IEC 80369-5:2016/COR2:2021
Corrigendum 2 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
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About This Item
IEC 80369-5:2016/COR2:2021 is a corrigendum linked to the parent document IEC 80369-5:2016, addressing the technical content for small-bore connectors used in limb cuff inflation applications in healthcare. It is relevant where organizations need a precise compliance reference for product review, design verification, procurement checks, or documented evaluation of connector compatibility. As a supporting document rather than a standalone full standard, it helps clarify the base requirements used in safety-oriented engineering and conformity assessment workflows.
Overview of IEC 80369-5:2016/COR2:2021
The document provides a correction to the published requirements for connectors intended for limb cuff inflation applications, which are used in healthcare systems where connection reliability and functional consistency matter. IEC 80369-5:2016/COR2:2021 should be read together with the parent reference because its role is to modify or clarify the underlying technical text. For engineering teams, laboratories, and compliance reviewers, it supports accurate technical documentation, risk management, and consistent interpretation during product evaluation.
Compliance applications of IEC 80369-5:2016/COR2:2021
This corrigendum is typically consulted during product qualification, technical review, and regulatory preparation for devices that use small-bore connectors in limb cuff inflation applications. It may be relevant for manufacturers, test laboratories, purchasing teams, and quality groups checking whether specifications, drawings, verification activities, and conformity assessment records align with the corrected parent document. IEC 80369-5:2016/COR2:2021 can also support engineering documentation when maintaining operational consistency across design, test, and release workflows.
Importance of compliance with IEC 80369-5:2016/COR2:2021
Using the corrected reference helps reduce ambiguity in safety-critical connector applications and supports more reliable technical validation. In procurement and quality assurance processes, it can improve confidence that requirements are being applied consistently and that testing results are based on the current documented text. For organizations preparing conformity assessment evidence, IEC 80369-5:2016/COR2:2021 helps maintain alignment with the parent document, which is important for interoperability, compliance workflows, and risk reduction in healthcare device development.
- Correction reference for the parent document IEC 80369-5:2016
- Supports review of small-bore connectors for limb cuff inflation applications
- Useful in testing workflows, engineering documentation, and conformity assessment preparation
- Helps maintain consistency in compliance interpretation and technical validation
- Publication Date: 2021-05-21
- Standard Status: Corrigendum
- Publisher: IEC
- Edition: 1
- This Version: IEC 80369-5:2016 (2021-05-21)
- Previous Version: IEC 80369-5:2016 (2017-09-02)
- Previous Version: IEC 80369-5:2016 (2016-04-03)
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