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YY 0989.7-2017 English PDF (YY0989.7-2017)

YY 0989.7-2017 English PDF (YY0989.7-2017)

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

YY 0989.7-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
YY 0989.7-2017 / ISO 14708-7:2013
Implants for Surgery - Active Implantable Medical
Devices - Part 7: Particular Requirements
for Cochlear Implant Systems
(ISO 14708-7:2013, MOD)
ISSUED ON: JULY 17, 2017
IMPLEMENTED ON: JANUARY 01, 2018
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 4
1 Scope ... 6
2 Normative References ... 6
3 Terms and Definitions ... 8
4 Symbols and Abbreviations ... 10
5 General Requirements for Non-Implantable Parts ... 10
6 Inspection and Measurement ... 10
7 General Arrangement of the Packaging ... 11
8 General Markings for Active Implantable Medical Devices ... 11
9 Markings on the Sales Packaging ... 11
10 Construction of the Sales Packaging ... 12
11 Markings on the Sterile Pack ... 12
12 Construction of the Non-Reusable Pack ... 13
13 Markings on the Active Implantable Medical Device ... 13
14 Protection from Unintentional Biological Effects Being Caused by the Active Implantable Medical Device ... 13
15 Protection from Harm to the Patient or User Caused by External Physical Features of the Active Implantable Medical Device ... 14
16 Protection from Harm to the Patient Caused by Electricity ... 14
17 Protection from Harm to the Patient Caused by Heat ... 15
18 Protection from Ionizing Radiation Released or Emitted from the Active Implantable Medical Device ... 15
19 Protection from Unintended Effects Caused by the Device... 15
20 Protection of the Device from Damage Caused by External Defibrillators 16 21 Protection of the Device from Changes Caused by High Power Electrical Fields Applied Directly to the Patient ... 17
22 Protection of the Active Implantable Medical Device from Changes Caused by Miscellaneous Medical Treatments ... 18
23 Protection of the Active Implantable Medical Device from Mechanical Forces ... 21
24 Protection of the Active Implantable Medical Device from Damage Caused by Electrostatic Discharge ... 28
25 Protection of the Active Implantable Medical Device from Damage Caused by Atmospheric Pressure Changes ... 28
26 Protection of the Active Implantable Medical Device from Damage Caused by Temperature Changes ... 29
27 Protection of the Active Implantable Medical Device from Electromagnetic Nonionizing Radiation ... 29
28 Accompanying Documentation... 32
Annex A (Informative) Basic Principle of this Part ... 35
Annex B (Informative) Notes on Theoretical Modelling to Demonstrate
Compliance with Clause 27 ... 46
Annex C (Informative) Notes on EMI Measurements to Demonstrate
Compliance with Clause 27 ... 49
Bibliography ... 54
Foreword
YY 0989 “Implants for Surgery – Active Implantable Medical Devices” consists of the following 7 parts:
--- Part 1: General Requirements for Safety, Marking and for Information to be Provided by the Manufacturer;
--- Part 2: Cardiac Pacemakers;
--- Part 3: Implantable Neurostimulators;
--- Part 4: Implantable Infusion Pumps;
--- Part 5: Circulatory Support Devices;
--- Part 6: Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia (Including Implantable Defibrillators);
--- Part 7: Particular Requirements for Cochlear Implant Systems.
This Part is Part 7 of YY 0989.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
This Part adopts the redrafting method to modify-adopt ISO 14708-7:2013 Implants for Surgery – Active Implantable Medical Device – Part 7: Particular Requirements for Cochlear Implant Systems. Compared with ISO 14708-7:2013, this Part has the major technical changes as follows:
--- Modify the formulation format according to GB/T 1.1-2009;
--- Delete the cover, foreword and introduction from the standard ISO 14708-7:2013 (the first edition);
--- For the international standards cited in this Standard, if they have been converted into China’s domestic standards, then quote Chinese standards;
--- According to the requirements of the Chinese version, modify the page number, font and font size, etc.; which shall not affect the degree of consistency; --- Delete Annexes AA and BB from the standard ISO 14708-7:2013 (the first edition).
Please note some contents of this document may involve patents. The issuing agency of this document shall not assume the responsibility to identify these patents. This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of Subcommittee for Standardization of Medical Electronic Instrument under National Technical Committee for Standardization of Medical Electrical Equipment (SAC/TC 10/SC 5).
Drafting organization of this Part: Shanghai Testing and Inspection Institute for Medical Device.
Chief drafting staffs of this Part: Zhang Diedong, Ni Shicheng, and Hu Cheng. Implants for Surgery - Active Implantable Medical
Devices - Part 7: Particular Requirements
for Cochlear Implant Systems
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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