• 16/30346835 DC : 0

    NA Status of Standard is Unknown

    BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements for testing
    5 General requirements
    6 Identification, marking and
       ACCOMPANYING DOCUMENTATION
    7 HUMIDIFICATION OUTPUT
    8 Systems requirements
    9 Specific SINGLE FAULT CONDITIONS
    10 Cleaning and disinfection
    11 BREATHING SYSTEM connectors and ports
    12 Requirements for the BREATHING
       SYSTEM and ACCESSORIES
    13 Compatibility with substances
    14 BIOCOMPATIBILITY
    15 Requirements for fire prevention
    16 USABILITY
    Annex A (informative) - Rationale and guidance
    Annex B (informative) - Symbols on marking
    Annex C (normative) - Determination of
            HUMIDIFICATION OUTPUT
    Annex D (informative) - Reference to the Essential Principles
    Annex E (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

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/121/9
    Document Type Draft
    Publisher British Standards Institution
    Status NA

    Standards Referencing This Book - (Show below) - (Hide below)

    EN ISO 5367:2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
    ISO 80601-2-69:2014 Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
    IEC 60601-2-19:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    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
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    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
    EN ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    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 80601-2-70:2015 Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
    EN 60601-2-19:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009/A1:2016)
    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)
    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
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    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
    EN 61672-1:2013 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013)
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    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 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
    ISO 10780:1994 Stationary source emissions — Measurement of velocity and volume flowrate of gas streams in ducts
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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
    EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    PREN 3744 : 200P1 AEROSPACE SERIES - STRAIGHT PINS, SPRING TYPE, LIGHT DUTY, IN CORROSION RESISTING SPRING STEEL, PASSIVATED
    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 (IEC 60601-1-11:2015)
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    ISO 27427:2013 Anaesthetic and respiratory equipment Nebulizing systems and components
    ISO 7396-1:2016 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum
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