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BS EN ISO 14708-2:2022

BS EN ISO 14708-2:2022

$215.11

Implants for surgery. Active implantable medical devices – Cardiac pacemakers

Published By Publication Date Number of Pages
BSI 2022 80
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This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance. This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies. Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6. NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
13 4 Symbols and abbreviated terms
14 5 General requirements for non-implantable parts
5.1 General requirements for non-implantable parts
5.2 General requirements for software
5.3 Usability of non-implantable parts
5.4 Data security and protection from harm caused by unauthorized information tampering
5.5 General requirements for risk management
5.6 Misconnection of parts of the active implantable medical device
6 Measurements of implantable pulse generator and lead characteristics
6.1 Measurement of implantable pulse generator characteristics
6.1.1 General considerations
6.1.2 Measurement of pulse amplitude, pulse duration, pulse interval, and pulse rate
15 6.1.3 Measurement of sensitivity (epos and eneg)
16 6.1.4 Measurement of input impedance (Zin)
6.1.5 Measurement of escape interval (te)
18 6.1.6 Measurement of sensing refractory period (tsr)
21 6.1.7 Measurement of pacing refractory period (tpr) (applicable only to inhibited implantable pulse generators)
6.1.8 Measurement of AV interval (applicable only to dual-chamber implantable pulse generators)
22 6.1.9 Measurement of the post-ventricular atrial refractory period (PVARP) (applicable only to implantable pulse generators with atrial sensing and ventricular pacing)
23 6.1.10 Measurement of the atrial-ventricular (AV) interval after sensing (applicable only to implantable pulse generators with atrial sensing and ventricular pacing)
24 6.2 Measurement of the lead pacing impedance (Zp)
6.2.1 Measurement equipment accuracy
6.2.2 Methods of measuring lead pacing impedance
25 6.2.3 In vitro method for measurement of lead pacing impedance
26 7 General arrangement of the packaging
8 General markings for active implantable medical devices
9 Markings on the sales packaging
28 10 Construction of the sales packaging
11 Markings on the sterile pack
30 12 Construction of the non-reusable pack
13 Markings on the active implantable medical device
31 14 Protection from unintentional biological effects being caused by the active implantable medical device
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
33 17 Protection from harm to the patient caused by heat
18 Protection from ionizing radiation released or emitted from the active implantable medical device
34 19 Protection from unintended effects caused by the device
35 20 Protection of the device from damage caused by external defibrillators
21 Protection of the device from changes caused by high power electrical fields applied directly to the patient
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
23 Protection of the active implantable medical device from mechanical forces
39 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
40 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
28 Accompanying documentation
45 Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this document
65 Annex B (informative) Rationale
73 Annex C (informative) Code for describing modes of implantable pulse generators
76 Annex D (normative) Pulse forms
78 Bibliography

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BS EN ISO 14708-2:2022
$215.11