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ANSI/AAMI/IEC 60601-1-8:2006/A2:2021

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

04-06-2014

Published date

01-01-2012

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of
IEC 60601-1-8:2006 & A1:2012
FOREWORD
INTRODUCTION TO THE AMENDMENT
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.

Committee
JWG
DevelopmentNote
New child AMD 2 2021 is added.
DocumentType
Standard
ProductNote
New child AMD 2 2021 is added.
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

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

AAMI TIR71 : 2017 GUIDANCE FOR LOGGING OF ALARM SYSTEM DATA
AAMI TIR72 : 2017 DIALYSIS FLUID CHEMICAL COMPOSITION

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
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 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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