EN ISO 8536-8-2015 en Infusion equipment for medical use - Part 8 Infusion sets for single use with pressure infusion apparatus《医用输液设备 第4部分 一次性压力输液器的医用设备》.pdf

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1、BSI Standards PublicationBS EN ISO 8536-8:2015Infusion equipment for medicalusePart 8: Infusion sets for single use withpressure infusion apparatusBS EN ISO 8536-8:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO8536-8:2015. It supersedes BS EN ISO 8536-

2、8:2004 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. U

3、sers are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 83276 5ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of

4、 theStandards Policy and Strategy Committee on 30 June 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-8 June 2015 ICS 11.040.20 Supersedes EN ISO 8536-8:2004English Version Infusion equipment for medical use - Part 8: Infusion

5、sets for single use with pressure infusion apparatus (ISO 8536-8:2015)Matriel de perfusion usage mdical - Partie 8: Appareils de perfusion non rutilisables avec des appareils de perfusion sous pression (ISO 8536-8:2015) Infusionsgerte zur medizinischen Verwendung - Teil 8: Infusionsgerte zur einmali

6、gen Verwendung mit Druckinfusionsapparaten (ISO 8536-8:2015) This European Standard was approved by CEN on 16 April 2015. 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 witho

7、ut 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 l

8、anguage 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, Den

9、mark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTE

10、E FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-8:2015 EBS EN ISO 85

11、36-8:2015EN ISO 8536-8:2015 (E) 3 European foreword This document (EN ISO 8536-8:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” in collaboration with Technical Committee CEN/TC 205 “Non

12、-active 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 an identical text or by endorsement, at the latest by December 2015, and conflicting national standards shall be withdrawn at the latest

13、 by December 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-8:2004. In this edition the fo

14、llowing changes have been made: the part title has been changed from Infusion equipment to Infusion sets ; the former Clause 4 on designation has been deleted; 6.14 has been amended and an appropriate Annex B Storage volume added; Clause 10 on labelling was amended by a note regarding the usage of t

15、he symbol “XXX” according ISO 7000-2725; Clause 11 on disposal has been added; A.3 Tests for leakage has been amended; the former A.4 specifying a test of male conical fitting for leakage has been deleted; normative references and the Bibliography have been updated; document has been editorially rev

16、ised. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Accord

17、ing to the CEN-CENELEC Internal Regulations, the national standards organizations 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,

18、Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN ISO 8536-8:2015EN ISO 8536-8:2015 (E) 4 Endorsement notice The text of ISO 8536-8:2015

19、has been approved by CEN as EN ISO 8536-8:2015 without any modification. Table Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2 Equivalent dated standard EN ISO ISO 594-2 ISO 594-2:1998 ISO 7000 ISO 7000:2014 ISO 8536-4 EN IS

20、O 8536-4:2013 and EN ISO 8536-4:2013/A1:2013 ISO 8536-4:2010 and Amd.1:2013 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 BS EN ISO 8536-8:2015EN ISO 8536-8:2015 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on me

21、dical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices Once this standard is cited in

22、the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity w

23、ith the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks

24、/Notes 3.2, Clause 4 7.2 The part of ER 7.2 relating to packaging is not addressed. For packaging see Clause 8 of this standard Clause 4 7.3 ER covered by biological evaluation 5.3, 5.5, A.3 7.5 Presumption of conformity with the Essential Requirements relating to the biological evaluation can only

25、be provided if the manufacturer chooses to apply the ISO 10993- series of standards 5.2 7.6 Section 5.1 of this EN refers to ISO 8536-4, sections 6.1 3.2, Clause 4 8.1 The part of ER 8.1 relating to handling is not addressed. Manufacturing processes are not covered. Only sterility of product is cove

26、red 8.3 8.4 8.5 9.2, 9.3 8.7 Clause 4, 9.2 i) 9.1 The second sentence of ER 9.1 is not addressed 3.2 9.2 BS EN ISO 8536-8:2015EN ISO 8536-8:2015 (E) 6 Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5.2, A.2 12.7.1 Only tensile strength

27、is addressed Clause 9 13.1 9.2 d), e), f), g), 9.3 c) and d) 13.2 9.2, 9.3 13.3 The part of 13.3 a) relating to the authorized representative is not addressed. Presumption of conformity to the rest of 13.3 a) is only provided if the name and address of the manufacturer are given 13.3 d) is only cove

28、red if the batch number is preceded by the word LOT 13.3 f) Requirement indication of single use must be consistent across the Community“ is not addressed in the standard 13.3 g), h) is not addressed in the standard 9.2, 9.3 13.4 13.4 is addressed regarding to the label 9.2, 9.3 13.5 13.5 is not add

29、ressed regarding to the detachable components 9.2, 9.3 13.6 13.6 e), f), h), i), j), l), m), o) are not applicable for devices according to this standard 13.6 q) is not addressed WARNING Other requirements and other EC Directives may be applicable to the product(s) falling within the scope of this s

30、tandard. BS EN ISO 8536-8:2015ISO 8536-8:2015(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 25 Materials . 56 Physical requirements 56.1 Particulate contamination . 56.2 Tensile strength 56.3 Leakage 56.4 Male conical fitting 66.5 Injection site

31、66.6 Fluid filter 66.7 Flow rate of infusion fluid . 66.8 Closure-piercing device . 66.9 Air-inlet device 66.10 Drip chamber and drip tube 66.11 Tubing . 66.12 Flow regulator . 66.13 Protective caps 66.14 Storage volume . 67 Chemical requirements . 68 Biological requirements . 69 Packaging . 710 Lab

32、elling 710.1 General . 710.2 Label on unit container 710.3 Label on shelf or multi-unit container 711 Disposal 8Annex A (normative) Physical tests . 9Annex B (normative) Storage volume.10Bibliography .13 ISO 2015 All rights reserved iiiContents PageBS EN ISO 8536-8:2015ISO 8536-8:2015(E)ForewordISO

33、(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 technical comm

34、ittee 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 matters of electrote

35、chnical 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 drafte

36、d 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 patent rights. ISO shall not be held responsible for identifying any or all such patent righ

37、ts. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constit

38、ute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe commi

39、ttee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This second edition cancels and replaces the first edition (ISO 8536-8:2004), which has been technically revised with the following changes: The par

40、t title has been changed from Infusion equipment to Infusion sets ; The former Clause 4 on designation has been deleted; 6.14 has been amended and an appropriate Annex B Storage volume added; Clause 10 on labelling was amended by a note regarding the usage of the symbol “XXX” according ISO 7000-2725

41、; Clause 11 on disposal has been added; A.3 Tests for leakage has been amended; The former A.4 specifying a test of male conical fitting for leakage has been deleted; Normative references and the Bibliography have been updated; Document has been editorially revised.ISO 8536 consists of the following

42、 parts, under the general title Infusion equipment for medical use: Part 1: Infusion glass bottles Part 2: Closures for infusion bottles Part 3: Aluminium caps for infusion bottles Part 4: Infusion sets for single use, gravity feediv ISO 2015 All rights reservedBS EN ISO 8536-8:2015ISO 8536-8:2015(E

43、) Part 5: Burette infusion sets for single use, gravity feed Part 6: Freeze drying closures for infusion bottles Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 8: Infusion sets for single use with pressure infusion apparatus Part 9: Fluid lines for single use with pre

44、ssure infusion equipment Part 10: Accessories for fluid lines for single use with pressure infusion equipment Part 11: Infusion filters for single use with pressure infusion equipment Part 12: Check valvesThe following parts are under preparation: Part 13: Graduated flow regulators for single use wi

45、th infusion sets Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact ISO 2015 All rights reserved vBS EN ISO 8536-8:2015BS EN ISO 8536-8:2015Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus1 ScopeThi

46、s part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.2 N

47、ormative referencesThe 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 (including any amendment

48、s) applies.ISO 594-21), Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittingsISO 7000, Graphical symbols for use on equipment Registered symbolsISO 8536-4, Infusion equipment for medical use Part 4: Infusion sets for single use, gravit

49、y feedISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.NOTE These terms and definitions are specifically applicable to Annex B.3.1filling volumeVFvolume of tube during pressure less“-filling respectively filling by gravity, the tube remains unstressedNote 1 to entry: The filling vo