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en-iso-10993-10-assessment-of-skin-irritation
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 10993-18 Chemical Characterization for Dermal SafetyEN 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 10993-10 Assessment of Skin Irritation Laboratory Testing Service: A Comprehensive Guide

EN ISO 10993-10 is a harmonized European Standard that specifies the testing requirements for assessing skin irritation caused by medical devices, including implantable and non-implantable products. This standard is part of the larger EN ISO 10993 series, which provides a comprehensive framework for evaluating the biocompatibility of medical devices.

Legal and Regulatory Framework

The EN ISO 10993-10 standard is based on international standards, including ISO 10993-10 and ASTM F2456-08. It has been adopted by various countries as part of their regulatory frameworks for medical device safety. The European Union (EU) requires that medical devices comply with this standard as part of the EU Medical Device Regulation (MDR).

International and National Standards

The EN ISO 10993-10 standard is an international standard that has been harmonized across multiple countries, including those in the EU, Australia, Canada, Japan, and the United States. The standard has also been adopted by various national standards organizations, such as the American Society for Testing and Materials (ASTM) and the Japanese Industrial Standard Committee (JISC).

Standard Development Organizations

The EN ISO 10993-10 standard was developed by the International Organization for Standardization (ISO), a non-governmental organization that brings together experts from around the world to develop voluntary international standards. The European Committee for Standardization (CEN) is responsible for adopting and publishing the standard in Europe.

Standard Evolution and Update

Standards are constantly evolving as new technologies, materials, and testing methods become available. The EN ISO 10993-10 standard has undergone several revisions since its initial publication in 2002. Each revision aims to reflect advances in medical device technology and improve the accuracy of skin irritation testing.

Standard Numbers and Scope

The EN ISO 10993-10 standard is part of a larger series of standards that cover various aspects of biocompatibility testing. The scope of this standard includes:

  • Skin irritation caused by medical devices

  • Testing methods for assessing skin irritation

  • Evaluation criteria for interpreting test results

    • Industry-Specific Requirements

    Different industries have specific requirements for complying with the EN ISO 10993-10 standard. For example, implantable medical devices require more stringent testing and evaluation compared to non-implantable products.

    Standard Compliance Requirements

    Medical device manufacturers must comply with the EN ISO 10993-10 standard to ensure that their products meet regulatory requirements. This includes:

  • Conducting skin irritation testing in accordance with the standard

  • Interpreting test results correctly

  • Maintaining records of testing and evaluation

    • Consequences of Non-Compliance

    Failure to comply with the EN ISO 10993-10 standard can result in severe consequences, including product recalls, regulatory fines, and reputational damage.

    Why This Test is Needed and Required

    The EN ISO 10993-10 assessment of skin irritation testing is essential for ensuring the safety and efficacy of medical devices. Skin irritation caused by medical devices can lead to serious health complications, including infections, allergic reactions, and tissue damage.

    Business and Technical Reasons for Conducting Testing

    Medical device manufacturers must conduct skin irritation testing as part of their quality assurance and compliance programs. This includes:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Maintaining customer trust and confidence

    • Consequences of Not Performing This Test

    Failure to perform skin irritation testing can result in severe consequences, including:

  • Regulatory non-compliance

  • Product recalls

  • Reputational damage

  • Customer dissatisfaction

    • Industries and Sectors that Require This Testing

    The EN ISO 10993-10 standard applies to various industries and sectors, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Research institutions

    • Risk Factors and Safety Implications

    Skin irritation caused by medical devices can result in serious health complications, including infections, allergic reactions, and tissue damage. Manufacturers must consider the following risk factors when conducting skin irritation testing:

  • Material selection and compatibility

  • Device design and functionality

  • Testing methodology and evaluation criteria

    • Quality Assurance and Quality Control Aspects

    Medical device manufacturers must implement quality assurance and control measures to ensure that their products meet regulatory requirements. This includes:

  • Conducting regular audits and inspections

  • Maintaining records of testing and evaluation

  • Ensuring compliance with regulatory standards

    • Contribution to Product Safety and Reliability

    The EN ISO 10993-10 assessment of skin irritation testing contributes significantly to product safety and reliability by:

  • Identifying potential skin irritation hazards

  • Evaluating the effectiveness of device design and functionality

  • Informing material selection and compatibility decisions

    • Competitive Advantages and Market Positioning

    Conducting skin irritation testing in accordance with the EN ISO 10993-10 standard can provide medical device manufacturers with competitive advantages, including:

  • Improved product safety and efficacy

  • Enhanced customer trust and confidence

  • Regulatory compliance and non-conformity prevention

    • Testing Methods and Evaluation Criteria

    The EN ISO 10993-10 standard specifies various testing methods for assessing skin irritation, including:

  • In vitro tests (e.g., keratinocyte culture)

  • In vivo tests (e.g., patch test, occluded patch test)

  • Interlaboratory comparisons and validation studies

    • Interpretation of Test Results

    Manufacturers must interpret test results correctly to ensure that their products meet regulatory requirements. This includes:

  • Evaluating the severity of skin irritation

  • Determining the likelihood of skin irritation in clinical use

  • Informing design and functionality improvements

    • Testing Laboratories and Equipment

    Medical device manufacturers must select testing laboratories that are accredited to perform skin irritation testing in accordance with the EN ISO 10993-10 standard. Testing equipment, including patch testers and occluded patch testers, must be calibrated and validated regularly.

    Test Specimens and Controls

    Manufacturers must provide test specimens and controls for skin irritation testing, including:

  • Device materials

  • Control materials (e.g., blank or positive control)

  • Validation samples

    • Testing Frequency and Replication

    The EN ISO 10993-10 standard specifies that skin irritation testing should be performed at various stages of device development, including:

  • Design stage

  • Prototyping stage

  • Clinical trial stage

    • Evaluation Criteria and Scoring Systems

    Manufacturers must evaluate test results using established criteria and scoring systems, including:

  • Skin irritation severity scores (e.g., 0-4)

  • Frequency and duration of skin irritation occurrence

    • Quality Assurance and Control Measures

    Medical device manufacturers must implement quality assurance and control measures to ensure that their products meet regulatory requirements. This includes:

  • Regular audits and inspections

  • Maintaining records of testing and evaluation

  • Ensuring compliance with regulatory standards

    • Industry-Specific Requirements

    Different industries have specific requirements for complying with the EN ISO 10993-10 standard. For example, implantable medical devices require more stringent testing and evaluation compared to non-implantable products.

    Consequences of Non-Compliance

    Failure to comply with the EN ISO 10993-10 standard can result in severe consequences, including product recalls, regulatory fines, and reputational damage.

    Biocompatibility Testing

    The EN ISO 10993-10 assessment of skin irritation testing is part of a larger series of biocompatibility tests that evaluate the compatibility of medical devices with the human body. These tests include:

  • Cytotoxicity testing (e.g., MTT assay)

  • Sensitization and irritation testing (e.g., patch test, occluded patch test)

  • Genotoxicity testing (e.g., Ames test)

    • Conclusion

    The EN ISO 10993-10 assessment of skin irritation testing is a critical component of medical device development and regulation. Manufacturers must comply with this standard to ensure that their products meet regulatory requirements and provide safe and effective treatment options for patients.

    Biocompatibility Testing and Evaluation

    The EN ISO 10993-10 assessment of skin irritation testing is part of a larger series of biocompatibility tests that evaluate the compatibility of medical devices with the human body. These tests include:

  • Cytotoxicity testing

  • Sensitization and irritation testing

  • Genotoxicity testing

    • Interpretation of Test Results

    Manufacturers must interpret test results correctly to ensure that their products meet regulatory requirements. This includes:

  • Evaluating the severity of skin irritation

  • Determining the likelihood of skin irritation in clinical use

  • Informing design and functionality improvements

    • Industry-Specific Requirements

    Different industries have specific requirements for complying with the EN ISO 10993-10 standard. For example, implantable medical devices require more stringent testing and evaluation compared to non-implantable products.

    Consequences of Non-Compliance

    Failure to comply with the EN ISO 10993-10 standard can result in severe consequences, including product recalls, regulatory fines, and reputational damage.

    The EN ISO 10993-10 assessment of skin irritation testing is part of a larger series of biocompatibility tests that evaluate the compatibility of medical devices with the human body. These tests include:

  • Cytotoxicity testing

  • Sensitization and irritation testing

  • Genotoxicity testing

    • Test Specimens and Controls

    Manufacturers must provide test specimens and controls for skin irritation testing, including:

  • Device materials

  • Control materials (e.g., blank or positive control)

  • Validation samples

    • Testing Frequency and Replication

    The EN ISO 10993-10 standard specifies that skin irritation testing should be performed at various stages of device development, including:

  • Design stage

  • Prototyping stage

  • Clinical trial stage

    • Evaluation Criteria and Scoring Systems

    Manufacturers must evaluate test results using established criteria and scoring systems, including:

  • Skin irritation severity scores (e.g., 0-4)

  • Frequency and duration of skin irritation occurrence

    • Quality Assurance and Control Measures

    Medical device manufacturers must implement quality assurance and control measures to ensure that their products meet regulatory requirements. This includes:

  • Regular audits and inspections

  • Maintaining records of testing and evaluation

  • Ensuring compliance with regulatory standards

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