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eLibrary > ANSI/AAMI/ IEC 60601-1-8:2006 & A1: 2013 & A2:2021, Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical >

ANSI/AAMI/ IEC 60601-1-8:2006 & A1: 2013 & A2:2021, Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical, 2021

ANSI/AAMI/ IEC 60601-1-8:2006 & A1: 2013 & A2:2021, Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical, 2021

ANSI/AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021; Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical equipment and medical electrical systems (Consolidated Text; Redline Version)
Title page
AAMI Standard
Copyright information
CONTENTS
Committee representation
Background of ANSI/AAMI adoption of IEC 60601-1-8:2006 and Amendment 2:2020
Foreword
Introduction
1 * Scope, object and related standards [Go to Page]
1.1 Scope
1.2 Object
1.3 Related standards [Go to Page]
1.3.1 IEC 60601-1
1.3.2 Particular standards
2 Normative references
3 Terms and definitions
4 General requirements
5 Me equipment identification marking and documents [Go to Page]
5.1 Indicator lights and controls
5.2 Accompanying documents [Go to Page]
5.2.1 Instructions for use
5.2.2 Technical description
6 Alarm systems [Go to Page]
6.1 Alarm condition [Go to Page]
6.1.1 * General
6.1.2 * Alarm condition priority Determination of alarm conditions and assignment of priority
6.2 * Disclosures for Intelligent alarm system
6.3 Generation of alarm signals [Go to Page]
6.3.1 General
6.3.2 * Visual alarm signals [Go to Page]
6.3.2.1 General
6.3.2.2 * Characteristics of visual alarm signals [Go to Page]
6.3.2.2.1 * 4 m (distant) visual alarm signals
6.3.2.2.2 1 m (operator’s position) visual alarm signals and information signals
6.3.3 * Auditory alarm signals [Go to Page]
6.3.3.1 * Characteristics of auditory alarm signals
6.3.3.2 * Volume and characteristics of auditory alarm signals and information signals
6.3.4 * Characteristics of verbal alarm signals
6.4 * Disclosure of delays [Go to Page]
6.4.1 * Alarm system delays
6.4.2 * Delays to or from a distributed alarm system information system about alarm conditions (dis) or a distributed alarm system (das)
6.5 Alarm presets [Go to Page]
6.5.1 * General requirements
6.5.2 Manufacturer-configured alarm presets
6.5.3 * responsible organization- and operator-configured alarm presets [Go to Page]
6.5.3.1 Alarm systems with one alarm preset
6.5.3.2 Alarm systems with more than one alarm preset
6.5.4 Default alarm preset [Go to Page]
6.5.4.1 General requirements
6.5.4.2 * Selection of default alarm preset
6.5.5 * Interruptions of less than or equal to 30 s
6.6 Alarm limit [Go to Page]
6.6.1 General requirements
6.6.2 * Adjustable alarm limit [Go to Page]
6.6.2.1 Indication of operator-adjustable alarm limit
6.6.2.2 * Indication of automatically set alarm limit
6.6.2.3 * Alarm system operation during adjustment of alarm limit or alarm preset
6.7 * Alarm system security
6.8 * Alarm signal inactivation states [Go to Page]
6.8.1 * General
6.8.2 * Reminder signals
6.8.3 * Global indefinite alarm signal inactivation states
6.8.4 * Termination of inactivation of alarm signals
6.8.5 * Indication and access
6.9 * Alarm reset
6.10 * Non-latching and latching alarm signals
6.11 * Distributed alarm systems and distributed information systems about alarm conditions [Go to Page]
1.1.1 * Existence of distributed alarm system
1.1.1 Requirements for distributed alarm system communication of alarm conditions [Go to Page]
1.1.1.1 Source and identification of alarm conditions
1.1.1.1 * Failure of remote communication of alarm conditions [Go to Page]
1.1.1.1.1 * Distributed alarm system intended for confirmed delivery of alarm conditions
1.1.1.1.1 * Distributed alarm system not intended for confirmed delivery of alarm conditions
1.1.1.1.1 * Me equipment with a global audio off in a distributed alarm system
1.1.1.1 * Remote alarm system controls
6.11.1 * Existence of a dis or das
6.11.2 Requirements for communication of alarm conditions
6.12 * Alarm condition system logging [Go to Page]
6.12.1 General
6.12.2 * Operator alarm system logging
6.12.3 * Responsible organization alarm system logging
6.13 Alarm system functions [Go to Page]
6.13.1 General
6.13.2 Source (src)
6.13.3 Integrator (int)
6.13.4 Communicator (com)
Annex A (informative) General guidance and rationale [Go to Page]
A.1.1 Overview
A.1.2 Alarm systems
A.1.3 Algorithm quality and performance
Table A.2 – Examples of me equipment for each category of the source of an alarm condition
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 [Go to Page]
E.1.1 General
E.1.2 Intensity
E.1.3 Type of voice
E.1.4 Delivery style
E.1.5 Speech processing
E.1.6 Message content
E.1.7 High priority verbal alarm signals
E.1.8 Message priorities
E.1.9 Privacy and security
E.1.10 Language
E.1.11 Clarity
E.1.12 Multiple alarm conditions
E.1.13 Emotional responses
Annex F (normative) * Reserved melodies for alarm signals
Annex G (normative) * Auditory alarm signals
Table G.1 – Characteristics of the burst of the auditory pointer
Figure G.1 – Illustration of spacing of auditory pointer
Figure G.2 – Illustration of temporal characteristics of an auditory pointer
Table G.4 – * Characteristics of the auditory icon
Table G.5 – Characteristics of the auditory alarm signal
Annex H (informative) Validation of auditory icons [Go to Page]

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ANSI/AAMI/ IEC 60601-1-8:2006 & A1: 2013 & A2:2021, Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance for alarm systems in medical electrical, 2021

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