applies.

30、For undated references, the latest edition of the referenced document (including 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 (specif

31、ied in EN 868-5) - Requirements and test methods EN ISO 1924-2, Paper and 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

32、11140-1) EN ISO 11607-1:2009+A1:2014, Packaging for terminally sterilized 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 requirem

33、ents for forming, sealing and assembly processes (ISO 11607-2) ISO 6588-2:2012, 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 p

34、ulps Determination of water-soluble chlorides ISO 9198, Paper, board and 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. BS EN 868-4:2017EN 868-4:2017 (E) 6 4 Requirements 4.

35、1 General For any preformed sterile barrier system or sterile barrier 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

36、 add or modify the general requirements specified in EN ISO 11607-1. 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 116

37、07-1. A confirmation of compliance to EN 868-4 shall contain a statement 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 fi

38、lter, 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, can apply. 4.2 Construction and design 4.2.1 G

39、eneral 4.2.1.1 The bags shall be manufactured from single web paper 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 wher

40、e the length of both the front and back surfaces are the same and the 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 w

41、here the construction of the bag includes side panels; f) ungusseted 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)

42、plain top where there is no seal adhesive. 4.2.1.3 The adhesive(s) used in the construction of the bag shall be water resistant and non-corrosive, subsequently referred to as “construction adhesive(s)”. BS EN 868-4:2017EN 868-4:2017 (E) 7 4.2.2 Bottom seal formation The bottom seal shall be formed b

43、y 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 mm in depth, or c) the bottom shall be sealed across

44、 the entire width as described in b) and then folded once, or more, each fold being bonded with (a) construction adhesive(s) or with a heat seal. 4.2.3 Back seam construction 4.2.3.1 The longitudinal seam shall be made at the back of the bag with a continuous double line of “construction adhesive(s)

45、”. 4.2.3.2 A coloured adhesive shall be used to enable a simple visual check on the continuity of both glue lines. 4.2.3.3 The dye shall not impair the adhesive. 4.3 Process indicator If one or more Type I indicator(s) (process indicator(s) are printed on the pouches and tubes, the indicators perfor

46、mance shall comply with the requirements of EN ISO 11140-1. Each individual indicator shall be not less than 100 mm2in area. Indicators shall not be affected by the sealing procedure. 4.4 Seal strip 4.4.1 For bags with a seal closure the seal adhesive shall be applied as a continuous strip to the in

47、ner surface of the front, back and (if gusseted) the gussets of the bag. 4.4.2 The width of the seal strip shall be (25 3) mm for bags with a width not exceeding 200 mm and (40 3) mm for bags with a width exceeding 200 mm. 4.4.3 The top edge of the seal strip shall be positioned not less than 2 mm a

48、nd not more than 10 mm from the lower lip or bottom of the thumb cut. 4.5 Performance requirements and test methods NOTE See Annex D for repeatability and reproducibility of the test methods: sulphate content and chloride content. For information on statement of precision and/or bias, repeatability

49、and reproducibility of other test methods, see EN ISO 11607-1:2009+A1:2014, Table B.1. 4.5.1 The pH of the aqueous extract of the paper and adhesive sandwich shall be within the range 4,5 to 8,0 when tested in accordance with Annex B. 4.5.2 The chloride content of the aqueous extract of the paper and adhesive sandwich, calculated as sodium chloride, shall not exceed 0,05 % when tested in accordance with Annex B. 4.5.3 The sulphate content of the aqueous extract of the paper and adhesive sandwich, calcu