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  • ISO 9626:2016

    Current The latest, up-to-date edition.

    Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  02-08-2016

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.

    It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device.

    It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).

    It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

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

    Development Note Supersedes ISO/DIS 9626. (08/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    UNE-EN 60695-11-5:2017 Fire hazard testing - Part 11-5: Test flames - Needle-flame test method - Apparatus, confirmatory test arrangement and guidance
    13/30276989 DC : 0 BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS
    03/113406 DC : DRAFT OCT 2003 ISO 7886-3 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED DOSE IMMUNIZATION
    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)
    14/30298393 DC : 0 BS EN ISO 6009 - HYPODERMIC NEEDLES FOR SINGLE USE - COLOUR CODING FOR IDENTIFICATION
    17/30350521 DC : 0 BS EN ISO 7886-4 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 4: SYRINGES WITH RE-USE PREVENTION FEATURE
    IEC 60695-11-5:2016 RLV Fire hazard testing - Part 11-5: Test flames - Needle-flame test method - Apparatus, confirmatory test arrangement and guidance
    UNE-EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
    UNI EN ISO 7886-4 : 2009 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 4: SYRINGES WITH RE-USE PREVENTION FEATURE
    DIN EN ISO 11070:2015-03 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
    I.S. EN ISO 3826-1:2013 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
    ISO 10555-5:2013 Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
    BS EN ISO 7885:2010 Dentistry. Sterile injection needles for single use
    DIN EN ISO 7886-4:2010-01 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 4: SYRINGES WITH RE-USE PREVENTION FEATURE
    ONORM EN ISO 11608-2 : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)
    14/30296389 DC : 0 BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
    17/30345938 DC : 0 BS ISO 20698 - CATHETER SYSTEMS FOR NEURAXIAL APPLICATION - STERILE AND SINGLE-USE CATHETERS AND ACCESSORIES
    CEI EN 60695-11-5 : 2006 FIRE HAZARD TESTING - PART 11-5: TEST FLAMES - NEEDLE-FLAME TEST METHOD - APPARATUS, CONFIRMATORY TEST ARRANGEMENT AND GUIDANCE
    17/30357741 DC : 0 BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
    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)
    14/30294895 DC : 0 BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
    09/30168835 DC : 0 BS EN ISO 7885 - STERILE DENTAL INJECTION NEEDLES FOR SINGLE USE
    BS ISO 11040-4:2015 Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
    BS EN ISO 11070 : 2014 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
    I.S. EN ISO 11070:2014 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    EN ISO 7886-4:2009 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
    BS EN ISO 7886-4:2009 Sterile hypodermic syringes for single use Syringes with re-use prevention feature
    DIN EN ISO 3826-1:2013-09 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
    UNI EN ISO 3826-1 : 2013 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
    BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
    BS EN ISO 7886-3:2009 Sterile hypodermic syringes for single use Auto-disable syringes for fixed-dose immunization
    BS EN ISO 6009 : 1995 HYPODERMIC NEEDLES FOR SINGLE USE - COLOUR CODING FOR IDENTIFICATION
    DIN EN ISO 7886-3:2010-01 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
    I.S. EN ISO 6009:2016 HYPODERMIC NEEDLES FOR SINGLE USE - COLOUR CODING FOR IDENTIFICATION (ISO/DIS 6009:2014)
    UNI EN ISO 7886-3 : 2009 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
    I.S. EN ISO 10555-5:2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS (ISO 10555-5:2013)
    DIN EN ISO 7885:2010-06 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
    I.S. EN ISO 8537:2016 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
    I.S. EN ISO 7885:2010 DENTISTRY - STERILE INJECTION NEEDLES FOR SINGLE USE
    I.S. EN ISO 11608-2:2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)
    I.S. EN ISO 7864:2016 STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
    DIN EN ISO 1135-3:2017-05 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    UNI EN ISO 11070 : 2015 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
    PD ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
    I.S. EN 60695-11-5:2017 FIRE HAZARD TESTING - PART 11-5: TEST FLAMES - NEEDLE-FLAME TEST METHOD - APPARATUS, CONFIRMATORY TEST ARRANGEMENT AND GUIDANCE
    PREN ISO 11608-2 : DRAFT 2010 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
    13/30273499 DC : 0 BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    I.S. EN ISO 1135-3:2017 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
    DIN EN ISO 7886-4 E : 2010 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 4: SYRINGES WITH RE-USE PREVENTION FEATURE
    ISO 17218:2014 Sterile acupuncture needles for single use
    ISO 7886-4:2006 Sterile hypodermic syringes for single use Part 4: Syringes with re-use prevention feature
    NF EN ISO 7886-3 : 2009 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
    DIN EN ISO 7886-3 E : 2010 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
    UNE-EN ISO 10555-5:2014 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)
    ONORM EN ISO 7886-3 : 2010 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
    EN ISO 7886-3:2009 Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
    I.S. EN ISO 7886-3:2009 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
    UNE-EN ISO 7885:2010 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
    UNI EN ISO 10555-5 : 2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS
    UNI EN ISO 11608-2 : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
    UNI EN ISO 7885 : 2010 DENTISTRY - STERILE INJECTION NEEDLES FOR SINGLE USE
    15/30282343 DC : 0 BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
    15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
    16/30339096 DC : 0 BS EN ISO 7886-3 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
    13/30259011 DC : 0 BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
    ISO 18746:2016 Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use
    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 60695-11-5:2017 Fire hazard testing Test flames. Needle-flame test method. Apparatus, confirmatory test arrangement and guidance
    10/30209603 DC : 0 BS EN ISO 11608-2 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
    ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
    PREN ISO 3826-1 : DRAFT 2010 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
    ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    I.S. EN ISO 7886-4:2009 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 4: SYRINGES WITH RE-USE PREVENTION FEATURE
    DIN EN ISO 11608-2 E : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)
    BS EN ISO 11608-2:2012 Needle-based injection systems for medical use. Requirements and test methods Needles
    UNE-EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    ISO 1135-3:2016 Transfusion equipment for medical use Part 3: Blood-taking sets for single use
    ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
    ISO 7885:2010 Dentistry Sterile injection needles for single use
    BS EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components Conventional containers
    UNE-EN ISO 6009:2017 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    UNE-EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    BS EN ISO 10555-5:2013 Intravascular catheters. Sterile and single-use catheters Over-needle peripheral catheters
    DIN EN ISO 11608-2:2012-12 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
    ISO 7886-3:2005 Sterile hypodermic syringes for single use Part 3: Auto-disable syringes for fixed-dose immunization
    ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
    UNE-EN ISO 11070:2015 Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    UNE-EN ISO 7864:2017 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
    EN ISO 10555-5:2013 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)
    EN ISO 1135-3:2017 Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
    EN ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    EN ISO 7885:2010 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
    EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
    BS ISO 17218:2014 Sterile acupuncture needles for single use
    ONORM EN ISO 7886-4 : 2010 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 4: SYRINGES WITH RE-USE PREVENTION FEATURE
    BS EN ISO 1135-3:2017 Transfusion equipment for medical use Blood-taking sets for single use
    10/30233840 DC : 0 BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
    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
    DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    11/30235338 DC : 0 BS EN ISO 10555-5 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS
    EN 60695-11-5:2017 Fire hazard testing - Part 11-5: Test flames - Needle-flame test method - Apparatus, confirmatory test arrangement and guidance
    NF EN ISO 7886-4 : 2009 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 4: SYRINGES WITH RE-USE PREVENTION FEATURE
    IEC 60695-11-5 : 2.0 FIRE HAZARD TESTING - PART 11-5: TEST FLAMES - NEEDLE-FLAME TEST METHOD - APPARATUS, CONFIRMATORY TEST ARRANGEMENT AND GUIDANCE
    DIN EN ISO 10555-5:2013-11 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS (ISO 10555-5:2013)
    DIN ISO 11040-4:2017-07 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    IEC 60695-11-5:2016 Fire hazard testing - Part 11-5: Test flames - Needle-flame test method - Apparatus, confirmatory test arrangement and guidance

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

    ISO 15510:2014 Stainless steels Chemical composition
    ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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