• EN 60601-2-30:2000

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

    Available format(s): 

    Superseded date:  01-09-2010

    Language(s): 

    Published date:  18-05-2000

    Publisher:  European Committee for Standards - Electrical

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

    INTRODUCTION
    SECTION ONE - GENERAL
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    4 General requirements for tests
    5 Classification
    6 Identification, marking and documents
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    14 Requirements related to classification
    17 Separation
    19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
       CURRENTS
    20 Dielectric strength
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    21 Mechanical strength
    22 Moving parts
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
                   EXCESSIVE RADIATION
    36 ELECTROMAGNETIC COMPATIBILITY
    SECTION SIX - PROTECTION AGAINST THE HAZARDS OF IGNITION OF
                  FLAMMABLE ANAESTHETIC MIXTURES
    SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
                    OTHER SAFETY HAZARDS
    42 Excessive temperatures
    44 Overflow, spillage, leakage, humidity, ingress of
       liquids, cleaning, sterilization and disinfection, and
       compatibility
    45 Pressure vessels and parts subject to PRESSURES OUTPUTS
    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
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    56 Components and general assembly
    57 MAINS PARTS, components and lay-out
    Annex L (normative) References - Publications mentioned in
                        this standard
    Annex AA (informative) General guidance and rationale
    Annex BB (informative) Alarm diagrams
    Annex ZA (normative) Normative references to international
                         publications with their corresponding
                         European publications
    Annex ZB (informative) Other international publications
                           mentioned in this standard with the
                           references of the relevant European
                           publications
    Figure 101 - Test for protection against defibrillator
                 discharge
    Figure 102 - Safety means, SINGLE FAULT CONDITION, adult
                 (neonatal) determination
    Figure 103 - Safety means, SINGLE FAULT CONDITION, adult
                 (neonatal) determination
    Figure 104 - Maximum inflation time, NORMAL CONDITION and
                 SINGLE FAULT CONDITION, adult (neonatal)
                 determination
    Figure 105 - LONG TERM AUTOMATIC MODE NORMAL CONDITION, adult
                 (neonatal) determination
    Figure 106 - LONG TERM AUTOMATIC MODE SINGLE FAULT CONDITION,
                 adult (neonatal) determination
    Figure 107 - SHORT TERM AUTOMATIC MODE, adult (neonatal)
                 determination
    Figure 108 - Test layout
    Figure 109 - ESU test layout
    Figure 110 - Patient simulator

    Abstract - (Show below) - (Hide below)

    Specifies particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment, with special attention being paid to the avoidance of hazards due to the inflation process.

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

    Committee CLC/TC 62
    Development Note To be read in conjunction with EN 60601-1:1990, EN 60601-1-2:1993, and EN 60601-1-4:1996 (05/2001)
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
    I.S. EN 740:1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    DIN EN 1060-3:2010-03 NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
    ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
    EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
    BS 5724-2.204(1999) : 1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
    UNE-EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    I.S. EN 1060-3:1997 NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    UNE-EN 16372:2015 Aesthetic surgery services
    UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    UNI EN 1060-3 : 2010 NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
    PREN 13976-2 : DRAFT 2016 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
    16/30333925 DC : 0 BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
    I.S. EN 13976-2:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    BS EN 13976-2:2011 Rescue systems. Transportation of incubators System requirements
    BS EN 740:1999 Anaesthetic workstations and their modules. Particular requirements
    DIN EN 13976-2 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    EN 16372:2014 Aesthetic surgery services
    EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
    EN 740:1998/A1:2004 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
    BS EN 16372:2014 Aesthetic surgery services
    IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
    DIN EN 13976-2:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
    BS EN 1060-3 : 1997 NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
    DIN EN 13976-2:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS

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

    IEC 61000-4-8 : 2.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
    HD 395.2.2 : 200S1 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH FREQUENCY SURGICAL EQUIPMENT
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
    IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
    IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
    EN 61000-4-3 : 2006 AMD 2 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    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
    IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    EN 61000-4-8:2010 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
    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
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    EN 61000-4-6:2014/AC:2015 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013)
    EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
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