What is ISO 80369-1- General requirements for small-bore connectors about?
ISO 80369 is an international standard that discusses small-bore connectors for liquids and gases in healthcare applications. ISO 80369-1 provides the best industry guidance on the general requirements for small-bore connectors to ensure the safety and health of patients and operators.
ISO 80369-1 is the first part of a multi-part series that layouts 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 also specifies the healthcare fields in which these small-bore connectors are intended to be used.
These healthcare fields include but are not limited to breathing systems and driving gases, enteral, limb cuff inflation, neuraxial, and intravascular or hypodermic.
ISO 80369-1 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in ISO 80369-1 as well as those that will be developed under future parts of the ISO 80369 series.
Note 1: ISO 80369-1 does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given International Standards for specific medical devices or accessories.
Who is ISO 80369-1- General requirements for small-bore connectors for?
ISO 80369-1 on the general requirements for small-bore connectors is useful for:
- Small-bore connectors manufacturers
- Test centers for small-bore connectors
- Healthcare professionals
- Medical device regulatory authorities
Why should you use ISO 80369-1- General requirements for small-bore connectors?
Small-bore connectors are parts used to connect medical devices such as tubing, syringes, and other accessories that deliver fluids and gases. Small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. However, several 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.
ISO 80369-1 guideline assists you with materials, small-bore connector incompatibility, clinical applications, and alternative small-bore connectors for liquids and gases in healthcare applications.
ISO 80369-1 assist in the proper assessment and evaluation of the biocompatibility of small-bore connectors for liquids and gases in healthcare applications.
In addition, with compliance and obedience to ISO 80369-1, you can prevent hazardous situations and can ensure the safety and health of patients and operators.
What’s changed since the last update?
BS EN ISO 80369-1:2018 supersedes ISO 80369-1:2010, which is withdrawn. BS EN ISO 80369-1:2018 has made some technical changes compared to ISO 80369-1:2010. These include:
- The normative references have been updated
- The requirement for alternative small-bore connectors, including disclosure and marking requirements, have been updated
- In annex b, the test methods for demonstrating non-interconnectable characteristics to reflect the testing used in the development of ISO 80369‑2, ISO 80369‑3, IEC 80369‑5, ISO 80369‑6, and ISO 80369‑7 have been updated
- Annex d has been created with the assessment procedures small-bore connectors which replaces clause 7 of the previous edition and contains a description of the computer-aided design (cad) analysis that was used in the evaluation of the non-interconnectable characteristics
