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iso-10993-10-leather-biological-evaluation-for-skin-irritation
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ISO 10993-10 Leather Biological Evaluation for Skin Irritation: Laboratory Testing Services

The ISO 10993-10 standard is a part of the International Organization for Standardizations (ISO) 10993 series, which provides guidelines for the biological evaluation of medical devices. Specifically, ISO 10993-10 focuses on the biological evaluation for skin irritation testing of leather materials used in medical devices.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 10993-10 is governed by international and national standards, including:

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

  • ISO 10993-2:2012 (Biological Evaluation of Medical Devices Part 2: Animal Welfare Requirements)

  • EN ISO 10993-10:2020 (Biological Evaluation of Medical Devices Part 10: Irritation)

  • TSE (Turkish Standards Institution) standards for medical devices

  • ASTM F963.11 (Standard Guide for Labeling and Classification of Textile Materials)

    • International and National Standards

    The ISO 10993 series is developed by the Technical Committee ISO/TC 194, which focuses on biological evaluation of medical devices. The international standards are then adopted and implemented by national standards organizations, such as EN in Europe.

    Standard Development Organizations

    Standard development organizations (SDOs) play a crucial role in creating and updating international and national standards. In the case of ISO 10993-10, SDOs include:

  • International Organization for Standardization (ISO)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

  • American Society for Testing and Materials (ASTM)

    • Evolution and Updates

    Standards evolve and get updated to reflect advances in technology, new scientific discoveries, or changes in regulatory requirements. For example, ISO 10993-10 was revised in 2020 to include new testing methods and criteria.

    Specific Standard Numbers and Scope

    The following are specific standard numbers related to ISO 10993-10:

  • ISO 10993-1:2009 (Evaluation and Testing)

  • ISO 10993-2:2012 (Animal Welfare Requirements)

  • EN ISO 10993-10:2020 (Irritation)

  • TSE EN ISO 10993-10:2020 (Turkish version of the standard)

    • Standard Compliance Requirements

    Industry-specific compliance requirements for medical devices include:

  • Medical Device Directive (MDD) 93/42/EEC

  • Active Implantable Medical Devices Directive (AIMD) 90/683/EEC

  • In Vitro Diagnostic Devices Regulation (IVDR) 2017/746

    • Why ISO 10993-10 is Needed

    The testing of leather materials used in medical devices is essential to ensure product safety and reliability. Skin irritation can cause serious health issues, including allergic reactions, rashes, and even burns.

    Business and Technical Reasons for Testing

    Conducting ISO 10993-10 testing provides several business and technical benefits:

  • Ensures product safety and compliance with regulatory requirements

  • Reduces liability risks associated with skin irritation

  • Improves product performance and quality

  • Enhances customer confidence and trust

    • Consequences of Not Performing the Test

    Failure to conduct ISO 10993-10 testing can result in:

  • Regulatory non-compliance

  • Product recalls

  • Financial losses due to litigation or compensation claims

  • Damage to brand reputation and customer loyalty

    • Industries and Sectors that Require Testing

    Medical device manufacturers, particularly those producing implantable devices, skin contact devices, and wound care products, require ISO 10993-10 testing.

    Risk Factors and Safety Implications

    Skin irritation can cause serious health issues, including:

  • Allergic reactions

  • Rashes

  • Burns

    • Quality Assurance and Quality Control Aspects

    Conducting ISO 10993-10 testing involves several quality assurance and control measures, including:

  • Sample preparation and testing procedures

  • Equipment calibration and maintenance

  • Data collection and analysis

  • Reporting and documentation

    • Step-by-Step Explanation of the Test

    The ISO 10993-10 test involves several steps:

    1. Sample preparation: The leather material is prepared for testing by cutting it into small pieces.

    2. Testing equipment and instruments: A skin irritation testing device, such as a Draize or EpiDerm assay system, is used to assess skin irritation.

    3. Testing environment: The testing is conducted in a controlled environment with specific temperature (22-25C), humidity (50-60), and pressure conditions.

    4. Sample application: The leather sample is applied to the skin of test subjects, usually rats or mice.

    5. Observation and scoring: The test subjects are observed for signs of skin irritation, which are scored using a standardized method.

    Data Collection and Analysis

    The data collected from the test is analyzed using statistical methods to determine the skin irritation potential of the leather material.

    Reporting and Documentation

    A comprehensive report detailing the testing results, including any adverse effects or observations, is prepared in accordance with ISO 10993-1:2009.

    Additional Requirements and Considerations

    Several additional requirements and considerations are relevant for ISO 10993-10 testing:

  • Animal welfare requirements

  • Testing protocols

  • Data validation and verification

    • The following tables provide a summary of the standard-related information, standard compliance requirements, and test conditions and methodology for ISO 10993-10.

    Standard Title

    --- ---

    ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

    ISO 10993-2:2012 Biological Evaluation of Medical Devices Part 2: Animal Welfare Requirements

    EN ISO 10993-10:2020 Biological Evaluation of Medical Devices Part 10: Irritation

    Industry-specific Compliance Requirement Title

    --- ---

    MDD 93/42/EEC Medical Device Directive

    AIMD 90/683/EEC Active Implantable Medical Devices Directive

    IVDR 2017/746 In Vitro Diagnostic Devices Regulation

    Step-by-Step Explanation of the Test

    1. Sample preparation

    2. Testing equipment and instruments

    3. Testing environment

    4. Sample application

    5. Observation and scoring

    We can continue this guide by providing a detailed explanation of each step, including any additional requirements or considerations relevant for ISO 10993-10 testing.

    Let me know if you would like to proceed with the next section of the guide.

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