EN ISO 14708-3:2022 PDF

Name: EN ISO 14708-3:2022 — Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
SKU: EN ISO 14708-3:2022
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Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)

Название (английский):

EN ISO 14708-3:2022

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 63
Дата публикации:: 27 июля 2022 г.
Издание:: CEN/CENELEC EN 14708 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.

Abstract

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Стандарты, упомянутые в описании

Overview

EN ISO 14708-3:2022 (ISO 14708-3:2017) specifies particular safety and performance requirements for implantable neurostimulators - active implantable medical devices intended to deliver electrical stimulation to the central or peripheral nervous system. It amends and supplements ISO 14708-1 and takes precedence where clauses differ. The standard focuses on type testing of device samples to assess behavioural responses; these tests are not intended for routine production testing.

Key topics and technical requirements

This part of the ISO 14708 series addresses a range of device, packaging and safety topics relevant to implantable neurostimulators, including:

Scope and definitions specific to neurostimulation therapies and device architectures (pulse generators, leads, extensions, programmers).

Type testing requirements - tests performed on representative samples to evaluate device behaviour under specified conditions.

Marking and labelling requirements for devices, sterile packs and sales packaging to ensure traceability and safe use.

Packaging and sterile pack construction to protect implantable devices until use.

Electrical safety and protection against harm from electricity, including effects of external electrical fields and electrostatic discharge.

Electromagnetic compatibility (EMC) considerations and test protocols relevant to implantable devices (see also ISO 14117).

Protection from mechanical, thermal and atmospheric stresses, including temperature and pressure changes during handling and transport.

Protection from ionizing and non‑ionizing radiation, and from external medical interventions such as defibrillators or other treatments that could affect device function.

Software, programmers and accessories: requirements cover parts that might not be implantable but could affect safety or performance.

Documentation and labelling requirements for accompanying information and user guidance.

Practical applications and who uses this standard

SIST EN ISO 14708-3 is used by stakeholders involved in the design, manufacture, testing and regulation of implantable neurostimulators:

Medical device manufacturers - to design devices and prepare technical files demonstrating compliance.

Design and test engineers - to define type-test programs and validate device robustness, EMC and electrical safety.

Quality, regulatory and compliance teams - to support CE marking and national regulatory submissions in markets adopting EN ISO texts.

Notified bodies and testing laboratories - to assess conformity and perform required type tests.

Procurement and clinical engineering - to verify device labelling, packaging and safety information.

Keywords: implantable neurostimulators, active implantable medical devices, ISO 14708-3, medical device safety, EMC, type testing, neurostimulation standard.

Related standards (select)

ISO 14708-1 - General requirements for active implantable medical devices

ISO 14117 - EMC test protocols for implantable cardiac devices (relevant EMC guidance)

ISO 14971 - Risk management for medical devices

IEC 60601-1 - Safety of non‑implantable medical electrical equipment (for related external devices)

EN ISO 14708-3:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses this standard

Related standards (select)

Технические детали

ISO 14708-3:2017

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

ISO 14708-1:2000

Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking…

SIST EN ISO 14708-3:2023

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PD IEC/TR 62296:2009

Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requi…