1、BSI Standards PublicationBS EN ISO 80369-20:2015Small-bore connectors forliquids and gases in healthcareapplicationsPart 20: Common test methodsBS EN ISO 80369-20:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO80369-20:2015.The UK participation in its p
2、reparation was entrusted to TechnicalCommittee CH/210/5, Small Bore Connectors for Medical Devices.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. Users are respon
3、sible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 82893 5ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards P
4、olicy and Strategy Committee on 30 June 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80369-20 May 2015 ICS 11.040.25 English Version Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test met
5、hods (ISO 80369-20:2015) Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant - Partie 20: Mthodes dessai communes (ISO 80369-20:2015) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendungen - Teil 20: Allgemeine Prfverfahren (ISO 8
6、0369-20:2015) This European Standard was approved by CEN on 5 March 2015. CEN and CENELEC 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
7、and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translat
8、ion under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulga
9、ria, 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tur
10、key 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 2015 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national M
11、embers and for CENELEC Members. Ref. No. EN ISO 80369-20:2015 EBS EN ISO 80369-20:2015EN ISO 80369-20:2015 (E) 3 Foreword This document (EN ISO 80369-20:2015) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collaborati
12、on with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the l
13、atest by November 2015, and conflicting national standards shall be withdrawn at the latest by November 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
14、all such patent rights. 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part
15、of this document. According 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 Mace
16、donia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 80369-20:2015 has been approved by
17、 CEN as EN ISO 80369-20:2015 without any modification. BS EN ISO 80369-20:2015EN ISO 80369-20:2015 (E) 4 Annex ZA (informative) Relationship between this part of EN ISO 80369 and the essential requirements of EU Directive 93/42/EEC This part of EN ISO 80369 has been prepared under a mandate given to
18、 CEN by the European Commission and the European Free Trade Association to provide a means to conforming to essential requirements of the New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the member states concerning medical devices” (Medical Dev
19、ice Directive). Once this part of EN ISO 80369 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 this document given in Table ZA.1 confers, within the limits of the
20、scope of this part of EN ISO 80369, a presumption of conformity with the corresponding essential requirements of that directive and associated EFTA regulations. Table ZA.1 Correspondence between this part of EN ISO 80369 and Directive 93/42/EEC Clause(s)/sub-clause(s) of this part of EN ISO 80369 Es
21、sential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/notes 4, Annex B, Annex C 7.5 4, Annex D 7.6 4, Annex F, Annex G, Annex H, Annex I 9.1 4, Annex E 12.7.1 4 12.7.4 WARNING Other requirements and other EU Directives might be applicable to the products falling within the scope of
22、 this part of EN ISO 80369. For devices which are also machinery within the meaning of Directive 2006/42/EC on Machinery, Article 2(a), in accordance with Directive 93/42/EEC, Article 3, the following Table ZA.2 details the relevant essential health and safety requirements of Directive 2006/42/EC on
23、 Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this part of EN ISO 80369. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of conformity
24、 for the machinery directive. Table ZA.2 Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC on machinery that are addressed by this document Clause(s)/sub-clause(s) of this part of EN ISO 80369 EHSR of 2006/42/EC Qualifying remarks/notes 4 1.5.4 BS EN ISO 80369-20:20
25、15ISO 80369-20:2015(E)Foreword ivIntroduction v1 *Scope 12 Normative references 13 Terms and definitions . 14 Test methods for small-bore connectors 1Annex A (informative) Rationale and guidance 3Annex B (normative) *Leakage by pressure decay test method . 6Annex C (normative) Falling drop positive-
26、pressure liquid leakage test method . 9Annex D (normative) Subatmospheric-pressure air leakage test method 11Annex E (normative) Stress cracking test method 15Annex F (normative) Resistance to separation from axial load test method .17Annex G (normative) Resistance to separation from unscrewing test
27、 method .19Annex H (normative) Resistance to overriding test method .21Annex I (normative) Disconnection by unscrewing test method .23Annex J (informative) Modification of the test methods to generate variable data for statistical analysis 25Annex K (informative) Terminology alphabetized index of de
28、fined terms .28Bibliography .29 ISO 2015 All rights reserved iiiContents PageBS EN ISO 80369-20:2015ISO 80369-20:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Sta
29、ndards is normally carried out through ISO technical committees. Each member body interested in a subject for which a 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
30、take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters 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
31、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
32、of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. 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 (se
33、e www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute 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 t
34、o the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information .The committee responsible for this document is ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC62D, Electromedical equipment. The
35、draft was circulated for voting to the national bodies of both ISO and IEC.ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements Part 3: Connectors for enteral applications Part 5: Connec
36、tors for limb cuff inflation applications Part 6: Connectors for neuraxial applications Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications Part 20: Common test methodsThe following parts are under preparation: Part 2: Connectors for breathing systems and driving gas
37、es applicationsAn additional part on Connectors for urethral and urinary applications is planned.iv ISO 2015 All rights reservedBS EN ISO 80369-20:2015ISO 80369-20:2015(E)IntroductionIn this part of ISO 80369, the following print types are used: requirements and definitions: roman type; informative
38、material appearing outside of tables, such as notes, examples, and references: in smaller type. Normative text of tables is also in a smaller type; terms defined in ISO 80369-1 and Clause 3: small capitals.In this part of ISO 80369, the conjunctive “or” is used as an “inclusive or” so a statement is
39、 true if any combination of the conditions is true.The verbal forms used in this International Standard conform to usage described in ISO/IEC Directives, Part 2, Annex H. For the purposes of this part of ISO 80369, the auxiliary verb “shall” means that compliance with a requirement or a test is mand
40、atory for compliance with this part of ISO 80369, “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this part of ISO 80369, and “may” is used to describe a permissible way to achieve compliance with a requirement or test.An asterisk (
41、*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.The following paragraph is directed to authorities with jurisdiction and is not intended to address clinical implementation.The attenti
42、on of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations might need a transitional period following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to
43、equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than three years from the date of publication for equipment newly designed and not earlier than five years from th
44、e date of publication for equipment already in production.This part of ISO 80369 describes the common test methods for evaluating the performance requirements of the small-bore connectors specified in this series.During the development of the ISO 80369- series, it became evident that many of the tes
45、t methods were very similar for each of the applications. It was therefore decided to standardize all the test methods into a separate part of the series to prevent unnecessary duplication and minor differences. It is also recognized that not all connectors can be evaluated using each test method in
46、 this part. The test methods applicable to each connector are specified in the respective part of the ISO 80369- series. ISO 2015 All rights reserved vBS EN ISO 80369-20:2015BS EN ISO 80369-20:2015Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods1 *S
47、copeThis part of ISO 80369 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369- series.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its ap
48、plication. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part)
49、 to which they apply.NOTE 2 Informative references are listed in the bibliography.ISO 14971:2007, Medical devices Application of risk management to medical devicesISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 80369-1:2010, ISO 14971:2007, and the following apply.3.1test methoddefinitive procedure for evaluating connectors that produces a test result3.2type testtest on
