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AAMI 60601 2 47 2012 RA 2016

AAMI 60601 2 47 2012 RA 2016

$140.32

ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 – Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

Published By Publication Date Number of Pages
AAMI 2012 77
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Specifies the basic safety and essential performance of ambulatory electrocardiographic (ECG) systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyze it later on a separate unit or record and analyze the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; and b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.

PDF Catalog

PDF Pages PDF Title
2 Title page
3 AAMI Standard

Copyright information
4 Contents
6 Glossary of equivalent standards
8 Committee representation
9 Background of ANSI/AAMI adoption of IEC 60601-2-47:2012
10 Foreword
12 Introduction
14 201.1 Scope, object and related standards

201.1.1 Scope
15 201.1.2 Object
201.1.3 Collateral Standards
201.1.4 Particular standards
16 201.2 Normative references
201.3 Terms and definitions
19 201.4 General requirements
201.4.3 Essential performance
201.4.101 Additional essential performance requirements
201.5 General requirements for testing of me equipment
201.5.3 Ambient temperature, humidity, atmospheric pressure
201.6 Classification of me equipment and me systems
20 201.6.2 Protection against electrical shock
201.6.6 Mode of operation
201.7 ME
equipment identification, marking and documents
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.101 Lead wire identification
21 201.7.9.2 Instructions for use

201.7.9.2.101 Additional instructions for use
22 201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12.1 Accuracy of controls and instruments
201.12.1.101 *Algorithm testing
201.12.1.101.1 General
201.12.1.101.1.1 *Databases
201.12.1.101.1.1.1 General description of available databases
23 201.12.1.101.1.1.2 *Records to be excluded during testing
24 201.12.1.101.1.2 *Testing requirements

201.12.1.101.1.3 *Test environment
25 201.12.1.101.1.4 Multiple-lead analysis

201.12.1.101.1.5 *Requirements for the evaluation report

201.12.1.101.1.5.1 *Required statistics

201.12.1.101.1.5.2 *Requirements for all arrhythmia algorithms
26 201.12.1.101.1.5.3 *Requirements for algorithms with optional capabilities
28 202.12.1.101.1.6 Simulated test patterns

201.12.1.101.2 *Automated analysis
201.12.1.101.2.1 Use of standard databases
29 201.12.1.101.2.2 *Use of annotation files
30 201.12.1.101.2.3 Beat-by-beat comparison
201.12.1.101.2.3.1 General description
31 201.12.1.101.2.3.2 Method for beat-by-beat comparison
32 201.12.1.101.2.3.3 Heart rate, and heart rate or RR interval variability
201.12.1.101.2.3.3.1 *Heart rate measurement
201.12.1.101.2.3.3.2 *Heart rate variability or RR interval variability measurement test patterns
34 201.12.1.101.2.4 Run-by-run comparison

201.12.1.101.2.4.1 General description
35 201.12.1.101.2.4.2 Terms and symbols
36 201.12.1.101.2.4.3 Run sensitivity summary matrix
201.12.1.101.2.4.4 Run positive predictivity summary matrix
201.12.1.101.2.5 VF and AF
comparisons
37 201.12.1.101.3 *Physician report – minimum requirements
201.12.1.101.3.1 Heart rate
201.12.1.101.3.2 Supraventricular ectopy
201.12.1.101.3.3 Ventricular ectopy
38 201.12.1.101.3.4 Bradycardia data
201.12.1.101.3.5 Pauses
201.12.1.101.3.6 *ST
segment shifts
201.12.1.101.3.7 ECG
hard copy
39 201.12.4 Protection against hazardous output
201.12.4.4 Incorrect output
201.12.4.4.101 *Linearity and dynamic range
41 201.12.4.4.102 *Input impedance
201.12.4.4.103 *Common mode rejection
44 201.12.4.4.104 *Gain accuracy
201.12.4.4.105 *Gain stability
201.12.4.4.106 *System noise
201.12.4.4.107 *Multichannel crosstalk
45 201.12.4.4.108 *Frequency response
46 201.12.4.4.109 *Function in the presence of pacemaker pulses
47 201.12.4.4.110 *Timing accuracy
201.12.4.4.111 *Gain settings and switching
201.12.4.4.112 *Temporal alignment
48 201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (PEMS
)
201.15 Construction of ME
equipment
201.15.3 Mechanical strength
201.15.3.4.1 Hand held ME
equipment
201.15.3.4.2 Portable me equipment
49 201.15.4 ME
equipment components and general assembly
201.15.4.3 Batteries
201.15.4.3.101 Monitoring time and retention of data
201.15.4.3.101.1 *Monitoring time
201.15.4.3.101.2 *Data retention
50 201.16 ME
systems
201.16.5 Separation devices
201.17 *Electromagnetic compatibility of ME equipment and ME
systems
202 Electromagnetic compatibility – Requirements and tests
202.6.1.1 Protection of radio services
202.6.1.1.1 Requirements
202.6.1.1.2 Tests
52 202.6.2 Immunity
202.6.2.3 *Radiated RF electromagnetic fields
202.6.2.3.2 Tests
Annexes
53 Annex AA (informative) Particular guidance and rationale
AA.1 General
AA.2 Rationale for particular clauses and subclauses
Subclause 201.7.9.2.101 — Additional instructions for use

Subclause 201.12.1.101.1 — Algorithm testing
54 Subclause 201.12.1.101.1.1 — Databases

Subclause 201.12.1.101.1.1.2 — Records to be excluded during testing
55 Subclause 201.12.1.101.1.2 — Testing requirements

Subclause 201.12.1.101.1.3 — Test environment
56 Subclause 201.12.1.101.1.5 — Requirements for the evaluation report

Subclause 201.12.1.101.1.5.1 — Required statistics
57 Subclause 201.12.1.101.1.5.2 — Requirements for all arrhythmia algorithms
61 Subclause 201.12.1.101.1.5.3 — Requirements for algorithms with optional capabilities
64 Subclause 201.12.1.101.2 — Automated analysis

Subclause 201.12.1.101.2.2 — Use of annotation files

Subclause 201.12.1.101.2.3.3.1 — Heart rate measurements
65 Subclause 201.12.1.101.2.3.3.2 — Heart rate variability or RR interval variability measurement test patterns
70 Subclause 201.12.1.101.3 — Physician report — minimum requirements

Subclause 201.12.1.101.3.6 — ST segment shifts
71 Subclause 201.12.4.4.101 — Linearity and dynamic range

Subclause 201.12.4.4.102 — Input impedance

Subclause 201.12.4.4.103 — Common mode rejection
72 Subclause 201.12.4.4.104 — Gain accuracy

Subclause 201.12.4.4.105 — Gain stability
Subclause 201.12.4.4.106 — System noise

Subclause 201.12.4.4.107 — Multichannel crosstalk
73 Subclause 201.12.4.4.108 — Frequency response

Subclause 201.12.4.4.109 — Function in the presence of pacemaker pulses
74 Subclause 201.12.4.4.110 — Timing accuracy

Subclause 201.12.4.4.111 — Gain settings and switching

Subclause 201.12.4.4.112 — Temporal alignment

Subclause 201.15.4.3.101.1 — Monitoring time
75 Subclause 201.15.4.3.101.2 — Data retention

Clause 201.17 — Electromagnetic compatibility of ME equipment and ME systems

Subclause 202.6.2.3 — Radiated RF electromagnetic fields
76 Bibliography
77 Index of defined terms used in this particular standard

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