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  • IEC 60601-2-26:2012

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

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

    Superseded date:  31-12-2021

    Language(s):  English - French

    Published date:  29-05-2012

    Publisher:  International Electrotechnical Committee

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

    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
    202 ELECTROMAGNETIC COMPATIBILITY - Requirements
           and tests
    Annexes
    Annex AA (informative) - Particular guidance and rationale
    Index of defined terms used in this particular standard

    Abstract - (Show below) - (Hide below)

    IEC 60601-2-26:2012 standard applies to basic safety and essential performance of electroencephalographs used in a clinical environment (e.g., hospital, physician's office, etc.). This standard does not cover requirements for other equipment used in electroencephalography. This third edition cancels and replaces the second edition of IEC 60601-2-26 published in 2003. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard IEC 60601-1:2005 Edition 3, through reformatting and technical changes.

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

    Development Note Stability Date: 2018. (10/2012)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Supersedes

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

    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    BS 5724-2.204(1999) : 1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
    I.S. EN ISO 11073-10406:2012 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
    UNE-EN 16372:2015 Aesthetic surgery services
    BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    I.S. EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    BS EN 740:1999 Anaesthetic workstations and their modules. Particular requirements
    EN 16372:2014 Aesthetic surgery services
    EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
    BS EN 16372:2014 Aesthetic surgery services
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)

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

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    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
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
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