ISO 14708-3-2017 PDF

Full title and description

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators. This International Standard specifies type-test requirements and safety/performance considerations for active implantable devices intended to provide electrical stimulation to the central or peripheral nervous system (implantable neurostimulators).

Abstract

ISO 14708-3:2017 applies to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. The document defines type tests (performed on samples) to assess device behavioural responses; it is not intended for routine production testing. Key areas include electrical performance, packaging and marking, specific construction and safety requirements for neurostimulator systems (generator, leads, electrodes), and applicable normative references for electromagnetic compatibility and medical electrical equipment.

General information

• Status: Published / Current (confirmed by ISO review).
• Publication date: April 2017 (Edition 2, 2017).
• Publisher: International Organization for Standardization (ISO). ANSI/AAMI published an adopted version for U.S. market use.
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 2 (2017).
• Number of pages: 54 pages.

Scope

ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system (implantable neurostimulators). It specifies type-test methods to evaluate device behaviour, safety and performance; it covers device-level and system-level considerations for the implanted pulse generator, leads and electrodes, as well as packaging, marking and information supplied by the manufacturer. The tests defined are for type approval and design verification, not for routine batch testing of manufactured units.

Key topics and requirements

• General requirements for active implantable medical devices (safety, risk management, essential performance).
• Specific requirements for implantable neurostimulators: electrical output characteristics, pulse parameters, charge balancing and limits, lead/electrode integrity and connector interfaces.
• Type tests for electrical safety and performance, electromagnetic compatibility (references to IEC 60601-1, IEC 60601-1-2 and relevant IEC EMC test standards).
• Mechanical and environmental tests (vibration, shock, ingress, lifecycle durability, hermeticity where applicable).
• Packaging, labeling and information requirements for safe use and traceability (sales packaging, markings, and instructions for use).
• Sterilization, biocompatibility references and requirements (where applicable to implanted components).
• Telemetry, programmability and software-related considerations relevant to neurostimulator control and safety.

Typical use and users

Primary users include implantable neurostimulator manufacturers (design and regulatory teams), test laboratories performing type testing, notified bodies and conformity assessment organizations, clinical engineers, hospitals and procurement staff evaluating compliance, and regulatory authorities referencing recognized standards for device assessment. Guidance in the standard is used for design verification, regulatory submissions, and technical documentation.

Related standards

ISO 14708-3 is part of the ISO 14708 series for active implantable medical devices. Closely related documents include ISO 14708-1 (general requirements for active implantable medical devices) and other parts of ISO 14708 addressing different device types and aspects; relevant IEC standards cited as normative references include IEC 60601-1, IEC 60601-1-2 and applicable IEC EMC test standards. Work to revise parts of the 14708 series (including an AWI for part 3) is in progress.

Keywords

implantable neurostimulator, active implantable medical device, neurostimulation, type tests, electrical stimulation, leads, electrodes, implantable pulse generator (IPG), EMC, medical device standard, ISO 14708.

FAQ

Q: What is this standard?

A: ISO 14708-3:2017 is an international standard that specifies type-test and safety/performance requirements for implantable neurostimulators (active implantable devices that provide electrical stimulation to the central or peripheral nervous system).

Q: What does it cover?

A: It covers device-level and system-level requirements and type tests: electrical performance and limits, lead and electrode requirements, packaging/marking, environmental and mechanical tests, and references to relevant EMC and medical electrical equipment standards. The tests are intended for type approval and design verification rather than routine manufacturing inspection.

Q: Who typically uses it?

A: Device manufacturers, design and regulatory engineers, test laboratories, conformity assessment bodies, clinical engineers, and regulators use this standard for design verification, conformity assessment and regulatory submissions.

Q: Is it current or superseded?

A: ISO 14708-3:2017 is the published (second) edition from 2017 and was reviewed/confirmed by ISO (remains current). An ISO work item to develop a further edition (ISO/AWI 14708-3) has been registered, indicating a revision is under development but the 2017 edition remains the active published standard until replaced.

Q: Is it part of a series?

A: Yes — it is part of the ISO 14708 series (active implantable medical devices); ISO 14708-1 provides general requirements and other parts address other implantable device types or specific topics.

Q: What are the key keywords?

A: Implantable neurostimulator, active implantable medical device, electrical stimulation, implantable pulse generator, leads and electrodes, type tests, EMC, risk management.