IEC 80369-5-2016 cor2-2021 PDF

Full title and description

IEC 80369-5:2016/COR2:2021 — Corrigendum 2 to IEC 80369-5:2016, "Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications". This document is a technical corrigendum issued to correct and clarify aspects of the 2016 Part 5 standard (bilingual English/French publication, short corrigendum file addressing specific editorial and technical corrections).

Abstract

This corrigendum updates and corrects elements of IEC 80369-5:2016 relevant to connectors used for limb cuff inflation (for example blood-pressure cuffs and tourniquet inflation connections). It provides editorial and technical corrections intended to remove ambiguity in dimensional requirements, test references and wording so that manufacturers and test laboratories can unambiguously apply the Part 5 requirements to connector design and conformity assessment.

General information

• Status: Published
• Publication date: 21 May 2021
• Publisher: IEC (International Electrotechnical Commission)
• ICS / categories: 11.040.20 (Transfusion, infusion and injection equipment / small-bore medical connectors)
• Edition / version: Corrigendum 2, Edition 1.0 (IEC 80369-5:2016/COR2:2021)
• Number of pages: 2

Basic publication metadata above reflects the IEC webstore and bibliographic listings for the corrigendum.

Scope

This corrigendum applies to IEC 80369-5:2016 and contains targeted corrections to the published Part 5 text and/or figures. Its scope is limited to correcting errors or ambiguities in the 2016 standard (for example, dimensional notes, references to test methods, editorial wording and figures) and does not constitute a full technical revision of the Part 5 requirements. The corrected material is intended to ensure consistent interpretation by manufacturers, test laboratories and regulators for limb cuff inflation connectors so they continue to meet the series objective of preventing hazardous misconnection with other medical systems.

Key topics and requirements

• Targeted editorial and technical corrections to IEC 80369-5:2016 (clarifications to text and figures).
• Assurance of dimensional requirements and tolerances for limb cuff inflation connectors to prevent incompatible connections.
• Clarifications to referenced test methods and performance checks applicable to Part 5 connectors.
• Maintaining the series objective of non-interconnectability with other medical connector families (misconnection prevention).
• Applicability to design, marking and verification activities for blood-pressure cuff and limb cuff inflation assemblies.

The above topics reflect the corrigendum purpose and the wider Part 5 emphasis on connector geometry, tests and safety against misconnections.

Typical use and users

Primary users include medical-device manufacturers (blood-pressure cuffs, tourniquets, inflation devices), connector suppliers, test laboratories, notified bodies and regulatory authorities who evaluate compliance. Engineers and regulatory authors reference the corrigendum when applying IEC 80369-5:2016 requirements to product design, testing and technical files. Standards committees and technical experts also use the corrigendum to maintain consistency of interpretation.

Related standards

IEC/ISO 80369 is a multipart series addressing small-bore connectors for different clinical applications. Part 1 covers general requirements; other application parts include (among others) parts for breathing systems, enteral feeding, urinary, neuraxial and intravascular connectors and a common test-methods part (e.g., ISO/IEC 80369-1, -2, -3, -6, -7 and -20). IEC 80369-5 (Part 5) sits within that family and the corrigendum is specifically tied to the 2016 Part 5 publication. Users should consult the Part 1 general requirements and the appropriate application parts when designing or testing connectors.

Keywords

IEC 80369-5; COR2:2021; corrigendum; small-bore connectors; limb cuff inflation; blood-pressure cuff; misconnections; dimensions; test methods; TC 62/SC 62D.

FAQ

Q: What is this standard?

A: IEC 80369-5:2016/COR2:2021 is the second technical corrigendum to the 2016 edition of IEC 80369-5, which addresses small‑bore connectors used for limb cuff inflation applications (e.g., blood-pressure cuffs). It amends and clarifies specific parts of the 2016 document.

Q: What does it cover?

A: It covers targeted corrections (editorial and technical) to the 2016 Part 5 text and figures — mainly clarifying dimensional/tolerance statements, references to test methods and other wording so that the Part 5 requirements can be applied consistently in design and testing. It does not replace or substantially revise the full technical content of the 2016 standard.

Q: Who typically uses it?

A: Medical device and connector manufacturers, test laboratories, conformity assessment bodies, regulators and standards committees use the corrigendum when implementing or assessing compliance with IEC 80369-5:2016. Engineers preparing technical documentation or test reports will refer to the corrigendum to ensure they apply the corrected text.

Q: Is it current or superseded?

A: Corrigendum 2 (2021) is a published correction to IEC 80369-5:2016 and remains the applicable corrigendum for that edition. It does not itself supersede the parent standard but modifies it; users should apply IEC 80369-5:2016 together with COR1 (2017) and COR2 (2021) as appropriate. The IEC bibliographic entry lists the corrigendum as published and indicates bibliographic stability to a stated stability date in the IEC catalogue.

Q: Is it part of a series?

A: Yes — IEC/ISO 80369 is a multipart series of standards for small‑bore connectors used in different healthcare applications. Part 5 (with its corrigenda) is the limb cuff inflation part within that broader family; Part 1 contains general requirements and other numbered parts cover other clinical application areas.

Q: What are the key keywords?

A: Key keywords include: IEC 80369-5, COR2:2021, corrigendum, small-bore connectors, limb cuff inflation, blood-pressure cuff, misconnections, dimensions, test methods, TC 62/SC 62D.