EUROLAB
iso-13355-shock-and-vibration-resistance-of-medical-devices
Vibration and Shock Testing ASTM D1876 Peel Resistance Testing under VibrationASTM D2444 Abrasion Resistance under Dynamic LoadASTM D256 Impact Resistance of PlasticsASTM D2794 Impact Resistance of CoatingsASTM D3359 Adhesion Testing under Dynamic LoadsASTM D3574 Dynamic Mechanical Analysis of FoamASTM D4052 Mechanical Vibration and Shock AnalysisASTM D4169 Performance Testing of Shipping Containers by VibrationASTM D5116 Shock and Vibration Testing of PackagingASTM D522 Impact Testing of Coatings on SubstratesASTM D7028 Compression and Impact Testing of PolymersASTM D7136 Impact and Shock Resistance of CompositesASTM D7137 Compression and Shock Testing of MaterialsASTM D999 Mechanical Shock Testing of Shipping ContainersASTM E756 Vibration Testing and InstrumentationASTM F1264 Dynamic Load Testing of Medical DevicesASTM F2330 Vibration Testing of Medical DevicesASTM F2503 Vibration Analysis of Medical DevicesASTM F2792 Vibration Endurance of Medical Device ComponentsASTM F2817 Shock Testing of Electronic ComponentsASTM F2978 Dynamic Mechanical Testing of Medical MaterialsASTM F3001 Vibration Testing of ImplantsIEC 60068-2-14 Shock Testing ProceduresIEC 60068-2-27 Shock Resistance TestIEC 60068-2-27 Shock TestingIEC 60068-2-29 Impact Testing ProceduresIEC 60068-2-6 Vibration (Sinusoidal) TestingIEC 60068-2-64 Random Vibration TestingIEC 60068-2-64 Vibration (Broadband Random) TestingIEC 60512 Functional Electrical Testing after VibrationIEC 60529 Protection against Environmental Vibration (IP Codes)IEC 60529 Vibration Protection for EquipmentIEC 60601-1-11 Vibration in Medical Electrical EquipmentIEC 60721 Classification of Environmental ConditionsIEC 60721-3-6 Classification of Environmental ConditionsIEC 61373 Railway Equipment Shock TestingIEC 61373 Shock and Vibration Testing for Railway ApplicationsIEC 61373-1 Shock and Vibration Test Methods for RailwayISO 10816 Mechanical Vibration - Evaluation of Machine VibrationISO 10816-1 Vibration Measurement ProceduresISO 10816-3 Vibration Severity for Rotating MachineryISO 10993-12 Sample Preparation for Mechanical TestingISO 11210 Mechanical Shock Testing of EquipmentISO 13355 Environmental Shock Testing of EquipmentISO 13355 Shock Resistance Testing of Electronic EquipmentISO 15614 Mechanical Shock Performance of AssembliesISO 16750-3 Environmental Conditions and Testing for Electrical EquipmentISO 16750-4 Mechanical Vibration and ShockISO 178 Dynamic Mechanical Properties of PlasticsISO 178 Mechanical Properties of Plastics Under ShockISO 21920-1 Mechanical Shock Test MethodsISO 21920-2 Mechanical Shock TestingISO 2631 Human Exposure to Whole Body VibrationISO 2631-1 Mechanical Vibration and Shock Effects on HumansISO 5348 Shock Testing of ElectronicsISO 5349 Measurement and Evaluation of Vibration ExposureMIL-STD-167 Vibration and Shock Testing of EquipmentMIL-STD-167-1 Vibration Testing of EquipmentMIL-STD-810F Transportation Vibration and Shock TestingMIL-STD-810G Environmental Engineering Considerations and Laboratory TestsMIL-STD-810H Environmental Vibration Testing

Complete Guide to ISO 13355 Shock and Vibration Resistance of Medical Devices Laboratory Testing Service Provided by Eurolab

ISO 13355 is an international standard that specifies the requirements for testing the shock and vibration resistance of medical devices. The standard is developed by the International Organization for Standardization (ISO) in collaboration with other standard development organizations, including the European Committee for Electrotechnical Standardization (CENELEC) and the American Society for Testing and Materials (ASTM).

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 13355 testing is governed by various national and international regulations. In the European Union, the Medical Device Regulation (MDR) requires medical devices to comply with the essential requirements of the Directive on the Safety Assessment of Medical Devices (93/42/EEC). Similarly, in the United States, the FDAs Code of Federal Regulations (21 CFR Part 800) governs the testing and certification of medical devices.

International and National Standards

The following international and national standards apply to ISO 13355 shock and vibration resistance testing:

  • ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes

  • EN 60601-1:2006A12:2015 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance

  • ASTM F1500.1-16 Standard Practice for Design, Testing, and Labeling of Portable Electronic Devices Used in Medical Settings

    • Standard Development Organizations

    The following standard development organizations play a crucial role in the development and maintenance of ISO 13355:

  • International Organization for Standardization (ISO)

  • European Committee for Electrotechnical Standardization (CENELEC)

  • American Society for Testing and Materials (ASTM)

    • Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulatory requirements, and industry practices. The ISO 13355 standard is reviewed and updated regularly to ensure that it remains relevant and effective.

    Standard Numbers and Scope

    The following standard numbers and scope are relevant to ISO 13355 shock and vibration resistance testing:

  • ISO 13355:2015 Medical Devices Requirements for the validation and verification of the clinical performance of medical devices

  • EN 60601-1:2006A12:2015 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance

    • Standard Compliance Requirements

    Compliance with ISO 13355 is mandatory for all medical device manufacturers, distributors, and importers. The standard requires that medical devices be designed and tested to withstand the rigors of transportation, storage, and use.

    Business and Technical Reasons for Conducting ISO 13355 Testing

    Conducting ISO 13355 testing is essential for ensuring the safety and efficacy of medical devices. The business and technical reasons for conducting this test include:

  • Ensuring compliance with regulatory requirements

  • Validating and verifying clinical performance

  • Reducing risk and liability

  • Improving product quality and reliability

  • Enhancing market access and competitiveness

    • Consequences of Not Performing ISO 13355 Testing

    Failure to conduct ISO 13355 testing can result in severe consequences, including:

  • Regulatory non-compliance

  • Product recall or ban

  • Damage to reputation and brand image

  • Financial losses and liabilities

    • Industries and Sectors Requiring ISO 13355 Testing

    ISO 13355 testing is required for medical devices used in various industries and sectors, including:

  • Medical device manufacturing

  • Healthcare services

  • Pharmaceutical industry

  • Biotechnology sector

    • Risk Factors and Safety Implications

    The risk factors associated with non-compliance to ISO 13355 include:

  • Product failure or malfunction

  • Patient harm or injury

  • Financial losses and liabilities

  • Damage to reputation and brand image

    • Quality Assurance and Quality Control Aspects

    Quality assurance and quality control are critical aspects of ISO 13355 testing. The following measures can be taken to ensure compliance with the standard:

  • Implementing a quality management system (QMS)

  • Conducting regular internal audits and assessments

  • Maintaining accurate records and documentation

  • Ensuring that personnel are trained and qualified

    • Contributing to Product Safety and Reliability

    ISO 13355 testing contributes significantly to product safety and reliability by ensuring that medical devices meet the required standards for shock and vibration resistance.

    Competitive Advantages of Having ISO 13355 Testing Performed

    Conducting ISO 13355 testing can provide significant competitive advantages, including:

  • Improved market access and competitiveness

  • Enhanced brand image and reputation

  • Increased customer confidence and trust

  • Reduced risk and liability

    • Cost-Benefit Analysis of Performing ISO 13355 Testing

    The cost-benefit analysis of performing ISO 13355 testing is as follows:

  • Benefits: improved product safety, reduced risk, enhanced market access, increased customer confidence

  • Costs: testing costs, personnel training and certification, quality management system implementation

    • Complete Guide to ISO 13355 Shock and Vibration Resistance Testing

    ISO 13355 is an international standard that specifies the requirements for testing the shock and vibration resistance of medical devices. The standard is developed by the International Organization for Standardization (ISO) in collaboration with other standard development organizations, including the European Committee for Electrotechnical Standardization (CENELEC) and the American Society for Testing and Materials (ASTM).

    Business and Technical Reasons for Conducting ISO 13355 Testing

    Conducting ISO 13355 testing is essential for ensuring the safety and efficacy of medical devices. The business and technical reasons for conducting this test include:

  • Ensuring compliance with regulatory requirements

  • Validating and verifying clinical performance

  • Reducing risk and liability

  • Improving product quality and reliability

  • Enhancing market access and competitiveness

    • Consequences of Not Performing ISO 13355 Testing

    Failure to conduct ISO 13355 testing can result in severe consequences, including:

  • Regulatory non-compliance

  • Product recall or ban

  • Damage to reputation and brand image

  • Financial losses and liabilities

    • Industries and Sectors Requiring ISO 13355 Testing

    ISO 13355 testing is required for medical devices used in various industries and sectors, including:

  • Medical device manufacturing

  • Healthcare services

  • Pharmaceutical industry

  • Biotechnology sector

    • Risk Factors and Safety Implications

    The risk factors associated with non-compliance to ISO 13355 include:

  • Product failure or malfunction

  • Patient harm or injury

  • Financial losses and liabilities

  • Damage to reputation and brand image

    • Quality Assurance and Quality Control Aspects

    Quality assurance and quality control are critical aspects of ISO 13355 testing. The following measures can be taken to ensure compliance with the standard:

  • Implementing a quality management system (QMS)

  • Conducting regular internal audits and assessments

  • Maintaining accurate records and documentation

  • Ensuring that personnel are trained and qualified

    • Contributing to Product Safety and Reliability

    ISO 13355 testing contributes significantly to product safety and reliability by ensuring that medical devices meet the required standards for shock and vibration resistance.

    Competitive Advantages of Having ISO 13355 Testing Performed

    Conducting ISO 13355 testing can provide significant competitive advantages, including:

  • Improved market access and competitiveness

  • Enhanced brand image and reputation

  • Increased customer confidence and trust

  • Reduced risk and liability

    • Cost-Benefit Analysis of Performing ISO 13355 Testing

    The cost-benefit analysis of performing ISO 13355 testing is as follows:

  • Benefits: improved product safety, reduced risk, enhanced market access, increased customer confidence

  • Costs: testing costs, personnel training and certification, quality management system implementation

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers