1、 IEC 80369-5 Edition 1.0 2016-03 INTERNATIONAL STANDARD NORME INTERNATIONALE Small-bore connectors for liquids and gases in healthcare applications Part 5: Connectors for limb cuff inflation applications Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant Partie 5: Racc
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20、 for liquids and gases in healthcare applications Part 5: Connectors for limb cuff inflation applications Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant Partie 5: Raccords destins des applications au gonflage de brassard INTERNATIONAL ELECTROTECHNICAL COMMISSION CO
21、MMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.20 ISBN 978-2-8322-3211-8 Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 IEC 80369-5:2016 IEC 2016 CONTENTS FO
22、REWORD . 4 INTRODUCTION . 6 1 * Scope . 7 2 Normative references. 7 3 Terms and definitions 8 4 General requirements 9 4.1 General requirements for the limb cuff inflation APPLICATION . 9 4.2 Materials used for SMALL-BORE CONNECTORS . 9 4.3 TYPE TESTS 10 5 Dimensional requirements for sphygmomanomet
23、er and cuff SMALL-BORE CONNECTORS 10 5.1 * Requirements for adult or paediatric PATIENT SMALL-BORE CONNECTORS (S1) . 10 5.2 Void 10 6 Performance requirements . 10 6.1 Air leakage 10 6.2 * Resistance to separation from axial load . 10 Annex A (informative) Rationale and guidance 11 A.1 General guida
24、nce 11 A.2 Rationale for particular clauses and subclauses . 11 Annex B (normative) SMALL-BORE CONNECTORS for the limb cuff inflation APPLICATION 13 Annex C (normative) Reference CONNECTORS . 17 C.1 General requirements for reference CONNECTORS . 17 C.2 * Sphygmomanometer and cuff S1 reference CONNE
25、CTORS . 17 Annex D (informative) Assessment of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION . 18 Annex E (informative) Summary of the usability requirements for SMALL-BORE CONNECTORS for limb cuff inflation APPLICATIONS 19 E.1 USER PROFILE 19 E.2 Use scenarios . 19 E
26、.3 Use environments and scenarios . 20 E.4 Generic USER needs 20 Annex F (informative) Summary of SMALL-BORE CONNECTOR design requirements for limb cuff inflation APPLICATIONS 21 Annex G (informative) Summary of assessment of the design of the CONNECTORS for limb cuff inflation APPLICATION . 29 G.1
27、General . 29 G.2 Summary of the engineering analysis of the design 29 G.2.1 NON-INTERCONNECTABLE analysis 29 G.2.2 S1 male to N1 male 29 G.3 Summary of the design VERIFICATION 29 G.4 Summary of the design validation 30 G.5 Summary of the design review . 30 Annex H (informative) Obsolete limb cuff in
28、flation CONNECTOR 31 Annex I (informative) Air leakage by pressure decay TEST METHOD 34 I.1 Principle . 34 IEC 80369-5:2016 IEC 2016 3 I.2 * Test conditions . 34 I.2.1 Test sample preconditioning . 34 I.2.2 Environmental test conditions . 34 I.3 Apparatus . 34 I.4 PROCEDURE . 34 I.5 Test report 35 A
29、nnex J (informative) Resistance to separation from axial load TEST METHOD . 36 J.1 Principle . 36 J.2 * Test conditions . 36 J.2.1 Test sample preconditioning . 36 J.2.2 Environmental test conditions . 36 J.3 Apparatus . 36 J.4 PROCEDURE . 36 J.5 Test report 36 Annex K (informative) Reference to the
30、 essential principles 37 Index of defined terms 39 Bibliography . 40 Figure B.1 Male cuff S1 SMALL-BORE CONNECTOR . 13 Figure B.2 Female sphygmomanometer S1 SMALL-BORE CONNECTOR 15 Figure B.3 Sphygmomanometer and cuff SMALL-BORE CONNECTOR (S1) assembly . 15 Figure H.1 Obsolete sphygmomanometer and c
31、uff SMALL-BORE CONNECTOR . 32 Table B.1 Male cuff S1 SMALL-BORE CONNECTOR dimensions 14 Table B.2 Female sphygmomanometer S1 SMALL-BORE CONNECTOR dimensions . 16 Table E.1 USER PROFILE . 19 Table F.1 Adult or paediatric PATIENT sphygmomanometer and cuff S1 CONNECTOR- specific design requirements (1
32、of 4) . 21 Table F.2 Neonatal sphygmomanometer and cuff CONNECTOR-specific design requirements (1 of 4) 25 Table G.1 Summary of possible misconnection from CAD analysis 29 Table H.1 Obsolete male sphygmomanometer and cuff SMALL-BORE CONNECTOR dimensions . 33 Table H.2 Obsolete female sphygmomanomete
33、r and cuff SMALL-BORE CONNECTOR dimensions . 33 Table K.1 Correspondence between this document and the essential principles (1 of 2) . 37 4 IEC 80369-5:2016 IEC 2016 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS Part 5: Connectors
34、for limb cuff inflation applications FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questi
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44、 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 80369-5 has been prepared by a Joint Working Group of subcommit
45、tee 62D: Electromedical equipment of IEC technical committee 62: Electrical equipment in medical practice, ISO technical committee 210, Quality management and corresponding general aspects for medical devices and CEN/CENELEC TC3/WG 2, Small- bore connectors. The text of this standard is based on the
46、 following documents: FDIS Report on voting 62D/1306/FDIS 62D/1329/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 23 P members out of 23 having cast a vote. This publica
47、tion has been drafted in accordance with the ISO/IEC Directives, Part 2. IEC 80369-5:2016 IEC 2016 5 A list of all parts in the International Standard 80369 series, published under the general title Small-bore connectors for liquids and gases in healthcare applications, can be found on the IEC and I
48、SO websites. In this standard, the following print types are used: Requirements and definitions: roman 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 CLAUSE 3 OF THI
49、S STANDARD OR AS NOTED IN THE INDEX OF DEFINED TERMS: SMALL CAPITALS. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a t
