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iec-60601-2-28-acoustic-noise-limits-for-respirators
Noise and Acoustic Performance Testing ANSI S1.11 Specification for Octave-Band and Fractional-Octave-Band FiltersANSI S1.13 Method for Measurement of Noise ExposureANSI S1.13-2013 Methods for Environmental Noise MeasurementANSI S1.4 Sound Level Meters – Performance SpecificationsANSI S12.10 Measurement of Noise in Healthcare FacilitiesANSI S12.10 Measurement of Noise in Occupational EnvironmentsANSI S12.19 Measurement of Aircraft NoiseANSI S12.19 Measurement of Noise from Industrial EquipmentANSI S12.19 Measurement of Noise from Power GeneratorsANSI S12.2 Criteria for Evaluating Noise ControlANSI S12.2 Criteria for Noise Control in Medical SettingsANSI S12.50 Measurement of Noise from Recreational ActivitiesANSI S12.53 Measurement of Noise from Industrial FansANSI S12.54 Measurement of Noise in Educational FacilitiesANSI S12.6-2016 Methods for Measuring Noise Reduction of Hearing ProtectorsANSI S12.60 Acoustical Performance in ClassroomsANSI S12.60 Noise Criteria for Schools and 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 60601-2-31 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 60601-2-73 Acoustic Limits for Blood Pressure MonitorsIEC 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 60601-2-28 Acoustic Noise Limits for Respirators Testing Services

Provided by Eurolab: A Leader in Laboratory Testing and Certification

Table of Contents

1. Standard-Related Information

Overview of Relevant Standards

Legal and Regulatory Framework

International and National Standards

Standard Development Organizations

2. Standard Requirements and Needs

Business and Technical Reasons for Testing

Consequences of Not Performing This Test

Industries and Sectors Requiring This Testing

3. Test Conditions and Methodology

Step-by-Step Explanation of the Test Procedure

Testing Equipment and Instruments Used

Testing Environment Requirements

4. Test Reporting and Documentation

Report Format and Structure

Interpretation of Test Results

5. Why This Test Should Be Performed

Benefits and Advantages

Risk Assessment and Mitigation

Quality Assurance and Compliance Benefits

6. Why Eurolab Should Provide This Service

Expertise and Experience in this Field

State-of-the-Art Equipment and Facilities

Qualified and Certified Personnel

Standard-Related Information

IEC 60601-2-28 is a standard that specifies the requirements for acoustic noise limits of respiratory equipment, including ventilators and oxygen concentrators. This standard is part of the IEC 60601 series, which covers medical electrical equipment.

The legal and regulatory framework surrounding this testing service includes international standards such as ISO 13485 (Medical devices - Quality management systems), ASTM F739-19 (Standard Test Method for Respiratory Protection Against Cytotoxic Chemicals), and EN ISO 13485:2016 (Medical devices Requirements for regulatory purposes).

National standards, such as the US FDAs guidance on medical device testing, also apply to this specific laboratory test. Standard development organizations, like the International Electrotechnical Commission (IEC) and the American Society for Testing and Materials (ASTM), play a crucial role in updating and refining these standards.

Standard Requirements and Needs

This specific test is required to ensure that respiratory equipment meets the necessary safety and performance criteria. The business and technical reasons for conducting this test include:

  • Ensuring product safety and reliability

  • Complying with regulatory requirements

  • Reducing liability risks

  • Improving product quality and performance

    • Consequences of not performing this test may include:

  • Inadequate product safety and performance

  • Regulatory non-compliance

  • Increased liability risks

  • Reduced customer confidence and trust

    • Industries and sectors requiring this testing include medical device manufacturers, healthcare providers, and regulatory agencies.

    Test Conditions and Methodology

    The IEC 60601-2-28 acoustic noise limits for respirators test involves the following steps:

    1. Sample preparation: The equipment under test (EUT) is prepared according to the manufacturers instructions.

    2. Testing environment setup: The testing environment, including temperature, humidity, and pressure, is set up according to the standard.

    3. Acoustic noise measurement: The EUT is measured for acoustic noise using specialized instruments.

    4. Data analysis: The test data is analyzed and compared to the specified limits.

    The testing equipment and instruments used include sound level meters, spectrum analyzers, and signal generators. The testing environment requirements include a temperature range of 20C 5C, relative humidity between 40 and 60, and atmospheric pressure at sea level.

    Test Reporting and Documentation

    The test report format includes:

  • Introduction

  • Test setup and conditions

  • Test results and data analysis

  • Conclusion and recommendations

    • Interpretation of test results involves comparing the measured acoustic noise levels to the specified limits. Certification and accreditation aspects are also considered, including traceability and documentation requirements.

    Why This Test Should Be Performed

    Performing this test offers numerous benefits and advantages, including:

  • Ensuring product safety and performance

  • Complying with regulatory requirements

  • Reducing liability risks

  • Improving product quality and performance

    • Risk assessment and mitigation through testing are also critical aspects. Quality assurance and compliance benefits include reduced errors, improved efficiency, and enhanced customer confidence.

    Why Eurolab Should Provide This Service

    Eurolabs expertise and experience in this field make it an ideal choice for IEC 60601-2-28 acoustic noise limits for respirators testing services. Our state-of-the-art equipment and facilities ensure accurate and reliable results.

    Our qualified and certified personnel, including experienced engineers and technicians, are trained to handle complex testing requirements. We maintain international recognition and partnerships with leading standard development organizations.

    Eurolabs quality management systems and procedures ensure that all testing activities meet the highest standards of quality and reliability. Our customer service and support capabilities provide unparalleled assistance throughout the testing process.

    Conclusion

    IEC 60601-2-28 acoustic noise limits for respirators testing services are essential to ensuring product safety and performance. Eurolabs expertise, experience, and commitment to quality make us an ideal choice for this critical testing requirement. By choosing Eurolab, you can ensure that your respiratory equipment meets the necessary standards, reducing liability risks and improving customer confidence.

    References

    1. IEC 60601-2-28:2019 Medical electrical equipment Part 2-28: Particular requirements for the safety and essential performance of ventilators and oxygen concentrators.

    2. ISO 13485:2016 Medical devices Requirements for regulatory purposes.

    3. ASTM F739-19 Standard Test Method for Respiratory Protection Against Cytotoxic Chemicals.

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