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12/30245174 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
Available format(s)

Hardcopy , PDF

Superseded date

06-30-2015

Language(s)

English

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 Classification of ME EQUIPMENT and ME
   SYSTEMS
6 ME EQUIPMENT identification, marking and
   documents
7 Protection against electrical HAZARDS from
   ME EQUIPMENT
8 Protection against excessive temperatures and
   other HAZARDS
9 Accuracy of controls and instruments and protection
   against hazardous outputs
10 Construction of ME EQUIPMENT
11 Additional requirements for electromagnetic
   compatibility of ME EQUIPMENT and ME
   SYSTEMS
Annex A (informative) - General guidance and
        rationale
Annex B (informative) - Guide to marking and
        labelling requirements for ME EQUIPMENT
        and ME SYSTEMS
Annex C (informative) - Symbols on marking
Bibliography
Index of defined terms used in this collateral standard

BS EN 60601-1-12

Committee
CH/62/1
DocumentType
Draft
Pages
44
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
IEC 60038:2009 IEC standard voltages
IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
MIL-STD-810 Revision G:2008 ENVIRONMENTAL ENGINEERING CONSIDERATIONS AND LABORATORY TESTS
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
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 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
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
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
IEC TR 60721-4-7:2001+AMD1:2003 CSV Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
MIL-HDBK-310 Base Document:1997 DEPARTMENT OF DEFENSE HANDBOOK - GLOBAL CLIMATIC DATA FOR DEVELOPING MILITARY PRODUCTS
EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
IEC 61032:1997 Protection of persons and equipment by enclosures - Probes for verification
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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