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BS EN ISO 14708-4:2022

BS EN ISO 14708-4:2022

$198.66

Implants for surgery. Active implantable medical devices. – Implantable infusion pump systems

Published By Publication Date Number of Pages
BSI 2022 70
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This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products. NOTE       This document is not intended to apply to non-implantable infusion systems.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
13 4 Symbols and abbreviated terms
5 General requirements for active implantable medical devices
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 Requirements for particular active implantable medical devices
6.1 Implantable infusion pump system specifications
14 6.2 Septum puncture test
15 7 General arrangement of the packaging
8 General markings for active implantable medical devices
16 9 Markings on the sales packaging
10 Construction of the sales packaging
17 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 caused by the active implantable medical device
18 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
19 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 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 high-power electrical fields applied directly to the patient
22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments
22.1 Diagnostic ultrasound
22.2 Magnetic resonance imaging
21 23 Protection of the active implantable medical device from mechanical forces
22 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
27.1 General
23 27.2 Test conditions
27.2.1 Acceptance criteria
27.2.2 Test configuration
27.2.3 Operating functions, modes, and settings
27.3 Documentation
24 27.4 Protection from static magnetic fields of flux density up to 50 mT
25 27.5 Protection from magnetic fields over the frequency range 16 Hz to 26 MHz
26 27.6 Protection from EM disturbances over the frequency range 80 MHz to 2,7 GHz
27 27.7 Protection from proximity fields due to RF wireless communications equipment
28 27.8 Optional characterization testing
28 Accompanying documentation
31 Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283 and the clauses of this document
52 Annex B (informative) Rationale
61 Annex C (informative) Guidance on the allocation of requirements to non-implantable parts connected to a power source
68 Bibliography

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BS EN ISO 14708-4:2022
$198.66