BS EN 868-2-2017 Packaging for terminally sterilized medical devices Sterilization wrap Requirements and test methods《最终灭菌医疗器械的包装 灭菌套 试验方法和要求》.pdf

1、BS EN 868-2:2017Packaging for terminally sterilized medical devicesPart 2: Sterilization wrap Requirements and test methodsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 868-2:2017 BRITISH STANDARDNational forewordThis British Standard is the UK implementation

2、 of EN 868-2:2017.It supersedes BS EN 868-2:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of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 secret

3、ary.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 90656 5 ICS 11.080.30; 55.040 Compliance with a British Standar

4、d 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 868-2:2017EUROPEAN STANDARD NORME EUROPENNE EUROP

5、ISCHE NORM EN 868-2 February 2017 ICS 11.080.30 Supersedes EN 868-2:2009English Version Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods Emballages des dispositifs mdicaux striliss au stade terminal - Partie 2: Enveloppe de strilisation

6、 - Exigences et mthodes dessai Verpackungsmaterialien fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Sterilisierverpackung - Anforderungen und Prfverfahren This European Standard was approved by CEN on 4 December 2016. CEN members are bound to comply with the CEN/CENELEC Intern

7、al Regulations which stipulate 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 C

8、EN member. This European 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 vers

9、ions. CEN members are the 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,

10、Poland, Portugal, Romania, 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 e

11、xploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 868-2:2017 EBS EN 868-2:2017EN 868-2:2017 (E) 2 Contents Page European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 7 4 Requirements . 7 5 Information to be s

12、upplied by the manufacturer . 11 Annex A (informative) Details of significant technical changes between this European Standard and the previous edition 12 Annex B (informative) Method for the determination of drape . 13 B.1 Apparatus 13 B.1.1 Softness tester . 13 B.1.2 Rule . 13 B.2 Procedure 13 B.3

13、 Test report 13 Annex C (normative) Method for the determination of water repellency 14 C.1 Apparatus 14 C.2 Reagent 14 C.3 Procedure 14 C.4 Repeatability and reproducibility 14 C.5 Test report 15 Annex D (normative) Method for the determination of pore size . 16 D.1 Principle 16 D.2 Test liquid . 1

14、6 D.3 Apparatus 16 D.4 Preparation of test specimens . 18 D.5 Procedure 18 D.6 Result 19 D.6.1 Calculation and expression of results . 19 D.6.2 Derivation of formula for calculation of equivalent pore radius 19 D.7 Repeatability and reproducibility 20 D.8 Test report 20 BS EN 868-2:2017EN 868-2:2017

15、 (E) 3 Annex E (informative) Repeatability and reproducibility of test methods 21 Bibliography . 23 BS EN 868-2:2017EN 868-2:2017 (E) 4 European foreword This document (EN 868-2:2017) has been prepared by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical

16、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 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.

17、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 responsible for identifying any or all such patent rights. This document supersedes EN 868-2:2009. Annex A provides details of significant technical changes bet

18、ween 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 the manufacture of paper bags (specified in EN

19、 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 and test methods; Part 6: Paper for low tempe

20、rature 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 Requirements and test methods; Part 9: Uncoated

21、 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 “Sterilizers and associated equipment for pro

22、cessing of medical devices” has prepared the series EN ISO 11607 “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, sealing and a

23、ssembly processes (Part 2). According to the CEN-CENELEC Internal Regulations, 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 Republ

24、ic 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 the United Kingdom. BS EN 868-2:2017EN 868-2:2017 (E) 5 Introduction Th

25、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 i

26、ntended 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. General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1. The EN 868 se

27、ries can be used to demonstrate compliance with one 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

28、 during the next edition of the EN ISO 11607- series that is the basic reference for all parts of the EN 868 series. BS EN 868-2:2017EN 868-2:2017 (E) 6 1 Scope This European Standard specifies test methods and values for materials for sterile barrier systems and/or packaging systems that are intend

29、ed 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 Sta

30、ndard. While materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable

31、 for its application. 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 conditioning and testing and procedure for monitoring the atm

32、osphere and conditioning of samples (ISO 187) EN 20811, Textiles Determination of resistance to water penetration Hydrostatic pressure test (ISO 811) EN 29073-3, Textiles Test methods for nonwovens Part 3: Determination of tensile strength and elongation (ISO 9073-3) EN ISO 535, Paper and board Dete

33、rmination 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) (ISO 1924-2) EN ISO 1974, Paper Determination of tearing r

34、esistance Elmendorf method (ISO 1974) EN ISO 2758, Paper Determination of bursting strength (ISO 2758) EN ISO 9237, Textiles Determination of permeability of fabrics to air (ISO 9237) EN ISO 11607-1:2009+A1:2014, Packaging for terminally sterilized medical devices Part 1: Requirements for materials,

35、 sterile barrier systems and packaging systems (ISO 11607-1:2006+AMD1:2014) EN ISO 13937-1, Textiles Tear properties of fabrics Part 1: Determination of tear force using ballistic pendulum method (Elmendorf) (ISO 13937-1) EN ISO 13938-1, Textiles Bursting properties of fabrics Part 1: Hydraulic meth

36、od for determination of bursting strength and bursting distension (ISO 13938-1) ISO 2470-2, Paper, board and pulps Measurement of diffuse blue reflectance factor Part 2: Outdoor daylight conditions (D65 brightness) BS EN 868-2:2017EN 868-2:2017 (E) 7 ISO 3689, Paper and board Determination of bursti

37、ng 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 6588-2:2012, Paper, board and pulps Determination of pH of aqueous extracts

38、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 pulp Determination of water-soluble sulfates 3 Terms and definitions F

39、or the purposes of this 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 perform

40、ance 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 can be used to demonstrate compliance with one or more but not all of the r

41、equirements of EN ISO 11607-1. NOTE 1 Compliance to EN 8682 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-2 shall contain a statement whether EN ISO 11607-1 is covered. NOTE 2 When additional materials are used inside the sterile barrier system in o

42、rder 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 additional envelope around the medical device) then other requirements, including the determination of the acceptability of

43、these materials during validation activities, can apply. 4.2 Performance requirements and test methods NOTE See Annex E 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

44、 bias, repeatability and reproducibility of other test methods, see EN ISO 11607-1:2009+A1:2014, Table B.1. BS EN 868-2:2017EN 868-2:2017 (E) 8 4.2.1 General 4.2.1.1 No colour shall leach out of the wrap. Compliance shall be tested by visual examination of a hot aqueous extract prepared in accordanc

45、e with the method given in ISO 6588-2. 4.2.1.2 The average mass of 1 m2of the conditioned wrap when tested in accordance with EN ISO 536 shall be within 5 % of the nominal value stated by the manufacturer. 4.2.1.3 The pH of an aqueous extract of the wraps shall be not less than 5 or greater than 8 w

46、hen tested in accordance with ISO 6588-2, hot extraction method. 4.2.1.4 The chloride content of the wrap, 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 6588-2:2012, 7.2 except that 2 ml of potassium

47、 chloride solution is not added. 4.2.1.5 The sulphate content of the wrap, 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 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added

48、. 4.2.1.6 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 measured with the 420 nm UV-cut-off filter in place to the D65 brightness measured w

49、ithout 420 nm UV-cut-off filter. 4.2.1.7 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 used is the one described as per Annex C. 4.2.1.8 The manufacturer shall provide drapeability results and associated test method on request. NOTE For test method, see e.g. EN ISO 9073-9 and Annex B. 4.2.2 Specific requirements 4.2.2.1 Wrap made of plain p