ISO 80601-2-12:2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Hardcopy , PDF
07-04-2011
09-04-2025
ISO 80601-2-12:2011 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
- intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.
ISO 80601-2-12:2011 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.
ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation.
ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation.
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.
ISO 80601-2-12:2011 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). ISO 80601-2-12:2011 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.
ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13.
ISO 80601-2-12:2011 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.
ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3.
ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6.
| Committee |
ISO/TC 121/SC 3
|
| DevelopmentNote |
Supersedes IEC 60601-2-12. (05/2011) DRAFT ISO/DIS 80601-2-12 is also available for this standard. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
82
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DS EN ISO 80601-2-12 : 2011 COR 2011 | Identical |
| DS/EN ISO 80601-2-12:2011 | Identical |
| PN EN ISO 80601-2-12 : 2011 AC 2011 | Identical |
| NBN EN ISO 80601-2-12 : 2011 COR 2011 | Identical |
| NEN EN ISO 80601-2-12 : 2011 C1 2011 | Identical |
| NS EN ISO 80601-2-12 : 2011 AC 2011 | Identical |
| VDE 0750-2-12 : 2012 | Identical |
| DIN EN ISO 80601-2-12 : 2012 | Identical |
| NF EN ISO 80601-2-12 : 2011 | Identical |
| BS EN ISO 80601-2-12:2011 | Identical |
| PN-EN ISO 80601-2-12:2011 | Identical |
| GOST R ISO 80601-2-12 : 2013 | Identical |
| I.S. EN ISO 80601-2-12:2011 | Identical |
| SS-EN ISO 80601-2-12 :2011 | Identical |
| NEN-EN-ISO 80601-2-12:2011 en | Identical |
| NBR ISO 80601-2-12 : 2014 | Identical |
| OVE/ONORM EN ISO 80601-2-12 : 2012 | Identical |
| UNE-EN ISO 80601-2-12:2011 | Identical |
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