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ANSI/AAMI/ISO 80369-3:2016

Current
Current

The latest, up-to-date edition.

SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-03-2016

Glossary of equivalent standards
Committee representation
Background on ANSI/AAMI adoption
of ISO 80369-3:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for
  ENTERAL SMALL-BORE CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and
        guidance
Annex B (normative) - ENTERAL SMALL-BORE
       CONNECTORS
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 ENTERAL applications
Annex F (informative) - Summary of SMALL-BORE
        CONNECTOR criteria and requirements for
        ENTERAL APPLICATIONS
Annex G (informative) - Summary of assessment
        of the design of the CONNECTORS for ENTERAL
        APPLICATIONS
Annex H (informative) - Reference to the essential
        principles
Annex I (informative) - Terminology - Alphabetized
        index of defined terms
Bibliography

Describes the dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS on ENTERAL MEDICAL DEVICES and ACCESSORIES.

Committee
ISO/TC 210
DevelopmentNote
NEW CHILD AMD 1 NOW IS ADDED
DocumentType
Standard
ISBN
1-57020-620-1
Pages
66
ProductNote
NEW CHILD AMD 1 NOW IS ADDED
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

Standards Relationship
ISO 80369-3:2016 Identical

EN 1618 : 1997 CATHETERS OTHER THAN INTRAVASCULAR CATHETERS - TEST METHODS FOR COMMON PROPERTIES
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 10241-2:2012 Terminological entries in standards — Part 2: Adoption of standardized terminological entries
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
EN 1615 : 2000 ENTERAL FEEDING CATHETERS AND ENTERAL GIVING SETS FOR SINGLE USE AND THEIR CONNECTORS - DESIGN AND TESTING
ISO 10241-1:2011 Terminological entries in standards — Part 1: General requirements and examples of presentation
ISO 14971:2007 Medical devices Application of risk management to medical devices
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

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