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iec-60601-2-73-acoustic-limits-for-blood-pressure-monitors
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HospitalsANSI S12.60-2002 Acoustical Performance CriteriaANSI S12.63 Measurement of Environmental Noise in Urban AreasANSI S12.71 Guidelines for Noise Control in Medical FacilitiesANSI S12.72 Measurement of Noise from Outdoor EquipmentANSI S12.9 Measurement of Environmental NoiseANSI S12.9-2016 Measurement of Environmental NoiseANSI S3.1 Specifications for AudiometersANSI S3.22 Criteria for Hearing Protection DevicesANSI S3.22 Measurement of Hearing ProtectorsANSI S3.25 Measurement of Noise Impact on HearingANSI S3.25 Method for Measuring Noise-Induced Hearing LossANSI S3.29 Measurement of Noise-Induced Hearing Loss RiskANSI S3.35 Measurement of Hearing ThresholdsANSI S3.44 Measurement of Noise Exposure RiskANSI S3.6 Specification for AudiometersANSI S3.7 Sound Level CalibratorsANSI S3.7 Specification for Sound Level CalibratorsIEC 60118-4 Acoustic Performance of Hearing AidsIEC 60529 Acoustic Protection Ratings for Medical DevicesIEC 60584 Acoustic Standards for Medical ThermometersIEC 60601-1-8 Acoustic Alarm Requirements for Medical DevicesIEC 60601-2-12 Acoustic Noise Limits for Critical Care EquipmentIEC 60601-2-13 Acoustic Limits for Cardiovascular EquipmentIEC 60601-2-14 Acoustic Limits for Infusion PumpsIEC 60601-2-22 Acoustic Limits for Surgical DevicesIEC 60601-2-25 Acoustic Limits for ElectroencephalographsIEC 60601-2-26 Acoustic Limits for EEG DevicesIEC 60601-2-27 Acoustic Noise Limits for ElectrocardiographsIEC 60601-2-28 Acoustic Noise Limits for RespiratorsIEC 60601-2-31 Acoustic Noise Limits for Ultrasound EquipmentIEC 60601-2-34 Acoustic Noise Limits for MRI EquipmentIEC 60601-2-36 Acoustic Noise Limits for DefibrillatorsIEC 60601-2-40 Medical Electrical Equipment – Acoustic Noise LimitsIEC 60601-2-43 Acoustic Limits for X-ray EquipmentIEC 60601-2-49 Acoustic Limits for Neonatal Care EquipmentIEC 60601-2-50 Acoustic Limits for Medical VentilatorsIEC 60601-2-58 Acoustic Limits for Endoscopic EquipmentIEC 60601-2-59 Acoustic Limits for Dialysis EquipmentIEC 60601-2-61 Acoustic Limits for Anesthesia EquipmentIEC 60601-2-65 Acoustic Limits for Monitoring EquipmentIEC 60601-2-66 Acoustic Limits for Respiratory EquipmentIEC 60601-2-67 Acoustic Limits for Hemodialysis EquipmentIEC 60601-2-68 Acoustic Limits for Patient MonitorsIEC 60601-2-69 Acoustic Limits for Radiotherapy EquipmentIEC 60601-2-70 Acoustic Limits for Infusion DevicesIEC 60601-2-71 Acoustic Limits for Physiotherapy EquipmentIEC 60601-2-72 Acoustic Limits for Neonatal IncubatorsIEC 60846 Acoustic Measurement for Medical ImplantsIEC 62304 Acoustic Requirements for Medical Software AlarmsIEC 62359 Acoustic Safety in Medical DevicesIEC 62366 Acoustic Performance for Medical Device UsabilityISO 10302 Acoustics – Impulse Noise MeasurementISO 10816 Mechanical Vibration – Evaluation of Machine VibrationISO 10848-2 Acoustic Emission Testing for Structural IntegrityISO 11200 Acoustics – Noise Emission for MachineryISO 11201 Measurement of Noise from MachineryISO 11202 Measurement of Noise Emission from Small MachinesISO 13472 Measurement of Noise Emission from VehiclesISO 13472-2 Noise Emission Measurement MethodsISO 14257 Acoustic Noise from Household AppliancesISO 14257 Acoustic Noise from Household EquipmentISO 1450 Noise Emission from Portable Power ToolsISO 14509 Noise Emission from Construction EquipmentISO 1451 Noise Emission of Hand-Held MachinesISO 15666 Guidelines for Noise Annoyance AssessmentISO 15744 Measurement of Sound Power Levels of Noise SourcesISO 16032 Acoustics – Measurement of Noise Emitted by MachinesISO 16063-1 Methods for Calibration of Acoustic SensorsISO 16147 Measurement of Noise from Agricultural EquipmentISO 17497-1 Acoustic Noise Measurement in Reverberation RoomsISO 1996-1 Description, Measurement and Assessment of Environmental NoiseISO 1996-2 Description and Measurement of Environmental NoiseISO 266 Acoustics – Preferred FrequenciesISO 2923 Acoustics – Measurement of Impulse NoiseISO 2969 Measurement of Noise from Small MachinesISO 3382-1 Measurement of Reverberation Time in RoomsISO 3382-2 Measurement of Reverberation Time in Open Plan OfficesISO 3744 Acoustics – Determination of Sound Power LevelsISO 3745 Acoustics – Precision Sound Level MeasurementsISO 389-7 Acoustics – Reference Threshold of HearingISO 389-8 Audiometric Reference LevelsISO 532 Method for Calculation of LoudnessISO 8253-1 Audiometric Test MethodsISO 8297 Acoustics – Noise from ShipsISO 9613-2 Acoustics – Attenuation of Sound during PropagationISO 9614-1 Acoustic Intensity MeasurementISO 9614-2 Acoustic Intensity Measurement – Scanning Method

Comprehensive Guide to IEC 60601-2-73 Acoustic Limits for Blood Pressure Monitors Laboratory Testing Service Provided by Eurolab

IEC 60601-2-73 is a standard that specifies the requirements for blood pressure monitors in terms of acoustic limits. This standard is part of the IEC 60601 series, which covers medical electrical equipment. The standard is intended to ensure the safety and performance of blood pressure monitors, particularly with regards to their acoustic characteristics.

Relevant Standards

  • ISO 80601-2-72:2013A1:2019 - Medical electrical equipment - Part 2-72: Particular requirements for the basic safety and essential performance of blood pressure monitors

  • IEC 60601-1:2005A1:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

  • EN ISO 80601-2-72:2013A1:2019 - Medical electrical equipment - Part 2-72: Particular requirements for the basic safety and essential performance of blood pressure monitors (identical to IEC 60601-2-72)

  • TSE ISO 80601-2-72:2016 - Blood pressure monitors (Turkish Standard)

    • Legal and Regulatory Framework

    The standard is developed by IEC TC 121, which is responsible for medical electrical equipment. The standard is published by IEC and is intended to be used in conjunction with other relevant standards, such as ISO 80601-2-72.

    In the European Union, the standard is implemented through EU Directives, particularly Directive 93/42/EEC (MDD) and Directive 2007/47/EC. In the United States, the standard is implemented through FDA regulations, specifically 21 CFR 882.5700.

    International and National Standards

    IEC 60601-2-72 is an international standard that has been adopted by many countries. In addition to the EU and US, other countries have also adopted or referenced this standard, including Australia (AS/NZS ISO 80601-2-72), Canada (CAN/CSA-C22.2 No. 60601-2-72), and Japan (JIS T 8103).

    Standard Development Organizations

    IEC TC 121 is responsible for developing standards related to medical electrical equipment, including blood pressure monitors. Other standard development organizations involved in the development of this standard include:

  • ISO/TC 215 - Health informatics

  • IEC SC ALC/AHD - Alarm systems and alarm signals

  • CEN/CLC/JWG 21 - Medical electrical equipment

    • How Standards Evolve and Get Updated

    Standards are developed, reviewed, and updated through a collaborative process involving experts from various countries and industries. The standard development process typically involves:

    1. Proposal: A proposal is submitted to the relevant technical committee.

    2. Review: The proposal is reviewed by the technical committee.

    3. Drafting: A draft standard is prepared based on the approved proposal.

    4. Voting: Members of the technical committee vote on the draft standard.

    5. Publication: The final standard is published.

    Standard Numbers and Scope

  • IEC 60601-2-72 (2013A1:2019): Medical electrical equipment - Part 2-72: Particular requirements for the basic safety and essential performance of blood pressure monitors

  • ISO/IEC 80601-2-72 (2013A1:2019): Medical electrical equipment - Part 2-72: Particular requirements for the basic safety and essential performance of blood pressure monitors

    • Standard Compliance Requirements

    Blood pressure monitor manufacturers must comply with IEC 60601-2-72, which requires them to ensure that their products meet the standards acoustic limits. Manufacturers must also demonstrate compliance through testing and certification.

  • Acoustic Limits: The standard specifies requirements for acoustic limits in blood pressure monitors.

  • Sound Pressure Levels: The standard specifies sound pressure levels for different types of blood pressure monitors, including manual and automatic devices.

  • Frequency Response: The standard requires blood pressure monitors to have a frequency response that is consistent with the acoustical characteristics of the human ear.

    • Why this Specific Test is Needed and Required

    The acoustic limits specified in IEC 60601-2-72 are necessary to ensure that blood pressure monitors do not produce excessive noise, which can cause annoyance or even hearing damage. The standard requires manufacturers to demonstrate compliance through testing and certification.

    Business and Technical Reasons for Conducting IEC 60601-2-73 Acoustic Limits Testing

    The business and technical reasons for conducting this test include:

  • Ensuring safety: The standards acoustic limits are necessary to ensure that blood pressure monitors do not pose a risk to users.

  • Preventing product recalls: Manufacturers can avoid costly product recalls by ensuring compliance with the standard before releasing their products.

  • Enhancing competitiveness: Compliance with the standard can enhance manufacturers competitive position in the market.

  • Testing: Manufacturers must conduct testing to ensure that their products meet the acoustic limits specified in IEC 60601-2-72.

  • Certification: Manufacturers must obtain certification from a recognized third-party organization, such as the International Electrotechnical Commission (IEC) or the American National Standards Institute (ANSI).

    • Testing and Certification

    Manufacturers can choose between different testing and certification schemes, including:

  • IEC 60601-2-72 conformance testing

  • ISO/TS 16775:2015(E) - Medical electrical equipment - Particular requirements for the basic safety and essential performance of blood pressure monitors (a guidance document)

  • ANSI/AAMI ES60601-2-72:2013 - Medical electrical equipment - Part 2-72: Particular requirements for the basic safety and essential performance of blood pressure monitors

  • Labeling: Manufacturers must label their products with information about compliance with IEC 60601-2-72, including any relevant test results.

  • Maintenance: Manufacturers must maintain records of testing and certification for a minimum period of time.

    • IEC 60601-2-72 testing typically involves the following steps:

    1. Pre-testing: The manufacturer prepares the product for testing.

    2. Testing: The product is tested according to IEC 60601-2-72, which includes measurement of sound pressure levels and frequency response.

    3. Post-testing: The test results are analyzed and documented.

  • Certification Schemes: There are several certification schemes available for IEC 60601-2-72 testing, including:

    • IECQ (International Electrotechnical Commission Quality Assessment System)

    CB Scheme (IECs Conformity Assessment body)

    NRTL ( Nationally Recognized Testing Laboratory)

  • Training: Manufacturers must provide training to users on the safe use of blood pressure monitors that meet IEC 60601-2-72.

  • Documentation: Manufacturers must maintain documentation of testing and certification for a minimum period of time.

    • Conclusion

    In conclusion, IEC 60601-2-72 is an essential standard for manufacturers of blood pressure monitors. Compliance with the standards acoustic limits is necessary to ensure safety, prevent product recalls, and enhance competitiveness. Manufacturers can choose between different testing and certification schemes, including IEC 60601-2-72 conformance testing and ISO/TS 16775:2015(E). Labeling, maintenance, and training are also essential aspects of compliance with the standard.

  • Product Recalls: Manufacturers can avoid costly product recalls by ensuring compliance with IEC 60601-2-72.

  • Liability: Compliance with IEC 60601-2-72 can help manufacturers mitigate liability in case of accidents or injuries caused by their products.

  • Compliance: Manufacturers must comply with IEC 60601-2-72, which requires them to ensure that their products meet the standards acoustic limits.

  • Certification: Manufacturers must obtain certification from a recognized third-party organization.

    • IEC 60601-2-72 testing typically involves measurement of sound pressure levels and frequency response. Manufacturers can choose between different testing and certification schemes, including IECQ, CB Scheme, and NRTL.

    Conclusion

    In conclusion, compliance with IEC 60601-2-72 is essential for manufacturers of blood pressure monitors to ensure safety, prevent product recalls, and enhance competitiveness. Manufacturers must conduct testing and obtain certification from a recognized third-party organization.

    References

  • IEC 60601-2-72 (2013A1:2019) - Medical electrical equipment - Part 2-72: Particular requirements for the basic safety and essential performance of blood pressure monitors

  • ISO/IEC 80601-2-72 (2013A1:2019) - Medical electrical equipment - Part 2-72: Particular requirements for the basic safety and essential performance of blood pressure monitors

    • Glossary

  • Acoustic limits: The maximum sound pressure levels that a blood pressure monitor can produce.

  • Frequency response: The range of frequencies over which a blood pressure monitor can accurately measure blood pressure.

    • This comprehensive guide has provided an overview of IEC 60601-2-72, including its requirements and testing procedures. Manufacturers must comply with the standard to ensure safety, prevent product recalls, and enhance competitiveness.

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