Corrigendum 2 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

Corrigendum 2 - Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 5: Raccords destinés à des applications au gonflage de brassard

General Information

Status: Published
Publication Date: 20-May-2021

ICS: 11.040.20 - Transfusion, infusion and injection equipment

Technical Committee: SC 62D - Particular medical equipment, software, and systems
Drafting Committee: JWG 10 - TC 62/SC 62D/JWG 10

Current Stage: PPUB - Publication issued
Start Date: 21-May-2021
Completion Date: 12-Jul-2021

Relations

Corrects: IEC 80369-5:2016/COR1:2017 - Corrigendum 1 - Small bore connectors for liquids and gases in healthcare application - Part 5: Connectors for limb cuff inflation applications
Effective Date: 05-Sep-2023

Corrects: IEC 80369-5:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
Effective Date: 05-Sep-2023

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
Released:5/21/2021 - Page 1 preview

Standard

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 Released:5/21/2021

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Frequently Asked Questions

What is IEC 80369-5:2016/COR2:2021?

IEC 80369-5:2016/COR2:2021 is a standard published by the International Electrotechnical Commission (IEC). Its full title is "Corrigendum 2 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications". This standard covers: Corrigendum 2 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

What is the scope of 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

What ICS categories does IEC 80369-5:2016/COR2:2021 belong to?

IEC 80369-5:2016/COR2:2021 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.

What standards are related to IEC 80369-5:2016/COR2:2021?

IEC 80369-5:2016/COR2:2021 has the following relationships with other standards: It is inter standard links to IEC 80369-5:2016/COR1:2017, IEC 80369-5:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

How can I access IEC 80369-5:2016/COR2:2021?

IEC 80369-5:2016/COR2:2021 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)

IEC 80369-5:2016/COR2:2021 - C...

 IEC 2021
INTERNATIONAL ELECTROTECHNICAL COMMISSION
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
IEC 80369-5 IEC 80369-5
Edition 1.0 2016-03 Édition 1.0 2016-03

Small-bore connectors for liquids and gases in Raccords de petite taille pour liquides
healthcare applications – et gaz utilisés dans le domaine de la santé –

Part 5: Connectors for limb cuff inflation Partie 5: Raccords destinés à des applications
appli
...

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IEC

ISO 80369-1:2025(Main)

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
- respiratory;
- enteral;
- limb cuff inflation;
- neural;
- intravascular or hypodermic;
- other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE Clause A.2 contains guidance or rationale for this Clause.

Standard
41 pages
English language
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IEC

IEC 60601-2-16:2025(Main)

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document does not take into consideration specific safety details of the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety. This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision. This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment duration and location. If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments.
The particular requirements in this document do not apply to:
– EXTRACORPOREAL CIRCUITS (see ISO 8637-2),
– DIALYSERS (see ISO 8637-1 [2]),
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4),
– pre-manufactured DIALYSIS FLUID bags,
– DIALYSIS WATER supply systems (see ISO 23500-2),
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
IEC 60601-2-16:2024 cancels and replaces the fifth edition published in 2018. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, of references to IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, of references to IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, of references to IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020, of references to IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 and of references to IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020;
b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601‑1:2005/AMD1:2012/ISH1:2021;
c) including the information given in the document 62D/1771A/INF regarding 201.11.8;
d) including withdrawn IEC PAS 63023 as Annex CC;
e) including SECURITY (CYBERSECURITY) requirements;
f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags;
g) improvements for labelling;
h) other minor technical improvements;
i) editorial improvements.

Standard
311 pages
English language
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IEC

IEC 60601-2-40:2024(Main)

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
The following ME EQUIPMENT are excluded:
- ME EQUIPMENT intended for therapeutic application;
- ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10).
IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) added requirements for constant voltage stimulators;
b) clarified requirements for VISUAL STIMULATORS.

Standard
94 pages
English language
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IEC

ISO 80369-2:2024(Main)

Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications

This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.

Standard
50 pages
English language
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IEC

IEC TR 62653:2020(Main)

Guideline for safe operation of medical equipment used for haemodialysis treatments

IEC TR 62653:2020 describes the technical recommendations for use of medical equipment in chronic Haemodialysis, Haemofiltration and Haemodiafiltration. These principles are important to be complied with to ensure safe, permissible and appropriate application. The term Haemodialysis is used in this document as synonym for all therapy modalities.
The scope can be applicable to the use of the medical equipment in home, acute and pediatrics environment. The scope may also be applicable to Sorbent Dialysis Systems.
The physician is responsible for the treatment prescription. However, the Organization administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. The requirements of IEC 60601-2-16 ensure that medical electrical equipment used for extracorporeal renal replacement therapy operates with a high level of safety. Despite that high level of safety, however, some residual risk remains, related to medical-biological, physical-chemical and technical Hazards. The Organization administering the treatment is responsible for managing the residual risk. This document is not intended to be used as the basis of regulatory inspection or certification assessment activities. IEC TR 62653:2020 cancels and replaces the first edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) update the relevant references to the new numbering scheme of the ISO 23500 family;
b) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 62353:2014 and 60601-2-16:2018;
c) technical additions in several sections.

Technical report
36 pages
English language
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Technical report
75 pages
English language
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IEC

ISO 80369-1:2018(Main)

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

ISO 80369-1:2018 This document specifies 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.
This document 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;
- intravascular or hypodermic.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.
NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.
NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

Standard
31 pages
English language
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Standard
34 pages
French language
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IEC

IEC 60601-2-16:2018(Main)

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015;
b) widening of the scope;
c) editorial improvements;
d) addition of requirements for anticoagulant delivery means;
e) other few small technical changes.

Standard
236 pages
English language
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Standard
156 pages
English and French language
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IEC

IEC 80369-5:2016/COR1:2017(Corrigendum)

Corrigendum 1 - Small bore connectors for liquids and gases in healthcare application - Part 5: Connectors for limb cuff inflation applications

Standard
1 page
English and French language
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08-Feb-2017
11.040.20
SC 62D

IEC

IEC 60601-2-40:2016(Main)

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

IEC 60601-2-40:2016 applies to the basic safety and essential performance of electromyographs and evoked response equipment, hereafter referred to as ME equipment. ME equipment intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators are excluded (covered by IEC 60601-2-10). This second edition cancels and replaces the first edition of IEC 60601-2-40 published in 1998. This edition constitutes a technical revision.

Standard
60 pages
English and French language
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IEC

IEC 80369-5:2016(Main)

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

IEC 80369-5:2016 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in limb cuff inflation applications of medical devices and accessoires. Limb cuff inflation applications include connections between a sphygmomanometer and its cuff. The contents of the corrigenda 1 (2017) and 2 (2021) have been included in this copy.

Standard
89 pages
English and French language
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03-Mar-2016
11.040.20
SC 62D

Corrigendum 2 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

Corrigendum 2 - Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 5: Raccords destinés à des applications au gonflage de brassard

General Information

Relations

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 Released:5/21/2021

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