ISO 80369-1 2018 医疗应用中用于液体和气体的小口径连接器一 第1部分 一般要求(英文版).pdf

2018,80369,ISO,pdf,连接器,国外及港澳台标准
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American National Standard

ANSI/AAMI/ISO 80369-1:2018

Small-bore connectorsfor liquids and gases inhealthcare applications-Part 1: General requirements

Small-bore connectors for liquids and gases in healthcare applicationsPart 1: General requirements

Approved 11July 2019byAAMI

Approved9December2019byAmericanNationalStandardsInstitute

Abstract:

healthcareAPPLICATIONS.TheseSMALL-BORECONNECTORSareusedinMEDICALDEVICESorACCESSORIESintendedforusewithaPATIENT.

AAMIStandard

ThisAssociationfor theAdvancementof Medical Instrumentation(AAMl)standard impliesaconsensusofthosesubstantially concerned with its scope andprovisions.The existence of anAAMlstandard does not in anyrespectproducts processes orproceduresnotconformingtothestandard.AAMlstandardsaresubjecttoperiodicreview andusersarecautionedtoobtainthelatesteditions.

partiesmayobtaincurrent informationonall AAMI standardsbycalling orwritingAAMI.

AllAAMIstandards remendedpractices technicalinformationreports andothertypesoftechnical documentsdeveloped by AAMI are voluntary and their application is solely within the discretion and professional judgment of theprocurementauthorities inwhichcasetheadoptingagencyisresponsibleforenforcementofitsrulesandregulations.

Publishedby

901N.GlebeRoad Suite300 AAMI Arlington VA22203

2019bytheAssociationfortheAdvancementofMedicalInstrumentation

All RightsReserved

ThispublicationissubjecttocopyrightclaimsofISOandAAMl.Nopartof thispublicationmaybereproducedortomakecopiesofalloranypartofthisdocument(whetherinternallyorexternally)withoutthepriorwrittenpermissionof theAssociationfor the Advancement of Medical Instrumentation.Violatorsrisk legal action including civil andcriminalpenalties anddamagesof$1oo oo0peroffense.Forpermissionregardingtheuseofalloranypartofthisdocument contactAAMl 901N.GlebeRoad Suite300 Arlington VA22203Phone:(703)525-4890;Fax:(703)525-1067.

PrintedintheUnitedStatesofAmerica

ISBN978-1-57020-735-8

Contents

Committeerepresentation....IVBackgroundofANS/AAMI adoption of ISO 80369-1:2018.Foreword... ..vii...viiIntroduction..1 *Scope....2 *Normativereferences... .23 Terms and definitions....4 *Materials.5 SMALL-BORECONNECTORincOmpatibility6 *CLINIcAL applicationS....7 *AIternativeSMALL-BORECONNECTORS...AnnexA(informative)Rationale......0Annex C(informative)Symbolsand safety signs.. ...23AnnexD(normative)AsSeSSmentPROcEDURESSMALL-BOREcONNECToRS. ...24AnnexE(informative)APPLICATIONSofSMALL-BORECONNECTORS... ..26AnnexF(informative)ReferencetotheEssentialPrinciples.. ...8Bibliography.... ...29Alphabetizedindexofdefinedterms. .31

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