EN ISO 8536-4-2013 en Infusion equipment for medical use - Part 4 Infusion sets for single use gravity feed (Incorporates Amendment A1 2013)《医疗用输液设备 第4部分 一次性使用重力输液式输液器》.pdf

1、BSI Standards PublicationBS EN ISO 8536-4:201 +A1:2013Infusion equipment for medical usePart 4: Infusion sets for single use, gravity feed3BS EN ISO 8536-4:2013+A1:2013National forewordThis British Standard is the UK implementation of EN ISO 8536-4:2013+A1:2013. It is identical to ISO 8536-4:2010, i

2、ncorporating amendment 1:2013. It supersedes BS EN ISO 8536-4:2013, which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendme

3、nt 1 is indicated by !“.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations 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.

4、 Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 77072 2ICS 11.040.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authori

5、ty of the Standards Policy and Strategy Committee on 31 March 2013.Amendments/corrigenda issued since publicationDate Text affected31 August 2013 Implementation of ISO amendment 1:2013 with CEN endorsement A1:2013.BRITISH STANDARDEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-4:201 +A

6、1 March 2013 ICS 11.040.20 English Version Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010) Matriel de perfusion usage mdical - Partie 4: Appareils de perfusion non rutilisables, alimentation par gravit (ISO 8536-4:2010) Infusionsgerte zur med

7、izinischen Verwendung - Teil 4: Infusionsgerte fr Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010) This European Standard was approved by CEN on 14 September 2010. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving thi

8、s 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 Management Centre or to any CEN member. This European Standard exists in three official versions

9、(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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bul

10、garia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FO

11、R STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-4:2010: E33 Foreword Foreword to ame

12、ndment A1 This document (EN ISO 8536-4:2013/A1:2013) 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-active medical devices” the secre

13、tariat 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 September 2013, and conflicting national standards shall be withdrawn at the latest by September 2013. Attention is

14、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 has been prepared under a mandate given to CEN by the European Commission and the Eur

15、opean 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. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countr

16、ies 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, Norway, Pola

17、nd, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement notice The text of ISO 8536-4:2010/Amd 1:2013 has been approved by CEN as EN ISO 8536-4:2013/A1:2013without any modification. BS EN ISO 8536-4:2013+A1:2013 EN ISO 8536-4:2013+A1:2013 (E)T

18、he text of ISO 8536-4:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8536-4:2013 by Technica

19、l Committee CEN/TC 205 “Non-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 August 2013, and conflicting national standards shall be

20、 withdrawn at the latest by August 2013.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 8536-4:2010.Th

21、is 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. According to th

22、e 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, Greece, H

23、ungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 8536-4:2010 has been approved by CEN as EN ISO 8536-4:2013 without an

24、y modification.Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 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 co

25、nforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of thi

26、s 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. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC, Medi

27、cal devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.1, 6.7, 8.3, 8.4, 8.5 7.2 8.1 7.5 Presumption of conformity with the Essential Requirements relating to the biological evaluation can only be provided if the manufacturer cho

28、oses to apply the EN ISO 10993 series standards 6.2, 6.4, 6.5 7.6 6.11, 6.13 8 3.2 8.1 10 8.3 8.2 8.4 6.3, 6.12 9.1 6.9, 6.10 10 6.3 12.7.1 6.6, 6.8, 6.9, 6.10 12.8 9 13 The part of ER 13.3 a) relating to the authorized representative is not addressed. ERs 13.3 f) and 13.6 h) relating to single-use

29、are not fully addressed. ER 13.6 q) is not addressed. 4 13.3 WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN ISO 8536-4:2013+A1:2013 EN ISO 8536-4:2013+A1:2013 (E)5 BS EN ISO 8536-4:2013+A1:2013 EN ISO 8536-4:2013

30、+A1:2013 (E) ISO 2013 All rights reserved iiiContents Page 1 Scope1 2 Normative references1 3 General requirements .1 4 Designation 4 4.1 Infusion set 4 4.2 Air-inlet device.4 5 Materials .4 6 Physical requirements 5 6.1 Particulate contamination.5 6.2 Leakage 5 6.3 Tensile strength.5 6.4 Closure-pi

31、ercing device5 6.5 Air-inlet device.5 6.6 Tubing.6 6.7 Fluid filter .6 6.8 Drip chamber and drip tube6 6.9 Flow regulator6 6.10 Flow rate of infusion fluid.6 6.11 Injection site.6 6.12 Male conical fitting 6 6.13 Protective caps 6 7 Chemical requirements.7 7.1 Reducing (oxidizable) matter .7 7.2 Met

32、al ions .7 7.3 Titration acidity or alkalinity.7 7.4 Residue on evaporation7 7.5 UV absorption of extract solution7 8 Biological requirements7 8.1 General .7 8.2 Sterility7 8.3 Pyrogenicity .7 8.4 Haemolysis.7 8.5 Toxicity .8 9 Labelling.8 9.1 Unit container 8 9.2 Shelf or multi-unit container 8 10

33、Packaging.9 Annex A (normative) Physical tests10 Annex B (normative) Chemical tests 14 Annex C (normative) Biological tests .16 Bibliography17 BS EN ISO 8536-4:2013+A1:2013 ISO 8536-4:2010+A1:2013 (E)BS EN ISO 8536-4:201 +A1:2013INTERNATIONAL STANDARD ISO 2013 All rights reserved 1Infusion equipment

34、 for medical use Part 4: Infusion sets for single use, gravity feed 1 Scope This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims

35、of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and t

36、ake precedence over this part of ISO 8536. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amen

37、dments) applies. ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 3696, Wate

38、r for analytical laboratory use Specification and test methods ISO 7864, Sterile hypodermic needles for single use ISO 14644-1, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness1)ISO 15223-1, Medical devices Symbols to be used with medical device labels, lab

39、elling and information to be supplied Part 1: General requirements2)3 General requirements 3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and ai

40、r-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only be used for collapsible plastic containers. Infusion sets as illustrated in Figure 2 used 1) Under preparation. (Revision of ISO 14644-1:1999) 2) To be publi

41、shed. (Revision of ISO 15223-1:2007) ISO 8536-4:2010+A1:2013 (E)32 ISO 2013 All rights reservedwith separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used for rigid containers. 3.2 The infusion set shall be provided with protective caps to m

42、aintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle. Key 1 protective cap of closure-piercing device 7 fluid filter 2 closure-piercing device 8 tubing 3 air inlet with air fi

43、lter and closure 9 flow regulator 4 fluid channel 10 injection site 5 drip tube 11 male conical fitting 6 drip chamber 12 protective cap of male conical fitting aClosure of the air inlet is optional. bThe fluid filter may be positioned at other sites, preferably near the patient access. Generally, t

44、he fluid filter used has a nominal pore size of 15 m. cThe injection site is optional. Figure 1 Example of a vented infusion set BS EN ISO 8536-4:2013+A1:2013 ISO 8536-4:2010+A1:2013 (E) ISO 2013 All rights reserved 3Key 1 protective cap of closure-piercing device 7 tubing 2 closure-piercing device

45、8 flow regulator 3 fluid channel 9 injection site 4 drip tube 10 male conical fitting 5 drip chamber 11 protective cap of the male conical fitting 6 fluid filter aThe fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a nominal por

46、e size of 15 m. bThe injection site is optional. Figure 2 Example of a non-vented infusion set BS EN ISO 8536-4:2013+A1:2013 ISO 8536-4:2010+A1:2013 (E)4 ISO 2013 All rights reservedKey 1 protective cap 4 clamp 2 closure-piercing device or needle 5 air-inlet with air filter 3 tubing aOther designs a

47、re acceptable if the same safety aspects are ensured. Figure 3 Example of an air-inlet device 4 Designation 4.1 Infusion set Infusion sets complying with the requirements specified in this part of ISO 8536 shall be designated by the descriptor words, followed by a reference to this part of ISO 8536,

48、 followed by the letters IS, followed by the letter G: Infusion set ISO 8536-4 - IS - G 4.2 Air-inlet device Air-inlet devices complying with the requirements specified in this part of ISO 8536 shall be designated by the descriptor words, followed by a reference to this part of ISO 8536, followed by

49、 the letters IS, followed by the letters AD: Air-inlet device ISO 8536-4 - IS - AD 5 Materials The materials from which the infusion set and its components are manufactured (as described in Clause 3) shall comply with the requirements specified in Clause 6. Where components of the infusion set come into contact with solutions, the materials shall also comply with the requirements specified in Clauses 7 and 8. BS EN ISO 8536-4:2013+A1:2013 ISO 8536-4:2010+A1:2013 (E) ISO 2013 All rights reserved 56 Physical requirements 6.1 Pa