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ISO 80601-2-12

Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators TECHNICAL CORRIGENDUM 1

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Organization: ISO
Publication Date: 15 October 2011
Status: inactive
Page Count: 4
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT:

- intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and

NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.

- intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.

NOTE 2 A critical care VENTILATOR intended for use in transport within a professional healthcare facility is not considered an emergency and transport ventilator.

This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM, or to a VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR.

NOTE 3 A critical care VENTILATOR, when operating in such a mode, is not considered LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.

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.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13 and 8.4.1

NOTE 4 Additional information can be found in IEC 60601-1:2005, 4.2.

This International Standard is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, sleep apnoea therapy ME EQUIPMENT, HOME HEALTHCARE ENVIRONMENT VENTILATORS, ventilatory support ME EQUIPMENT, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs).[26] This International Standard does not specify the requirements for ME EQUIPMENT that is intended solely to augment the ventilation of spontaneously breathing PATIENTS within a professional healthcare facility.

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for anaesthetic applications which are given in ISO 80601-2-13.

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-21).

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-32).

This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support devices which are given in ISO 10651-63).

1) In the future, this standard is expected to be harmonized with IEC 60601-1:2005 and IEC 60601-1-11:2010, at which time it will be replaced by ISO 80601-2-xx.

2) In the future, this standard is expected to be harmonized with IEC 60601-1:2005, at which time it will be replaced by ISO 80601-2-xx.

3) In the future, this standard is expected to be harmonized with IEC 60601-1:2005 and IEC 60601-1-11:2010, at which time it will be replaced by ISO 80601-2-xx.

Document History

February 1, 2020
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: — intended for use in an environment...
ISO 80601-2-12
October 15, 2011
Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators TECHNICAL CORRIGENDUM 1
Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES,...
April 15, 2011
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES,...

References

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