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I.S. EN ISO 80601-2-55:2018

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2018

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
201.10Protection against unwanted and
      excessive radiation HAZARDS
201.11Protection against excessive temperatures
      and other HAZARDS
201.12Accuracy of controls and instruments
      and protection against hazardous outputs
201.13HAZARDOUS SITUATIONS and fault conditions
201.14PROGRAMMABLE ELECTRICAL MEDICAL
      SYSTEMS (PEMS)
201.15Construction of ME EQUIPMENT
201.16ME SYSTEMS
201.17Electromagnetic compatibility of ME
      EQUIPMENT and ME SYSTEMS
201.101 Interfering gas and vapour effects
201.102 Gas leakage
201.103 Port connectors for DIVERTING RGMs
201.104 Sampling flowrate
201.105 Contamination of breathing systems
201.106 FUNCTIONAL CONNECTION
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 General requirements, tests and guidance
    for medical electrical equipment and medical
    electrical systems used in the home healthcare environment
212 General requirements, tests and guidance for
    MEDICAL ELECTRICAL EQUIPMENT and
    MEDICAL ELECTRICAL SYSTEMS intended
    for use in the EMERGENCY MEDICAL SERVICES
    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) - Test gas mixtures for calibration
Annex CC (informative) - Data interface requirements
Annex DD (informative) - Alphabetized index of defined
         terms used in this document
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the essential requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be covered

Describes particular requirements for the Basic safety and essential performance of A respiratory gas monitor (RGM), hereafter Referred to as me equipment, intended for Continuous operation for use with a patient.

DevelopmentNote
Supersedes I.S. EN ISO 21647. (01/2013)
DocumentType
Standard
Pages
82
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
ISO 80601-2-55:2011 Identical
EN ISO 80601-2-55:2018 Identical
ISO 80601-2-55:2018 Identical

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IEC 60038:2009 IEC standard voltages
ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
ASTM F 1452 : 2001 Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors
ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
ISO/TS 29041:2008 Gas mixtures — Gravimetric preparation — Mastering correlations in composition
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
MIL-STD-810 Revision G:2008 ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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 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
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IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
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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
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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
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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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IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
ISO 80000-1:2009 Quantities and units — Part 1: General
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 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 6142-1:2015 Gas analysis Preparation of calibration gas mixtures Part 1: Gravimetric method for Class I mixtures
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

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