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BS EN ISO 80601-2-12:2011

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators
Available format(s)

Hardcopy , PDF

Superseded date

16-03-2020

Language(s)

English

Published date

31-08-2013

Publisher

British Standards Institution

Foreword
Introduction
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from ME
            EQUIPMENT
    201.9 Protection against mechanical HAZARDS of ME
            EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive radiation
            HAZARDS
    201.11 Protection against excessive temperatures and other
            HAZARDS
    201.12 Accuracy of controls and instruments and protection
            against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL
            SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT
            and ME SYSTEMS
    201.101 Gas connections
    201.102 Requirements for the VBS and ACCESSORIES
    201.103 Spontaneous breathing during loss of power supply
    201.104 Training
    201.105 Indication of duration of operation
    201.106 SIGNAL INPUT/OUTPUT PART
    201.108 Timed ventilatory pause
202 Medical electrical equipment - Part 1-2: General
    requirements for basic safety and essential performance
    - Collateral standard: Electromagnetic compatibility -
    Requirements and tests
206 Medical electrical equipment - Part 1-6: General
    requirements for basic safety and essential performance
    - Collateral Standard: Usability
208 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
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Reference to the Essential Principles
Bibliography
Alphabetized index of defined terms used in this particular
 standard
Annex ZA (informative) - Relationship between this
         Document and the Essential Requirements
         of EU Directive 93/42/EEC

Pertains 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.

Committee
CH/121/5
DevelopmentNote
Supersedes BS EN 794-1, BS EN 60601-2-12 and 09/30203808 DC. (09/2011)
DocumentType
Standard
Pages
94
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN ISO 80601-2-12:2011/AC:2011 Identical
ISO 80601-2-12:2011 Identical

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
ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
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
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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