MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE

Amended by

BS EN 60601-2-31:2008+A1:2011

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2008

Publisher

British Standards Institution

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 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
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EC Directives

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT.

Committee	CH/150/2
DevelopmentNote	Supersedes 91/53412 DC. (11/2005) Supersedes BS 5724-2.31(1995) and 07/30165025 DC. To be read in conjunction with BS EN 60601-1. (08/2009) 2008 Edition remains current. 2008 Edition Re-issued in September 2011 & incorporates AMD 1 2011. (10/2011)
DocumentType	Standard
Pages	40
PublisherName	British Standards Institution
Status	Current
Supersedes	91/53412 DC : JUN 91 07/30165025 DC : 0 BS 5724-2.31(1995) : 1995

Standards	Relationship
IEC 60601-2-31:2008+AMD1:2011 CSV	Identical
DIN EN 60601-2-31 : 2012	Identical
EN 60601-2-31:2008/A1:2011	Identical
UNE-EN 60601-2-31:2009	Identical
SN EN 60601-2-31 : 1995 AMD 1 1998	Identical
I.S. EN 60601-2-31:2008	Identical

AAMI PC69 : 2007
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
ISO 14708-2:2012	Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
ISO 14708-1:2014	Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
IEC 60086-2:2015	Primary batteries - Part 2: Physical and electrical specifications
IEC 60086-1:2015	Primary batteries - Part 1: General

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BS EN 60601-2-31 : 2008

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Abstract

General Product Information

International Equivalents

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