EUROLAB
iso-10993-1-biological-evaluation-process
Chemical Resistance and Material Compatibility Testing ASTM D130 Copper Corrosion TestingASTM D130 Corrosion Testing of MetalsASTM D2240 Hardness Testing of Polymer MaterialsASTM D2240 Hardness Testing Post Chemical ExposureASTM D256 Impact Resistance After Chemical ExposureASTM D257 Electrical Resistivity Post Chemical ExposureASTM D2765 Thermal Analysis After Chemical ExposureASTM D3359 Adhesion of Coatings Post Chemical ExposureASTM D3359 Adhesion Testing After Chemical ExposureASTM D3762 Abrasion Resistance Post Chemical ExposureASTM D3985 Oxygen Transmission Rate After Chemical ExposureASTM D4216 Chemical Resistance of PolypropyleneASTM D471 Swelling Resistance in LiquidsASTM D4727 Resistance of Rubber to ChemicalsASTM D522 Flexibility Post Chemical ExposureASTM D543 Chemical Resistance of PlasticsASTM D543 Resistance of Plastics to Chemical ReagentsASTM D543-14 Chemical Resistance of Plastics and ElastomersASTM D570 Water Absorption of PlasticsASTM D570 Water Absorption of Polymer SamplesASTM D638 Tensile Properties After Chemical TreatmentASTM D638 Tensile Testing of Chemical-Exposed SamplesASTM D638 Tensile Testing Post Chemical ExposureASTM D648 Heat Deflection Temperature After Chemical ExposureASTM D7338 Chemical Resistance of PolyethyleneASTM D746 Low Temperature Impact Post Chemical ExposureASTM D7569 Resistance to Chemical ExposureASTM D792 Density of Plastics After Chemical ExposureASTM D882 Tensile Properties of Thin Plastic SheetingASTM E96 Water Vapor Transmission Post Chemical ExposureASTM F1515 Chemical Resistance of Medical PlasticsASTM F1522 Resistance to Chemicals in Medical DevicesASTM F1874 Chemical Resistance of ElastomersASTM F2026 Chemical Resistance of Polymeric MaterialsASTM F2028 Chemical Compatibility of Surgical InstrumentsASTM F2033 Chemical Resistance of Medical PolymersASTM F2299 Resistance to Bacterial PenetrationASTM F2397 Chemical Resistance of ElastomersASTM F739 Chemical Permeation TestingASTM F748 Resistance of Polymers to ChemicalsASTM F903 Liquid Penetration ResistanceASTM F904 Chemical Resistance of Polymers in Medical UseISO 10993-10 Biological Evaluation of MaterialsISO 10993-10 Irritation Testing Post Chemical ExposureISO 10993-11 Cytotoxicity Testing Post Chemical ExposureISO 10993-12 Chemical Resistance Sample PreparationISO 10993-13 Extraction Methods for Medical DevicesISO 10993-14 Degradation Products in Medical MaterialsISO 10993-15 Identification of Degradation ProductsISO 10993-16 Toxicokinetics of MaterialsISO 10993-17 Toxicological Risk AssessmentISO 10993-18 Chemical Characterization of Medical DevicesISO 10993-19 Chemical Characterization for Medical DevicesISO 10993-2 Animal Welfare Requirements in TestingISO 10993-20 Sensitization TestingISO 10993-21 Evaluation of Degradation ProductsISO 10993-22 Evaluation of Material InteractionISO 10993-23 Assessment of ToxicityISO 10993-24 Evaluation of Extractables and LeachablesISO 10993-25 Material Compatibility ValidationISO 10993-26 Chronic Toxicity TestingISO 10993-27 Immunotoxicology TestingISO 10993-28 Mutagenicity TestingISO 10993-29 Chemical Residue LimitsISO 10993-3 Genotoxicity Testing of Medical MaterialsISO 10993-30 Toxicological Risk AssessmentISO 10993-4 Blood Compatibility TestingISO 10993-4 Hemocompatibility TestingISO 10993-5 In Vitro CytotoxicityISO 10993-6 Local Effects after Chemical ExposureISO 10993-7 Ethylene Oxide Residue LimitsISO 10993-8 Material Compatibility with BloodISO 10993-9 Selection of Tests for Medical MaterialsISO 11135 Material Compatibility in EO SterilizationISO 11135-1 EO Sterilization Material CompatibilityISO 11135-2 EO Sterilization Effects on MaterialsISO 11137 Chemical Resistance of Sterilized DevicesISO 11607 Material Compatibility with SterilizationISO 13485 Material Compatibility RequirementsISO 14644-1 Cleanroom Material CompatibilityISO 14644-3 Cleanroom Material CompatibilityISO 22442 Compatibility of Implants with Biological SystemsISO 22442-2 Biocompatibility TestingISO 22442-3 Evaluation of Material Safety

ISO 10993-1 Biological Evaluation Process Testing Services

Standard-Related Information

ISO 10993-1 is a widely recognized international standard that governs the biological evaluation of medical devices. The standard specifies the requirements for evaluating the potential biological effects of materials used in medical devices. In this section, we will provide an overview of the relevant standards, legal and regulatory framework, and industry-specific requirements.

Relevant Standards

  • ISO 10993-1:2009(E): Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

  • ASTM F748-05: Standard Practice for Selecting, Testing, and Specifying Metal and Ceramic Materials for Surgical Implants

  • EN ISO 10993-1:2009A1:2015: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

  • TSE ISO 10993-1:2013: Biyolojik değerlendirme için tıbbi cihazlar - 1. Bölüm: Risk yönetim süreci içinde değerlendirmeyi ve testi

    • The standards mentioned above are widely recognized and accepted globally, and compliance with these standards is mandatory for medical device manufacturers.

    Legal and Regulatory Framework

    The use of ISO 10993-1 in the medical device industry is governed by various laws and regulations. The key regulatory bodies include:

  • European Union (EU): Medical Device Regulation (MDR) 2017/745

  • United States (US): Food and Drug Administration (FDA) guidance documents

  • China: Chinese National Standard (CNS) GB/T 16886.1-2008

    • These regulations require medical device manufacturers to conduct biological evaluations of their products to ensure compliance with the relevant standards.

    International and National Standards

    The international standard ISO 10993-1 is widely adopted globally, but national standards may vary depending on the country. Some examples include:

  • EU: EN ISO 10993-1

  • US: ASTM F748-05

  • Japan: JIS T 8114

  • China: CNS GB/T 16886.1-2008

    • It is essential to understand the specific national standards and regulations applicable to your country or region.

    Standard Development Organizations

    The standard development process involves organizations that specialize in developing and maintaining international standards. Some key players include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Chinese National Standardization Committee (SAC)

    • These organizations work together to develop, maintain, and update the relevant standards.

    Evolution of Standards

    Standards evolve over time as new technologies emerge or existing practices become outdated. The standard development process involves:

    1. Review and analysis of existing standards

    2. Development of new standards or updates to existing ones

    3. Balloting and voting by member countries

    4. Publication and implementation

    This continuous cycle ensures that the standards remain relevant and effective.

    Standard Numbers and Scope

    Here are some key standard numbers and their scope:

  • ISO 10993-1:2009(E): Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

  • ASTM F748-05: Standard Practice for Selecting, Testing, and Specifying Metal and Ceramic Materials for Surgical Implants

  • EN ISO 10993-1:2009A1:2015: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

    • Standard Compliance Requirements

    Compliance with the relevant standards is mandatory for medical device manufacturers. Failure to comply can result in:

  • Product recall

  • Regulatory actions (e.g., fines, penalties)

  • Loss of market share and reputation

    • It is essential to understand the specific compliance requirements for your industry and country.

    ---

    Standard Requirements and Needs

    In this section, we will explain why ISO 10993-1 biological evaluation process testing is necessary and required.

    Why This Test Is Needed

    Biological evaluation of medical devices is crucial to ensure patient safety. The test helps to identify potential risks associated with the device, such as:

  • Allergic reactions

  • Toxicity

  • Infection

    • The test also ensures compliance with regulatory requirements and industry standards.

    Business and Technical Reasons

    Conducting ISO 10993-1 biological evaluation process testing provides several business and technical benefits, including:

  • Compliance with regulatory requirements

  • Enhanced product safety and reliability

  • Competitive advantage in the market

  • Reduced risk of product recall

    • The test also helps to identify potential issues early in the development phase, reducing costs associated with rework or redesign.

    Consequences of Not Performing This Test

    Failure to conduct ISO 10993-1 biological evaluation process testing can result in:

  • Regulatory actions (e.g., fines, penalties)

  • Loss of market share and reputation

  • Product recall

    • It is essential to understand the consequences of non-compliance to ensure that your products meet the necessary standards.

    Industry-Specific Requirements

    Biological evaluation requirements vary depending on the industry. For example:

  • Orthopedic devices: ISO 10993-1, ASTM F748-05, and EN ISO 10993-1

  • Cardiovascular devices: ISO 10993-1 and FDA guidance documents

    • It is essential to understand the specific requirements for your industry.

    ---

    Biological Evaluation Process

    In this section, we will outline the biological evaluation process according to ISO 10993-1.

    Risk Management Process

    The risk management process involves:

    1. Hazard identification

    2. Risk assessment

    3. Risk control

    This process helps to identify potential risks associated with the device and implement measures to mitigate them.

    Biological Evaluation Test Methods

    ISO 10993-1 specifies several biological evaluation test methods, including:

  • In vitro tests (e.g., cytotoxicity, genotoxicity)

  • In vivo tests (e.g., implantation, skin irritation)

    • These tests help to assess the potential biological effects of materials used in medical devices.

    Test Selection and Performance

    The selection and performance of biological evaluation tests depend on several factors, including:

  • Device type

  • Material composition

  • Intended use

    • It is essential to select relevant test methods and perform them according to the standard requirements.

    ---

    Biological Evaluation Report

    In this section, we will outline the content of a biological evaluation report according to ISO 10993-1.

    Report Content

    A biological evaluation report should include:

    1. Introduction

    2. Device description

    3. Test methods used

    4. Results and discussion

    5. Conclusion

    The report provides a comprehensive summary of the biological evaluation process, including test results and recommendations for device design or manufacturing.

    Certification and Accreditation

    Biological evaluation reports may be certified or accredited by regulatory bodies or third-party organizations. Certification ensures that the report meets specific standards and requirements.

    ---

    In this guide, we have provided an overview of ISO 10993-1 biological evaluation process testing services. We hope you find this information helpful in understanding the standard requirements and needs for your industry.

    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