1、September 2015 Translation by DIN-Sprachendienst.English price group 15No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).
2、ICS 11.040.25!%F0-“2351310www.din.deDDIN EN ISO 80369-20Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods (ISO 80369-20:2015);English version EN ISO 80369-20:2015,English translation of DIN EN ISO 80369-20:2015-09Verbindungsstcke mit kleinem Durchmes
3、ser fr Flssigkeiten undGase in medizinischen Anwendungen Teil 20: Allgemeine Prfverfahren (ISO 80369-20:2015);Englische Fassung EN ISO 80369-20:2015,Englische bersetzung von DIN EN ISO 80369-20:2015-09Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant Partie 20: Mthode
4、s dessai communes (ISO 80369-20:2015);Version anglaise EN ISO 80369-20:2015,Traduction anglaise de DIN EN ISO 80369-20:2015-09www.beuth.deDocument comprises 38 pagesIn case of doubt, the German-language original shall be considered authoritative.08.15 DIN EN ISO 80369-20:2015-09 2 A comma is used as
5、 the decimal marker. National 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” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/CLC/TC 3 “Quality manageme
6、nt and corresponding general aspects for medical devices” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-11 AA Kleinlumige Konnektoren fr Flssigkeiten und Gas
7、e zur Verwendung im Gesundheitsbereich. EN 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: Connectors for limb cuff inflation ap
8、plications Part 6: Connectors for neuraxial applications Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications Part 20: Common test methods The following parts are under preparation: Part 2: Connectors for breathing systems and driving gases applications An additional
9、 part on Connectors for urethral and urinary applications is planned. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 5479 DIN EN ISO 5479 ISO 14971 DIN EN ISO 14971 ISO 80000 (all parts) DIN EN ISO 80000 (all parts) ISO 80369-1 DIN EN
10、ISO 80369-1 IEC 60027 (all parts) DIN EN 60027 (all parts) DIN EN ISO 80369-20:2015-09 3 National Annex NA (informative) Bibliography DIN EN 60027 (all parts), Letter symbols to be used in electrical technology DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN E
11、N ISO 80000 (all parts), Quantities and units DIN EN ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements DIN ISO 5479, Statistical interpretation of data Tests for departure from the normal distribution DIN EN ISO 80369-20:2015-09 4 This p
12、age is intentionally blank EUROPEAN 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 methods(ISO 80369-20:2015) Raccords de petite taille pour liquides et gaz
13、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 80369-20:2015) This European Standard was approved by CEN on 5 March 2015
14、. 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 and bibliographical references concerning such national standards may be
15、 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 translation under the responsibility of a CEN and CENELEC member into its own la
16、nguage 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former
17、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 COMMITTEE FOR STANDARDIZATION COMIT EUR
18、OPEN 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 Members and for CENELEC Members. Ref. No. EN ISO 80369-20:2015 EForeword
19、3Introduction 41 *Scope 52 Normative references 53 Terms and definitions . 54 Test methods for small-bore connectors 5Annex A (informative) Rationale and guidance 7Annex B (normative) *Leakage by pressure decay test method 10Annex C (normative) Falling drop positive-pressure liquid leakage test meth
20、od 13Annex D (normative) Subatmospheric-pressure air leakage test method 15Annex E (normative) Stress cracking test method 19Annex F (normative) Resistance to separation from axial load test method .21Annex G (normative) Resistance to separation from unscrewing test method .23Annex H (normative) Res
21、istance to overriding test method .25Annex I (normative) Disconnection by unscrewing test method .27Annex J (informative) Modification of the test methods to generate variable data for statistical analysis 29Annex K (informative) Terminology alphabetized index of defined terms .32Bibliography .34Con
22、tents PageAnnex ZA (informative) Relationship between this part of EN ISO 80369 and the essential requirements of EU Directive 93/42/EEC 33 .DIN EN ISO 80369-20:2015-09 EN ISO 80369-20:2015 (E) 2 Foreword This document (EN ISO 80369-20:2015) has been prepared by Technical Committee ISO/TC 210 “Quali
23、ty management and corresponding general aspects for medical devices” in collaboration 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 nation
24、al standard, either by publication of an identical text or by endorsement, at the latest 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 pate
25、nt 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 European Free Trade Association, and supports essential requirements of EU Directive(s). For rela
26、tionship with EU Directive(s), 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 countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
27、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, Turkey and the Un
28、ited Kingdom. Endorsement notice The text of ISO 80369-20:2015 has been approved by CEN as EN ISO 80369-20:2015 without any modification. DIN EN ISO 80369-20:2015-09 EN ISO 80369-20:2015 (E) 3 IntroductionIn this part of ISO 80369, the following print types are used: requirements and definitions: ro
29、man type; informative 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
30、 or” so a statement is 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 require
31、ment or a test is mandatory 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
32、 or test.An asterisk (*) 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 impl
33、ementation.The attention 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 ne
34、w requirements and to 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 t
35、han five years from the 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 eviden
36、t that many of the test 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 usi
37、ng each test method in this part. The test methods applicable to each connector are specified in the respective part of the ISO 80369- series.DIN EN ISO 80369-20:2015-09 EN ISO 80369-20:2015 (E) 4 1 *ScopeThis part of ISO 80369 specifies the test methods to evaluate the performance requirements for
38、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 application. For dated references, only the edition cited applies. For undated references, the latest
39、 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) to which they apply.NOTE 2 Informative references are listed in the bibliography.ISO 14971:2007, M
40、edical 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 1497
41、1:2007, and the following apply.3.1test methoddefinitive procedure for evaluating connectors that produces a test result3.2type testtest on a representativeSOURCE: IEC 60601-1:2005, definition 3.1354 Test methods for small-bore connectorsTable 1 contains the list of test methods and their correspond
42、ing Annex included in this part of ISO 80369.DIN EN ISO 80369-20:2015-09 EN ISO 80369-20:2015 (E) 5 Table 1 Test methods and corresponding Annex of this part of ISO 80369Test method AnnexLeakage by pressure decay Annex BPositive pressure liquid leakage Annex CSubatmospheric-pressure air leakage Anne
43、x DStress cracking Annex EResistance to separation from axial load Annex FResistance to separation from unscrewing Annex GResistance to overriding Annex HDisconnection by unscrewing Annex IModification of the test methods to generate variable data for statistical analysisAnnex JNOTE Manufacturers ca
44、n use the modified test methods of Annex J.DIN EN ISO 80369-20:2015-09 EN ISO 80369-20:2015 (E) 6 Annex A (informative) Rationale and guidanceA.1 General guidanceThis annex provides a rationale for some requirements of this part of ISO 80369 and is intended for those who are familiar with the subjec
45、t of this part of ISO 80369, but who have not participated in its development. An understanding of the rationale underlying these requirements is considered to be essential for their proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale for the
46、present requirements will facilitate any revision of this part of ISO 80369 necessitated by those developments.The committee attempted to harmonize the functional test methods for the connectors of each application in this part of ISO 80369. The test method annexes in this part of ISO 80369 describe
47、 a specific test procedure for a type test, but allow for modification to specific test conditions or acceptance criteria as necessary for each application.Many of the test methods in this part of ISO 80369 were extracted from the ISO 594- series of standards. The committee attempted to minimize changes to these test methods. However, changes were made to test methods which contained subjective acceptance cr
