• IEC 62353:2014

    Current The latest, up-to-date edition.

    Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English - French, Spanish, Castilian

    Published date:  04-09-2014

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Tests
    6 Results of test and evaluation
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Sequence of testing
    Annex C (normative) - Requirements for the measurement equipment and for measurement circuits for
    PROTECTIVE EARTH RESISTANCE and leakage currents
    Annex D (informative) - PATIENT ENVIRONMENT
    Annex E (normative) - Allowable values for leakage currents from IEC 60601-1
    Annex F (informative) - Testing intervals
    Annex G (informative) - Example of test documentation
    Annex H (informative) - Notes on testing ME SYSTEMS
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    IEC 62353:2014 applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. This standard contains "general requirements", which contain clauses of general concern, and "particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements". This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME systems. For assembling ME systems see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. All maintenance, inspection, servicing, and repair done in accordance with the manufacturer's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after repair. This second edition cancels and replaces the first edition of IEC 62353 published in 2007. This edition constitutes a technical revision including the following main revisions:
    - clarification in 5.3.4.1 that measurements of leakage currents based on test configurations derived from IEC 60601-1 are an allowable alternative method and the inclusion of informative explanation in Annex A;
    - revision of the protective earth resistance requirements for ME systems using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on the safe allowed values of protective earth resistance of plugged-in equipment;
    - the inclusion of expected minimum insulation resistance values in Table 2; and
    - a reordering of the sequence of testing in Annex B.

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

    Committee TC 62/SC 62A
    Development Note Stability date: 2019. (09/2014)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

    BS PD IEC PAS 63077 : 2016 GOOD REFURBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT
    12/30262863 DC : 0 BS EN 61557-16 - ELECTRICAL SAFETY IN DISTRIBUTION SYSTEMS UP TO 1000 V A.C AND 1500 V D.C - EQUIPMENT FOR TESTING, MEASURING OR MONITORING OF PROTECTIVE MEASURES - PART 16: EQUIPMENT FOR TESTING THE SAFETY OF ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL EQUIPMENT ACCORDING TO IEC 62638 AND IEC 62353
    CSA SPE 3000 : 2015 MODEL CODE FOR THE FIELD EVALUATION OF MEDICAL ELECTRICAL EQUIPMENT AND SYSTEMS
    BS EN 61557-16:2015 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. Equipment for testing, measuring or monitoring of protective measures Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment
    17/30332162 DC : 0 BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    NEMA/MITA 1 : 2015 GOOD REFURBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT
    10/30205392 DC : 0 BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    I.S. EN 61557-16:2015 ELECTRICAL SAFETY IN LOW VOLTAGE DISTRIBUTION SYSTEMS UP TO 1000 V A.C. AND 1500 V D.C. - EQUIPMENT FOR TESTING, MEASURING OR MONITORING OF PROTECTIVE MEASURES - PART 16: EQUIPMENT FOR TESTING THE EFFECTIVENESS OF THE PROTECTIVE MEASURES OF ELECTRICAL EQUIPMENT AND/OR MEDICAL ELECTRICAL EQUIPMENT
    IEC TR 60930:2008 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
    CSA C22.2 No. 60601.1 : 2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    I.S. EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    UNI EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    UNE-EN ISO 7494-1:2012 Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011)
    I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
    NBR ISO 6875 : 2014 DENTISTRY - PATIENT CHAIR
    EN ISO 7494-1:2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    BS EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    DIN EN ISO 7494-1:2011-11 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011)
    NF EN ISO 7494-1 : 2011 DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS
    IEC TR 62653:2012 Guideline for safe operation of medical equipment used for haemodialysis treatments
    AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    AAMI ES60601-1 : 2005 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
    DIN EN ISO 6875:2011-10 DENTISTRY - PATIENT CHAIR
    UNE-EN ISO 6875:2012 Dentistry - Patient chair (ISO 6875:2011)
    BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 6875:2011 Dentistry Patient chair
    BS EN ISO 6875 : 2011 DENTISTRY - PATIENT CHAIR
    IEC 61557-16:2014 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c - Equipment for testing, measuring or monitoring of protective measures - Part 16: Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment
    I.S. EN ISO 6875:2011 DENTISTRY - PATIENT CHAIR
    EN 61557-16 : 2015 ELECTRICAL SAFETY IN LOW VOLTAGE DISTRIBUTION SYSTEMS UP TO 1000 V A.C. AND 1500 V D.C. - EQUIPMENT FOR TESTING, MEASURING OR MONITORING OF PROTECTIVE MEASURES - PART 16: EQUIPMENT FOR TESTING THE EFFECTIVENESS OF THE PROTECTIVE MEASURES OF ELECTRICAL EQUIPMENT AND/OR MEDICAL ELECTRICAL EQUIPMENT (IEC 61557-16:2014)
    EN ISO 6875:2011 DENTISTRY - PATIENT CHAIR
    UNI EN ISO 6875 : 2011 DENTISTRY - PATIENT CHAIR

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

    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    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
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 61557-1:2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 1: General requirements
    IEC 61557-16:2014 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c - Equipment for testing, measuring or monitoring of protective measures - Part 16: Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment
    IEC 62020:1998+AMD1:2003 CSV Electrical accessories - Residual current monitors for household and similar uses (RCMs)
    IEC 61010-031:2015 RLV Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test
    IEC 61557-4:2007 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 4: Resistance of earth connection and equipotential bonding
    IEC 61010-2-010:2014 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 61140:2016 Protection against electric shock - Common aspects for installation and equipment
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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