1、April 2011 Translation by DIN-Sprachendienst.English price group 14No 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).ICS
2、11.040.10!$noe“1757666www.din.deDDIN EN ISO 80369-1Small bore connectors for liquids and gases in healthcare applications Part 1: General requirements (ISO 80369-1:2010)English translation of DIN EN ISO 80369-1:2011-04Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen
3、Anwendungen Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)Englische bersetzung von DIN EN ISO 80369-1:2011-04Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant Partie 1: Exigences gnrales (ISO 80369-1:2010)Traduction anglaise de DIN EN ISO 80369-1:2011-04Supersede
4、sDIN EN 15546-1:2008-08www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.2803.11 DIN EN ISO 80369-1:2011-04 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 210 “Q
5、uality 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” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was the
6、Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-11 AA Kleinlumige Konnektoren fr Flssigkeiten und Gase zur Verwendung im Gesundheitsbereich. ISO 80369 consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcar
7、e applications: Part 1: General requirements The following parts are under preparation: Part 2: Connectors for breathing systems and driving gases applications Part 3: Connectors for enteral applications Part 4: Connectors for urethral and urinary applications Part 5: Connectors for limb cuff inflat
8、ion applications Part 6: Connectors for neuraxial applications Part 7: Connectors for intravascular or hypodermic applications The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 5356-1 DIN EN ISO 5356-1 ISO 5356-2 DIN EN ISO 5356-2 ISO 535
9、9 DIN EN ISO 5359 ISO 8185 DIN EN ISO 8185 ISO 14971 DIN EN ISO 14971 IEC 60601-1 DIN EN 60601-1 2 DIN EN ISO 80369-1:2011-04 Amendments This standard differs from DIN EN 15546-1:2008-08 as follows: a) Clause 3 “Terms and definitions” has been editorially revised and amended by the terms “accessory”
10、, “breathing system”, “non-interconnectable”, “patient” and “responsible organization”. The terms “risk” and “safety” have been cancelled and replaced by a general reference to the appropriate terms given in EN ISO 14971 and IEC 62366; b) Clause 4 on materials has been amended by a reference to two
11、ASTM standards for tests on conformity; c) Clause 5 on the requirements has been completely revised and amended by a sub-section on incompatibility; d) a new Clause 6 on additional applications has been added; e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (valida
12、tion) has been completely revised, more detailed in the structure and amended. Especially the sections on the proposal initiation (7.2) and on the procedure to assess acceptability and non-interconnectable characteristics (7.3) have been stated more detailed; f) Annex A “Rationale” has been complete
13、ly revised by providing the reasons for this standard by clauses. In addition, Table A.1 on risk analysis of possible misconnections has been cancelled; g) a new Annex B “Mechanical tests for verifying non-interconnectable characteristics” has been added; h) Annex C “Applications” (respectively Clau
14、se B in DIN EN 15546-1) has been editorially revised; i) Annex C “Small bore connectors for vascular systems applications” of DIN EN 15546-1 has been cancelled; j) a new Annex D “Reference to the Essential Principles” according to ISO/TR 16142 has been added; k) Annex ZA on the relationship to the M
15、edical Device Directive (93/42/EWG) has been aligned; l) the Bibliography has been updated and amended; m) a new Clause “Terminology” has been added at the end of the standard; n) the standard has been editorially revised to reflect the current rules for drafting publications. Previous editions DIN
16、EN 15546-1: 2008-08 3 DIN EN ISO 80369-1:2011-04 4 National Annex NA (informative) Bibliography DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded wei
17、ght-bearing connectors DIN EN ISO 5359, Low-pressure hose assemblies for use with medical gases DIN EN ISO 8185, Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems DIN EN ISO 14971, Medical devices Application of risk management to medical de
18、vices DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80369-1 December 2010 ICS 11.040.10; 11.040.20 Supersedes EN 15546-1:2008 English version Small bore connectors for liqu
19、ids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant - Partie 1: Exigences gnrales (ISO 80369-1:2010) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinisc
20、hen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010) This European Standard was approved by CEN on 14 December 2010. 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
21、 national standard without 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 and CENELEC member. This European Standard exists in three official versions (English, Frenc
22、h, German). A version in any other language made by translation 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 nat
23、ional electrotechnical committees of Austria, Belgium, Bulgaria, 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, Swe
24、den, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Re
25、f. No. EN ISO 80369-1:2010 EAnnex ZA .Relationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EEC.22Contents Page Foreword .3 Introduction .5 1 Scope 7 2 Normative references 8 3 Terms and definitions .8 4 Materials used for SMALL-BORE CONNECTORS 9 5 Requireme
26、nts for SMALL-BORE CONNECTORS for specific APPLICATIONS 10 5.1 SMALL-BORE CONNECTOR incompatibility.10 5.2 BREATHING SYSTEMS and driving gases APPLICATIONS 10 5.3 Enteral and gastric APPLICATIONS10 5.4 Urethral and urinary APPLICATIONS 10 5.5 Limb cuff inflation APPLICATIONS .10 5.6 Neuraxial APPLIC
27、ATIONS 11 5.7 Intravascular or hypodermic APPLICATIONS .11 5.8 Alternative SMALL-BORE CONNECTORS 11 6 Additional SMALL-BORE CONNECTOR APPLICATIONS .11 7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for inclusion in this series of standards 12 7.1 General .12 7.2 Proposal initiat
28、ion .12 7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics 12 7.3.1 Design .12 7.3.2 Design realization 12 7.3.3 Design VERIFICATION . 7.3.4 Design validation .13 7.4 Design review 13 7.5 Subsequent parts of this series of standards 13 Annex A (informative) Rationale Anne
29、x B (normative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics .17 Annex C (informative) APPLICATIONS of SMALL-BORE CONNECTORS .18 Annex D (informative) Reference to the Essential Principles 20 Bibliography23 Terminology Alphabetized index of defined terms 24 (informative)EN ISO
30、 80369-1:2010 (E) DIN EN ISO 80369-1:2011-04 21314Foreword This document (EN ISO 80369-1:2010) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices“ in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and
31、 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 latest by June 2011, and conflicting national standards shall be
32、withdrawn at the latest by June 2011. 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 15546-1:2008. This d
33、ocument 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. Compared to EN 155
34、46-1:2008 the following changes were implemented: a) Clause 3 “Terms and definitions“ has been editorially revised and amended by the terms “accessory“, “breathing system“, “non-interconnectable“, “patient“ and “responsible organization“. The terms “risk“ and “safety“ have been cancelled and replace
35、d by a general reference to the appropriate terms given in EN ISO 14971 and IEC 62366; b) Clause 4 on materials has been amended by a reference to two ASTM standards for tests on conformity; c) Clause 5 on the requirements has been completely revised and amended by a sub-section on incompatibility;
36、d) A new Clause 6 on additional applications has been added; e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (validation) has been completely revised, more detailed in the structure and amended. Especially the sections on the proposal initiation (7.2) and on the pr
37、ocedure to assess acceptability and non-interconnectable characteristics (7.3) have been stated more detailed; f) Annex A “Rationale“ has been completely revised by providing the reasons for this standard by clauses. In addition the Table A.1 on risk analysis of possible misconnections has been canc
38、elled; g) A new Annex B “Mechanical tests for verifying non-interconnectable characteristics“ has been added; h) Annex C “Applications“ (respectively Clause B in EN 15546-1) has been editorially revised; i) Annex C “Small bore connectors for vascular systems applications“ of EN 15546-1 has been canc
39、elled; j) A new Annex D “Reference to the Essential Principles“ according ISO/TR 16142 has been added; k) Annex ZA on the relationship to the Medical Device Directive (93/42/EWG) has been aligned; l) The Bibliography has been updated and amended; 3EN ISO 80369-1:2010 (E) DIN EN ISO 80369-1:2011-04 m
40、) A new clause Terminology has been added at the end of the standard; n) Editorial revision in alignment with the overtaking of the original European Standard into an International Standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following coun
41、tries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slov
42、enia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 80369-1:2010 has been approved by CEN as a EN ISO 80369-1:2010 without any modification. EN ISO 80369-1:2010 (E) DIN EN ISO 80369-1:2011-04 4Introduction In the 1990s concern grew regarding the proliferation
43、of MEDICAL DEVICES fitted with Luer CONNECTORS and the reports of PATIENT death or injury arising from misconnections that resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases. Concerns regarding the use of Luer CONNECTORS with enteral feeding tubes
44、 and gas sampling and gas delivery systems were raised with CEN/BT and the European Commission. In November 1997 the newly created CHeF steering group set up a Forum Task Group (FTG) to consider the problem. The FTG produced CEN Report CR 13825, in which they concluded that there is a problem arisin
45、g from the use of a single CONNECTOR design to a number of incompatible APPLICATIONS. In a coronary care unit there are as many as 40 Luer CONNECTORS on the MEDICAL DEVICES used with a single PATIENT. Therefore it is not surprising that misconnections are made. MEDICAL DEVICES have for many years fo
46、llowed the established principle of “safety under single fault conditions”. Simply stated this means that a single fault should not result in an unacceptable RISK. This principle is embodied in the requirements of numerous MEDICAL DEVICE standards. Extending this principle to the application of Luer
47、 CONNECTORS, i.e. that misconnection should not result in an unacceptable RISK to a PATIENT, the FTG recommended that the Luer CONNECTOR should be restricted to MEDICAL DEVICES intended to be connected to the vascular system or a hypodermic syringe. In addition, new designs of SMALL-BORE CONNECTORS
48、should be developed for other APPLICATIONS, and these should be NON-INTERCONNECTABLE with Luer CONNECTORS and each other. ISO/TR 16142:2006 addresses this type of problem in Essential Principle A.1.2: The solutions adopted by the manufacturer for the design and construction of the devices should con
49、form to safety principles, taking into account the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer should apply the following principles in the following order: identify hazards and the associated risks arising from the intended use and foreseeable misuse; eliminate or reduce risks as far as possible (inherently safe design and construction); It is understood that SMALL-BORE CONNECTOR systems cannot be designed to overcome all chances of misconnection or to eliminat
