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en-iso-10993-18-chemical-characterization-for-dermal-safety
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6125 Evaluation of Skin Sensitization Using In Vitro ModelsASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance for Dermatological Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716 Good Manufacturing Practices for Dermatological ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionISO/TR 29622 Allergens in Cosmetics and Personal Care ProductsJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Evaluation of Skin Irritation for Topical Dosage FormsUSP <151> Skin Sensitization Studies in Pharmaceuticals

EN ISO 10993-18 Chemical Characterization for Dermal Safety Laboratory Testing Service: A Comprehensive Guide

EN ISO 10993-18 is a standard that specifies the requirements for chemical characterization of medical devices and materials intended to come into contact with the skin. This standard is part of the ISO 10993 series, which provides guidelines for biocompatibility testing of medical devices.

The legal and regulatory framework surrounding this testing service is governed by various international and national standards. In the European Union (EU), the Medical Device Regulation (MDR) requires manufacturers to perform biocompatibility testing on their products before they can be placed on the market. The EUs MDR is aligned with the ISO 10993 series, including EN ISO 10993-18.

In the United States, the Food and Drug Administration (FDA) regulates medical devices under the Federal Food, Drug, and Cosmetic Act (FDC Act). The FDA requires manufacturers to perform biocompatibility testing on their products before they can be cleared for market. The FDAs guidance document, Use of International Standard ISO 10993-1:2018, recommends that manufacturers follow the ISO 10993 series, including EN ISO 10993-18.

The international and national standards that apply to this specific laboratory test include:

  • ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)

  • ISO 10993-2:2006 (Biological evaluation of medical devices - Part 2: Guidance on selection of tests for interaction with blood)

  • EN ISO 10993-18:2020 (Chemical characterization of materials intended to come into contact with the skin)

  • ASTM F748-17 (Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices)

    • Standard development organizations, such as the International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM), play a crucial role in developing and maintaining standards. These organizations ensure that standards are updated regularly to reflect new scientific knowledge and technological advancements.

    EN ISO 10993-18 is essential for manufacturers who produce medical devices or materials intended to come into contact with the skin. This standard ensures that these products do not cause adverse reactions or harm to users.

    The business and technical reasons for conducting EN ISO 10993-18 chemical characterization for dermal safety testing include:

  • Ensuring compliance with regulatory requirements

  • Protecting consumers from potential harm

  • Maintaining product reputation and brand image

  • Reducing liability risks

  • Enhancing product safety and reliability

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

  • Product recalls

  • Financial losses due to legal actions

  • Damage to company reputation

  • Decreased consumer confidence

    • Industries that require EN ISO 10993-18 testing include medical device manufacturers, pharmaceutical companies, cosmetics and personal care products, and food packaging.

    Risk factors associated with dermal exposure to chemicals include skin irritation, allergic contact dermatitis, and other adverse reactions. Safety implications can be severe, especially for patients who have compromised immune systems or pre-existing skin conditions.

    Quality assurance and quality control aspects of EN ISO 10993-18 testing involve:

  • Ensuring accuracy and reliability of test results

  • Maintaining calibration and validation of equipment

  • Following standard operating procedures (SOPs) and guidelines

  • Documenting all testing activities

    • This test contributes to product safety and reliability by ensuring that materials intended for dermal contact do not contain harmful chemicals.

    EN ISO 10993-18 chemical characterization for dermal safety testing involves the following steps:

    1. Sample Preparation: Materials are prepared according to standard protocols, including cutting, cleaning, and drying.

    2. Extraction: Chemicals are extracted from the material using solvents or other methods.

    3. Chromatographic Analysis: Extracted chemicals are separated and identified using techniques such as high-performance liquid chromatography (HPLC) or gas chromatography-mass spectrometry (GC-MS).

    4. Mass Spectrometry: Chemicals are detected and quantified using mass spectrometry.

    5. Data Analysis: Test results are analyzed to determine the presence of chemicals, their concentrations, and potential risks.

    The testing equipment and instruments used for EN ISO 10993-18 testing include:

  • HPLC or GC-MS systems

  • Mass spectrometers (e.g., triple quadrupole or Orbitrap)

  • Centrifuges and other laboratory equipment

    • Testing environment requirements include:

  • Temperature control

  • Humidity control

  • Pressure control

  • Ventilation and fume hood access

    • Sample preparation procedures involve:

  • Cutting, cleaning, and drying materials

  • Weighing and homogenizing samples

  • Mixing solvents and chemicals for extraction

    • Data Analysis

    Test results are analyzed using specialized software to determine the presence of chemicals, their concentrations, and potential risks. This includes:

  • Identifying chemical peaks in chromatograms or mass spectra

  • Calculating peak areas or intensities

  • Comparing test results to established limits or thresholds

    • Perspectives and Applications

    EN ISO 10993-18 testing is essential for manufacturers who produce medical devices or materials intended for dermal contact. This standard ensures that these products do not contain harmful chemicals, protecting consumers from potential harm.

    The following perspectives and applications are relevant to EN ISO 10993-18 testing:

  • Regulatory compliance

  • Consumer safety

  • Product reputation and brand image

  • Liability risks

    • By understanding the requirements and methodology for EN ISO 10993-18 chemical characterization for dermal safety testing, manufacturers can ensure that their products meet regulatory standards and protect consumers from potential harm.

    Conclusion

    EN ISO 10993-18 is a critical standard for ensuring the biocompatibility of medical devices and materials intended to come into contact with the skin. Manufacturers must perform this test to comply with regulatory requirements and protect consumers from potential harm. By understanding the requirements, methodology, and applications of EN ISO 10993-18 testing, manufacturers can enhance product safety and reliability while maintaining a strong reputation in the market.

    Recommendations for Further Research

    1. Investigate new methods or techniques for extracting and analyzing chemicals.

    2. Develop standardized protocols for sampling and preparation.

    3. Explore the use of advanced analytical techniques (e.g., machine learning, AI) to improve test accuracy and efficiency.

    By addressing these research areas, manufacturers can further enhance their understanding of EN ISO 10993-18 testing and contribute to the development of safer and more reliable medical devices and materials.

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