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I.S. EN ISO 80601-2-72:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015)
Available format(s)

Hardcopy , PDF

Superseded date

12-18-2023

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
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 FUNCTIONAL CONNECTION
201.107 Display loops
201.108 POWER SUPPLY CORDS
201.109 VENTILATOR security
202 Electromagnetic disturbances - Requirements
    and tests
206 Usability
208 General requirements, tests and guidance for alarm
    systems in medical electrical equipment and
    medical electrical systems
211 Requirements for medical electrical equipment
    and medical electrical systems used in the home
    healthcare environment
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) - Data interface requirements
Annex CC (informative) - Reference to the Essential
         Principles
Annex DD (informative) - Alphabetized index of
         defined terms used in this particular standard
Bibliography
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 for use in the home healthcare environment; - intended for use by a lay operator; and - intended for use with patients who are dependent on mechanical ventilation for their life support.

DevelopmentNote
Supersedes I.S. EN ISO 10651-2. (10/2015)
DocumentType
Standard
Pages
110
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 80601-2-72:2015 Identical
EN ISO 80601-2-72:2015 Identical

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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
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EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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
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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
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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
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
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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
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
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ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
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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
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ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
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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
EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
ISO 14971:2007 Medical devices Application of risk management to medical devices
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ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
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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