• BS EN ISO 11197:2009

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL SUPPLY UNITS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  31-03-2016

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    SECTION ONE - GENERAL
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements and requirements for tests
    5 Classification
    6 Identification, marking and documents
    7 Power input
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    8 Basic safety categories
    9 Removable protection means
    10 Environmental conditions
    11 Not Used
    12 Not Used
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    13 General
    14 Requirements related to classification
    15 Limitation of voltage and/or energy
    16 Enclosures and protective covers
    17 Separation
    18 Protective earthing, functional earthing and potential
       equalization
    19 Continuous leakage current and patient auxiliary currents
    20 Dielectric strength
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    21 Mechanical strength
    22 Moving parts
    23 Surfaces, corners and edges
    24 Stability in normal use
    25 Expelled parts
    26 Vibration and noise
    27 Pneumatic and hydraulic power
    28 Suspended masses
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
                   OR EXCESSIVE RADIATION
    29 X-Radiation
    30 Alpha, beta, gamma, neutron radiation and other particle
       radiation
    31 Microwave radiation
    32 Light radiation (including lasers)
    33 Infra-red radiation
    34 Ultraviolet radiation
    35 Acoustical energy (including ultrasonics)
    36 Electromagnetic compatibility
    SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
                  FLAMMABLE ANAESTHETIC MIXTURES
    37 Locations and basic requirements
    38 Marking and accompanying documents
    39 Common requirements for Category AP and Category APG
       Equipment
    40 Requirements and tests for Category AP Equipment,
       parts and components thereof
    41 Requirements and tests for Category APG Equipment,
       parts and components thereof
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
                    AND OTHER SAFETY HAZARDS
    42 Excessive temperatures
    43 R Fire prevention
    44 Overflow, spillage, leakage, humidity, ingress of
       liquids, cleaning, sterilization and disinfection
    45 Pressure vessels and parts subject to pressure
    46 Human errors
    47 Electrostatic charges
    48 Material in applied parts in contact with the body of
       the patient
    49 Interruption of the power supply
    SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                    AGAINST HAZARDOUS OUTPUT
    50 Accuracy of operating data
    51 Protection against hazardous output
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS,
                   ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
    53 Environmental tests
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    54 General
    55 Enclosures and covers
    56 Components and general assembly
    57 Mains parts, components and layout
    58 Protective earthing - terminals and connections
    59 Construction and layout
    Annexes
    Annex AA (normative) - Special National Conditions
    Annex BB (informative) - Rationale
    Annex ZB (Informative) - Normative references to
             international publications with their relevant
             European publications
    Bibliography
    Annex ZA (Informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Pertains to medical supply units.

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

    Committee CH/121/6
    Development Note Supersedes BS EN 793 & 02/561691 DC. (02/2005) To be read in conjunction with BS EN 60601-1. (06/2009)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Superseded By
    Supersedes

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

    EN 60446:2007 Basic and safety principles for man-machine interface, marking and identification - Identification of conductors by colours or alphanumerics
    IEC 60364-5-54:2011 Low-voltage electrical installations - Part 5-54: Selection and erection of electrical equipment - Earthing arrangements and protective conductors
    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
    IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60364-5-51:2005 Electrical installations of buildings - Part 5-51: Selection and erection of electrical equipment - Common rules
    ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
    EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
    EN 737-2:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS
    EN 737-3:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
    ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
    EN 61386-1:2008 Conduit systems for cable management - Part 1: General requirements
    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 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    EN 50174-2 : 2009 AMD 2 2014 INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 2: INSTALLATION PLANNING AND PRACTICES INSIDE BUILDINGS
    EN 739:1998/A1:2002 LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    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 60598-1:2014+AMD1:2017 CSV Luminaires - Part 1: General requirements and tests
    DIN VDE 0107 : 1994 ELECTRICAL INSTALLATIONS IN HOSPITALS AND LOCATIONS FOR MEDICAL USE OUTSIDE HOSPITALS
    IEC 60669-1:2017 Switches for household and similar fixed-electrical installations - Part 1: General requirements
    NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
    EN 1089-3:2011 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    IEC 61386-1:2008+AMD1:2017 CSV Conduit systems for cable management - Part 1: General requirements
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    EN 737-4 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS
    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)
    EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
    IEC 61950:2007 Cable management systems - Specifications for conduit fittings and accessories for cable installations for extra heavy duty electrical steel conduit
    ISO 7396-1:2016 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum
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