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

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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

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Superseded date: 06-04-2014

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Published date: 01-01-2012

Publisher: Association for the Advancement of Medical Instrumentation

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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

Abstract - (Show below) - (Hide below)

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.

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Committee	JWG
Development Note	New child AMD 2 2021 is added.
Document Type	Standard
ISBN
Pages
Product Note	New child AMD 2 2021 is added.
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
IEC 60601-1-8:2006+AMD1:2012 CSV	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

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

Standards Referencing This Book - (Show below) - (Hide below)

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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