EN ISO 7886-1-2018 en Sterile hypodermic syringes for single use - Part 1 Syringes for manual use.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Sterile hypodermic syringes for single usePart 1: Syringes for manual useBS EN ISO 78861:2018Incorporating corrigendum June 2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7886-1 March 2018 ICS 11.040.25 Su

2、persedes EN ISO 7886-1:1997English Version Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017) Seringues hypodermiques striles, non rutilisables - Partie 1: Seringues pour utilisation manuelle (ISO 7886-1:2017) Sterile Einmalspritzen fr medizinische Zwecke

3、- Teil 1: Spritzen zum manuellen Gebrauch (ISO 7886-1:2017) This European Standard was approved by CEN on 28 February 2017. 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 wit

4、hout 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 version in any other

5、 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, Cyprus, Czech Republic, D

6、enmark, 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 United Kingdom. EUROPEA

7、N COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7886-1:2018

8、 ENational forewordThis British Standard is the UK implementation of EN ISO 78861:2018. It is identical to ISO 78861:2017. It supersedes BS EN ISO 78861:1997, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes.A list of organ

9、izations represented on this committee can be obtained 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 2018 Published by BSI Standards Limited 201

10、8ISBN 978 0 539 01620 8ICS 11.040.25Compliance 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 30 April 2018.Amendments/corrigenda issued since publicationDate Text affect

11、ed30 June 2018 Implementation of CEN correction notice 18 April 2018: Title and supersession details of European Foreword correctedBRITISH STANDARDBS EN ISO 78861:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7886-1 March 2018 ICS 11.040.25 Supersedes EN ISO 7886-1:1997English Version

12、 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017) Seringues hypodermiques striles, non rutilisables - Partie 1: Seringues pour utilisation manuelle (ISO 7886-1:2017) Sterile Einmalspritzen fr medizinische Zwecke - Teil 1: Spritzen zum manuellen Gebrauch

13、(ISO 7886-1:2017) This European Standard was approved by CEN on 28 February 2017. 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

14、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 translation under the re

15、sponsibility 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, Finland, Former Yugoslav

16、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 STANDARDIZATION COMIT EURO

17、PEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7886-1:2018 EBS EN ISO 78861:2018EN ISO 7886-1:2018 (

18、E) 3 European foreword This document (EN ISO 7886-1:2017) has been prepared by Technical Committee ISO/TC 84 “ Devices for administration of medicinal products and catheters “ in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. T

19、his 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 September 2018, and conflicting national standards shall be withdrawn at the latest by September 2018. Attention is drawn to the possibility that som

20、e 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 ISO 7886-1:1997. This document has been prepared under a mandate given to CEN by the European Commission and the Europe

21、an Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. The following referenced documents are indispensable for the application of this document. For undated refer

22、ences, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and t

23、hat its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the

24、ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. Table 1 Correlation between normative references and dated EN and ISO standards Normative references as listed i

25、n Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 15223-1:2016 EN ISO 15223-1:2016 ISO 15223-1:2016 ISO 23908 EN ISO 23908:2013 ISO 23908:2011 ISO 80369-7 EN ISO 80369-7:2017 ISO 80369-7:2016 According to the CEN-CENELEC Internal Regulations, the national standards organizat

26、ions 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, Lithuania, Luxembourg, Malt

27、a, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN ISO 78861:2018EN ISO 7886-1:2018 (E) 4 Endorsement notice The text of ISO 7886-1:2017 has been approved by CEN as EN ISO 7886-1:2018 without any modificatio

28、n. BS EN ISO 78861:2018EN ISO 7886-1:2018 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European standard has been prepared under a Commissions standardisation request M/295 concerning

29、the development of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under

30、that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference

31、from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or remove

32、d, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according t

33、o the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex I of Dire

34、ctive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/subclause(s) of this EN Remarks/Notes 7.3 6.2 Standard Clause 6.2 meets ER 7.3 in respect of the device altering the pH of the contents of the device. 7.5 13.2 Standard Clause 13.2 covers ER 7.5 only in respect of leaka

35、ge past the plunger. 7.6 14.1.1, 14.1.2 Standard Clause 14.1.1 meets ER 7.6 in respect of packaging only. Standard Clause 14.1.2 meets the ER 7.6 up to the point of use. BS EN ISO 78861:2018EN ISO 7886-1:2018 (E) 6 Essential Requirements of Directive 93/42/EEC Clause(s)/subclause(s) of this EN Remar

36、ks/Notes 8.3 14.1.1, 14.1.2 9.2 5, 6, 10, 11 Standard Clauses 5, 6, 10 and 11 meet ER 9.2 for the aspects detailed in the Standard Clauses. 10.1 8, 9.4, 11.2 Standard Clause 8 meets ER 10.1 except for the last sentence. Standard Clauses 9.4 and 11.2 meet the requirements of ER 10.1 as they relates t

37、o the relationship between the zero graduation line of the scale and the fiducial line on the plunger stopper only. 10.2 9.1, 9.2 10.3 15.2.1 b) 13.1 15 13.3 (a) 15.2.2 b), 15.3 f), 15.4.1 b), 15.5 e) 13.3 (b) 15.3 e), 15.4.1 e), 15.5 f), 15.6 a) 13.3 (c) 15.3 a), 15.4.2 a), 15.5 a), 15.5 b), 15.6 c

38、) 13.3 (d) 15.3 c), 15.4.1 c), 15.5 d), 15.6 b) 13.3 (e) 15.3 g), 15.4.1 f), 15.5 g), 15.6 f) 13.3 (f) 15.2.2 a), 15.3 b), 15.4.1 a), 15.5 c) 13.3 (i) 15.6 e) 13.3 (k) 15.4.2 b) WARNING 1: Presumption of conformity stays valid only as long as a reference to this European standard is maintained in th

39、e list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this standard.

40、BS EN ISO 78861:2018ISO 7886-1:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Nomenclature 35 General requirements . 56 Extraneous matter 56.1 General . 56.2 Limits for acidity or alkalinity . 56.3 Limits for extractable metals 57 Lubricant 68 Toleran

41、ce on graduated capacity 69 Graduated scale . 79.1 Scale 79.2 Numbering of scales . 89.3 Overall length of scale to nominal capacity line . 89.4 Position of scale 910 Barrel 910.1 Dimensions . 910.2 Barrel flanges . 911 Plunger stopper/plunger assembly 911.1 Design . 912 Nozzle 1012.1 Conical fittin

42、g 1012.2 Position of nozzle on end of barrel . 1012.3 Nozzle lumen . 1013 Performance .1013.1 Dead space . 1013.2 Freedom from air and liquid leakage past plunger stopper .1013.3 Force to operate the piston 1013.4 Fit of plunger stopper/plunger in barrel 1014 Packaging 1114.1 Unit packaging and self

43、-contained syringe units .1114.1.1 Unit packaging 1114.1.2 Self-contained syringe units . 1114.2 Multiple unit pack 1114.3 User packaging . 1115 Information supplied by the manufacturer 1215.1 General 1215.2 Syringes 1215.2.1 General. 1215.2.2 Additional marking for self-contained syringe units.1215

44、.3 Unit packaging 1215.4 Multiple unit packs . 1315.4.1 General. 1315.4.2 Multiple unit packs with self-contained syringes.1315.5 User packaging . 13 ISO 2017 All rights reserved iiiContents PageBS EN ISO 78861:2018ISO 7886-1:2017(E)15.6 Storage container . 1415.7 Transport wrapping 14Annex A (norma

45、tive) Method for preparation of extracts 15Annex B (normative) Test method for air leakage past syringe plunger stopper during aspiration, and for separation of plunger stopper and plunger 16Annex C (normative) Method for determination of dead space 18Annex D (normative) Test method for liquid leaka

46、ge at syringe plunger stopper under compression .19Annex E (informative) Test method for the determination of forces required to operate the piston .21Annex F (informative) Test method for the quantity of silicone .25Bibliography .28iv ISO 2017 All rights reservedBS EN ISO 78861:2018ISO 7886-1:2017(

47、E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a

48、technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matter

49、s of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of p