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iso-10993-34-evaluation-of-chemical-residues
Biocompatibility Testing ASTM F1609 Evaluation of Surface ContaminationASTM F1904 Protein Adsorption TestingASTM F1980 Accelerated Aging of Medical DevicesASTM F2027 Cytotoxicity EvaluationASTM F2028 Evaluation of Sterilization ResidualsASTM F2052 Magnetically Induced DisplacementASTM F2080 Durability TestingASTM F2095 Evaluation of Additives in Medical PolymersASTM F2096 Particulate TestingASTM F2100 Medical Mask TestingASTM F2130 Endotoxin TestingASTM F2149 Antimicrobial Activity TestingASTM F2180 Sterilization Validation for HydrogelsASTM F2182 RF Induced Heating TestsASTM F2213 Evaluation of Magnetic Resonance CompatibilityASTM F2255 Acute Systemic ToxicityASTM F2273 Cytokine AnalysisASTM F2392 Implant Wear Debris AnalysisASTM F2458 Biofilm Formation TestingASTM F2459 Adhesion of Medical Device CoatingsASTM F2478 Safety Evaluation of PolymersASTM F2503 MR Safety LabelingASTM F2900 Testing of BiopolymersASTM F2941 Shelf Life TestingASTM F640 Extraction of Medical DevicesASTM F748 Evaluation of Medical Device BiocompatibilityASTM F756 Assessment of Hemolytic PropertiesEN ISO 10993-1 Biological Evaluation – Part 1EN ISO 10993-10 Sensitization TestingEN ISO 10993-11 Systemic ToxicityEN ISO 10993-5 Cytotoxicity TestingIEC 60601-1 Safety Requirements for Medical Electrical EquipmentISO 10993-1 Biological Evaluation of Medical DevicesISO 10993-10 Sensitization TestingISO 10993-11 Systemic Toxicity TestingISO 10993-12 Sample Preparation and Reference MaterialsISO 10993-13 Identification and Quantification of Degradation ProductsISO 10993-14 Degradation TestingISO 10993-15 Toxicokinetic StudyISO 10993-16 Toxicokinetic Study ProtocolISO 10993-17 Establishing Allowable LimitsISO 10993-18 Chemical Characterization TechniquesISO 10993-19 Biodegradation TestingISO 10993-2 Animal Welfare RequirementsISO 10993-20 Toxicology Data AnalysisISO 10993-21 Evaluation of Metals and AlloysISO 10993-22 Irradiation of Medical DevicesISO 10993-23 Biological Evaluation of ResidualsISO 10993-24 Toxicological Risk AssessmentISO 10993-25 Genotoxicity in Medical DevicesISO 10993-26 Immunotoxicology TestingISO 10993-27 Implant Material CharacterizationISO 10993-28 Evaluation of Metallic ImplantsISO 10993-29 Extraction ConditionsISO 10993-3 Genotoxicity TestingISO 10993-30 Analytical TechniquesISO 10993-31 Mutagenicity TestingISO 10993-32 Toxicity Tests for Medical PolymersISO 10993-33 Biological Evaluation of Degradation ProductsISO 10993-35 Assessment of Extractables and LeachablesISO 10993-36 Nonclinical Safety EvaluationISO 10993-37 Evaluation of Cytokine ReleaseISO 10993-38 Endocrine Disruption TestingISO 10993-39 Evaluation of Material ExtractsISO 10993-4 Hemocompatibility TestingISO 10993-40 Evaluation of HemocompatibilityISO 10993-41 Toxicological Risk Assessment FrameworkISO 10993-42 Assessment of NanomaterialsISO 10993-5 Cytotoxicity TestingISO 10993-6 Local Effects after ImplantationISO 10993-7 Ethylene Oxide ResidualsISO 10993-9 Chemical CharacterizationISO 11135 Ethylene Oxide SterilizationISO 11137 Radiation SterilizationISO 11607 Packaging for Terminally Sterilized DevicesISO 11607-1 Packaging ValidationISO 11607-2 Packaging MaterialsISO 11607-3 Packaging TestingISO 11737-1 Sterilization ValidationISO 11737-2 Microbial Limit TestsISO 11737-3 Bioburden DeterminationISO 13408 Aseptic ProcessingISO 13408-1 Cleanroom TestingISO 13408-2 Aseptic Processing ValidationISO 13485 Quality Management Systems for Medical DevicesISO 13485 Risk Management IntegrationISO 13485-1 Quality System RequirementsISO 14117 Pulse Oximeter PerformanceISO 14155 Clinical Investigation StandardsISO 14155-1 Clinical Trial DesignISO 14155-2 Clinical Trial ConductISO 14160 Biocompatibility for Transfusion EquipmentISO 14161 Sterilization by Ethylene OxideISO 14161 Validation of Sterilization ProcessesISO 14630 Non-active Surgical ImplantsISO 14644 Cleanroom StandardsISO 14708 Active Implantable Medical DevicesISO 14708-3 Active Implantable Device TestingISO 14708-4 Implantable Device SafetyISO 14969 Quality Management for Sterile DevicesISO 14971 Risk Management DocumentationISO 14971 Risk Management for Medical DevicesISO 14971-2 Risk Management ReportingISO 15223 Medical Device SymbolsISO 17025 Testing Laboratory AccreditationISO 18113 Medical Device LabelingISO 18562 Biocompatibility of Breathing Gas PathwaysISO 22442 Medical Device Material TestingISO 25539 Cardiovascular ImplantsISO 25539-2 Coronary StentsISO 7405 Evaluation of Biocompatibility for DentistryISO 80369 Small-Bore ConnectorsUSP <87> Biological Reactivity TestsUSP <88> Tests for Plastic Materials

Comprehensive Guide to ISO 10993-34 Evaluation of Chemical Residues Testing Services by Eurolab

The ISO 10993 series is a collection of international standards that cover the biological evaluation of medical devices. The ISO 10993-34 standard specifically deals with the evaluation of chemical residues in materials used in medical devices. This standard provides guidelines for testing the extraction and analysis of chemicals from materials, which is essential for ensuring the safety and efficacy of medical devices.

The legal and regulatory framework surrounding this testing service is governed by various national and international standards. In the European Union, the Medical Devices Regulation (MDR) 2017/745 requires manufacturers to conduct biological evaluation in accordance with ISO 10993-1, which includes the use of ISO 10993-34 for chemical residue testing.

Internationally, the ISO 10993 series is widely recognized and adopted by regulatory authorities. The US FDA, for example, accepts data from ISO 10993-34 tests as part of the biocompatibility evaluation process for medical devices.

Standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Standardization (CEN) play a crucial role in developing and updating standards. These organizations work together to ensure that standards are aligned and harmonized across regions and industries.

The ISO 10993-34 standard has undergone revisions over the years, with the latest version being published in 2017. This revision introduced new testing methods and updated the requirements for chemical residue analysis.

In terms of compliance requirements, medical device manufacturers must adhere to the relevant national and international standards. For example, in Europe, devices must comply with the MDR, while in the US, they must meet FDA regulations.

The ISO 10993-34 Evaluation of Chemical Residues testing is a critical component of medical device safety and efficacy evaluation. This test ensures that materials used in medical devices do not leach chemicals that can cause adverse reactions or interactions with the human body.

Business and technical reasons for conducting this test include:

  • Ensuring product safety and efficacy

  • Compliance with regulatory requirements

  • Protecting consumers from potential harm

  • Maintaining brand reputation and integrity

  • Enhancing market competitiveness

    • Consequences of not performing this test include:

  • Non-compliance with regulations

  • Product recalls or bans

  • Damage to brand reputation

  • Financial losses due to litigation or settlements

  • Loss of customer trust and loyalty

    • Industries that require ISO 10993-34 Evaluation of Chemical Residues testing include medical device manufacturers, pharmaceutical companies, and biotechnology firms.

    Risk factors and safety implications associated with this test include:

  • Leaching of chemicals from materials into the human body

  • Adverse reactions or interactions with the human body

  • Cancer, reproductive toxicity, or other health hazards

  • Impact on product safety and efficacy

    • Quality assurance and quality control aspects of this test include:

  • Ensuring accuracy and reliability of test results

  • Maintaining calibration and validation of testing equipment

  • Implementing robust sample preparation procedures

  • Adhering to regulatory requirements and industry standards

    • This test contributes significantly to product safety and reliability by identifying potential chemical residues that can cause harm. Competitive advantages of having this testing performed include:

  • Enhanced brand reputation and integrity

  • Compliance with regulatory requirements

  • Protection from financial losses due to litigation or settlements

  • Improved market competitiveness

    • Cost-benefit analysis of performing this test includes:

  • Reduced costs associated with product recalls or bans

  • Prevention of financial losses due to litigation or settlements

  • Enhanced customer trust and loyalty

  • Improved brand reputation and integrity

    • The ISO 10993-34 Evaluation of Chemical Residues testing involves a series of steps, including:

    1. Sample preparation: Materials are extracted using a solvent to release any chemical residues.

    2. Analysis: The extracted chemicals are analyzed using techniques such as gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS).

    3. Data analysis: Results are evaluated and compared against established limits for chemical residues.

    Testing equipment and instruments used include:

  • GC-MS or LC-MS/MS analyzers

  • Sample preparation equipment, such as extractors and concentrators

    • Testing environment requirements include:

  • Temperature control (e.g., 25C 2C)

  • Humidity control (e.g., 60 10)

  • Pressure control (e.g., atmospheric pressure)

    • Sample preparation procedures involve:

  • Extraction of materials using a solvent

  • Concentration of extracted chemicals using techniques such as evaporation or centrifugation

    • Testing parameters and conditions include:

  • Chemicals to be tested (e.g., heavy metals, volatile organic compounds)

  • Limits for chemical residues (e.g., ppm, μg/g)

    • Calibration and validation of testing equipment are crucial to ensure accurate results. This involves:

  • Regular calibration of instruments using certified reference materials

  • Verification of analytical methods against established protocols

    • Conclusion

    The ISO 10993-34 Evaluation of Chemical Residues testing is an essential component of medical device safety and efficacy evaluation. Manufacturers must adhere to regulatory requirements and industry standards to ensure compliance with this standard.

    Eurolab, as a leading provider of laboratory services, offers expert analysis and testing capabilities for the ISO 10993-34 Evaluation of Chemical Residues testing. Our team of experienced scientists and technicians ensures accurate and reliable results using state-of-the-art equipment and analytical techniques.

    By partnering with Eurolab, manufacturers can ensure compliance with regulatory requirements, protect consumers from potential harm, and maintain brand reputation and integrity.

    Further Resources

    For more information on the ISO 10993-34 Evaluation of Chemical Residues testing or to schedule a test, please contact us at insert contact details.

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