EUROLAB
en-iso-10993-21-evaluation-of-skin-irritation-from-medical-device-extracts
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 10993-18 Chemical Characterization for Dermal SafetyEN 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

Evaluation of Skin Irritation from Medical Device Extracts: EN ISO 10993-21 Testing Services

EN ISO 10993-21 is a standard developed by the International Organization for Standardization (ISO) in collaboration with the European Committee for Standardization (CEN). The standard specifies the requirements for evaluating skin irritation from medical device extracts. This testing service is crucial for ensuring the safety and efficacy of medical devices, particularly those that come into contact with human skin.

Legal and Regulatory Framework

The legal and regulatory framework surrounding EN ISO 10993-21 testing is governed by international and national standards. The EUs Medical Device Regulation (MDR) requires manufacturers to perform biocompatibility testing, including skin irritation testing, on their medical devices. The US FDA also recommends that medical device manufacturers conduct skin irritation testing as part of their regulatory compliance.

International and National Standards

EN ISO 10993-21 is an international standard, but it has been adopted by many countries around the world, including the EU, US, Canada, Australia, and Japan. In addition to EN ISO 10993-21, there are other standards that apply to skin irritation testing, such as ASTM F1671 and TSE ISO 10993-21.

Standard Development Organizations

The standard development process involves organizations like ISO, CEN, and ASTM, which work together to develop and maintain international and national standards. These organizations ensure that the standards are updated regularly to reflect changes in technology and regulatory requirements.

How Standards Evolve and Get Updated

Standards evolve through a continuous cycle of review, revision, and update. This process involves stakeholders from various industries, including medical device manufacturers, regulatory bodies, and standard development organizations. The goal is to ensure that the standards remain relevant and effective in addressing emerging issues and technologies.

Standard Numbers and Scope

EN ISO 10993-21 is a specific standard that addresses skin irritation testing for medical devices. The standards scope includes:

  • Evaluation of skin irritation from extracts of medical device materials

  • Testing methods for assessing skin irritation, including patch testing and occlusive patch testing

  • Requirements for sample preparation, testing conditions, and data analysis

    • Standard Compliance Requirements

    Medical device manufacturers must comply with EN ISO 10993-21 as part of their regulatory requirements. The standard is applicable to a wide range of medical devices, including implantable devices, surgical instruments, and wound care products.

    Industries and Sectors that Require this Testing

    The following industries and sectors require skin irritation testing:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

  • Cosmetic manufacturers

    • Risk Factors and Safety Implications

    Skin irritation can be a serious health risk for patients who use medical devices. The consequences of not performing EN ISO 10993-21 testing include:

  • Adverse reactions to medical devices, including skin irritation and allergic contact dermatitis

  • Product recalls and regulatory actions

  • Damage to brand reputation and customer trust

    • Quality Assurance and Quality Control

    EN ISO 10993-21 testing requires a high level of quality assurance and quality control. Manufacturers must ensure that their testing is conducted in accordance with the standards requirements, including:

  • Validation and calibration of testing equipment

  • Training and qualification of testing personnel

  • Maintenance of testing records and documentation

    • Contribution to Product Safety and Reliability

    EN ISO 10993-21 testing contributes significantly to product safety and reliability by:

  • Identifying potential skin irritation risks

  • Ensuring that medical devices meet regulatory requirements

  • Enhancing product quality and performance

    • Competitive Advantages

    Performing EN ISO 10993-21 testing provides manufacturers with several competitive advantages, including:

  • Improved product safety and reputation

  • Enhanced regulatory compliance

  • Increased customer trust and confidence

  • Competitive market positioning

    • Cost-Benefit Analysis

    The cost-benefit analysis of performing EN ISO 10993-21 testing reveals significant benefits for manufacturers, including:

  • Reduced risk of adverse reactions and product recalls

  • Improved brand reputation and customer loyalty

  • Compliance with regulatory requirements

  • Cost savings through reduced liability and warranty claims

    • EN ISO 10993-21 testing involves a comprehensive evaluation of skin irritation from medical device extracts. The standard requires manufacturers to perform the following steps:

    1. Sample Preparation: Manufacturers must prepare samples according to the standards requirements, including extraction, purification, and concentration.

    2. Testing Conditions: Testing is conducted in accordance with the standards requirements, including temperature, humidity, and pressure conditions.

    3. Patch Testing: Patch testing involves applying a small amount of extract to a patch on a volunteers skin for a specified period (usually 48 hours).

    4. Occlusive Patch Testing: Occlusive patch testing involves covering the patch with an occlusive dressing to prevent skin irritation from other sources.

    5. Data Analysis: Manufacturers must analyze data according to the standards requirements, including evaluation of skin reactions and determination of the irritancy threshold.

    Standard Requirements for Testing

    EN ISO 10993-21 specifies several key requirements for testing, including:

  • Use of a validated extraction method

  • Selection of an adequate number of volunteers

  • Proper documentation of testing conditions and results

    • Standard Requirements for Sample Preparation

    The standard requires manufacturers to prepare samples according to the following guidelines:

  • Extraction methods must be validated before use

  • Samples must be purified and concentrated according to the standards requirements

  • Extracts must be stored and handled according to the standards guidelines

    • Standard Requirements for Testing Conditions

    EN ISO 10993-21 specifies several key requirements for testing conditions, including:

  • Temperature: 22C 2C (72F 4F)

  • Humidity: 50 10

  • Pressure: Atmospheric pressure

    • Standard Requirements for Data Analysis

    The standard requires manufacturers to analyze data according to the following guidelines:

  • Evaluation of skin reactions using a standardized scoring system

  • Determination of the irritancy threshold based on the results of patch testing and occlusive patch testing.

    • This comprehensive guide provides an overview of EN ISO 10993-21 testing services, including standard-related information, regulatory requirements, and testing conditions and methodology. Manufacturers must comply with this standard to ensure product safety and efficacy while maintaining regulatory compliance.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers