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13/30254355 DC : 0

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Status of Standard is Unknown

BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT
Available format(s)

Hardcopy , PDF

Language(s)

English

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 BREATHING GAS PATHWAY connectors
201.102 Requirements for the BREATHING GAS PATHWAY
        and ACCESSORIES
201.103 FUNCTIONAL CONNECTION
201.104 Training
202 Medical electrical equipment - Part 1-2: General requirements
    for basic safety and essential performance
    - Collateral standard: Electromagnetic
    compatibility - Requirements and tests
206 Medical electrical equipment - Part 1-6: General requirements
    for basic safety and essential performance - Collateral
    Standard: Usability
208 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
211 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
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
Bibliography
Alphabetized index of defined terms used in this particular standard
Annex ZA (informative) - Relationship between this Document and
         the Essential Requirements of EU Directive 93/42/EEC

BS ISO 80601-2-70

Committee
CH/121/5
DocumentType
Draft
Pages
60
PublisherName
British Standards Institution
Status
NA

Standards Relationship
PREN ISO 80601-2-70 : DRAFT 2013 Identical

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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
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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
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
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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 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
DIN 45681:2005-03 ACOUSTICS - DETERMINATION OF TONAL COMPONENTS OF NOISE AND DETERMINATION OF A TONE ADJUSTMENT FOR THE ASSESSMENT OF NOISE IMMISSIONS
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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