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iso-10993-15-identification-of-degradation-products
Chemical Resistance and Material Compatibility Testing ASTM D130 Copper Corrosion TestingASTM D130 Corrosion Testing of MetalsASTM D2240 Hardness Testing of Polymer MaterialsASTM D2240 Hardness Testing Post Chemical ExposureASTM D256 Impact Resistance After Chemical ExposureASTM D257 Electrical Resistivity Post Chemical ExposureASTM D2765 Thermal Analysis After Chemical ExposureASTM D3359 Adhesion of Coatings Post Chemical ExposureASTM D3359 Adhesion Testing After Chemical ExposureASTM D3762 Abrasion Resistance Post Chemical ExposureASTM D3985 Oxygen Transmission Rate After Chemical ExposureASTM D4216 Chemical Resistance of PolypropyleneASTM D471 Swelling Resistance in LiquidsASTM D4727 Resistance of Rubber to ChemicalsASTM D522 Flexibility Post Chemical ExposureASTM D543 Chemical Resistance of PlasticsASTM D543 Resistance of Plastics to Chemical ReagentsASTM D543-14 Chemical Resistance of Plastics and ElastomersASTM D570 Water Absorption of PlasticsASTM D570 Water Absorption of Polymer SamplesASTM D638 Tensile Properties After Chemical TreatmentASTM D638 Tensile Testing of Chemical-Exposed SamplesASTM D638 Tensile Testing Post Chemical ExposureASTM D648 Heat Deflection Temperature After Chemical ExposureASTM D7338 Chemical Resistance of PolyethyleneASTM D746 Low Temperature Impact Post Chemical ExposureASTM D7569 Resistance to Chemical ExposureASTM D792 Density of Plastics After Chemical ExposureASTM D882 Tensile Properties of Thin Plastic SheetingASTM E96 Water Vapor Transmission Post Chemical ExposureASTM F1515 Chemical Resistance of Medical PlasticsASTM F1522 Resistance to Chemicals in Medical DevicesASTM F1874 Chemical Resistance of ElastomersASTM F2026 Chemical Resistance of Polymeric MaterialsASTM F2028 Chemical Compatibility of Surgical InstrumentsASTM F2033 Chemical Resistance of Medical PolymersASTM F2299 Resistance to Bacterial PenetrationASTM F2397 Chemical Resistance of ElastomersASTM F739 Chemical Permeation TestingASTM F748 Resistance of Polymers to ChemicalsASTM F903 Liquid Penetration ResistanceASTM F904 Chemical Resistance of Polymers in Medical UseISO 10993-1 Biological Evaluation ProcessISO 10993-10 Biological Evaluation of MaterialsISO 10993-10 Irritation Testing Post Chemical ExposureISO 10993-11 Cytotoxicity Testing Post Chemical ExposureISO 10993-12 Chemical Resistance Sample PreparationISO 10993-13 Extraction Methods for Medical DevicesISO 10993-14 Degradation Products in Medical MaterialsISO 10993-16 Toxicokinetics of MaterialsISO 10993-17 Toxicological Risk AssessmentISO 10993-18 Chemical Characterization of Medical DevicesISO 10993-19 Chemical Characterization for Medical DevicesISO 10993-2 Animal Welfare Requirements in TestingISO 10993-20 Sensitization TestingISO 10993-21 Evaluation of Degradation ProductsISO 10993-22 Evaluation of Material InteractionISO 10993-23 Assessment of ToxicityISO 10993-24 Evaluation of Extractables and LeachablesISO 10993-25 Material Compatibility ValidationISO 10993-26 Chronic Toxicity TestingISO 10993-27 Immunotoxicology TestingISO 10993-28 Mutagenicity TestingISO 10993-29 Chemical Residue LimitsISO 10993-3 Genotoxicity Testing of Medical MaterialsISO 10993-30 Toxicological Risk AssessmentISO 10993-4 Blood Compatibility TestingISO 10993-4 Hemocompatibility TestingISO 10993-5 In Vitro CytotoxicityISO 10993-6 Local Effects after Chemical ExposureISO 10993-7 Ethylene Oxide Residue LimitsISO 10993-8 Material Compatibility with BloodISO 10993-9 Selection of Tests for Medical MaterialsISO 11135 Material Compatibility in EO SterilizationISO 11135-1 EO Sterilization Material CompatibilityISO 11135-2 EO Sterilization Effects on MaterialsISO 11137 Chemical Resistance of Sterilized DevicesISO 11607 Material Compatibility with SterilizationISO 13485 Material Compatibility RequirementsISO 14644-1 Cleanroom Material CompatibilityISO 14644-3 Cleanroom Material CompatibilityISO 22442 Compatibility of Implants with Biological SystemsISO 22442-2 Biocompatibility TestingISO 22442-3 Evaluation of Material Safety

Comprehensive Guide to ISO 10993-15 Identification of Degradation Products Laboratory Testing Service Provided by Eurolab

Standard-Related Information

ISO 10993-15 is a standard that governs the identification of degradation products in medical devices and materials. This standard is part of the larger ISO 10993 series, which provides guidelines for the biocompatibility evaluation of medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-15 testing is governed by various international and national standards, including:

  • ISO 10993-1:2009 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process)

  • ISO 10993-3:2014 (Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity)

  • EU Medical Device Regulation (EU) 2017/745

  • US FDA CFR 21 Part 810

    • International and National Standards

    The following international and national standards apply to ISO 10993-15 testing:

  • ISO 10993-1:2009 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process)

  • ASTM F739-17 (Standard Test Method for Leaching of Nonvolatile Substances from Plastic Materials by Chemical Extractors)

  • EN ISO 10993-15:2013 (Biological evaluation of medical devices Part 15: Identification of degradation products)

    • Standard Development Organizations

    The following standard development organizations are involved in the development and maintenance of ISO 10993-15:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time to reflect changing regulations, new technologies, and emerging risks. The ISO 10993 series is regularly updated to ensure that it remains relevant and effective.

    Standard Numbers and Scope

    The following standard numbers and scope apply to ISO 10993-15 testing:

  • ISO 10993-1:2009 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process)

    • Scope: Evaluates the biological safety of medical devices

  • ISO 10993-3:2014 (Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity)

    • Scope: Evaluates the potential health risks associated with genetic mutations, cancer, and reproductive effects

  • EN ISO 10993-15:2013 (Biological evaluation of medical devices Part 15: Identification of degradation products)

    • Scope: Identifies degradation products in medical devices

    Standard Compliance Requirements

    Compliance with ISO 10993-15 is required for the following industries:

  • Medical device manufacturers

  • Material suppliers

  • Regulators and government agencies

    • The following sections provide additional information on standard-related topics:

    Standard Development Process

    The standard development process involves several steps, including:

    1. Proposal submission: A proposal is submitted to the relevant standards organization for consideration.

    2. Drafting committee formation: A drafting committee is formed to develop a draft of the standard.

    3. Review and comment: The draft is reviewed and commented on by experts from various stakeholders.

    4. Balloting: A vote is taken among members of the standards organization to determine whether the standard should be adopted.

    5. Publication: If the standard is approved, it is published for public use.

    Standard Revision Process

    Standards are revised periodically to reflect changing regulations, new technologies, and emerging risks. The revision process involves:

    1. Review of existing standards

    2. Identification of areas for improvement

    3. Drafting a revised version of the standard

    4. Review and comment on the draft

    5. Balloting and publication

    Standard Maintenance Process

    Standards are regularly reviewed and updated to ensure that they remain relevant and effective. The maintenance process involves:

    1. Periodic review of existing standards

    2. Identification of areas for improvement

    3. Drafting revised versions of the standard

    4. Review and comment on the draft

    5. Balloting and publication

    Standard Requirements and Needs

    Business and Technical Reasons for Conducting ISO 10993-15 Testing

    The business and technical reasons for conducting ISO 10993-15 testing include:

  • Compliance with regulations: ISO 10993-15 is a regulatory requirement for medical device manufacturers.

  • Ensuring product safety: ISO 10993-15 helps to identify potential health risks associated with degradation products.

  • Maintaining market position: Companies that comply with ISO 10993-15 are more likely to maintain their market position.

    • Consequences of Not Performing ISO 10993-15 Testing

    The consequences of not performing ISO 10993-15 testing include:

  • Non-compliance with regulations

  • Potential health risks associated with degradation products

  • Damage to reputation and market position

    • Market Positioning

    Companies that comply with ISO 10993-15 are more likely to maintain their market position. Compliance with ISO 10993-15 demonstrates a commitment to product safety and regulatory compliance.

    The following sections provide additional information on standard requirements and needs:

    Regulatory Framework

    The regulatory framework surrounding ISO 10993-15 testing is governed by various international and national standards, including:

  • EU Medical Device Regulation (EU) 2017/745

  • US FDA CFR 21 Part 810

    • Standard Compliance Requirements

    Compliance with ISO 10993-15 is required for the following industries:

  • Medical device manufacturers

  • Material suppliers

  • Regulators and government agencies

    • The following sections provide additional information on standard requirements and needs:

    The regulatory framework surrounding ISO 10993-15 testing includes various regulations and guidelines, including:

  • EU Medical Device Regulation (EU) 2017/745

  • US FDA CFR 21 Part 810

    • The following sections provide additional information on standard requirements and needs:

    Compliance with ISO 10993-15 is required for the following industries:

  • Medical device manufacturers

  • Material suppliers

  • Regulators and government agencies

    • Test Methods

    ISO 10993-15 testing involves several test methods, including:

  • In vitro tests: Test methods that are performed in a laboratory setting.

  • In vivo tests: Test methods that are performed on animals or humans.

    • Validity and Reliability of Test Results

    The validity and reliability of test results depend on various factors, including:

  • Test method selection

  • Sample preparation

  • Data analysis

    • The following sections provide additional information on test methods:

    In Vitro Tests

    In vitro tests are performed in a laboratory setting. Examples of in vitro tests include:

  • Cell culture tests: Test methods that involve culturing cells.

  • Enzyme-linked immunosorbent assay (ELISA) tests: Test methods that use antibodies to detect specific substances.

    • In Vivo Tests

    In vivo tests are performed on animals or humans. Examples of in vivo tests include:

  • Acute toxicity tests: Test methods that assess the acute toxicity of a substance.

  • Chronic toxicity tests: Test methods that assess the chronic toxicity of a substance.

    • The following sections provide additional information on test methods:

    Data Analysis

    Data analysis involves several steps, including:

    1. Data collection

    2. Data processing

    3. Data interpretation

    Interpretation of Results

    The interpretation of results depends on various factors, including:

  • Test method selection

  • Sample preparation

  • Data analysis

    • Conclusion

    In conclusion, ISO 10993-15 testing is an essential requirement for medical device manufacturers and material suppliers. Compliance with ISO 10993-15 helps to ensure product safety and regulatory compliance.

    Recommendations

    Based on the information provided in this guide, we recommend that companies follow these steps:

    1. Familiarize themselves with the standard requirements.

    2. Select a suitable test method.

    3. Prepare samples for testing.

    4. Analyze data and interpret results.

    By following these steps, companies can ensure compliance with ISO 10993-15 and maintain their market position.

    Appendix

    The following appendix provides additional information on standard-related topics:

  • Glossary of terms

  • Acronyms and abbreviations

  • References

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