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  • IEC 60601-2-23:2011

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

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

    Language(s):  English, English - French

    Published date:  25-02-2011

    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
    208 General requirements, tests and guidance for
           alarm systems in medical electrical equipment
           and medical electrical systems
    Annexes
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Alarm diagrams of Clause
             208/IEC 60601-1-8:2006
    Index of defined terms used in this particular standard

    Abstract - (Show below) - (Hide below)

    IEC 60601-2-23:2011 applies to the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. It applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. IEC 60601-2-23:2011 does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). This third edition cancels and replaces the second edition published in 1999 and constitutes a technical revision. This edition of IEC 60601-2-23 was revised to align structurally with the 2005 edition of IEC 60601-1.

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

    Committee TC 62/SC 62D
    Development Note Stability Date: 2018. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

    EN 60601-3-1:1996 Medical electrical equipment - Part 3-1: Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
    03/111581 DC : DRAFT JULY 2003 BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    DIN EN ISO 18778 E : 2009 RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
    DIN EN ISO 18778:2009-08 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
    ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
    I.S. EN ISO 18778:2009 RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
    NF EN ISO 18778 : 2009 RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
    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
    BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
    BS EN 60601-3-1:1997 Medical electrical equipment. Particular requirements for performance Specification for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
    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
    UNI EN ISO 18778 : 2009 RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    CEI EN 60601-3-1 : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 3-1: ESSENTIAL PERFORMANCE REQUIREMENTS FOR TRANSCUTANEOUS OXYGEN AND CARBON DIOXIDE PARTIAL PRESSURE MONITORING EQUIPMENT
    ISO 18778:2005 Respiratory equipment — Infant monitors — Particular requirements
    BS EN ISO 18778:2009 Respiratory equipment. Infant monitors. Particular requirements
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    IEC 60601-3-1:1996 Medical electrical equipment - Part 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
    EN ISO 18778:2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
    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)
    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)
    UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    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)
    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 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    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 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
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