ISO 80369-1:2010 Withdrawn
Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
Abstract
ISO 80369-1:2010 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.
ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used.
These healthcare fields of use include, but are not limited to, applications for:
- breathing systems and driving gases,
- enteral and gastric,
- urethral and urinary,
- limb cuff inflation,
- neuraxial devices, and
- intravascular or hypodermic.
Small-bore connectors as specified in ISO 80369-1:2010 are non-interconnectable with:
- the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
- the temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and
- the nipples of EN 13544-2:2002.
ISO 80369-1:2010 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards.
It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used.
These healthcare fields of use include, but are not limited to, applications for:
- breathing systems and driving gases,
- enteral and gastric,
- urethral and urinary,
- limb cuff inflation,
- neuraxial devices, and
- intravascular or hypodermic.
Small-bore connectors as specified in ISO 80369-1:2010 are non-interconnectable with:
- the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
- the temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and
- the nipples of EN 13544-2:2002.
ISO 80369-1:2010 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards.
It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
Additional information
Publication type | International Standard |
---|---|
Publication date | 2010-12-15 |
Withdrawal date | 2018-11-05 |
Edition | 1.0 |
Available language(s) | English, French |
TC/SC | TC 62/SC 62D - Particular medical equipment, software, and systemsrss |
ICS | 11.040.10 - Anaesthetic, respiratory and reanimation equipment
11.040.20 - Transfusion, infusion and injection equipment |
Stability date | 2018 |
Pages | 17 |
File size | 698 KB |
The following test report forms are related:
More information
Share this page
Share your publications
Learn how to share your publications with your colleagues, using networking options.
Payment information
Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa, JCB and CUP), PayPal and bank transfers as form of payment.
Keep in touch
Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.
Contact customer services
Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 16:00 CET Monday to Friday.