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IEC 60118-1:1999 Hearing Aids Part 1: Hearing aids with induction pick-up coil input |
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Odense |
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IEC 60118-2:1983 Hearing Aids Part 2: Hearing aids with automatic gain control circuits |
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Odense |
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IEC 60118-2/am1:1993 Hearing Aids Part 2: Hearing aids with automatic gain control circuits |
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Odense |
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Medicinsk udstyr |
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IEC 60118-6:1999 Hearing Aids Part 6: Characteristics of electrical input circuits for hearing aids |
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Odense |
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Medicinsk udstyr |
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IEC 60118-7:2005 Hearing Aids Part 7: Measurement of the performance characteristics of hearing aids for production, supply and delivery quality assurance purposes |
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Odense |
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Medicinsk udstyr |
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IEC 60118-15:2012 Ed. 1 Electroacoustics - Hearing aids - Part 15: Methods for characterising signal processing in hearing aids with a speech-like signal |
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Odense |
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Medicinsk udstyr |
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ANSI/ASA S3.42-2012 / Part 2 Testing Hearing aids - Part 2: Methods for characterising signal processing in hearing aids with a speech-like signal |
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Identisk med IEC 60118-15:2012 Ed. 1 (Som givet i "Foreword") |
Odense |
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IEC 60118-8:2005 Hearing Aids Part 8: Methods of measurement of performance characteristics of hearing aids under simulated in situ working conditions |
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Odense |
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Medicinsk udstyr |
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IEC 60118-9:1985 Hearing Aids Part 9: Methods of measurement of characteristics of hearing aids with bone vibrator output |
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Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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IEC 60118-12:1996 Hearing Aids Part 12: Dimensions of electrical connector systems |
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Odense |
| EMC Prøvning |
Medicinsk udstyr |
Høreapparater |
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IEC 60118-13:2019, Ed. 5.0 Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices. |
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Odense |
| EMC Prøvning |
Medicinsk udstyr |
Høreapparater |
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EN IEC 60118-13:2020, Ed 5.0 Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices. |
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Odense |
| EMC Prøvning |
Medicinsk udstyr |
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AS/NZS 1088.9:1995 Hearing aids – Immunity requirements and methods of measurements for hearing aids exposed to radio frequency fields in the frequency range 300 MHz to 3 GHz |
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Odense |
| Akustisk prøvning |
Medicinsk udstyr |
Høreapparat |
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ANSI S3.22:2014 Specification of hearing aid characteristics |
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Electroacoustics charactheristics |
Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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NSH:2007 Hearing aids requirements and guidelines, 7. edition (Annex A) |
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Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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Nordic Requirements, HEARING AIDS, Requirements and guidelines, 7th edition, 2007-03-01. |
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Odense |
| EMC Prøvning |
Medicinsk udstyr |
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ANSI C63.19:2011 Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids, clause 6, Hearing aid RF near-field immunity test |
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Elektroakustik & EMC |
Odense |
| EMC Prøvning |
Medicinsk udstyr |
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ANSI C63.19:2019 Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids, clause 6, Hearing aid RF near-field immunity test |
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Electroacoustics and EMC, Clause 5 |
Odense |
| EMC Prøvning |
Medicinsk udstyr |
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ANSI/CTA-2051-2017 Personal Sound Amplification Performance Criteria |
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Odense |
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Medicinsk udstyr |
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IEC 60645-1:2017 Audiological equipment Part 1: Pure tone audiometers |
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Scope: Air conduction sound pressure level, frequency and speech level. Frequency range: Frequency: 125 Hz – 8 kHz. |
Odense |
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Medicinsk udstyr |
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ISO 389-1:2017 Acoustics — Reference zero for the calibration of audiometric equipment — Part 1: Reference equivalent threshold sound pressure levels for pure tones and supraaural earphones |
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Odense |
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Medicinsk udstyr |
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ISO 389-2:1994 Acoustics - Reference zero for the calibration of audiometric equipment Part 2: Reference equivalent threshold sound pressure levels for pure tones and insert earphones |
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Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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ISO 389-3:1994 /Cor 1:1995 Acoustics - Reference zero for the calibration of audiometric equipment - Part 3: Reference equivalent threshold force levels for pure tones and bone vibrators |
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Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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ISO 389-4:1994 Acoustics - Reference zero for the calibration of audiometric equipment - Part 4: Reference levels for narrow-band masking noise |
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Odense |
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Medicinsk udstyr |
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ISO 389-5:2006 Acoustics - Reference zero for the calibration of audiometric equipment - Part 5: Reference equivalent threshold sound pressure levels for pure tones in the frequency range 8 kHz to 16 kHz |
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Odense |
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Medicinsk udstyr |
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ISO 389-6:2007 Acoustics - Reference zero for the calibration of audiometric equipment - Part 6: Reference threshold of hearing for test signals of short duration |
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Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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ISO 389-7:2005 Acoustics - Reference zero for the calibration of audiometric equipment - Part 7: Reference threshold of hearing under free-field and diffuse-field listening conditions |
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Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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ISO 389-8:2004 Acoustics - Reference zero for the calibration of audiometric equipment - Part 8: Reference equivalent threshold sound pressure levels for pure tones and circumaural earphones |
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Odense |
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Medicinsk udstyr |
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Produktstandard |
IEC 60601-2-66:2012 Medical Electrical Equipment. Part 2-66 Particular requirements for basic safety and essential performance of hearing instruments and hearing instrument systems |
Medical Product - Type Testing |
All tests |
Hørsholm, Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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Produktstandard |
IEC 60601-2-66:2015 Ed 2 Medical Electrical Equipment. Part 2-66 Particular requirements for basic safety and essential performance of hearing instruments and hearing instrument systems |
Medical Product - Type Testing |
All tests |
Hørsholm, Odense |
| Akustisk prøvning |
Medicinsk udstyr |
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Produktstandard |
IEC 60601-2-66:2019 Ed 3 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems |
Medical Product - Type Testing |
All tests |
Hørsholm, Odense |
| Akustisk prøvning |
Medicinsk udstyr |
Audiometers |
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ISO 8253-1:2010 Part 1 Acoustics - Audiometric test methods - Part 1: Pure-tone air and bone conduction audiometry |
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Electroacoustic charactheristics |
Odense |
| Akustisk prøvning |
Medicinsk udstyr |
Audiometers |
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ISO 8253-3:2012 Acoustics -- Audiometric test methods -- Part 3: Speech audiometry |
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Electroacoustic charactheristics |
Odense |
| Akustisk prøvning |
Medicinsk udstyr |
Audiometers |
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ISO 8253-2:2012 Part 2: Acoustics - Audiometric test methods - Part 2: Sound field audiometry with pure-tone and narrow-band test signals |
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Electroacoustic charactheristics |
Odense |