ISO 80601-2-12:2011 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, 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.
This International Standard is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes intended for patients who are not dependent on mechanical ventilation.
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 10651-2 1).
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-3 2).
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support devices which are given in ISO 10651-6 3).
ISO 80601-2-12:2011 Referenced Document
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6:2010 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
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ISO 5359:2008 Low-pressure hose assemblies for use with medical gases
ISO 5367:2000 Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 7000:2004 Graphical symbols for use on equipment - Index and synopsis
ISO 7010:2003 Graphical symbols - Safety colours and safety signs - Safety signs used in workplaces and public areas
ISO 80601-2-12:2011 history
2023ISO 80601-2-12:2023 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
2020ISO 80601-2-12:2020 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
2011ISO 80601-2-12:2011/Cor 1:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators; Technical Corrigendum 1
2011ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators