ISO 14708-3:2017 PDF

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

Название (английский):

ISO 14708-3:2017

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 54
Дата публикации:: 12 апреля 2017 г.
Издание:: ISO IS 14708 edition 2 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

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 14708-3:2017 - Implants for surgery: Active implantable medical devices - Part 3: Implantable neurostimulators defines particular safety, performance and type‑test requirements for devices that provide electrical stimulation of the central or peripheral nervous system (commonly called implantable neurostimulators or INS). The standard supplements and takes priority over ISO 14708-1, and is intended for type testing (sample device testing to assess behaviour), not routine production testing.

Key scope points:

Applies to implantable neurostimulators and related parts/accessories (e.g., implantable pulse generators (IPG), leads, programmers, and software) that can affect safety or performance.

Excludes purely non‑implantable external neurostimulators (covered by IEC 60601‑1 series).

Addresses device design, markings, packaging, protection, and documentation to assure patient/user safety.

Key Topics and Technical Requirements

Terminology and definitions specific to neurostimulators (INS, IPG, MR Conditional, projected service life, DUT).

Type tests to evaluate device behavioural responses under defined conditions (explicitly not for routine manufacturing QA).

Risk management: manufacturers must evaluate risks (referencing ISO 14971), including wireless coexistence and wireless quality of service for devices with wireless links; compliance is checked via the risk management file.

Thermal safety: implantable parts not intended to supply heat must meet at least one criterion - e.g., outer surface ≤ 39 °C, or compliance with CEM43 thermal dose thresholds (Table 101) - or provide justification for higher temperatures.

Protection features: requirements for protection against unintended biological effects, electrical hazards, heat, ionizing radiation, electromagnetic non‑ionizing radiation, electrostatic discharge, mechanical forces, pressure and temperature changes, and external defibrillator effects.

Markings, packaging and documentation: requirements for device and packaging labels, sterile pack construction, and accompanying technical/user documentation.

Informative/Normative annexes provide rationale, relationships to fundamental principles, and board/layout guidance.

Practical Applications - Who Uses This Standard

Medical device manufacturers (design, R&D, and regulatory teams) for designing, validating and documenting implantable neurostimulators.

Test laboratories performing type tests and safety evaluations.

Regulatory and conformity assessors / notified bodies reviewing safety dossiers and risk management.

Clinical engineers and procurement teams assessing device specifications and MR Conditional status.

Design architects addressing EMC, wireless coexistence, thermal management (CEM43), and implantable packaging/marking.

Related Standards

ISO 14708-1 (general requirements for active implantable medical devices)

ISO 14971 (risk management for medical devices)

ISO 14117 (EMC test protocols for implantable cardiac devices)

IEC 60601-1 series (electrical safety for medical electrical equipment)

ISO/TS 10974 (MRI safety assessment for active implantable devices)

Keywords: ISO 14708-3:2017, implantable neurostimulators, active implantable medical devices, IPG, neurostimulator testing, type tests, risk management, EMC, MR Conditional, CEM43 thermal dose, ISO 14708-1.

ISO 14708-3:2017 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Technical Requirements

Practical Applications - Who Uses This Standard

Related Standards

Технические детали

ISO 14708-1:2000

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

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

BS/AAMI 34971:2023

Application of ISO 14971 to machine learning in artificial intelligence. Guide.

BS ISO 14117:2019-TC

Tracked Changes. Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for im…

PD IEC/TR 62296:2009

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

PD ISO/TR 21900:2018

Guidance for uncertainty analysis regarding the application of ISO/TS 10974