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  • EN ISO 7864:2016

    Current The latest, up-to-date edition.

    Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

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    Language(s): 

    Published date:  31-08-2016

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Packaging
    6 Information supplied by the manufacturer
    Annex A (normative) - Method for preparation
            of extracts
    Annex B (informative) - Fragmentation test for
            medical needles
    Annex C (informative) - Determination of flow
            rate through the needle
    Annex D (informative) - Test method for measuring
            the penetration force and drag force for needles
    Annex E (informative) - Needle bonding strength
            test method
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC [OJ L 169] aimed to be
             covered

    Abstract - (Show below) - (Hide below)

    ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

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

    Committee CEN/TC 205
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

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

    DIN EN ISO 1135-3:2014-12 (Draft) TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    I.S. EN 60601-2-24:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
    BS EN ISO 8536-9:2015 Infusion equipment for medical use Fluid lines for single use with pressure infusion equipment
    EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    I.S. EN ISO 8536-9:2015 INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015)
    CEI EN 60601-2-24 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
    14/30303657 DC : 0 BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE
    12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
    UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    UNE-EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    DIN EN ISO 1135-4:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    I.S. EN ISO 1135-4:2015 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    I.S. EN ISO 8537:2016 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
    DIN EN ISO 1135-3:2017-05 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    BS ISO 7886-2 : 1996 AMD 9835 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - SYRINGES FOR USE WITH POWER-DRIVEN SYRINGE PUMPS
    DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    EN ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)
    PREN 13976-2 : DRAFT 2016 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    DIN EN ISO 1135-3 E : 2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    BS EN 60601-2-24:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    03/100549 DC : DRAFT APR 2003 IEC 60664-4 ED. 2 - INSULATION COORDINATION FOR EQUIPMENT WITHIN LOW-VOLTAGE SYSTEMS - PART 4: CONSIDERATION OF HIGH-FREQUENCY VOLTAGE STRESS WITH RESPECT TO INSULATION COORDINATION OF EQUIPMENT WITHIN LOW-VOLTAGE SYSTEMS
    I.S. EN 13976-2:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    UNE-EN ISO 1135-4:2016 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
    UNE-EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    BS EN ISO 7886-2:1997 Sterile hypodermic syringes for single use Syringes for use with power-driven syringe pumps
    BS EN 13976-2:2011 Rescue systems. Transportation of incubators System requirements
    ISO 1135-4:2015 Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
    BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
    ISO 8536-9:2015 Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    DIN EN 13976-2 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    BS 5724-2.124(1998) : 1998 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS
    16/30333925 DC : 0 BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    DIN EN 13976-2:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    UNE-EN ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)
    EN 60601-2-24:2015 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    EN ISO 1135-4 : 2015 COR 2016 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    DIN EN 13976-2:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS

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

    ISO 8362-7:2006 Injection containers and accessories Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
    EN ISO 23908:2013 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
    ISO 8362-2:2015 Injection containers and accessories — Part 2: Closures for injection vials
    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
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
    EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    ISO 8362-4:2011 Injection containers and accessories Part 4: Injection vials made of moulded glass
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 8362-3:2001 Injection containers and accessories Part 3: Aluminium caps for injection vials
    ISO 8362-6:2010 Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials
    ISO 8362-5:2016 Injection containers and accessories Part 5: Freeze drying closures for injection vials
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 8362-1:2009 Injection containers and accessories Part 1: Injection vials made of glass tubing
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
    ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
    ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
    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 ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
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