ISO 14708-7-2019 PDF

Full title and description

Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems. This International Standard specifies particular safety, performance and test requirements for implantable systems that restore hearing by electrical stimulation of the auditory pathways; it also covers non‑implantable parts and accessories that could affect safety or performance.

Abstract

This document gives requirements applicable to active implantable medical devices intended to treat hearing impairment via electrical stimulation of the auditory pathways (cochlear implants and auditory brainstem implants). The tests specified are primarily type tests performed on samples to demonstrate conformity. Methods for determining electrical characteristics of the implantable part are specified or an equivalent method may be used if demonstrated.

General information

• Status: Published (International Standard; corrected English version published).
• Publication date: 20 December 2019 (corrected version issued May 2020).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: 2 (Second edition, 2019).
• Number of pages: 68 pages.

Scope

Applies to active implantable devices intended to treat hearing impairment by electrical stimulation of auditory pathways (cochlear implants and auditory brainstem implants). Devices that treat hearing impairment by non‑electrical means are excluded. The standard applies to both implantable components and those non‑implantable parts or accessories that could affect the safety or performance of the implantable part, and specifies type tests to demonstrate compliance.

Key topics and requirements

• Definitions, symbols and terminology specific to cochlear and auditory brainstem implant systems.
• General requirements for non‑implantable parts (including electrical safety and applicability of IEC 60601 series as determined by risk analysis).
• Software lifecycle and validation requirements for device software (alignment with IEC 62304 expectations).
• Usability engineering and mitigation of use‑related risks for non‑implantable parts (references to IEC 62366 processes).
• Data security and protection against harm caused by unauthorized information tampering (requirements for wireless communications and protection of implant control).
• Inspection and measurement requirements: measurement of output signal characteristics (amplitude, pulse width), impedance measurement accuracy, inductive link characterization, and sound processor battery testing.
• Electromagnetic compatibility (EMC) and immunity requirements (tests for radiated/static magnetic fields, ESD and high‑power field exposure).
• Protection against physical and environmental hazards (mechanical forces, temperature/pressure, ionizing radiation, atmospheric changes).
• Marking, packaging, labelling and accompanying documentation requirements (including sterile packaging considerations where applicable).
• Requirements and test procedures are primarily type tests performed on device samples to demonstrate conformity.

Typical use and users

Primary users are medical device manufacturers (design, verification and regulatory teams), test laboratories, notified/bodies and conformity assessors, clinical engineers, and procurement or compliance staff in hospitals and health systems. The standard is used during product design, type testing, risk management, regulatory submissions and pre‑market conformity assessments for cochlear and auditory brainstem implant systems.

Related standards

ISO 14708‑7 supplements the general requirements in ISO 14708‑1 and is part of the ISO 14708 series covering active implantable medical devices (other parts include specific requirements for pacemakers, neurostimulators, infusion pumps, circulatory support devices, tachyarrhythmia devices, etc.). Relevant cross‑references include ISO 14708‑1 (general requirements), IEC 62304 (software lifecycle), IEC 62366 (usability engineering) and applicable IEC 60601 series clauses for non‑implantable parts.

Keywords

cochlear implant; auditory brainstem implant; active implantable medical device; type tests; electrical characteristics; impedance measurement; inductive link; usability; data security; EMC; ISO 14708; implantable hearing device.

FAQ

Q: What is this standard?

A: ISO 14708‑7:2019 is the part of the ISO 14708 series that specifies particular requirements for cochlear and auditory brainstem implant systems — safety, performance and type‑test methods for devices that restore hearing by electrical stimulation.

Q: What does it cover?

A: It covers device definitions, measurement and inspection methods for electrical output (amplitude, pulse width, impedance), inductive link characterization, battery testing for external processors, EMC/immunity, environmental and mechanical protections, marking/packaging/documentation, usability, software lifecycle and data security for implantable hearing systems.

Q: Who typically uses it?

A: Device manufacturers, product development and verification teams, test laboratories, regulatory and conformity assessment bodies, clinical engineers and hospital procurement/compliance teams.

Q: Is it current or superseded?

A: ISO 14708‑7:2019 (second edition) replaced ISO 14708‑7:2013. A corrected English version was issued in May 2020; the 2019 edition is the current published edition. Users should check national adoption or amendment dates for any regional adoptions (for example EN/SS‑EN adoptions).

Q: Is it part of a series?

A: Yes — it is Part 7 of the ISO 14708 series (Implants for surgery — Active implantable medical devices). Other parts (e.g., ISO 14708‑1, ‑2, ‑3, ‑4, ‑5, ‑6) cover general requirements and other device types such as pacemakers, neurostimulators, infusion pumps and circulatory support devices.

Q: What are the key keywords?

A: cochlear implant, auditory brainstem implant, active implantable medical device, electrical stimulation, type tests, impedance, inductive link, EMC, usability, data security.