BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

FOREWORD
European 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
        for ME EQUIPMENT
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 VENTILATORY SUPPORT EQUIPMENT 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) - Terminology - Alphabetized index of
         defined terms
Annex ZA (informative) - Relationship between this Document
         and the Essential Requirements of EU Directive 93/42/EEC
Bibliography

BS ISO 80601-2-80.

Committee	CH/121/9
DocumentType	Draft
Pages	99
PublisherName	British Standards Institution
Status	NA

EN ISO 5367:2014	Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
ISO 8836:2014	Suction catheters for use in the respiratory tract
ISO 4871:1996	Acoustics — Declaration and verification of noise emission values of machinery and equipment
ISO 80601-2-74:2017	Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying 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 639-1:2002	Codes for the representation of names of languages — Part 1: Alpha-2 code
ISO 80601-2-13:2011	Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
ISO 18562-1:2017	Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
ISO 10651-6:2004	Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
EN ISO 5356-1:2015	Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
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
ISO 5356-1:2015	Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 16142-1:2016	Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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)
EN ISO 9360-2:2009	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 9360-2:2001)
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
EN ISO 23328-2:2009	Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
ISO 5367:2014	Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 80601-2-12:2011	Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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
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
ISO 10651-3:1997	Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
ISO 80601-2-72:2015	Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
ISO 23328-2:2002	Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
EN 61672-1:2013	Electroacoustics - Sound level meters - Part 1: Specifications
IEC TR 60878:2015	Graphical symbols for electrical equipment in medical practice
EN 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 3744:2010)
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
EN ISO 7396-1:2016	Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
ISO 80369-1:2010	Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
EN ISO 9360-1:2009	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 9360-1:2000)
ISO 80369-7:2016	Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
ISO 17510:2015	Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
ISO 23328-1:2003	Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
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 ISO 4871:2009	Acoustics - Declaration and verification of noise emission values of machinery and equipment (ISO 4871:1996)
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 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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 ISO 23328-1:2008	Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)
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)
ISO 7396-1:2016	Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum