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  • DIN EN ISO 80369-7 E : 2017

    Current The latest, up-to-date edition.

    SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Table of Contents - (Show below) - (Hide below)

    National foreword
    National Annex NA (informative) - Bibliography
    European foreword
    Annex ZA (informative) - Relationship between
             this European standard and the essential
             requirements of Directive 93/42/EEC
             [OJ L 169] aimed to be covered
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Dimensional requirements for LUER
      CONNECTORS
    6 Performance requirements
    Annex A (informative) - Rationale and guidance
    Annex B (normative) - LUER 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 LUER CONNECTORS for
            intravascular or hypodermic APPLICATIONS
    Annex F (informative) - Summary of LUER CONNECTOR
            design requirements for intravascular or
            hypodermic APPLICATIONS
    Annex G (informative) - Summary of assessment
            of the design of the LUER CONNECTOR
            for intravascular or hypodermic APPLICATIONS
    Annex H (informative) - Reference to the essential
            principles
    Annex I (informative) - Terminology - Alphabetized
            index of defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes DIN EN 1707 E and DIN EN 20594-1 E. (10/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 5366:2017-04 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016); German version EN ISO 5366:2016
    DIN EN ISO 5366 E : 2017 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES AND CONNECTORS (ISO 5366:2016)

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
    DIN EN ISO 80369-3 E : 2016 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO 80369-3:2016)
    EN ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)
    EN ISO 80369-6 : 2016 COR 2016 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO 80369-6:2016, CORRECTED VERSION 2016-11-15)
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
    ISO 8638:2010 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    ISO 10241-2:2012 Terminological entries in standards — Part 2: Adoption of standardized terminological entries
    DIN EN ISO 178 E : 2013 PLASTICS - DETERMINATION OF FLEXURAL PROPERTIES (ISO 178:2010 + AMD.1:2013)
    ISO 3040:2016 Geometrical product specifications (GPS) Dimensioning and tolerancing Cones
    DIN EN ISO 8638 E : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 527-2:2012 Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    DIN EN 62366-1 : 2017 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
    DIN EN ISO 80369-20 E : 2015 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 20: COMMON TEST METHODS (ISO 80369-20:2015)
    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
    VDE 0750-241-1 : 2017 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    EN ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012)
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    DIN ISO 3040:1991-09 TECHNICAL DRAWINGS - DIMENSIONING AND TOLERANCING - CONES
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    DIN ISO 11040-4 E : 2017 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    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 ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    VDE 0750-1 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
    VDE 0750-1-11 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
    ISO 178:2010 Plastics Determination of flexural properties
    DIN EN 60601-1-12 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT (IEC 60601-1-12:2014)
    EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - 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
    VDE 0750-1-12 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT (IEC 60601-1-12:2014)
    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
    EN ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
    DIN EN 60601-1-11 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11:2015)
    DIN EN ISO 80369-6 E : 2016 SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO 80369-6:2016)
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