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iso-10993-12-chemical-resistance-sample-preparation
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 10993-13 Extraction Methods for Medical DevicesISO 10993-14 Degradation Products in Medical MaterialsISO 10993-15 Identification of Degradation ProductsISO 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

ISO 10993-12 Chemical Resistance Sample Preparation Laboratory Testing Service

Understanding the Importance of this Critical Testing Service

Standard-Related Information

The ISO 10993-12 standard is part of the International Organization for Standardization (ISO) series on biological evaluation of medical devices. This specific standard focuses on the chemical resistance of materials and articles intended for contact with bodily tissues, including blood, urine, and other fluids.

International and National Standards

  • ISO 10993-1:2009(E): Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Inside the Body

  • ISO 10993-12:2012(E): Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials

  • ASTM F739-17: Standard Test Method for Permeation of Liquids Through Solvent-Swollen Elastomeric Materials Using a Diffusion Cell

  • EN ISO 10993-12:2017: Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and publishing international standards. The American Society for Testing and Materials (ASTM) and the European Committee for Standardization (CEN) are also involved in developing standards related to biological evaluation of medical devices.

    Evolution of Standards

    Standards evolve over time as new technologies, materials, and testing methods become available. ISO 10993-12 was revised in 2012 to incorporate changes in test methodology and requirements for sample preparation.

    Standard Compliance Requirements

    Compliance with the relevant standards is essential for medical device manufacturers to demonstrate safety and efficacy. Regulatory agencies, such as the FDA (U.S.), MHRA (UK), and CE Marking (EU), require compliance with these standards before approving or certifying medical devices.

    Industry-Specific Examples

    Medical device manufacturers must comply with ISO 10993-12 when developing products that come into contact with bodily tissues. Examples of such products include:

  • Surgical instruments

  • Implants

  • Diagnostic equipment

  • Wound care dressings

    • Why This Test is Needed and Required

    The chemical resistance test is crucial for ensuring the safety and efficacy of medical devices. If a device fails this test, it can lead to adverse reactions or even injuries to patients.

    Consequences of Not Performing This Test

    Not conducting the chemical resistance test can result in:

  • Device failure

  • Patient injury or death

  • Regulatory non-compliance

  • Loss of reputation and market share

    • Business and Technical Reasons for Conducting ISO 10993-12 Testing

    The primary reasons for conducting this testing are to ensure:

  • Safety and efficacy of medical devices

  • Compliance with regulatory requirements

  • Protection of patients and users

  • Preservation of device performance and lifespan

    • Test Conditions and Methodology

    The test involves exposing samples to various chemicals, such as saline solution, water, or other substances. The samples are then evaluated for their resistance to chemical penetration.

    Step-by-Step Explanation

    1. Sample preparation: Samples are prepared according to the standard requirements.

    2. Testing equipment: Specialized equipment is used to expose the samples to the test chemicals.

    3. Testing environment: Temperature, humidity, and pressure conditions are controlled during testing.

    4. Measurement and analysis: The permeation rate of the chemicals through the samples is measured using various techniques.

    Quality Assurance and Quality Control Measures

    Eurolab follows a quality management system that ensures:

  • Sample preparation and handling

  • Equipment calibration and maintenance

  • Data collection and recording

  • Reporting and documentation

    • Test Reporting and Documentation

    The test report includes:

  • Test parameters and conditions

  • Measurement and analysis methods

  • Calibration and validation procedures

  • Quality control measures during testing

  • Data collection and recording procedures

    • Why This Test Should Be Performed

    Performing the chemical resistance test has numerous benefits, including:

  • Ensuring safety and efficacy of medical devices

  • Compliance with regulatory requirements

  • Protection of patients and users

  • Preservation of device performance and lifespan

  • Competitive advantages in the market

  • Cost savings through reduced recalls and litigation

    • Why Eurolab Should Provide This Service

    Eurolab is well-equipped to provide this testing service due to its:

  • Expertise in biological evaluation of medical devices

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

  • Customer service and support capabilities

    • Conclusion

    ISO 10993-12 chemical resistance sample preparation testing is a critical component of ensuring the safety and efficacy of medical devices. Eurolabs expertise and state-of-the-art equipment make it an ideal choice for this testing service.

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    Appendix

  • Glossary of terms

  • Acronyms used in the article

  • References cited in the article

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