"Physically Preventing" Misconnection Accidents. Japanese Translation of International Medical Safety Standard "ISO 80369-1:2025" Now Available
The Japanese Standards Association published the Japanese translation of ISO 80369-1:2025 on April 1, 2026. This standard aims to prevent fatal misconnection accidents of medical tubes by specifying physical interface requirements for small-bore connectors.
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The Japanese Standards Association (Headquarters: Minato-ku, Tokyo, President: Hiroshi Asahi) published the Japanese translation of "ISO 80369-1:2025 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements" on Wednesday, April 1, 2026.
ISO 80369-1:2025 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
This standard specifies the general interface requirements for small-bore connectors used as part of medical devices or their accessories that convey liquids or gases to a patient.
It also identifies the application fields where these small-bore connectors are intended to be used, which include, but are not limited to, the following:
- Respiratory systems
- Enteral applications
- Limb cuff inflation applications
- Neuraxial applications
- Intravascular or hypodermic applications
- Other use cases utilizing ISO 80369-7 small-bore connectors
Furthermore, to reduce the risk of misconnections between medical devices or between accessories of different application fields, this standard provides a method for evaluating the "non-interconnectable characteristics" based on the specific design of the connectors. This covers not only the fields specified in this standard but also future fields to be defined in subsequent parts of the ISO and IEC 80369 series to be developed.
[Why is "ISO 80369-1" necessary?]
In medical settings, misconnections of lines that should not be connected have sometimes caused fatal accidents. The ISO 80369 series solves this human error not through "caution" but through "structure (standardization)". In particular, "Part 1: General requirements" is the most important document that stipulates the common rules for the entire series.
ISO 80369-1:2025 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
This standard specifies the general interface requirements for small-bore connectors used as part of medical devices or their accessories that convey liquids or gases to a patient.
It also identifies the application fields where these small-bore connectors are intended to be used, which include, but are not limited to, the following:
- Respiratory systems
- Enteral applications
- Limb cuff inflation applications
- Neuraxial applications
- Intravascular or hypodermic applications
- Other use cases utilizing ISO 80369-7 small-bore connectors
Furthermore, to reduce the risk of misconnections between medical devices or between accessories of different application fields, this standard provides a method for evaluating the "non-interconnectable characteristics" based on the specific design of the connectors. This covers not only the fields specified in this standard but also future fields to be defined in subsequent parts of the ISO and IEC 80369 series to be developed.
[Why is "ISO 80369-1" necessary?]
In medical settings, misconnections of lines that should not be connected have sometimes caused fatal accidents. The ISO 80369 series solves this human error not through "caution" but through "structure (standardization)". In particular, "Part 1: General requirements" is the most important document that stipulates the common rules for the entire series.