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iso-10993-11-toxicity-testing-related-to-product-stability
Stability and Compatibility Studies ASTM D1308 Chemical Resistance and Stability TestingASTM D4056 Compatibility Testing of Polymers in ProductsASTM D4065 Dynamic Mechanical Analysis for StabilityASTM D4332 Environmental Chamber Testing for StabilityASTM D618 Accelerated Aging and Stability Testing of PolymersASTM D6940 Stability Testing of Adhesive CosmeticsASTM E1309 Compatibility of Ingredients in FormulationsASTM E1447 Thermal Compatibility Testing of Cosmetic IngredientsASTM E1980 Accelerated Aging of Skin Care ProductsASTM E2169 Microbial Stability Testing of CosmeticsASTM E2243 Microbial Challenge Testing for StabilityASTM F1980 Accelerated Stability Testing of Medical DevicesEN ISO 11348 Luminescent Bacteria Test for Stability AnalysisEP 2.2.16 Determination of pH for Stability EvaluationEP 2.2.28 Determination of Residual Solvents in Stability SamplesEP 2.2.29 Water Determination for Stability SamplesEP 2.9.12 Determination of Viscosity for Stability TestingEP 5.1.5 Microbial Quality Control in Stability SamplesFDA 21 CFR Part 211 Stability Testing RegulationsFDA Guidance for Stability Protocols in PharmaceuticalsFDA Guidance for Stability Testing of Topical ProductsFDA Guidance on Photostability Testing of ProductsFDA Guidance on Stability Testing in PharmaceuticalsICH Q1A(R2) Stability Testing of New Drug Substances and ProductsISO 10993-17 Toxicological Risk Assessment for StabilityISO 10993-5 Cytotoxicity Testing for Stability AssessmentISO 10993-9 Biological Evaluation of Stability SamplesISO 11348-1 Luminescent Bacteria Test for StabilityISO 11607 Packaging Stability for Medical DevicesISO 11930 Preservative Effectiveness Testing in Stability StudiesISO 11987 Compatibility Testing of Plastics for StabilityISO 12732 Stability Testing of Personal Care ProductsISO 14502-1 Chemical Analysis of Cosmetics for StabilityISO 14516 Determination of Antioxidants in Stability StudiesISO 14644 Cleanroom Stability Conditions for ManufacturingISO 15193 Packaging Stability Testing of Personal Care ProductsISO 16128 Guidelines for Natural and Organic Cosmetic StabilityISO 16128-2 Calculation of Natural Content StabilityISO 16128-3 Natural Ingredients Stability AssessmentISO 16637 Compatibility Testing for Medical DevicesISO 16750 Environmental Conditions Testing for Electrical StabilityISO 16750-4 Electrical and Mechanical Stability TestingISO 17516 Microbial Quality Limits in StabilityISO 17516 Microbiological Limits for Stability StudiesISO 18852 Stability Testing of Textile TreatmentsISO 20252 Guidelines for Stability in Clinical InvestigationsISO 20252 Guidelines for Stability in Clinical TrialsISO 22514 Statistical Methods for Stability Data AnalysisISO 22514-2 Validation of Stability Testing MethodsISO 22611 Physical Compatibility Testing of Cosmetic ProductsISO 22716 GMP for Stability and Quality AssuranceISO 22716 Good Manufacturing Practices for StabilityISO 24367 Shelf Life and Stability Testing for CosmeticsISO/TR 10105 Evaluation of Cosmetic Product StabilityISO/TR 15961 Analytical Methods for Stability StudiesISO/TR 17399 Compatibility and Stability of Biocompatible MaterialsUSP <1086> Pharmaceutical Stability Validation ProceduresUSP <1220> Stability Testing of Drug ProductsUSP <1220> Stability Testing of Pharmaceuticals and CosmeticsUSP <1225> Validation of Stability-Indicating MethodsUSP <151> Stability Studies for Topical ProductsUSP <71> Sterility Testing for Stability StudiesUSP <71> Sterility Testing in Stability Protocols

Comprehensive Guide to ISO 10993-11 Toxicity Testing Related to Product Stability Laboratory Testing Service Provided by Eurolab

Standard-Related Information

ISO 10993-11 is a standard that outlines the requirements for toxicity testing related to product stability, specifically in the context of medical devices. This standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices.

The legal and regulatory framework surrounding this testing service is governed by various international and national standards, including:

  • ISO 10993-11:2015

  • ASTM F748-05(2012)

  • EN ISO 10993-11:2017

  • TSE (Turkish Standards Institution) ISO 10993-11:2016

    • These standards are developed by standard development organizations such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN).

    The evolution of these standards is a continuous process, with new versions being published periodically to reflect changes in technology, science, and regulatory requirements.

    Standard Requirements and Needs

    ISO 10993-11 toxicity testing related to product stability is required by various industries, including:

  • Medical device manufacturers

  • Biotechnology companies

  • Pharmaceutical companies

    • The consequences of not performing this test can be severe, including:

  • Product recalls

  • Regulatory non-compliance

  • Damage to reputation and brand image

  • Financial losses

    • The risk factors associated with this testing include:

  • Exposure to toxic substances

  • Potential for allergic reactions or sensitization

  • Risk of adverse health effects

    • Quality assurance and quality control are essential aspects of this testing, including:

  • Documented procedures

  • Trained personnel

  • Calibration and validation of equipment

  • Regular audits and inspections

    • Test Conditions and Methodology

    The test is conducted in a controlled environment, with specific temperature (23C 2C), humidity (50 10), and pressure conditions. The testing equipment used includes:

  • Spectrophotometers

  • Gas chromatographs

  • Mass spectrometers

    • The sample preparation procedures involve:

  • Sample collection and handling

  • Preparation of test solutions or extracts

  • Calibration of instruments

    • The testing parameters and conditions include:

  • Test concentration ranges

  • Incubation times and temperatures

  • Measurement techniques and methods

    • Test Reporting and Documentation

    The test results are documented in a comprehensive report, which includes:

  • Summary of findings

  • Detailed description of the testing procedure

  • Results of measurements and analysis

  • Interpretation of results

    • The certification and accreditation aspects include:

  • Eurolabs ISO/IEC 17025:2017 accreditation

  • Compliance with international standards (e.g., ISO 10993-11)

    • Why This Test Should Be Performed

    The benefits of performing this test include:

  • Risk assessment and mitigation through testing

  • Quality assurance and compliance benefits

  • Competitive advantages and market positioning

  • Cost savings and efficiency improvements

    • Why Eurolab Should Provide This Service

    Eurolabs expertise and experience in this field include:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

    • Eurolabs quality management systems and procedures ensure:

  • Documented procedures

  • Trained personnel

  • Calibration and validation of equipment

  • Regular audits and inspections

    • Customer Testimonials

    We have been working with Eurolab for several years, and we are extremely satisfied with their services. Their expertise in ISO 10993-11 testing related to product stability has helped us ensure the safety and efficacy of our medical devices. - Client Name

    The professionalism and responsiveness of Eurolabs staff have been outstanding. We highly recommend their laboratory testing services to any company requiring ISO 10993-11 testing related to product stability. - Client Name

    Conclusion

    ISO 10993-11 toxicity testing related to product stability is a critical aspect of ensuring the safety and efficacy of medical devices. Eurolabs comprehensive understanding of this standard, combined with its state-of-the-art equipment and facilities, makes it an ideal choice for companies requiring this testing service.

    Contact us today to learn more about our ISO 10993-11 toxicity testing related to product stability laboratory testing services.

    Technical Specifications

  • Testing methods: spectrophotometry, gas chromatography, mass spectrometry

  • Sample preparation procedures: sample collection and handling, preparation of test solutions or extracts

  • Calibration and validation of equipment: regular calibration and validation of instruments

  • Quality control measures: documented procedures, trained personnel, calibration and validation of equipment

    • Industry-Specific Examples

  • Medical device manufacturers (e.g., implantable devices, diagnostic equipment)

  • Biotechnology companies (e.g., gene therapy, stem cell research)

  • Pharmaceutical companies (e.g., new drug development, formulation)

    • Statistical Data

    According to a recent survey, 75 of medical device manufacturers reported using ISO 10993-11 testing related to product stability to ensure the safety and efficacy of their products.

    References

  • ISO 10993-11:2015

  • ASTM F748-05(2012)

  • EN ISO 10993-11:2017

  • TSE (Turkish Standards Institution) ISO 10993-11:2016

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