Name: UNI EN ISO 80601-2-55 : 2012
Brand: UNI

UNI EN ISO 80601-2-55 : 2012

Superseded

MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS

Superseded date

13-09-2022

Published date

01-01-2012

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.5 General requirements for testing 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 Interfering gas and vapour effects
201.102 Gas leakage
201.103 Port connector for DIVERTING RGM
201.104 Minimum sampling flowrate
201.105 Contamination of breathing systems
202 Electromagnetic compatibility - Requirements
        and tests
206 Usability
208 General requirements, tests and guidance for
        alarm systems in medical electrical
        equipment and medical electrical systems
209 Requirements for environmentally conscious design
210 Requirements for the development of physiologic
        closed-loop controllers
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT
        and MEDICAL ELECTRICAL SYSTEMS used in
        the home healthcare environment
Annex C (informative) - Guide to marking and labeling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Environmental aspects
Annex CC (informative) - Test gas mixtures for calibration
Annex DD (informative) - Reference to the essential
         principles
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

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 UNI EN ISO 21647. (06/2012)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 80601-2-55:2018
Supersedes	UNI EN ISO 21647 : 2009

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

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV	Information technology equipment - Safety - Part 1: General requirements
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
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
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
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
EN 12598 : 1999	OXYGEN MONITORS FOR PATIENT BREATHING MIXTURES - PARTICULAR REQUIREMENTS
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
ISO 7767:1997	Oxygen monitors for monitoring patient breathing mixtures — Safety requirements
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
IEC 60601-1-10:2007+AMD1:2013 CSV	Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
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
ISO 9918:1993	Capnometers for use with humans Requirements
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
EN 864 : 1996	MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS
ISO 21647:2004	Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
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 6143:2001	Gas analysis — Comparison methods for determining and checking the composition of calibration gas mixtures
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
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)
ISO 6142:2001	Gas analysis Preparation of calibration gas mixtures Gravimetric method
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 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
ISO 80369-1:2010	Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
NFPA 53M : 1990	FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
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 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