The registration testing for audiometric device in CFDA

Transcription

1 The registration testing for audiometric device in CFDA Beijing Center for Medical Devicee Quality Supervision and Testing of China Food and Drug Administration Beijing Institute of Medical Device Testing Tong Guohua

2 CONTENTS: Part1:Brief introduction about Regulations on Medical Devic Part2:Registration testing of audiometric device

3 Part1: Regulations on Medical Device The Medical Device were managed by CFDA through the registration management system in China. Regulations on Medical Device supervision and management, decree of The State Council(No.650). It was implemented form June 1 st,2014 Administrative measures on Medical Device registration,decree of the CFDA(No.4). It was implemented form October 1 st,2014

4 Part1:: Regulations on Medical Device Regulations on Medical Device supervision and management Article 5 medical device were classified as three categories based on risk analysis. The class I medical device is low risk product. Routine management can guarantee its safetey and effectivity. The class II medical device is middle risk product. The strict management and control is needed to guarantee its safety and effectivity. The class III medical device is high risk product. The extraordinary measures is implemented to guarantee its safety and effectivity. Article 8 for class I medical device to implement record management. For class II and class III medical device to implement registration management.

5 Part1:: Regulations on Medical Device Article 9 to put on record and register for class I class II and class III medical device shall provide the following materials : The risk analysis report The document of technical requirement The testing report The clinical evaluation report User manual and label The documentation for Quality management system Other materials for the product safty and effectivity

6 Part1:: Regulations on Medical Device Article 10 to put on record for the class I medical device, the testing report may be the manufacturer s self testing report Article 11 to register for the class II and class III medical device, the testing report shall be from the institute for medical device testing which was approved by the CFDA.

7 Part1:: Regulations on Medical Device Article 17 for class I medical device to put essential. on record, the clinical trial is non- The clinical trial is required to apply for registration for the class II and class III medical device. But there is exemption clause for the clinical trial. Exclusion: pure tone audiometer BTE-hearing aids ITE-hearing aids cassette hearing aids sorting code: :6821 sorting code: :6846 sorting code: :6846 sorting code: :6846

8 Part1:: Regulations on Medical Device Article 15 The registration certification is valid for 5 years and 6 months before the expiration,the applicant should apply for continued registration.

9 Part2:Registration testing Contents: 1. Part2-1:Electroacoustic testing 2. Part2-2:Electrical safety inspections 3. Part2-3:Other requirements

10 Part2-1 Electroacoustic testing Audiometric equipment: Pure-tone audiometers IEC (GB/T7341.1) Electroacoustics-Audiological equipment -Part1:Pure-tone audiometers Speech audiometry IEC (GB/T7341.2) Audiometers Part2:Equipment for speech audiometry high-frequency audiometry IEC (GB/T7341.4) Audiometers Part4:extended high-frequency audiometry Aural acoustic impedance/admittance measuring device IEC (GB/T15953) Electroacoustics-Audiometric equipment Part5:Instruments for the measurement of aural acoustic impedance/admittance

11 Part2-1 Electroacoustic testing Audiometric equipment OAE measuring equipment IEC Electroacoustics-Audiometric equipment Part6:Instruments for the measurement of otoacoustic emissionss ABR measuring equipment IEC Electroacoustics-Audiometric equipment Part7:Instruments for the measurement of auditory brainstem responses

12 Part2-1 Electroacoustic testing Reference standards: ISO389-1/-2/-3 Acoustics-Reference zero for the calibration of audiometric equipment IEC /-2/-3 Ear simulator acoustic coupler mechanical coupler for calibration of earphones(supra-aural earphones circumaural earphones insert earphones bone vibrator)

13 Part2-1 Electroacoustic testing Hearing aids: GB/T Electroacoustics-General specification for hearing aids IEC :1983 (GB/T ) Hearing aids-part 0:measurement of electroacoustic characteristics Cochlear implant systems: ISO (EN ) Implants for surgery Active implantable medical devices Part7: Particular requirements for cochlear implant systems

14 Part2-1 Electroacoustic testing Other standard relative to the electroacoustic character: GB/T14710 Environmental requirement and test methods for medical electrical equipment Exclusion: Hearing aids- Environmental requirement standard GB/T14199 and test methods refer to the national

15 Part2.1 Electroacoustic testing Main character of the audiometer: (GB/T IDT IEC :2001) Acoustic safety Environmental conditions Power supply variation Unwanted sound Frequency range and hearing level rang Frequency accuracy Total harmonic distortion Rate of frequency change(for automa ge atic audiometer)

16 Part2-1 Electroacoustic testing Main character of the audiometer: (GB/T IDT IEC :2001) Frequency modulation External signal source Masking sound Accuracy of sound pressure level and vi Accuracy of control Masking level range and accuracy Tone switch Automatic pulsed presentation Reference tone Calibration ibratory force level

17 Part2-1 Electroacoustic testing Differences between calibration items and registration testing items for pure tone audiometer Test items JJG GB/T Acoustic safety Environmental conditions Power supply variation Unwanted sound Frequency range and hearing level range Frequency accuracy Total harmonic distortion Rate of frequency change(for automatic audiometer)

18 Part2-1 Electroacoustic testing Test items Frequency modulation External signal source JJG GB/T Masking sound Accuracy of sound pressure level and vibratory force level Accuracy of control Masking level range and accuracy Tone switch Automatic pulsed presentation Reference tone Calibration

19 Part2-1 Electroacoustic testing The same item but different test procedure: Test items Accuracy of sound pressure level Accuracy of control GB/T Measuring the output at a hearing level setting of 70dB or the maximum whichever is lower The accuracy shall be tested at the lowest and highest frequency available from the audiometer. 125Hz and 8000Hz JJG Measuring the output at a hearing level setting of 50dB The accuracy shall be tested at the frequency of 1kHz.

20 Part2-1 Electroacoustic testing Differences between calibration items and registration testing items for Aural acoustic impedance/admittance measuring device Test items JJG GB/T Probe signal frequency accuracy and THD Measurement range Output of the electrical signal for volume(impedance) Temporal characteristics Pressure range Accuracy of the relative pressure indicator Rate of pressure change Output of the electrical signal for pressure

21 Part2-1 Electroacoustic testing Test items Acoustic reflex activating stimulus system JJG GB/T Pure tone signal frequency accuracy Pure tone harmonic distortion Stimulus level accuracy Broad band noise Stimulus presentation control on-off and SN ratio Rise-fall times Pulsed stimulus signal Output of the electrical signal for stimulus signal

22 Part2-1 Electroacoustic testing The same item but different requirement for accuracy : : items GB/T Pressure accuracy Stimulus level accuracy for insert or probe-type earphones For instruments of type 1 and For instruments of type 1 type 2: ±10daPa or±10%, and type 2: ±15daPa; whichever is greater; For instruments of type 3: For instruments of type 3: ±20daPa ±10daPa or±15% 500Hz~2000Hz: ±5dB, 4000Hz: +5/-10dB JJG ±5dB

23 Part2-1 Electroacoustic testing Other medical acoustic equipment: : The international standards For the OAE measuring device and ABR measuring device have not converted to the national standards. Medical acoustic equipment DPOAE measuring equipment TEOAE measuring equipment ABR measuring equipment Electroacoustic characteristics primary tones frequency accuracy and pressure level accuracy The characteristics of the brief tone or click Stimulus characteristics

24 Part2-1 Electroacoustic testing Rehabilitation acoustic equipment: : 1 Hearing aids: OSPL 90 Full-on acoustic gain Internal noise generated in the hearing Total harmonic distortion Frequency response Battery current Environmental testing 2 Cochlear implant system Characteristics of the electrical stimuluss signal (for the sound processor) aid

25 Part2-2 Electrical safety inspections International standards: IEC nd edition (GB ) Medical electrical equipment part1:general requirements for safety IEC (GB ) Medical electrical equipment part1-1: :General requirements for safety-collateral standard:safety requirements for medical electrical systems IEC (YY ) Medical electrical equipment part1-2: :General requirements for safety-collateral standard:electromagnetic compatibility-requirements and tests

26 Part2-2 Electrical safety inspections International standards: IEC ( YY/ /T ) Medical electrical equipment part1-6: :General requirements for safety Collateral standard:usability IEC Medical electrical equipment part1-6: :General requirements for safety Collateral standard:usability IEC st edition (YY/T ) Medical electrical equipment part1:general requirements for safety Collateral standard:general requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

27 Part2-2 Electrical safety inspections Audiometric equipment: IEC (GB ) IEC (GB ) IEC (YY ) Hearing aids: IEC (GB ) IEC (GB ) Cochlear implant system: IEC (GB ) IEC (GB )

28 Part2-2 Electrical safety inspections Main items of Electrical safety inspections: Leakage current Dielectric strength Protective earthing Power input Excessive temperatures Single fault condition Mains parts construction and layout

29 Part2-3:EMC testing Emission test Immunity test

30 Part2-3:Biocompatibility Biological evaluation: Test for in vitro cytotoxicity(gb/t IDT ISO ) Irritation ( GB/T IDT ISO :2002 ) Delayed-type hypesensitivity ( GB/T IDT ISO :2002 )

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