Plain-English interpretation of ISO 80369-1:2025 Annex C: the procedure for proposing a new small-bore connector design, including design proposal, engineering analysis, and conformance evaluation.
ISO 80369-1:2025 Annex C defines the procedure for proposing a new small-bore connector design for a new clinical application. The proposal must demonstrate that the connector is non-interconnectable with existing application connectors, that the risk of misconnection is acceptable, and that engineering analysis supports the design.
Interpretation based on ISO 80369-1:2025 (IDT GB/T XXXXX.1) Annex C normative text. The proposal process is intended for manufacturers or working groups seeking to add a new connector design to the ISO 80369 series.
Annex C (normative) defines the procedure by which a working group, manufacturer or individual proposes a new small-bore connector design for inclusion in the ISO/IEC 80369 series - either for a new clinical application or, via Clause 6, as an alternative within an existing one. The applicant applies to the standards body and, under C.1.2, carries the responsibility to identify and declare any patent rights in the design.
Annex A (A.2.11) explains the twin purpose of the proposal: justify a new application category, and introduce the connector design for it. Safety justification rests on severity analysis of wrong-route delivery - the same evidence base of risk analyses, adverse events and reported complaints used throughout Part 1.
The proposal must describe every related connection that needs to be non-interconnectable, support the case with a literature review and an analysis of adverse events and complaints, and be grounded in the existing harm profile of wrong-route delivery between applications.
Design requirements must cover the user profile and use environment, the functional requirements preserving clinical performance, the requirements needed to avoid unacceptable risk, and the requirements maintaining non-interconnectability - plus the ISO 14971 risk analysis, including results from comparable earlier designs. A complete user interface specification satisfying all design requirements closes the submission.
C.2c) requires the user interface specification to embed the risk controls needed for acceptable risk, explicitly considering misuse, ageing, and the effects of cleaning and disinfection and, where applicable, cleaning and sterilisation. These factors matter because a connector that loses its geometry in service loses its non-interconnectability.
Design confirmation (C.3.4) closes the loop with a summative evaluation of hazard-related use scenarios in a clinical or simulated environment, using the intended user population on the target device, with conclusions that are statistically justified and demonstrate the performance objectives were met.
The design is analysed against the non-interconnectability detail of Annex B and against the performance requirements: evaluation of the proposed design at minimum and maximum tolerance states against all existing and proposed series designs, using CAD evaluation or equivalent feasibility tools. This is where a proposal usually discovers which of the four Annex B interface types drives its critical clearances.
Verification combines design review with verification testing across four demonstration targets: conformance to the specification, satisfaction of the physical performance characteristics, compliance with the Clause 4 non-interconnectability requirement, and satisfaction of the medical device performance requirements.
The standards body reviews the submission and decides whether the connector is added to the series for the intended application. The applicant compiles a data and report summary as an informative annex that becomes the factual basis for drafting the future part of the standard. Annex E of Part 1 is itself the worked example: every residual misconnection, its test result and its risk justification, tabulated for public scrutiny.
Two strategic notes from the laboratory side. First, the Chapter 6 alternative-design route and the Annex C series-inclusion route share most of their evidence - dimensional analysis, misconnection testing and engineering analysis - so designing the evidence pack once for dual use avoids duplicated programmes. Second, connectability is not binary: Annex E teaches that accepted residual misconnections are normal, and a submission that honestly characterises them with severity-based reasoning is far stronger than one claiming absolute incompatibility.
Describe the connector and its intended clinical application.
Provide engineering analysis per Annex C.3: dimensional, material, and design rationale.
Demonstrate non-interconnectability per Annex B with all existing application connectors.
Perform risk analysis per ISO 14971 to confirm misconnection risk is acceptable.
Prepare a data and report summary for the standardization body review.
Annex C defines the procedure for proposing a new small-bore connector design for a new clinical application. It is used when a manufacturer or working group wants to add a new connector to the ISO 80369 series. The procedure includes design proposal requirements, engineering analysis, and conformance evaluation.
A design proposal must include: a description of the connector and its intended application, a description of any connector it needs to be non-interconnectable with, requirements for maintaining non-interconnectability, and evidence of compliance with Annex B non-interconnectability criteria. Engineering analysis per Annex C.3 is also required.
Engineering analysis per Annex C.3 includes dimensional analysis (per Annex B), material property evaluation (including elastic modulus), and design rationale. The analysis must demonstrate that the connector design prevents misconnection with all existing application connectors and that the design is suitable for the intended clinical use.
No. Annex C requires that a new connector design be proposed for a new application category. The proposal must demonstrate that the new application has a clinical need and that the connector design reduces misconnection risk compared to using existing application connectors. The standardization body evaluates both the application category and the connector design.
Annex C requires that a data and report summary be prepared as an informative annex. This summary provides the basis for future document development and serves as a reference for the standardization body reviewing the proposal. It includes the engineering analysis results, non-interconnectability evidence, and risk analysis conclusions.
Plain-English interpretation of ISO 80369-1:2025 Annex B: the three-step process for demonstrating non-interconnectability through dimensional analysis, interference testing, and risk analysis.
Plain-English interpretation of ISO 80369-1:2025 Chapter 4 non-interconnectability requirements, MMC/LMC dimensional analysis, and Chapter 6 alternative connector design path.
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