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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
Implants for surgery-Active implantable medical devices-Part 7. Particular requirements for cochlear implant systems
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
YY 0989.7-2017/ISO 14708-7.2013
Surgical implant active implantable medical device
Part 7. Special requirements for cochlear implant systems
Part 7.Particularrequirementsforcochlearimplantsystems
(ISO 14708-7.2013, MOD)
Released on.2017-07-17
2018-01-01 implementation
State Food and Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and Definitions 2
4 symbols and abbreviations term 3
5 General requirements for non-implanted parts 3
6 Inspection and measurement 3
7 General requirements for packaging 4
8 Commonly used markers for active implantable medical devices 4
9 Mark 4 on the sales package
10 sales package construction 5
11 Marking on aseptic packaging 5
12 Non-reusable packaging construction 5
13 Markings on active implantable medical devices 5
14 Protection against unintended biological effects caused by active implantable medical devices 6
15 External physical properties of active implantable medical devices protect against injury to patients or users 6
16 Protection against current injury to the patient 6
17 Protection against patient thermal injury 7
18 Protection against ionizing radiation emitted or emitted by active implantable medical devices 7
19 Protection against unintended effects from active implantable medical devices 7
20 Active implantable medical devices protected by external defibrillators 8
21 Active implantable medical devices directly protect the patient from changes caused by high-power electric fields 8
22 Active implantable medical devices protect against changes in hybrid medical care 9
23 Active implantable medical devices for mechanical protection 10
24 Active implantable medical devices protect against electrostatic discharges 14
25 Protection of damage caused by changes in atmospheric pressure by active implantable medical devices 14
26 Active implantable medical devices protect against damage from temperature changes 15
27 Active implantable medical devices for protection against non-ionizing electromagnetic radiation 15
28 random files 17
Appendix A (informative) The basic principles of this section 19
Appendix B (informative) Notes on the theoretical model for the certifying clause 27 compliance 25
Appendix C (informative) Notes on electromagnetic interference testing to certify clause 27 compliance 27
Reference 30
YY 0989.7-2017/ISO 14708-7.2013
Figure 1 Output signal amplitude and load impedance measurement 4
Figure 2 Test setup to verify the high frequency current generated by the anti-surgical device 8
Figure 3 Verification test setup for harmful output protection in MRI scans 10
Figure 4 stimulator drop test 12
Figure 5 bending test fixture 12
Figure 6 16Hz and 50Hz interference signals 16
Figure 7 Interference signal above 1 kHz 17
Figure C.1 Head phantom 28 for EMI measurement
Table 1 Peak magnetic field strength Hp 15
Table 2 Peak electric field strength Ep 16
Table C.1 Peak dipole power 29
YY 0989.7-2017/ISO 14708-7.2013
Foreword
YY 0989 "Surgical Implant Active Implantable Medical Device" consists of seven parts.
--- Part 1. General requirements for safety, marking and information provided by the manufacturer;
--- Part 2. Cardiac pacemakers;
--- Part 3. Implantable neurostimulators;
--- Part 4. Implantable syringe pumps;
---Part 5. Circulating support devices;
--- Part 6. Specific requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmia;
--- Part 7. Special requirements for cochlear implant systems.
This part is part 7 of YY 0989.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the redrafting method to modify the use of ISO 14708-7.2013 "Surgical implant active implanted medical devices Part 7.
Special requirements for cochlear implant systems. The main technical changes in this section compared to ISO 14708-7.2013 are as follows.
--- Modified some formatting formats in accordance with GB/T 1.1-2009;
--- Removed the cover, preface and introduction from the ISO 14708-7.2013 (first edition) standard;
--- For the international standards cited in the standard, if China has been converted into domestic standards, then instead refer to Chinese standards;
--- According to the requirements of the Chinese version, the page number, font and font size have been modified, which does not affect the degree of consistency;
--- Removed Appendix AA and Appendix BB of the ISO 14708-7.2013 (First Edition) standard.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part is divided into the National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5)
Return to the mouth.
This section drafted by. Shanghai Medical Device Testing Institute.
The main drafters of this section. Zhang Yidong, Ni Chengcheng, Hu Wei.
YY 0989.7-2017/ISO 14708-7.2013
Surgical implant active implantable medical device
Part 7. Special requirements for cochlear implant systems
1 Scope
This section of YY 0989 specifies active implantable medical devices that are intended for the treatment of hearing impairment through electrical stimulation of the auditory pathway.
Special requirements for machinery. This section does not apply to devices that treat hearing impairment by non-electrical stimulation.
The test specified in this section is a type test and the test is performed to confirm compliance.
This section also applies to certain non-implanted parts and accessories of the device (see note).
The electrical characteristics of the implanted part shall be verified by appropriate methods or other methods listed in this section. The accuracy of other methods shall be
Proven to be equal to or better than the prescribed method. In case of dispute, the method specified in this section should be used.
Note. What is commonly referred to as an "active implantable medical device" can actually be a single device, a combined device, or one or more devices.
A combination of one or more attachments. Not all components need to be partially or completely implanted if they affect the safety of the implanted device or
Performance requires the development of requirements for non-implanted parts and accessories.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
This chapter in Part 1 applies except as follows.
Supplementary reference documents.
GB/T 2423.5 Environmental testing of electric and electronic products - Part 2. Test methods Test Ea and guide. Impact (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 guides. plunging and overturning (mainly
For equipment type samples) (GB/T 2423.7-1995, IEC 60068-2-31. 1982, IDT)
GB/T 2423.43 Environmental testing of electric and electronic products - Part 2. Test methods - Vibration, shock and similar kinetic test
Installation of products (GB/T 2423.43-2008, IEC 60068-2-47.2005, IDT)
GB/T 2423.56 Environmental testing of electric and electronic products - Part 2. Test methods Test Fh. Wideband random vibration (digital control
System and guidelines (GB/T 2423.56-2006, IEC 60068-2-64.1993, IDT)
GB/T 2423.55 Environmental testing of electrical and electronic products - Part 2. Test methods Test Eh. Hammer test (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 in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 17626.2 Electromagnetic compatibility test and measurement technology Electrostatic discharge immunity test (GB/T 17626.2-2006,
IEC 61000-4-2.2001, IDT)
GB/T 19633 Packaging of terminally sterilized medical devices (GB/T 19633-2005, ISO 11607.2003, IDT)
YY/T 0316 Medical Device Risk Management for Medical Devices (YY/T 0316-2016, ISO 14971.2007 Correction
Edition, IDT)
YY 0505 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standards. Electromagnetic Compatibility Requirements and Testing
(YY 0505-2012, IEC 60601-1-2.2004)
YY 0989.7-2017/ISO 14708-7.2013
YY/T 0664 Medical Device Software Software Life Cycle Process (YY/T 0664-2008, IEC 62304.2006, IDT)
ISO 14155 Clinical investigation of human-oriented medical devices - Good clinical practice (Clinicalinvestigationofmedical
Devicesforhumansubjects-Goodclinicalpractice)
IEC 60118-6 Hearing aids - Part 6. Characteristics of hearing aid input circuits (Hearingaids-Part 6. Characters
Ofelectricalimputcircuitsforhearingaids)
IEC 60601-1 Requirements for basic safety and basic performance of medical electrical equipment (Medicalelectricalequipment-Part 1.
Generalrequirementsforbasicsafetyandessentialperformance)
EN1593 Non-destructive testing leak test foaming technology (Non-destructive testing-Leaktesting-Bubble
Emissiontechniques)
EN13185 Non-destructive testing leak test trace gas method (Non-destructive testing-Leaktesting-Tracer
Gasmethod)
3 Terms and definitions
The following terms and definitions as defined in Part 1 apply to this document.
3.3.1
Cochlear implant system cochlearimplantsystem; CIS
Active implantable medical devices, consisting of implanted and non-implanted parts, are expected to treat hearing impairment by electrically stimulating the cochlea.
3.3.2
Auditory brainstem implant system auditorybrainstemimplantsystem; BIS
Active implantable medical devices, consisting of implanted and non-implanted parts, are expected to treat hearing impairment by electrically stimulating the auditory brainstem.
3.3.3
Implant system implantsystem
Cochlear implant system or auditory brainstem implant system.
3.3.4
Non-implanted part non-implantsystem
The extracorporeal part of the implant system.
Note. Includes but is not limited to sound processors, microphones, coils or power supplies.
3.3.5
Stimulator stimulator
The implanted portion of the implant system includes electronic circuitry for generating electrical stimulation.
3.3.6
Wearable body-worn
The non-implanted portion of the implant system worn on the body (such as worn or ear worn).
3.5.1
Electrode contact
A conductive portion designed to form a connection with body tissue or body fluids.
3.5.2
Electrode array electrodearray
A distal portion of the wire that contains more than one electrode contact.
3.5.3
Reference electrode referenceelectrode
Designed to electrically stimulate the conductive portion of the current loop.
YY 0989.7-2017/ISO 14708-7.2013
3.5.4
Remote distal
Location away from the stimulator.
3.5.5
Proximal proximal
The location is closest to the stimulator.
3.9.1
Model modeldesignation
The name and/or combination of letters and numbers used by the manufacturer to distinguish between instruments in function or type.
3.9.2
Serial number serialnumber
A unique combination of letters and/or numbers selected by the manufacturer to distinguish between instruments of the same model.
3.20.1
Output signal outputsignal
The implant system is intended to stimulate a pulsed or analog electrical output of the auditory pathway.
3.20.2
Pulse pulse
Specifies the electrical output signal (voltage or current) of the amplitude and interval.
3.20.3
Biphasic pulse biphasicpulse
A pulse with a positive phase and a negative phase.
3.22.1
Expiration period use-before-date
After this date, the manufacturer recommends that the active implantable medical device should not be used.
3.22.2
Magnet magnet
A component that produces external magnetic flux.
4 symbols and abbreviations term
This chapter in Part 1 applies. However, it is not restricted to use symbol definitions in other standards or symbols defined in random files.
5 General requirements for non-implanted parts
This chapter in Part 1 applies except as follows.
5.2
replace.
Software for active implantable medical devices or software for active implantable medical device definitions should follow the software life cycle process
Designed to meet the requirements of YY/T 0664 and verified.
6 Inspection and measurement
If this section involves the inspection of the design analysis documents provided by the manufacturer, it should include the risk management documents required by YY/T 0316.
test.
YY 0989.7-2017/ISO 14708-7.2013
6.1 Measurement of output signal characteristics
Measurements should be made at the implanted portion of the implant system at a temperature of (37 ± 2) °C. The implant system should be set to use its maximum number
Output, and each output should be set to the maximum value (amplitude and pulse width). An input equivalent to 70dBSPL should be applied to the microphone
signal. If applicable, the percutaneous connection should be operated at a distance of (5 ± 1) mm. If the implant system provides an optional output signal, each signal
Both should be measured and listed separately. For ease of connection, the test sample can be an unfinished product. Considering all the errors, the accuracy of the amplitude measurement should be
Better than ±5%.
6.2 Measurement of output signal amplitude and pulse width
Representative implant system samples, each output should be connected to 1 × (1 ± 1%) kΩ load resistance (see Figure 1) and set according to 6.1
set. The oscilloscope should be tuned to display all outputs at maximum resolution. The output signal peak should be measured. Each output should be conne...
Get Quotation: Click YY 0989.7-2017 (Self-service in 1-minute)
Historical versions (Master-website): YY 0989.7-2017
Preview True-PDF (Reload/Scroll-down if blank)
YY 0989.7-2017: Implants for surgery -- Active implantable medical devices -- Part 7: Particular requirements for cochlear implant systems
YY 0989.7-2017
Implants for surgery-Active implantable medical devices-Part 7. Particular requirements for cochlear implant systems
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
YY 0989.7-2017/ISO 14708-7.2013
Surgical implant active implantable medical device
Part 7. Special requirements for cochlear implant systems
Part 7.Particularrequirementsforcochlearimplantsystems
(ISO 14708-7.2013, MOD)
Released on.2017-07-17
2018-01-01 implementation
State Food and Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and Definitions 2
4 symbols and abbreviations term 3
5 General requirements for non-implanted parts 3
6 Inspection and measurement 3
7 General requirements for packaging 4
8 Commonly used markers for active implantable medical devices 4
9 Mark 4 on the sales package
10 sales package construction 5
11 Marking on aseptic packaging 5
12 Non-reusable packaging construction 5
13 Markings on active implantable medical devices 5
14 Protection against unintended biological effects caused by active implantable medical devices 6
15 External physical properties of active implantable medical devices protect against injury to patients or users 6
16 Protection against current injury to the patient 6
17 Protection against patient thermal injury 7
18 Protection against ionizing radiation emitted or emitted by active implantable medical devices 7
19 Protection against unintended effects from active implantable medical devices 7
20 Active implantable medical devices protected by external defibrillators 8
21 Active implantable medical devices directly protect the patient from changes caused by high-power electric fields 8
22 Active implantable medical devices protect against changes in hybrid medical care 9
23 Active implantable medical devices for mechanical protection 10
24 Active implantable medical devices protect against electrostatic discharges 14
25 Protection of damage caused by changes in atmospheric pressure by active implantable medical devices 14
26 Active implantable medical devices protect against damage from temperature changes 15
27 Active implantable medical devices for protection against non-ionizing electromagnetic radiation 15
28 random files 17
Appendix A (informative) The basic principles of this section 19
Appendix B (informative) Notes on the theoretical model for the certifying clause 27 compliance 25
Appendix C (informative) Notes on electromagnetic interference testing to certify clause 27 compliance 27
Reference 30
YY 0989.7-2017/ISO 14708-7.2013
Figure 1 Output signal amplitude and load impedance measurement 4
Figure 2 Test setup to verify the high frequency current generated by the anti-surgical device 8
Figure 3 Verification test setup for harmful output protection in MRI scans 10
Figure 4 stimulator drop test 12
Figure 5 bending test fixture 12
Figure 6 16Hz and 50Hz interference signals 16
Figure 7 Interference signal above 1 kHz 17
Figure C.1 Head phantom 28 for EMI measurement
Table 1 Peak magnetic field strength Hp 15
Table 2 Peak electric field strength Ep 16
Table C.1 Peak dipole power 29
YY 0989.7-2017/ISO 14708-7.2013
Foreword
YY 0989 "Surgical Implant Active Implantable Medical Device" consists of seven parts.
--- Part 1. General requirements for safety, marking and information provided by the manufacturer;
--- Part 2. Cardiac pacemakers;
--- Part 3. Implantable neurostimulators;
--- Part 4. Implantable syringe pumps;
---Part 5. Circulating support devices;
--- Part 6. Specific requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmia;
--- Part 7. Special requirements for cochlear implant systems.
This part is part 7 of YY 0989.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the redrafting method to modify the use of ISO 14708-7.2013 "Surgical implant active implanted medical devices Part 7.
Special requirements for cochlear implant systems. The main technical changes in this section compared to ISO 14708-7.2013 are as follows.
--- Modified some formatting formats in accordance with GB/T 1.1-2009;
--- Removed the cover, preface and introduction from the ISO 14708-7.2013 (first edition) standard;
--- For the international standards cited in the standard, if China has been converted into domestic standards, then instead refer to Chinese standards;
--- According to the requirements of the Chinese version, the page number, font and font size have been modified, which does not affect the degree of consistency;
--- Removed Appendix AA and Appendix BB of the ISO 14708-7.2013 (First Edition) standard.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part is divided into the National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5)
Return to the mouth.
This section drafted by. Shanghai Medical Device Testing Institute.
The main drafters of this section. Zhang Yidong, Ni Chengcheng, Hu Wei.
YY 0989.7-2017/ISO 14708-7.2013
Surgical implant active implantable medical device
Part 7. Special requirements for cochlear implant systems
1 Scope
This section of YY 0989 specifies active implantable medical devices that are intended for the treatment of hearing impairment through electrical stimulation of the auditory pathway.
Special requirements for machinery. This section does not apply to devices that treat hearing impairment by non-electrical stimulation.
The test specified in this section is a type test and the test is performed to confirm compliance.
This section also applies to certain non-implanted parts and accessories of the device (see note).
The electrical characteristics of the implanted part shall be verified by appropriate methods or other methods listed in this section. The accuracy of other methods shall be
Proven to be equal to or better than the prescribed method. In case of dispute, the method specified in this section should be used.
Note. What is commonly referred to as an "active implantable medical device" can actually be a single device, a combined device, or one or more devices.
A combination of one or more attachments. Not all components need to be partially or completely implanted if they affect the safety of the implanted device or
Performance requires the development of requirements for non-implanted parts and accessories.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
This chapter in Part 1 applies except as follows.
Supplementary reference documents.
GB/T 2423.5 Environmental testing of electric and electronic products - Part 2. Test methods Test Ea and guide. Impact (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 guides. plunging and overturning (mainly
For equipment type samples) (GB/T 2423.7-1995, IEC 60068-2-31. 1982, IDT)
GB/T 2423.43 Environmental testing of electric and electronic products - Part 2. Test methods - Vibration, shock and similar kinetic test
Installation of products (GB/T 2423.43-2008, IEC 60068-2-47.2005, IDT)
GB/T 2423.56 Environmental testing of electric and electronic products - Part 2. Test methods Test Fh. Wideband random vibration (digital control
System and guidelines (GB/T 2423.56-2006, IEC 60068-2-64.1993, IDT)
GB/T 2423.55 Environmental testing of electrical and electronic products - Part 2. Test methods Test Eh. Hammer test (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 in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 17626.2 Electromagnetic compatibility test and measurement technology Electrostatic discharge immunity test (GB/T 17626.2-2006,
IEC 61000-4-2.2001, IDT)
GB/T 19633 Packaging of terminally sterilized medical devices (GB/T 19633-2005, ISO 11607.2003, IDT)
YY/T 0316 Medical Device Risk Management for Medical Devices (YY/T 0316-2016, ISO 14971.2007 Correction
Edition, IDT)
YY 0505 Medical Electrical Equipment - Part 1-2. Safety General Requirements Parallel Standards. Electromagnetic Compatibility Requirements and Testing
(YY 0505-2012, IEC 60601-1-2.2004)
YY 0989.7-2017/ISO 14708-7.2013
YY/T 0664 Medical Device Software Software Life Cycle Process (YY/T 0664-2008, IEC 62304.2006, IDT)
ISO 14155 Clinical investigation of human-oriented medical devices - Good clinical practice (Clinicalinvestigationofmedical
Devicesforhumansubjects-Goodclinicalpractice)
IEC 60118-6 Hearing aids - Part 6. Characteristics of hearing aid input circuits (Hearingaids-Part 6. Characters
Ofelectricalimputcircuitsforhearingaids)
IEC 60601-1 Requirements for basic safety and basic performance of medical electrical equipment (Medicalelectricalequipment-Part 1.
Generalrequirementsforbasicsafetyandessentialperformance)
EN1593 Non-destructive testing leak test foaming technology (Non-destructive testing-Leaktesting-Bubble
Emissiontechniques)
EN13185 Non-destructive testing leak test trace gas method (Non-destructive testing-Leaktesting-Tracer
Gasmethod)
3 Terms and definitions
The following terms and definitions as defined in Part 1 apply to this document.
3.3.1
Cochlear implant system cochlearimplantsystem; CIS
Active implantable medical devices, consisting of implanted and non-implanted parts, are expected to treat hearing impairment by electrically stimulating the cochlea.
3.3.2
Auditory brainstem implant system auditorybrainstemimplantsystem; BIS
Active implantable medical devices, consisting of implanted and non-implanted parts, are expected to treat hearing impairment by electrically stimulating the auditory brainstem.
3.3.3
Implant system implantsystem
Cochlear implant system or auditory brainstem implant system.
3.3.4
Non-implanted part non-implantsystem
The extracorporeal part of the implant system.
Note. Includes but is not limited to sound processors, microphones, coils or power supplies.
3.3.5
Stimulator stimulator
The implanted portion of the implant system includes electronic circuitry for generating electrical stimulation.
3.3.6
Wearable body-worn
The non-implanted portion of the implant system worn on the body (such as worn or ear worn).
3.5.1
Electrode contact
A conductive portion designed to form a connection with body tissue or body fluids.
3.5.2
Electrode array electrodearray
A distal portion of the wire that contains more than one electrode contact.
3.5.3
Reference electrode referenceelectrode
Designed to electrically stimulate the conductive portion of the current loop.
YY 0989.7-2017/ISO 14708-7.2013
3.5.4
Remote distal
Location away from the stimulator.
3.5.5
Proximal proximal
The location is closest to the stimulator.
3.9.1
Model modeldesignation
The name and/or combination of letters and numbers used by the manufacturer to distinguish between instruments in function or type.
3.9.2
Serial number serialnumber
A unique combination of letters and/or numbers selected by the manufacturer to distinguish between instruments of the same model.
3.20.1
Output signal outputsignal
The implant system is intended to stimulate a pulsed or analog electrical output of the auditory pathway.
3.20.2
Pulse pulse
Specifies the electrical output signal (voltage or current) of the amplitude and interval.
3.20.3
Biphasic pulse biphasicpulse
A pulse with a positive phase and a negative phase.
3.22.1
Expiration period use-before-date
After this date, the manufacturer recommends that the active implantable medical device should not be used.
3.22.2
Magnet magnet
A component that produces external magnetic flux.
4 symbols and abbreviations term
This chapter in Part 1 applies. However, it is not restricted to use symbol definitions in other standards or symbols defined in random files.
5 General requirements for non-implanted parts
This chapter in Part 1 applies except as follows.
5.2
replace.
Software for active implantable medical devices or software for active implantable medical device definitions should follow the software life cycle process
Designed to meet the requirements of YY/T 0664 and verified.
6 Inspection and measurement
If this section involves the inspection of the design analysis documents provided by the manufacturer, it should include the risk management documents required by YY/T 0316.
test.
YY 0989.7-2017/ISO 14708-7.2013
6.1 Measurement of output signal characteristics
Measurements should be made at the implanted portion of the implant system at a temperature of (37 ± 2) °C. The implant system should be set to use its maximum number
Output, and each output should be set to the maximum value (amplitude and pulse width). An input equivalent to 70dBSPL should be applied to the microphone
signal. If applicable, the percutaneous connection should be operated at a distance of (5 ± 1) mm. If the implant system provides an optional output signal, each signal
Both should be measured and listed separately. For ease of connection, the test sample can be an unfinished product. Considering all the errors, the accuracy of the amplitude measurement should be
Better than ±5%.
6.2 Measurement of output signal amplitude and pulse width
Representative implant system samples, each output should be connected to 1 × (1 ± 1%) kΩ load resistance (see Figure 1) and set according to 6.1
set. The oscilloscope should be tuned to display all outputs at maximum resolution. The output signal peak should be measured. Each output should be conne...
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