ISO 80601-2-12:2011
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
02-27-2020
Superseded by
Published date
04-07-2011
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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.
| DevelopmentNote |
Supersedes IEC 60601-2-12. (05/2011) DRAFT ISO/DIS 80601-2-12 is also available for this standard. (07/2017)
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| DocumentType |
Standard
|
| Pages |
78
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| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
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| 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 |
| SN EN ISO 80601-2-12:2011 | Identical |
| SN EN ISO 80601-2-12 : 2011 CORR 2012 | 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 |
| UNI EN ISO 80601-2-12 : 2011 | 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 |
| OVE/ONORM EN ISO 80601-2-12 : 2012 | Identical |
| UNE-EN ISO 80601-2-12:2011 | Identical |
| PNE-prEN ISO 80601-2-12 | Identical |
| 12/30210881 DC : DRAFT APR 2012 | BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| 15/30278540 DC : 0 | BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| CAN/CSA-C22.2 NO. 80601-2-70:17 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| ISO 80601-2-74:2017 | Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
| UNI EN ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| 15/30280904 DC : 0 | BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
| PD IEC/TR 60601-4-4:2017 | Medical electrical equipment Guidance and interpretation. Guidance for writers of particular standards when creating alarm system-related requirements |
| DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
| CSA Z8836 :2011 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| AAMI ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| BS EN ISO 5367:2014 | Anaesthetic and respiratory equipment. Breathing sets and connectors |
| UNE-EN ISO 5367:2015 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| PD IEC/TR 60601-4-1:2017 | Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| 16/30295446 DC : 0 | BS ISO 19223 - LUNG VENTILATORS AND RELATED EQUIPMENT - VOCABULARY AND SEMANTICS |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| 16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
| CSA Z8836 : 2011 : FR | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| UNI EN ISO 8836 : 2015 | A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| UNE-EN ISO 8836:2015 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| CSA Z8836 : 2011 : R2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| AAMI ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| CSA Z5359 : 2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
| IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
| BS EN ISO 5359 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. EN ISO 8836:2014 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
| EN ISO 8836:2014 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
| PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
| 17/30338756 DC : 0 | BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
| BS EN ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| IEC TR 60601-4-4:2017 | Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements |
| BS ISO 18190:2016 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
| 15/30278530 DC : 0 | BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| 12/30244415 DC : DRAFT APR 2012 | BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| IEC 80601-2-49:2018 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| 15/30278537 DC : 0 | BS ISO 18562-3 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 3: TESTS FOR EMISSIONS OF VOLATILE ORGANIC COMPOUNDS (VOCS) |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| DIN EN ISO 5367:2015-02 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| DIN EN ISO 5359:2015-02 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| ISO 80601-2-70:2015 | Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| BS EN 16372:2014 | Aesthetic surgery services |
| I.S. EN ISO 5367:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| I.S. EN ISO 5359:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| ISO 4871:1996 | Acoustics — Declaration and verification of noise emission values of machinery and equipment |
| ISO 3744:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| ISO 10651-2:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
| ISO 10651-6:2004 | Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| CFR 45(PTS1-199) : OCT 2017 | PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 60721-3-7:1995+AMD1:1996 CSV | Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 60068-2-31:2008 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 32:1977 | Gas cylinders for medical use — Marking for identification of content |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 5359:2014 | Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| ISO 10651-3:1997 | Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 14159:2002 | Safety of machinery — Hygiene requirements for the design of machinery |
| ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC TR 60721-4-7:2001+AMD1:2003 CSV | Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use |
| ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| ISO 23328-1:2003 | Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance |
| ISO 9360-1:2000 | Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| ISO 9360-2:2001 | Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml |
| ISO 10524-1:2006 | Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| IEC 60601-2-12:2001 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 11195:1995 | Gas mixers for medical use Stand-alone gas mixers |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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