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CSA C22.2 No. 60601.1.8 : 2008

CSA C22.2 No. 60601.1.8 : 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Amended by

CAN/CSA-C22.2 NO. 60601-1-8B:08

Available format(s)

Hardcopy , PDF

Superseded date

01-01-2018

Language(s)

English

Published date

01-01-2018

Publisher

Canadian Standards Association

FOREWORD
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

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.

DevelopmentNote
Supersedes CSA ISO 9703-1 & CSA ISO 9703-2. (02/2008) Amendment 1 is available separately, see CSA C22.2.60601.1.8A. (01/2015) NEW CHILD AMD 2 2021 IS NOW ADDED
DocumentType
Standard
ISBN
978-1-55491-042-7
Pages
246
ProductNote
Reconfirmed EN THIS STANDARD ALSO REFERS TO IEC 60417, NEW CHILD AMD 2 2021 IS NOW ADDED
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
IEC 60601-1-8:2006+AMD1:2012 CSV Identical

AAMI HE48 : 1993 HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
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
ISO 11428:1996 Ergonomics Visual danger signals General requirements, design and testing
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals

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