YY 0989.7-2017Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems (English PDF)

1 Scope

This Part of YY 0989 specifies requirements that are applicable to those active implantable medical devices that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this Part.

The tests that are specified in this Part are type tests and are to be carried out on samples of a device to show compliance.

This Part is also applicable to non-implantable parts and accessories of the devices (see NOTE).

The electrical characteristics of the implantable part are determined by either the appropriate method detailed in this Part or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Part applies.

NOTE: A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable part.

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.

This clause of Part 1 applies except as follows:

Additional references:

GB/T 2423.5 Environmental Testing for Electric and Electronic Products Part 2:

Test Methods Test Ea and Guidance: Shock (GB/T 2423.5-1995, IEC 60068-2-

27:1987, IDT)

GB/T 2423.7 Environmental Testing for Electric and Electronic Products - Part 2:

Test Methods Test Ec and Guidance: Drop and Topple Primarily for Equipment-

Type Specimens (GB/T 2423.7-1995, IEC 60068-2-31:1982, IDT)

GB/T 2423.43 Environmental Testing for Electric and Electronic Products - Part 2:

Test Methods - Mounting of Specimens for Vibration Impact and Similar Dynamic

Tests (GB/T 2423.43-2008, IEC 60068-2-47:2005, IDT)

GB/T 2423.56 Environmental Testing for Electric and Electronic Products - Part 2:

Test Methods - Test Fh: Vibration, Broad-Band Random (Digital Control) and

Guidance (GB/T 2423.56-2006, IEC 60068-2-64:1993, IDT)

GB/T 2423.55 Environmental Testing for Electric and Electronic Products - Part 2:

Test Methods - Test Eh: Hammer Tests (GB/T 2423.55-2006, IEC 60068-2-

75:1997, IDT)

GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and

Testing within a Risk Management Process (GB/T 16886.1-2011, ISO 10993-

1:2009, IDT)

GB/T 17626.2 Electromagnetic Compatibility (EMC) - Testing and Measurement

Techniques - Electrostatic Discharge Immunity Test (GB/T 17626.2-2006, IEC 61000-4-2:2001, IDT)

GB/T 19633 Packaging for Terminally Sterilized Medical Devices (GB/T 19633-

2005, ISO 11607:2003, IDT)

YY/T 0316 Medical Devices - Application of Risk Management to Medical Devices (YY/T 0316-2016, ISO 14971:2007 corrected version, IDT)

YY 0505 Medical Electrical Equipment - Part 1-2: General Requirements for Safety

-Collateral Standards: Electromagnetic Compatibility - Requirements and Tests (YY 0505-2012, IEC 60601-1-2:2004)

YY/T 0664 Medical Device Software - Software Life Cycle Processes (YY/T 0664

-2008, IEC 62304:2006, IDT)

ISO 14155 Clinical Investigation of Medical Devices for Human Subjects - Good

Clinical Practice

IEC 60118-6 Hearing Aids - Part 6: Characteristics of Electrical Input Circuits for

Hearing Aids

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