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AAMI 60601 1 8 2006

$485.05

ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012 – Medical elelectrical 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

Published By Publication Date Number of Pages
AAMI 2006 103
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This standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness, and data and system security.

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PDF Pages PDF Title
1 ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012, 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
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 AAMI Standard

Copyright information
5 Contents
7 Glossary of equivalent standards
8 Committee representation
10 Background of ANSI/AAMI adoption of IEC 60601-1-8:2006 and IEC 60601-1-8:2006/A1:2012
11 Foreword
14 Introduction to the Amendment
15 Introduction
17 1 Scope, object and related standards

1.1 Scope
1.2 Object
1.3 Related standards
1.3.1 IEC 60601-1
18 1.3.2 Particular standards
2 Normative references
19 3 Terms and definitions
23 4 General requirements
5 Me equipment identification marking and documents
5.1 Indicator lights and controls
5.2 Accompanying documents
5.2.1 Instructions for use
24 5.2.2 Technical description
6 Alarm systems
6.1 Alarm condition
6.1.1 * General
6.1.2 * Determination of alarm conditions and assignment of priority
26 6.2 * Disclosures for Intelligent alarm system
6.3 Generation of alarm signals
6.3.1 General
27 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
28 6.3.3 * Auditory alarm signals
6.3.3.1 * Characteristics of auditory alarm signals
31 6.3.3.2 * Volume and characteristics of auditory alarm signals and information signals
33 6.3.3.3 * Operator-adjustable sound pressure level

6.3.4 * Characteristics of verbal alarm signals
6.4 * Disclosure of delays
6.4.1 * Alarm system delays
34 6.4.2 * Delays to or from a distributed alarm system
6.5 Alarm presets
6.5.1 * General requirements
35 6.5.2 Manufacturer-configured alarm presets
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
36 6.5.4 Default alarm preset
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
37 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
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
38 6.7 * Alarm system security
6.8 * Alarm signal inactivation states
6.8.1 * General
39 6.8.2 * Reminder signals
6.8.3 * Global indefinite alarm signal inactivation states
40 6.8.4 * Termination of inactivation of alarm signals
6.8.5 * Indication and access
41 6.9 * Alarm reset
6.10 * Non-latching and latching alarm signals
42 6.11 * Distributed alarm system
6.11.1 * Existence of distributed alarm system
6.11.2 Requirements for distributed alarm system communication of alarm conditions
6.11.2.1 Source and identification of alarm conditions
43 6.11.2.2 * Failure of remote communication of alarm conditions
6.11.2.2.1 * Distributed alarm system intended for confirmed delivery of alarm conditions
6.11.2.2.2 * Distributed alarm system not intended for confirmed delivery of alarm conditions
6.11.2.2.3 * Me equipment with a global audio off in a distributed alarm system
44 6.11.2.3 * Remote alarm system controls
6.12 * Alarm
system logging
46 Annex A (informative) General guidance and rationale
A.1 General guidance
A.1.1 Overview
A.1.2 Alarm systems
47 A.1.3 Algorithm quality and performance
48 A.2 Rationale for particular clauses and subclauses
Clause 1 — Scope, object and related standards

Definition 3.1 — Alarm condition

Definition 3.2 — Alarm condition delay
49 Definition 3.3 — Alarm limit

Definition 3.5 — Alarm paused

Definition 3.10 — Alarm signal generation delay

Definition 3.17 — Distributed alarm system
50 Definition 3.23 — Information signal

Definition 3.24 — Intelligent alarm system

Definition 3.34 — Reminder signal
51 Definition 3.37 — Acknowledged

Subclause 5.2.1 — Instructions for use
52 Subclause 6.1.1 — General

Subclause 6.1.2 Determination of alarm conditions and assignment of priority
54 Subclause 6.2 — Disclosures for intelligent alarm systems

Subclause 6.3.2 — Visual alarm signals
55 Subclause 6.3.2.2.1 — 4 m (distant) visual alarm signals
56 Subclause 6.3.3 — Auditory alarm signals

Subclause 6.3.3.1 — Characteristics of auditory alarm signals
60 Subclause 6.3.3.1 — Characteristics of auditory alarm signals
63 Subclause 6.3.3.2 — Volume and characteristics of auditory alarm signals and information signals
64 Subclause 6.3.3.3 — Operator-adjustable sound pressure level

Subclause a) — Characteristics of verbal alarm signals

Subclause 6.4 — Disclosure of delays
66 Subclause 6.4.1 — Alarm system delays

Subclause 6.4.2 — Delays to or from a distributed alarm system
67 Subclause 6.5.1 — General requirements

Subclause 6.5.3 — Responsible organization- and operator-configured alarm presets

Subclause 6.5.4.2 — Selection of default alarm preset
68 Subclause 6.5.5 — Interruptions of less than or equal to 30 s

Subclause 6.6.2 — Adjustable alarm limit

Subclause 6.6.2.2 — Indication of automatically set alarm limit
69 Subclause 6.6.2.3 — Alarm system operation during adjustment of alarm limit or alarm preset

Subclause 6.7 — Alarm system security

Subclause 6.8 — Alarm signal inactivation states
71 Subclause 6.8.1 — General
73 Subclause 6.8.2 — Reminder signals

Subclause 6.8.3 — Global indefinite alarm signal inactivation states

Subclause 6.8.4 — Termination of inactivation of alarm signals

Subclause 6.8.5 — Indication and access
75 Subclause 6.9 — Alarm reset
76 Subclause 6.10 — Non-latching and latching alarm signals

Subclause 6.11 — Distributed alarm systems
77 Subclause 6.11.1 — Existence of distributed alarm system

Subclause 6.11.2.2 — Failure of remote communication of alarm conditions

Subclause 6.11.2.2.1 — Distributed alarm system intended for confirmed delivery of alarm conditions
78 Subclause 6.11.2.2.2 — Distributed alarm system not intended for confirmed delivery of alarm conditions
79 Subclause 6.11.2.2.3 — ME equipment with a global audio off in a distributed alarm system

Subclause 6.11.2.3 — Remote alarm system controls
81 Subclause 6.11.2.3 — Alarm system logging
83 Annex F
85 Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems
B.1 Marking of controls and instruments
86 B.2 Accompanying documents, General
B.3 Accompanying documents, Instructions for use
88 B.4 Accompanying documents, Technical description
89 Annex C (normative) Symbols on marking
95 Annex D (informative) Guidance for auditory alarm signals
D.1 General considerations
D.2 Frequency range
D.3 Continuous auditory alarm signals and information signals
96 D.4 Harmonics, timbre, fall time
97 Annex E (informative) Verbal alarm signals
E.1 Guidance
E.2 Characteristics of verbal alarm signals
E.2.1 General
E.2.2 Intensity
E.2.3 Type of voice
E.2.4 Delivery style
E.2.5 Speech processing
98 E.2.6 Message content
E.2.7 High priority verbal alarm signals
E.2.8 Message priorities
E.3 Limitations of verbal alarm signals
E.3.1 Privacy and security
E.3.2 Language
E.3.3 Clarity
E.3.4 Multiple alarm conditions
E.3.5 Emotional responses
99 Annex F (normative) * Reserved melodies for alarm signals
100 Bibliography
102 Index of defined terms used in this collateral standard
AAMI 60601 1 8 2006
$485.05