EN 868-6-2017 en Packaging for terminally sterilized medical devices - Part 6 Paper for low temperature sterilization processes - Requirements and test methods《最终灭菌医疗器械的包装-第6部分 低温灭.pdf

1、BS EN 868-6:2017Packaging for terminallysterilized medical devicesPart 6: Paper for low temperaturesterilization processes Requirements andtest methodsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 868-6:2017 BRITISH STANDARDNational forewordThis British Stand

2、ard is the UK implementation of EN 868-6:2017. It supersedes BS EN 868-6:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of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 obta

3、ined on request to its secretary.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 90657 2 ICS 11.080.30; 55.040 Comp

4、liance with a British Standard 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 868-6:2017EUROPEAN S

5、TANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-6 February 2017 ICS 11.080.30 Supersedes EN 868-6:2009English Version Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods Emballages des dispositifs mdicaux stri

6、liss au stade terminal - Partie 6: Papier pour des procds de strilisation basse temprature - Exigences et mthodes dessai Verpackungsmaterialien fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 6: Papier fr Niedertemperatur-Sterilisationsverfahren - Anforderungen und Prfverfahren Thi

7、s 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. Up-to-date lists and bibliographical refere

8、nces 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 translation under the responsibility of a CEN

9、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, Finland, Former Yugoslav Republic of Macedonia,

10、 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION E

11、UROPISCHES 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 868-6:2017 EBS EN 868-6:2017EN 868-6:2017 (E) 2 Contents Page European foreword . 3

12、 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 determination of water repellency . 10 B.1 A

13、pparatus 10 B.2 Reagent 10 B.3 Procedure 10 B.4 Repeatability and reproducibility 10 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 specimens . 14 C.5 Procedure 14 C.6 Result 15 C.6.

14、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 Bibliography . 19 BS EN 868-6:2017EN 868-6:20

15、17 (E) 3 European foreword This document (EN 868-6:2017) 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, eit

16、her 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 may be the subject of patent rights. CEN shall

17、 not be held responsible for identifying any or all such patent rights. This document supersedes EN 868-6:2009. 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

18、 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) Requirements and test methods; Part 4: Paper bags R

19、equirements 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 coated paper for low temperature sterilization p

20、rocesses 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: Adhesive coated nonwoven materials of polyolefines

21、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 terminally sterilized medical devices”. The EN

22、 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 organisations of the fol

23、lowing 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, Lithuania, Luxembourg, Malta, Netherlands,

24、 Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 868-6:2017EN 868-6:2017 (E) 4 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterilized medical devices”. Par

25、t 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 of use. Part 2 of this series specifies val

26、idation 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 specified in EN ISO 11607-1. CEN/TC 102/WG 4 al

27、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. BS EN 868-6

28、:2017EN 868-6:2017 (E) 5 1 Scope This European Standard specifies test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than t

29、he 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. Paper specified in this European Standard is intended for use in part or complete manufactur

30、e of pouches and form and fill packs and lidding material for trays. NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to

31、produce coated paper according to EN 8687. NOTE 2 Paper according to EN 8683 can also be used for these sterilization processes. 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 refer

32、enced 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 (including any amendments) applies. EN 20187, Paper, board and pulps - Standard atmosphere for conditioning an

33、d testing and procedure for monitoring the atmosphere and conditioning of samples (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

34、tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (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 ste

35、rilized medical devices - Part 1: Requirements for materials, sterile barrier 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 De

36、termination 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 BS EN 868-6:2017EN 868-6:2017 (E) 6 ISO 6588-2:2012, Paper,

37、 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 pulp Determin

38、ation 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. 4 Requirements 4.1 General For any material, preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607-1

39、 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. As such, the particular requirements in 4.2 can be used to dem

40、onstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 1 Compliance to EN 8686 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-6 shall contain a statement whether EN ISO 11607-1 is covered. NOTE 2 When additional

41、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, tray liners or an additional envelope around the medical device) then other requireme

42、nts, including the determination of the acceptability of these materials during 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 rep

43、ellency. For information on statement of precision and/or bias, repeatability and reproducibility of other test methods, see EN ISO 11607-1:2009+A1:2014, Table B.1. 4.2.1 When the paper is to be used to manufacture packaging intended to be irradiation sterilized only, it is not necessary for it to h

44、ave wet strength properties or any permeability to air, so 4.2.11, 4.2.12 and 4.2.15 need not apply. 4.2.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of a hot aqueous extract prepared in accordance with the method given in ISO 6588-2. 4.2.3 The average m

45、ass 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. BS EN 868-6:2017EN 868-6:2017 (E) 7 4.2.4 The pH of an aqueous extract of the paper shall be not less than 5 nor greater than 8 when tested in accordance

46、 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 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not

47、 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 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added. 4.2.7 When tested in acc

48、ordance 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 without 420 nm UV-cut-off fil

49、ter. 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 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 300 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 0,2 m/Pa s at an air pre