YY 0989.3-2023Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (English PDF)

1 Scope

This document specifies specific requirements for implantable neurostimulators.

This document applies to active implantable medical devices that perform electrical stimulation of the central nervous system or peripheral nervous system.

Note. The tests specified in this document are type tests and are performed on samples to evaluate the behavioral response of the device. These tests are not intended to be used in the manufacture of devices.

Routine testing of finished products.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations

For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

GB/T 2423.43-2008 Environmental testing of electrical and electronic products Part 2.Test methods vibration, impact and similar dynamics

Installation of test samples (IEC 60068-2-47.2005, IDT)

GB/T 2423.56-2018 Environmental testing Part 2.Test method Test Fh, broadband random vibration and guidelines (IEC 60068-2-64.2008,IDT)

GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (GB 9706.1-2020,

IEC 60601-1.2012, MOD)

GB 16174.1 Surgical implants Active implantable medical devices Part 1.Safety, marking and communication of information provided by the manufacturer

Application requirements (GB 16174.1-2015, ISO 14708-1.2000, IDT)

GB/T 17626.3 Electromagnetic compatibility testing and measurement technology Radio frequency electromagnetic field radiation immunity test (GB/T 17626.3-

2016,IEC 61000-4-3.2010,IDT)

YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007 correction version, IDT)

YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and basic performance Parallel standards. Electromagnetic and

Capacity requirements and tests (YY 9706.102-2021, IEC 60601-1-2.2007, MOD)

ISO 14117.2012 Electromagnetic compatibility of active implantable medical devices, implantable pacemakers, implantable cardioverter defibrillators

ISO /T S10974 Assessment of the safety of magnetic resonance imaging in patients wearing active implantable medical devices (Assessmentofthe

3 Terms and definitions

The terms and definitions defined in GB 16174.1 (hereinafter referred to as Part 1) and the following terms and definitions apply to this document.