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iso-14708-mechanical-safety-requirements
Mechanical Strength and Load Testing ASTM F1160 Mechanical Testing of External Fixation DevicesASTM F1264 Mechanical Testing of Endovascular DevicesASTM F1537 Mechanical Testing of Hip ProsthesesASTM F1798 Tensile Testing of Medical TubingASTM F1830 Mechanical Testing of Vascular ProsthesesASTM F1980 Accelerated Aging for Mechanical IntegrityASTM F2052 Evaluation of Magnetic Properties and Mechanical StrengthASTM F2077 Mechanical Testing of Spinal DevicesASTM F2129 Mechanical Fatigue Testing of Endovascular DevicesASTM F2193 Fatigue Testing of Medical DevicesASTM F2193 Mechanical Testing of Metal AlloysASTM F2213 Mechanical Testing of Vascular StentsASTM F2223 Mechanical Testing of Vascular GraftsASTM F2229 Mechanical Testing of Balloon CathetersASTM F2248 Load Testing of Cardiovascular DevicesASTM F2312 Load and Fatigue TestingASTM F2346 Mechanical Testing of StentsASTM F2391 Mechanical Fatigue Testing of DevicesASTM F2503 Mechanical Testing for Implant IdentificationASTM F2516 Mechanical Durability of ImplantsASTM F2633 Mechanical Testing of Bone PlatesASTM F2765 Load Testing of Medical ConnectorsASTM F2783 Mechanical Durability of Polymer ImplantsASTM F2847 Mechanical Testing of Polymer Medical DevicesASTM F2921 Mechanical Testing of Radiopaque MaterialsASTM F2924 Load Testing of Additive Manufactured DevicesASTM F2972 Mechanical Testing of Soft Tissue ImplantsASTM F3001 Mechanical Testing of Silicone ImplantsASTM F382 Flexural and Tensile Testing of ImplantsASTM F382 Flexural Strength Testing of Medical PolymersASTM F382 Mechanical Testing of Polymers in Medical DevicesASTM F543 Mechanical Testing of Orthopedic ScrewsISO 10555 Mechanical Testing of CathetersISO 10993-10 Mechanical Irritation TestingISO 10993-12 Sample Preparation for Mechanical TestsISO 10993-5 Mechanical Effects on CytotoxicityISO 11070 Mechanical Validation for Sterility PackagingISO 11070 Sterility Assurance Including Mechanical StressISO 11073 Mechanical Performance of Patient MonitorsISO 11137 Mechanical Validation for Mechanical LoadISO 11607 Mechanical Performance of PackagingISO 13485 Quality Management for Mechanical TestingISO 14242 Wear Testing of Hip ImplantsISO 14630 Mechanical Testing for Non-Active ImplantsISO 14644 Mechanical Testing in Controlled EnvironmentsISO 14644-1 Cleanroom Mechanical Testing StandardsISO 14644-2 Mechanical Cleanroom TestingISO 14644-3 Mechanical Test Methods for CleanroomsISO 14644-4 Mechanical Monitoring in CleanroomsISO 14644-5 Mechanical Test Protocols for CleanroomsISO 14708-2 Mechanical Requirements for Active ImplantablesISO 14708-3 Mechanical Strength of NeurostimulatorsISO 14731 Mechanical Testing of Orthopedic ImplantsISO 14971 Mechanical Risk ManagementISO 15621 Mechanical Testing of Bone CementISO 16428 Mechanical Testing of Joint ReplacementsISO 16429 Fatigue Testing for Medical ComponentsISO 20417 Load Testing of Surgical InstrumentsISO 25539 Cardiovascular Implants Mechanical TestingISO 25539 Mechanical Testing of Cardiovascular ImplantsISO 25539-2 Stent Mechanical TestingISO 5832 Metallic Implants - Mechanical PropertiesISO 5834 Mechanical Testing of Surgical Sutures

ISO 14708 Mechanical Safety Requirements Laboratory Testing Service: A Comprehensive Guide

ISO 14708 is a globally recognized standard that specifies the mechanical safety requirements for various products, including those used in medical, industrial, and consumer applications. The standard is developed by the International Organization for Standardization (ISO) through a consensus-based process involving experts from around the world.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 14708 testing is based on national and international standards. In the European Union, for example, the Medical Device Regulation (MDR) requires manufacturers to comply with ISO 14708 for certain medical devices. Similarly, in the United States, the FDA requires compliance with ISO 14708 for Class II and III medical devices.

International and National Standards

The following international and national standards apply to ISO 14708 testing:

  • ISO 14708:2012 Mechanical safety of electrosurgical equipment

  • EN 12442-1:2009 Medical sphygmomanometers - Part 1: Requirements for the safety of sphygmomanometers

  • ASTM F1166-18 Standard Specification for Electrically Operated Suction Apparatuses

    • Standard Development Organizations

    The ISO and IEC (International Electrotechnical Commission) are two prominent standard development organizations involved in the development of ISO 14708. These organizations bring together experts from various industries to develop consensus-based standards.

    Standards Evolution and Updates

    Standards evolve over time due to technological advancements, changes in regulations, or new requirements. For example, ISO 14708 was revised in 2012 to include updated safety requirements for electrosurgical equipment. Manufacturers must comply with the latest version of the standard to ensure their products meet the required safety standards.

    Industry-Specific Standard Compliance Requirements

    Manufacturers operating within specific industries must comply with relevant standards related to ISO 14708. For example:

  • Medical device manufacturers: MDR, FDA regulations

  • Industrial equipment manufacturers: IEC, EN, and ISO standards

  • Consumer product manufacturers: UL (Underwriters Laboratories) and ETL (Intertek) certifications

    • Standard Compliance Requirements for Different Industries

    The following table summarizes standard compliance requirements for different industries:

    Industry Relevant Standards

    --- ---

    Medical Devices MDR, FDA regulations, ISO 14708

    Industrial Equipment IEC, EN, ISO standards

    Consumer Products UL (Underwriters Laboratories), ETL (Intertek) certifications

    ISO 14708 testing is essential to ensure the mechanical safety of various products. The consequences of not performing this test can be severe, including:

  • Product recalls due to non-compliance

  • Financial losses due to compliance issues

  • Reputation damage for manufacturers

    • Business and Technical Reasons for Conducting ISO 14708 Testing

    The business and technical reasons for conducting ISO 14708 testing include:

  • Compliance with regulatory requirements

  • Ensuring product safety and reliability

  • Enhancing brand reputation and customer trust

  • Mitigating risk and liability

    • Consequences of Not Performing this Test

    Failure to conduct ISO 14708 testing can lead to:

  • Non-compliance with regulations, resulting in fines or penalties

  • Product recalls due to mechanical safety issues

  • Loss of market access due to non-compliance

  • Damage to brand reputation and customer trust

    • Industries and Sectors Requiring this Testing

    The following industries and sectors require ISO 14708 testing:

  • Medical devices (e.g., electrosurgical equipment, medical imaging equipment)

  • Industrial equipment (e.g., power tools, machinery)

  • Consumer products (e.g., household appliances, electronics)

    • Risk Factors and Safety Implications

    Mechanical safety is a critical concern for various industries. The risk factors associated with mechanical safety include:

  • Injuries or fatalities due to product failure

  • Property damage due to equipment malfunction

  • Financial losses due to compliance issues

    • Quality Assurance and Quality Control Aspects

    ISO 14708 testing involves rigorous quality assurance and control measures, including:

  • Sampling procedures

  • Testing protocols

  • Calibration and validation procedures

  • Data collection and analysis

    • Need help or have a question?
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