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AAMI 60601 1 8 2021

AAMI 60601 1 8 2021

$513.92

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

Published By Publication Date Number of Pages
AAMI 2021 135
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This standard specifies requirements for alarm systems and alarm signals in ME equipment and ME systems. The second amendment addresses changes to terminology and references since the main document was finalized in 2006 and first amended in 2012.

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PDF Pages PDF Title
1 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)
3 Title page
4 AAMI Standard
Copyright information
5 CONTENTS
7 Committee representation
9 Background of ANSI/AAMI adoption of IEC 60601-1-8:2006 and Amendment 2:2020
10 Foreword
13 Introduction
15 1 * Scope, object and related standards
1.1 Scope
1.2 Object
1.3 Related standards
1.3.1 IEC 60601-1
16 1.3.2 Particular standards
2 Normative references
17 3 Terms and definitions
24 4 General requirements
5 Me equipment identification marking and documents
25 5.1 Indicator lights and controls
5.2 Accompanying documents
5.2.1 Instructions for use
5.2.2 Technical description
6 Alarm systems
6.1 Alarm condition
6.1.1 * General
6.1.2 * Alarm condition priority Determination of alarm conditions and assignment of priority
27 6.2 * Disclosures for Intelligent alarm system
6.3 Generation of alarm signals
6.3.1 General
28 6.3.2 * Visual alarm signals
6.3.2.1 General
6.3.2.2 * Characteristics of visual alarm signals
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
29 6.3.3 * Auditory alarm signals
6.3.3.1 * Characteristics of auditory alarm signals
33 6.3.3.2 * Volume and characteristics of auditory alarm signals and information signals
35 6.3.4 * Characteristics of verbal alarm signals
6.4 * Disclosure of delays
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)
36 6.5 Alarm presets
6.5.1 * General requirements
6.5.2 Manufacturer-configured alarm presets
37 6.5.3 * responsible organization- and operator-configured alarm presets
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
6.5.4.1 General requirements
6.5.4.2 * Selection of default alarm preset
38 6.5.5 * Interruptions of less than or equal to 30 s
6.6 Alarm limit
6.6.1 General requirements
6.6.2 * Adjustable alarm limit
6.6.2.1 Indication of operator-adjustable alarm limit
39 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
6.8.1 * General
40 6.8.2 * Reminder signals
41 6.8.3 * Global indefinite alarm signal inactivation states
6.8.4 * Termination of inactivation of alarm signals
6.8.5 * Indication and access
43 6.9 * Alarm reset
6.10 * Non-latching and latching alarm signals
6.11 * Distributed alarm systems and distributed information systems about alarm conditions
1.1.1 * Existence of distributed alarm system
44 1.1.1 Requirements for distributed alarm system communication of alarm conditions
1.1.1.1 Source and identification of alarm conditions
1.1.1.1 * Failure of remote communication of alarm conditions
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
45 1.1.1.1 * Remote alarm system controls
6.11.1 * Existence of a dis or das
46 6.11.2 Requirements for communication of alarm conditions
47 6.12 * Alarm condition system logging
48 6.12.1 General
6.12.2 * Operator alarm system logging
49 6.12.3 * Responsible organization alarm system logging
50 6.13 Alarm system functions
6.13.1 General
6.13.2 Source (src)
51 6.13.3 Integrator (int)
6.13.4 Communicator (com)
52 Annex A (informative) General guidance and rationale
A.1.1 Overview
A.1.2 Alarm systems
53 A.1.3 Algorithm quality and performance
98 Table A.2 – Examples of me equipment for each category of the source of an alarm condition
99 Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems
102 Annex C (normative) Symbols on marking
111 Annex D (informative) Guidance for auditory alarm signals
113 Annex E (informative) Verbal alarm signals
E.1.1 General
E.1.2 Intensity
E.1.3 Type of voice
E.1.4 Delivery style
E.1.5 Speech processing
114 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
115 Annex F (normative) * Reserved melodies for alarm signals
116 Annex G (normative) * Auditory alarm signals
117 Table G.1 – Characteristics of the burst of the auditory pointer
118 Figure G.1 – Illustration of spacing of auditory pointer
119 Figure G.2 – Illustration of temporal characteristics of an auditory pointer
120 Table G.4 – * Characteristics of the auditory icon
121 Table G.5 – Characteristics of the auditory alarm signal
122 Annex H (informative) Validation of auditory icons

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AAMI 60601 1 8 2021
$513.92