ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
ISO 80369-1 Foreword
This part 1 of this International Standard contains general requirements to ensure the prevention of misconnection between small-bore connectors used in different applications. Subsequent parts of this series of standards are expected to include requirements with regard to the connectors used in different application categories. ISO 80369 consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applications:
- Part 1: General requirements (ISO 80369-1 cancels and replaces EN 15546-1.)
- Part 2: Connectors for breathing systems and driving gases applications
- Part 3: Connectors for enteral applications
- Part 4: Connectors for urethral and urinary applications
- Part 5: Connectors for limb cuff inflation applications
- Part 6: Connectors for neuraxial applications
- Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications (ISO 80369-7 cancels and replaces ISO 594.) - Part 20: Common test methods
ISO 80369-1 Introduction In the 1990s concern grew regarding the proliferation of medical devices fitted with Luer connectors and the reports of patient death or injury arising from misconnections that resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases.
Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas delivery systems were raised, and it was concluded that there is a problem arising from the use of a single connector design to a number of incompatible applications. In a coronary care unit there are as many as 40 Luer connectors on the medical devices used with a single patient. Therefore it is not surprising that misconnections are made.
Medical devices have for many years followed the established principle of “safety under single fault conditions”. Simply stated this means that a single fault should not result in an unacceptable risk. This principle is embodied in the requirements of numerous medical device standards. Extending this principle to the application of Luer connectors, i.e. that misconnection should not result in an unacceptable risk to a patient, it is recommended that the Luer connector should be restricted to medical devices intended to be connected to the vascular system or a hypodermic syringe. In addition, new designs of small-bore connectors should be developed for other applications, and these should be non-interconnectable with Luer connectors and each other.
It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the current situation and lead to greater patient safety can be taken. This will only be achieved through a long-term commitment involving industry, healthcare professionals, medical device purchasers and medical device regulatory authorities.
Part 1 of this International Standard and its parts are intended to be the reference documents in which the necessary measures and procedures to prevent misconnection between small-bore connectors used in different applications and designs of small-bore connectors for applications are listed. This series of standards is being developed in such a way that ISO 80369-1 includes general requirements to prevent misconnections between small-bore connectors used in different applications.
ISO 80369-1 Scope This Part 1 of ISO 80369 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices medical devices or accessories intended for use with a patient.
This International Standard 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
- intravascular or hypodermic
Small-bore connectors as specified in this International Standard 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.
This International Standard 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 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 Scope Notes
- NOTE 1 It is intended that new designs of small-bore connectors will be included in this series of standards after they have been assessed according to the procedure given in Clause 6.
- NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this series of standards into medical devices, medical systems 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 the series of standards will be included.
- NOTE 3 Manufacturers and responsible Organizations are encouraged to report their experience with the small-bore connectors specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during the revision of the relevant part of this series of standards.
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Original Posting: 11/7/2012
Last Revision: 9/4/2014
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