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ANSI/AAMI/ISO 80369-5:2016

Current
Current

The latest, up-to-date edition.

SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-01-2016

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI/ISO 80369-5:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for sphygmomanometer and cuff
  SMALL-BORE CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS for the
        limb cuff inflation APPLICATION
Annex C (normative) - Reference CONNECTORS
Annex D (informative) - Assessment of MEDICAL DEVICES
        and their attributes with CONNECTIONS within this
        APPLICATION
Annex E (informative) - Summary of the usability requirements
        for SMALL-BORE CONNECTORS for limb cuff inflation
        APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
        design requirements for limb cuff inflation
        APPLICATIONS
Annex G (informative) - Summary of assessment of the design
        of the CONNECTORS for limb cuff inflation
        APPLICATION
Annex H (informative) - Obsolete limb cuff inflation CONNECTOR
Annex I (informative) - Air leakage by pressure decay TEST METHOD
Annex J (informative) - Resistance to separation from axial load
        TEST METHOD
Annex K (informative) - Reference to the essential principles
Index of defined terms
Bibliography

Describes dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES.

Committee
ISO/TC 210
DocumentType
Standard
ISBN
1-57020-609-0
Pages
47
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

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ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
IEC 80601-2-30:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications

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