ISO 80369-3:2016 - $185.00   BUY NOW

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications

ISO 80369-3:2016 Publication Description:

ISO 80369-3:2016 specifies 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.

NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports.

It does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

It does not specify requirements for small-bore connectors that are used for the following:

- gastric suction-only medical devices;

- oral-only medical devices;

EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth.

- pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place;

- medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;

- gastrointestinal endoscopy equipment;

- skin level gastrostomy medical devices.

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Syringes/Catheters (11.040.25)

ICS Related Standards

Cart Document Number Document Title
$138.00 ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
$45.00 ISO 10555-3:2013 Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
$68.00 ISO 10555-4:2013 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
$68.00 ISO 10555-5:2013 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters
$103.00 ISO 10555-6:2015 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
$45.00 ISO 11040-1:2015 Prefilled syringes - Part 1: Glass cylinders for dental local anaesthetic cartridges
$45.00 ISO 11040-2:2011 Prefilled syringes - Part 2: Plunger stoppers for dental local anaesthetic cartridges
$45.00 ISO 11040-3:2012 Prefilled syringes - Part 3: Seals for dental local anaesthetic cartridges
$209.00 ISO 11040-4:2015 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
$88.00 ISO 11040-4:2007 Prefilled syringes - Part 4: Glass barrels for injectables
$45.00 ISO 11040-5:2012 Prefilled syringes - Part 5: Plunger stoppers for injectables
$68.00 ISO 11040-6:2012 Prefilled syringes - Part 6: Plastic barrels for injectables
$162.00 ISO 11040-7:2015 Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling
$68.00 ISO 11040-8:2016 Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes
$138.00 ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
$185.00 ISO 11608-1:2014 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
$180.00 ISO 11608-1:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
$103.00 ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
$68.00 ISO 11608-3:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
$68.00 ISO 11608-4:2006 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
$103.00 ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
$138.00 ISO 11608-7:2016 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
$45.00 ISO 13926-1:2004 Pen systems - Part 1: Glass cylinders for pen-injectors for medical use
$68.00 ISO 13926-2:2011 Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use
$19.00 ISO 13926-2:2011/Amd1:2015 - Amendment 1
$68.00 ISO 13926-3:2012 Pen systems - Part 3: Seals for pen-injectors for medical use
$45.00 ISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters
$138.00 ISO 17218:2014 Sterile acupuncture needles for single use
$68.00 ISO 18746:2016 Traditional Chinese medicine - Sterile intradermal acupuncture needles for single use
$68.00 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
$45.00 ISO 26825:2008 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
$45.00 ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification
$138.00 ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
$68.00 ISO 7885:2010 Dentistry - Sterile injection needles for single use
$138.00 ISO 7886-1:1993 Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use
$103.00 ISO 7886-2:1996 Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumps
$103.00 ISO 7886-3:2005 Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization
$68.00 ISO 7886-4:2006 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
$162.00 ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
$185.00 ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
$185.00 ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
$162.00 ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
$149.00 ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin
$162.00 ISO 8836:2014 Suction catheters for use in the respiratory tract
$138.00 ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
$68.00 ISO 9997:1999 Dental cartridge syringes
$58.00 JIS T 3213:2011 Enteral feeding catheters and enteral giving sets
$68.00 JIS T 3214:2011 Urethral catheters
$58.00 JIS T 3215:2011 Drainage catheters and accessory devices
$58.00 JIS T 3216:2012 Tubes and catheters for nephrostomy and cystostomy
$58.00 JIS T 3221:2011 Single-use needle for infusion port
$58.00 JIS T 3222:2011 Sterile winged intravenous devices
$107.00 JIS T 3223:2011 Sterile, single-use intravascular catheters over-needle peripheral catheters
$87.00 JIS T 3226-2:2015 Needle-based injection systems for medical use -- Part 2: Needles -- Requirements and test methods
$59.00 JIS T 3226-2:2011 Pen-injectors for medical use -- Part 2: Needles -- Requirements and test methods
$58.00 JIS T 3228:2011 Biopsy needles for single use
$58.00 JIS T 3229:2011 Single use puncture needle for internal organs and abdominal cavity
$29.00 JIS T 3235:2011 Endoscope puncture needle
$39.00 JIS T 3240:2011 The catheters and tubes for lower intestinal tracts
$39.00 JIS T 3243:2011 Catheters and tubes designed for the biliary tract
$39.00 JIS T 3244:2011 Urinary stone and foreign object extractor and forceps
$39.00 JIS T 3245:2011 Tubes and catheters designed for gamete or embryo transfers
$39.00 JIS T 3246:2011 Catheters designed for injection of contrast media (Non-vascular use)
$39.00 JIS T 3247:2011 Catheters and introducer kits designed for ureter, and uretheral dilatation balloon catheters
$162.00 ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use