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IEC 60601-2-23:2011

Current
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

02-25-2011

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

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.

Committee
TC 62/SC 62D
DevelopmentNote
Stability Date: 2018. (09/2017)
DocumentType
Standard
Pages
100
PublisherName
International Electrotechnical Committee
Status
Current
Supersedes

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)

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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