ISO 80369-7:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
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05-14-2021
French, English
10-14-2016
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ISO 80369-7:2016 specifies 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.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female luer slip connectors and luer lock connectors.
NOTE 1 The luer connector was originally designed for use at pressures up to 300 kPa.
ISO 80369-7:2016 does not specify 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.
ISO 80369-7:2016 does not specify requirements for the following small-bore connectors, which are specified in other International Standards:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);
- infusion system closure piercing connectors (ISO 85364).
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into 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.
NOTE 3 ISO 803691:2010, 5.8, specifies alternative methods of compliance with ISO 803691:2010, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not comply with this part of ISO 80369.
| DevelopmentNote |
Supersedes ISO/DIS 80369-7, ISO 594-1 & ISO 594-2. (10/2016)
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| DocumentType |
Standard
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| Pages |
47
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| ProductNote |
This standard has Corrected version (en) : 2016-12 , Corrected version (fr) : 2016-12
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 80369-7:2017-10 | Identical |
| ANSI/AAMI/ISO 80369-7:2016 | Identical |
| NF EN ISO 80369-7 : 2017 | Identical |
| NEN EN ISO 80369-7 : 2017 | Identical |
| NS EN ISO 80369-7 : 2017 | Identical |
| I.S. EN ISO 80369-7:2017 COR 2017 | Identical |
| PN EN ISO 80369-7 : 2017 | Identical |
| SN EN ISO 80369-7 : 2017 | Identical |
| UNI CEI EN ISO 80369-7 : 2017 | Identical |
| SS-EN ISO 80369-7:2017 | Identical |
| JIS T 3211-11:2019 | Identical |
| IS/ISO 80369 : Part 7 : 2016 | Identical |
| UNE-EN ISO 80369-7:2017 | Identical |
| BS EN ISO 80369-7:2017 | Identical |
| EN ISO 80369-7:2017 | Identical |
| OVE/ONORM EN ISO 80369-7 : 2017 | Identical |
| CEI UNI EN/ISO 80369-7 : 1ED 2017 | Identical |
| BS ISO 11040-6:2012 | Prefilled syringes Plastic barrels for injectables |
| 17/30346437 DC : 0 | BS ISO 18250-7 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR INFUSION |
| I.S. EN ISO 10555-6:2017 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015) |
| I.S. EN ISO 10555-1:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017) |
| UNE-EN ISO 80369-6:2016 | 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 5366:2016 | Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016) |
| 17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
| ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
| 17/30357741 DC : 0 | BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| ISO 8637-1:2017 | Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| AAMI ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| ISO 11040-8:2016 | Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| 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 5366:2015-10 (Draft) | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES AND CONNECTORS (ISO 5366:2016) |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| BS ISO 18190:2016 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
| ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
| ANSI/AAMI/ISO 80369-3:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS |
| 17/30338756 DC : 0 | BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
| UNE-EN ISO 80369-3:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
| BS EN ISO 5366:2016 | Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors |
| I.S. EN ISO 7886-1:1998 | STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017) |
| UNE-EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| UNE-EN ISO 7864:2017 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| BS EN 30-1-2:2012 | Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills |
| EN 30-1-2:2012 | Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills |
| ISO 11040-6:2012 | Prefilled syringes Part 6: Plastic barrels for injectables |
| 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) |
| EN ISO 10555-6:2017 | Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015) |
| CEI UNI EN ISO 80369-3 : 2017 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS |
| ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
| UNE-EN ISO 5366:2017 | Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016) |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| 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) |
| 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 |
| 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 |
| ISO 3040:2016 | Geometrical product specifications (GPS) Dimensioning and tolerancing Cones |
| 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 |
| 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 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| 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 |
| ISO 178:2010 | Plastics Determination of flexural properties |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
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