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I.S. EN 60601-2-23:2015

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

Language(s)

English

Published date

01-01-2015

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
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 standardard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT and hereinafter referred to as ME EQUIPMENT, whether this ME EQUIPMENT is stand alone or part of a system.

DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
110
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
SN EN 60601-2-23 : 2000 Identical
DIN EN 60601-2-23 : 2016 Identical
EN 60601-2-23:2015 Identical
NF EN 60601-2-23 : 2016 Identical
BS EN 60601-2-23:2015 Identical
IEC 60601-2-23:2011 Identical
UNE-EN 60601-2-23:2001 Identical

EN 60601-2-49:2015 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
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
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 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)

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