{"id":198380,"date":"2024-10-19T12:37:43","date_gmt":"2024-10-19T12:37:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-1-8-2006\/"},"modified":"2024-10-25T05:10:47","modified_gmt":"2024-10-25T05:10:47","slug":"aami-60601-1-8-2006","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-1-8-2006\/","title":{"rendered":"AAMI 60601 1 8 2006"},"content":{"rendered":"

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.<\/p>\n

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1<\/td>\nANSI\/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
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2<\/td>\nObjectives and uses of AAMI standards and recommended practices
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3<\/td>\nTitle page
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4<\/td>\nAAMI Standard
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Copyright information
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5<\/td>\nContents
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7<\/td>\nGlossary of equivalent standards
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8<\/td>\nCommittee representation
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10<\/td>\nBackground of ANSI\/AAMI adoption of IEC 60601-1-8:2006 and IEC 60601-1-8:2006\/A1:2012 <\/td>\n<\/tr>\n
11<\/td>\nForeword
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14<\/td>\nIntroduction to the Amendment
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15<\/td>\nIntroduction
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17<\/td>\n1 Scope, object and related standards
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1.1 Scope
1.2 Object
1.3 Related standards
1.3.1 IEC 60601-1 <\/td>\n<\/tr>\n
18<\/td>\n1.3.2 Particular standards
2 Normative references <\/td>\n<\/tr>\n
19<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
23<\/td>\n4 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 <\/td>\n<\/tr>\n
24<\/td>\n5.2.2 Technical description
6 Alarm systems
6.1 Alarm condition
6.1.1 * General
6.1.2 * Determination of alarm conditions and assignment of priority
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26<\/td>\n6.2 * Disclosures for Intelligent alarm system
6.3 Generation of alarm signals
6.3.1 General <\/td>\n<\/tr>\n
27<\/td>\n6.3.2 * 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
\n1 m (operator\u2019s position) visual alarm signals and information signals <\/td>\n<\/tr>\n
28<\/td>\n6.3.3 * Auditory alarm signals
6.3.3.1 * Characteristics of auditory alarm signals <\/td>\n<\/tr>\n
31<\/td>\n6.3.3.2 * Volume and characteristics of auditory alarm signals and information signals <\/td>\n<\/tr>\n
33<\/td>\n6.3.3.3 * Operator-adjustable sound pressure level
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6.3.4 * Characteristics of verbal alarm signals
6.4 * Disclosure of delays
6.4.1 * Alarm system delays <\/td>\n<\/tr>\n
34<\/td>\n6.4.2 * Delays to or from a distributed alarm system
6.5 Alarm presets
6.5.1 * General requirements <\/td>\n<\/tr>\n
35<\/td>\n6.5.2 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 <\/td>\n<\/tr>\n
36<\/td>\n6.5.4 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 <\/td>\n<\/tr>\n
37<\/td>\n6.6 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 <\/td>\n<\/tr>\n
38<\/td>\n6.7 * Alarm system security
6.8 * Alarm signal inactivation states
6.8.1 * General <\/td>\n<\/tr>\n
39<\/td>\n6.8.2 * Reminder signals
6.8.3 * Global indefinite alarm signal inactivation states <\/td>\n<\/tr>\n
40<\/td>\n6.8.4 * Termination of inactivation of alarm signals
6.8.5 * Indication and access <\/td>\n<\/tr>\n
41<\/td>\n6.9 * Alarm reset
6.10 * Non-latching and latching alarm signals <\/td>\n<\/tr>\n
42<\/td>\n6.11 * 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 <\/td>\n<\/tr>\n
43<\/td>\n6.11.2.2 * 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 <\/td>\n<\/tr>\n
44<\/td>\n6.11.2.3 * Remote alarm system controls
6.12 * Alarm
\nsystem logging <\/td>\n<\/tr>\n
46<\/td>\nAnnex A (informative) General guidance and rationale
A.1 General guidance
A.1.1 Overview
A.1.2 Alarm systems <\/td>\n<\/tr>\n
47<\/td>\nA.1.3 Algorithm quality and performance <\/td>\n<\/tr>\n
48<\/td>\nA.2 Rationale for particular clauses and subclauses
Clause 1 — Scope, object and related standards
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Definition 3.1 — Alarm condition
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Definition 3.2 — Alarm condition delay
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49<\/td>\nDefinition 3.3 — Alarm limit
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Definition 3.5 — Alarm paused
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Definition 3.10 — Alarm signal generation delay
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Definition 3.17 — Distributed alarm system
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50<\/td>\nDefinition 3.23 — Information signal
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Definition 3.24 — Intelligent alarm system
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Definition 3.34 — Reminder signal
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51<\/td>\nDefinition 3.37 — Acknowledged
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Subclause 5.2.1 — Instructions for use
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52<\/td>\nSubclause 6.1.1 — General
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Subclause 6.1.2 Determination of alarm conditions and assignment of priority
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54<\/td>\nSubclause 6.2 — Disclosures for intelligent alarm systems
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Subclause 6.3.2 — Visual alarm signals
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55<\/td>\nSubclause 6.3.2.2.1 — 4 m (distant) visual alarm signals
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56<\/td>\nSubclause 6.3.3 — Auditory alarm signals
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Subclause 6.3.3.1 — Characteristics of auditory alarm signals
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60<\/td>\nSubclause 6.3.3.1 — Characteristics of auditory alarm signals
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63<\/td>\nSubclause 6.3.3.2 — Volume and characteristics of auditory alarm signals and information signals
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64<\/td>\nSubclause 6.3.3.3 — Operator-adjustable sound pressure level
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Subclause a) — Characteristics of verbal alarm signals
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Subclause 6.4 — Disclosure of delays
\n <\/td>\n<\/tr>\n
66<\/td>\nSubclause 6.4.1 — Alarm system delays
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Subclause 6.4.2 — Delays to or from a distributed alarm system
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67<\/td>\nSubclause 6.5.1 — General requirements
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Subclause 6.5.3 — Responsible organization- and operator-configured alarm presets
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Subclause 6.5.4.2 — Selection of default alarm preset
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68<\/td>\nSubclause 6.5.5 — Interruptions of less than or equal to 30 s
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Subclause 6.6.2 — Adjustable alarm limit
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Subclause 6.6.2.2 — Indication of automatically set alarm limit
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69<\/td>\nSubclause 6.6.2.3 — Alarm system operation during adjustment of alarm limit or alarm preset
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Subclause 6.7 — Alarm system security
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Subclause 6.8 — Alarm signal inactivation states
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71<\/td>\nSubclause 6.8.1 — General
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73<\/td>\nSubclause 6.8.2 — Reminder signals
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Subclause 6.8.3 — Global indefinite alarm signal inactivation states
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Subclause 6.8.4 — Termination of inactivation of alarm signals
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Subclause 6.8.5 — Indication and access
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75<\/td>\nSubclause 6.9 — Alarm reset
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76<\/td>\nSubclause 6.10 — Non-latching and latching alarm signals
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Subclause 6.11 — Distributed alarm systems
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77<\/td>\nSubclause 6.11.1 — Existence of distributed alarm system
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Subclause 6.11.2.2 — Failure of remote communication of alarm conditions
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Subclause 6.11.2.2.1 — Distributed alarm system intended for confirmed delivery of alarm conditions
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78<\/td>\nSubclause 6.11.2.2.2 — Distributed alarm system not intended for confirmed delivery of alarm conditions
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79<\/td>\nSubclause 6.11.2.2.3 — ME equipment with a global audio off in a distributed alarm system
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Subclause 6.11.2.3 — Remote alarm system controls
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81<\/td>\nSubclause 6.11.2.3 — Alarm system logging
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83<\/td>\nAnnex F
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85<\/td>\nAnnex B (informative) Guide to marking and labelling requirements for me equipment and me systems
B.1 Marking of controls and instruments <\/td>\n<\/tr>\n
86<\/td>\nB.2 Accompanying documents, General
B.3 Accompanying documents, Instructions for use <\/td>\n<\/tr>\n
88<\/td>\nB.4 Accompanying documents, Technical description <\/td>\n<\/tr>\n
89<\/td>\nAnnex C (normative) Symbols on marking <\/td>\n<\/tr>\n
95<\/td>\nAnnex D (informative) Guidance for auditory alarm signals
D.1 General considerations
D.2 Frequency range
D.3 Continuous auditory alarm signals and information signals <\/td>\n<\/tr>\n
96<\/td>\nD.4 Harmonics, timbre, fall time <\/td>\n<\/tr>\n
97<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
98<\/td>\nE.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 <\/td>\n<\/tr>\n
99<\/td>\nAnnex F (normative) * Reserved melodies for alarm signals <\/td>\n<\/tr>\n
100<\/td>\nBibliography
\n <\/td>\n<\/tr>\n
102<\/td>\nIndex of defined terms used in this collateral standard
\n <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2006<\/td>\n103<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198384,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198380","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198380","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198384"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198380"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198380"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198380"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}