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AAMI 14708 3 2017

AAMI 14708 3 2017

$131.66

ANSI/AAMI/ISO 14708-3:2017 – Implants for surgery-Active implantable medical devices-Part 3: Implantable neurostimulators

Published By Publication Date Number of Pages
AAMI 2017 64
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Specifies particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system in order to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 14708-3:2017; Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
2 Objectives and uses of AAMI standards andrecommended practices
3 Title page
4 AAMI Standard
Copyright information
5 Contents
7 Glossary of equivalent standards
8 Committee representation
9 Background of AAMI adoption of ISO 14708-3:2017
10 Foreword
11 Introduction
13 1 Scope
2 Normative references
14 3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for active implantable medical devices
15 6 Requirements for particular active implantable medical devices
7 General arrangement of the packaging
8 General markings for active implantable medical devices
9 Markings on the sales packaging
10 Construction of the sales packaging
11 Markings on the sterile pack
12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
14 Protection from unintentional biological effects being caused by the active implantable medical device
16 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device
16 Protection from harm to the patient caused by electricity
17 Protection from harm to the patient caused by heat
Table 101 — CEM43 dose thresholds for various tissues
17 18 Protection from ionizing radiation released or emitted from the active implantable medical device
19 Protection from unintended effects caused by the active implantable medical device
20 Protection of the active implantable medical device from damage caused by external defibrillators
21 Protection of the active implantable medical device from changes caused by electrical fields applied directly to the patient
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
18 Table 102 — Acceptance criteria for test requirements of ISO/TS 10974
23 Protection of the active implantable medical device from mechanical forces
19 24 Protection of the active implantable medical device from damage caused by electrostatic discharge
25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes
26 Protection of the active implantable medical device from damage caused by temperature changes
27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation
21 Table 103 — Minimum risk management and test report contents
22 Figure 101 — Injection network diagram for the range of frequencies from 16,6 Hz to 80 MHz
23 Table 104 — Frequency steps for the voltage injection test
24 Table 105 — Peak-peak injected test levels VPP
Figure 102 — Amplitude modulated test signal for voltage injection test
25 Table 106 — Minimum magnetic field test levels H
Table 107 — Frequency steps for the radiated magnetic test
Figure 103 — Amplitude modulated test signal for radiated magnetic test
26 Figure 104 — IPG and lead layout
27 Table 108 — Proximity test method requirements
28 Table 109 — Test frequencies, modulations, and net RF power
28 Accompanying documentation
30 Annex AA (normative) Relationship between the fundamental principles in ISO/TR 14283 [1] and the clauses of this document
40 Annex BB (informative) Rationale
BB.1 General
BB.2 Notes on specific clauses and subclauses
41 Table BB.1 — Evaluating CEM43 formula at different temperatures
42 Figure BB.1 — CEM43 versus temperature for constant time
Figure BB.2 — Two examples of the same CEM43 result with different exposure times
43 Figure BB.3 — Example showing a time and temperature profile
47 Figure BB.4 — Magnetic field environment test reference level
Table BB.2 — Magnetic field test reference levels
48 Figure BB.5 — Injected voltage test levels (VPP) 16,6 Hz to 80 MHz
Table BB.3 — Peak-peak injected test levels VPP
50 Annex CC (informative) Injection network example and board layout guidance
CC.1 General
CC.2 Tissue equivalent circuit board example
51 Figure CC.1 — Tissue equivalent interface board example
52 Table CC.1 — Tissue interface circuit switch configuration examples
54 CC.3 DUT contactor board examples
55 Figure CC.2 — DUT contactor board examples
56 Figure CC.3 — Simplified lead model (distributed parameters)
57 Figure CC.4 — Simplified lead models (lumped parameters)
58 CC.4 Board layout guidance
62 CC.5 Example board layout floorplan
Figure CC.5 — Example board layout floorplan
63 Bibliography

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AAMI 14708 3 2017
$131.66