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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2007

Publisher

British Standards Institution

INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification marking and documents
6 ALARM 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 (normative) - Symbols on marking
Annex D (informative) - Guidance for auditory ALARM SIGNALS
Annex E (informative) - Verbal ALARM SIGNALS
Annex F (normative) - Reserved melodies for ALARM SIGNALS
Bibliography
Index of defined terms used in this collateral 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 MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

Committee	CH/62/1
DevelopmentNote	Supersedes BS EN 475. (02/2004) Supersedes 02/562586 DC. (10/2004) Supersedes 11/30206856 DC. (06/2013) 2007 Edition Re-issued in July 2017 & incorporates AMD 11 2017. 2007 + A1 2013 Edition remains current and will be withdrawn on 07/01/2020. (07/2017)
DocumentType	Standard
Pages	100
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN 475:1995 11/30206856 DC : 0 02/562586 DC : DRAFT JUN 2002

Standards	Relationship
IEC 60601-1-8:2006+AMD1:2012 CSV	Identical
SN EN 60601-1-8 : 2007 AMD 11 2017	Identical
EN 60601-1-8:2007/A11:2017	Identical
I.S. EN 60601-1-8:2007	Identical
UNE-EN 60601-1-8:2008	Identical
DIN EN 60601-1-8 : 2014 AMD 11 2018	Identical
NF EN 60601-1-8 : 2007 AMD 11 2018	Identical

AAMI HE48 : 1993	HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
ISO 3744:2010	Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
AAMI EC57 : 2012	TESTING AND REPORTING PERFORMANCE RESULTS OF CARDIAC RHYTHM AND ST SEGMENT MEASUREMENT ALGORITHMS
IEC TR 60513:1994	Fundamental aspects of safety standards for medical electrical equipment
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 11429:1996	Ergonomics System of auditory and visual danger and information signals
EN 61672-1:2013	Electroacoustics - Sound level meters - Part 1: Specifications
EN ISO 3744:2010	Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010)
ISO 11428:1996	Ergonomics Visual danger signals General requirements, design and testing
EN 62366 : 2008 AMD 1 2015	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 9703-2:1994	Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals

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BS EN 60601-1-8 : 2007

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)

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