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iso-11070-mechanical-validation-for-sterility-packaging
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 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 Mechanical Safety RequirementsISO 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

Comprehensive Guide to ISO 11070 Mechanical Validation for Sterility Packaging Testing Services

ISO 11070 is a standard developed by the International Organization for Standardization (ISO) that outlines the requirements for mechanical validation of sterility packaging. This standard is essential for ensuring the safety and efficacy of medical devices, pharmaceuticals, and other products packaged in sterile containers.

Legal and Regulatory Framework

The ISO 11070 standard is governed by various international and national regulations. In the European Union, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) mandate compliance with this standard for medical devices and IVDs, respectively. Similarly, in the United States, the FDA requires manufacturers to follow ISO 11070 for packaging validation of sterile products.

International and National Standards

The following standards are relevant to ISO 11070:

  • ISO 11607:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

  • ISO 11140-2:2007 Sterilization of surgical instruments and equipment - Part 2: Requirements for validation and routine testing

  • EN 868-5:2020 Sterilization indicators - Part 5: Packaging requirements

  • TSE (Turkish Standards Institution) TR CSN/EN 11607:2016

    • Standard Development Organizations

    The ISO 11070 standard is developed by the Technical Committee 198 (TC 198) on Implantable and external active implantable medical devices, in collaboration with other international organizations.

    Standards Evolution and Updates

    ISO standards are periodically reviewed and updated to reflect changes in technology, regulations, and industry practices. The latest version of ISO 11070 is 2019, which includes new requirements for packaging validation and testing.

    Standard Compliance Requirements

    Compliance with ISO 11070 is mandatory for various industries, including:

  • Medical devices

  • Pharmaceuticals

  • Biotechnology

  • Food packaging

  • Cosmetic packaging

    • Failure to comply with this standard can result in product recalls, regulatory penalties, and damage to a companys reputation.

    Standard-Related Organizations and Partnerships

    Eurolab is an accredited laboratory that collaborates with industry associations, such as the International Organization for Standardization (ISO), the European Federation of National Associations of Manufacturers of Medical Equipment (EUNMME), and the American Society for Testing and Materials (ASTM).

    Why This Test Should Be Performed

    Performing ISO 11070 mechanical validation is essential to ensure:

  • Product safety and efficacy

  • Regulatory compliance

  • Quality assurance and quality control

  • Customer confidence and trust building

  • International market access and trade facilitation

    • This test also contributes to reducing risks, costs, and environmental impacts associated with product packaging.

    Why Eurolab Should Provide This Service

    Eurolab offers the following advantages:

  • Expertise and experience in ISO 11070 testing

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

    • The ISO 11070 mechanical validation test involves the following steps:

    1. Sample preparation

    2. Testing equipment and instruments calibration

    3. Testing environment setup

    4. Sample testing

    5. Data analysis and interpretation

    Testing Equipment and Instruments

    Eurolab uses advanced equipment, such as:

  • Torsion testers (e.g., Instron 4500)

  • Compression testers (e.g., MTS 810)

  • Environmental chambers (e.g., Climastat SLM-15)

    • Testing Environment Requirements

    The testing environment must be controlled to ensure accurate results. Temperature, humidity, and pressure requirements are specified in the ISO 11070 standard.

    Sample Preparation Procedures

    Samples are prepared according to the standards requirements, including packaging material selection and sample sizing.

    Testing Parameters and Conditions

    Eurolab follows the standards testing parameters and conditions, including:

  • Torsion force

  • Compression force

  • Environmental conditions

    • Measurement and Analysis Methods

    Results are measured and analyzed using specialized software (e.g., Bluehill 3) to determine packaging performance.

    Calibration and Validation Procedures

    Equipment is calibrated and validated according to the standards requirements.

    Quality Control Measures During Testing

    Eurolab maintains quality control measures, such as:

  • Operator training

  • Equipment maintenance

  • Data validation

    • Data Collection and Recording Procedures

    Results are documented and recorded electronically.

    Testing Timeframes and Duration

    The testing duration is specified in the ISO 11070 standard (e.g., 5-10 minutes).

    Sample Size Requirements and Statistical Considerations

    The sample size requirements are specified in the standard, taking into account statistical considerations to ensure reliable results.

    Eurolabs test reports include:

  • Test summary

  • Results

  • Conclusions

  • Recommendations

    • Why Choose Eurolab for ISO 11070 Testing

    Eurolab offers a comprehensive testing service, including:

  • Expertise in packaging validation

  • State-of-the-art equipment and facilities

  • Accreditation and certification details

  • International recognition and partnerships

    • By partnering with Eurolab, companies can ensure compliance with regulatory requirements, product safety, and quality assurance.

    Conclusion

    ISO 11070 mechanical validation is essential for ensuring the safety and efficacy of packaged products. By following this standard, manufacturers can reduce risks, costs, and environmental impacts associated with packaging. Eurolab offers a comprehensive testing service that includes expertise in packaging validation, state-of-the-art equipment and facilities, accreditation and certification details, and international recognition and partnerships.

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