16/30312315 DC : 0

Superseded

BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS

Available format(s)

Hardcopy , PDF

Superseded date

03-16-2018

Language(s)

English

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 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
212 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) - Test gas mixtures for calibration
Annex CC (informative) - Data interface requirements
Annex DD (informative) - Reference to the essential principles
Annex EE (informative) - Alphabetized index of defined terms
         used in this document
Annex ZA (informative) - Relationship between this European
         Standard and the the essential requirements of Directive
         93/42/EEC [OJ L 169] aimed to be covered
Bibliography

BS EN ISO 80601-2-55.

Committee	CH/121/1
DocumentType	Draft
Pages	74
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 80601-2-55:2011

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
EN 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 (ISO 14937:2009)
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
EN 60068-2-64:2008	ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE
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
EN 60601-1-6:2010/A1:2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
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 60068-2-64:2008	Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
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
EN 60601-1-2:2015	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60068-2-27:2009	Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
EN 60601-1-12:2015	Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
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)
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
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
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 14971:2007	Medical devices Application of risk management to medical devices
EN 60529:1991/AC:2016-12	DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
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
EN ISO 7010 : 2012 AMD 7 2017	GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016)
EN ISO 80601-2-13:2012	Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
EN 60601-1-11:2015	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
EN 60601-1-8:2007/A11:2017	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 (IEC 60601-1-8:2006/A1:2012)