EUROLAB
iso-10993-21-evaluation-of-degradation-products
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 10993-1 Biological Evaluation ProcessISO 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 10993-22 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

Complete Guide to ISO 10993-21 Evaluation of Degradation Products Laboratory Testing Service Provided by Eurolab

ISO 10993-21 is a standard for the evaluation of degradation products from medical devices, specifically focusing on the assessment of potential health hazards associated with these products. This standard is part of the ISO 10993 series, which provides guidelines for the biological evaluation of medical devices.

Relevant Standards

  • ISO 10993-1:2018 - Biological evaluation of medical devices -- Part 1: Evaluation and testing

  • ISO 10993-2:1994 - Biological safety evaluation of medical devices -- Part 2: Guidance on testing to detect delayed type hypersensitivity

  • EN ISO 10993-3:2009 - Biological safety evaluation of medical devices -- Part 3: Tests for in vitro cytotoxicity (ISO 10993-3:1996)

  • ASTM F748 - Standard Practice for Selecting Glass and Ceramic Materials for Use in Medical Implant Applications

    • Legal and Regulatory Framework

    The ISO 10993 series is widely recognized as a standard for the biological evaluation of medical devices. Compliance with these standards is mandatory for medical device manufacturers seeking to market their products globally. Non-compliance can result in product recalls, financial penalties, and damage to reputation.

    International and National Standards

  • International: ISO 10993-21

  • European Union: EN ISO 10993-21

  • United States: ASTM F748

    • Standard Development Organizations

    The standards development process is managed by international organizations such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN).

    Evolution of Standards

    Standards are regularly updated to reflect new scientific evidence, advances in technology, and changing regulatory requirements. Manufacturers must stay informed about updates to ensure compliance.

    Standard Numbers and Scope

  • ISO 10993-1:2018 - Biological evaluation of medical devices -- Part 1: Evaluation and testing

    • Scope: Provides a framework for the biological evaluation of medical devices.

  • ISO 10993-2:1994 - Biological safety evaluation of medical devices -- Part 2: Guidance on testing to detect delayed type hypersensitivity

    • Scope: Provides guidance on testing for delayed type hypersensitivity.

    Standard Compliance Requirements

    Compliance with these standards is mandatory for medical device manufacturers seeking to market their products globally. Failure to comply can result in product recalls, financial penalties, and damage to reputation.

    Standard-Related Testing Services Provided by Eurolab

    Eurolab offers a comprehensive range of testing services related to ISO 10993-21 Evaluation of Degradation Products, including:

  • Biological evaluation of medical devices

  • In vitro cytotoxicity testing

  • Delayed type hypersensitivity testing

  • Material characterization and identification

    • Why This Specific Test is Needed and Required

    The ISO 10993-21 Evaluation of Degradation Products test is required to assess the potential health hazards associated with medical devices. This includes evaluating the toxicity, genotoxicity, and carcinogenicity of degradation products.

    Business and Technical Reasons for Conducting the Test

  • To ensure compliance with regulatory requirements

  • To protect patients from potential health risks

  • To maintain product safety and reliability

  • To improve product quality

    • Consequences of Not Performing This Test

    Failure to conduct this test can result in:

  • Product recalls

  • Financial penalties

  • Damage to reputation

    • Industries and Sectors that Require This Testing

    Medical device manufacturers, regulatory authorities, and industry associations require this testing.

    Risk Factors and Safety Implications

    The risk factors associated with medical devices include:

  • Toxicity of degradation products

  • Genotoxicity of degradation products

  • Carcinogenicity of degradation products

    • Quality Assurance and Quality Control Aspects

    Eurolab ensures the quality of its services through:

  • Regular calibration and validation of testing equipment

  • Participation in interlaboratory comparisons and proficiency testing programs

  • Implementation of quality management systems (QMS) in accordance with international standards (e.g., ISO 9001:2015)

    • Why This Test Contributes to Product Safety and Reliability

    This test contributes to product safety and reliability by:

  • Identifying potential health hazards associated with medical devices

  • Ensuring compliance with regulatory requirements

  • Improving product quality

    • Competitive Advantages of Having This Testing Performed

    Performing this testing provides competitive advantages, including:

  • Improved product reputation and brand image

  • Enhanced customer trust and confidence

  • Increased market access and trade facilitation

    • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of performing this test is positive, as it ensures compliance with regulatory requirements, protects patients from potential health risks, and improves product quality.

    Introduction to Testing

    Eurolabs testing services for ISO 10993-21 Evaluation of Degradation Products involve the following steps:

    1. Sample preparation

    2. In vitro cytotoxicity testing

    3. Delayed type hypersensitivity testing

    4. Material characterization and identification

    Test Conditions

    The test conditions are as follows:

  • Temperature: 37C 1C

  • pH: 7.2 0.2

  • Humidity: 50 10

    • Methodology

    Eurolabs methodology for testing degradation products involves the following steps:

    1. Sample preparation

    Material sampling and extraction

    Preparation of test samples

    2. In vitro cytotoxicity testing

    Cell culture preparation

    Testing of sample extracts

    3. Delayed type hypersensitivity testing

    Cell culture preparation

    Testing of sample extracts

    4. Material characterization and identification

    Spectroscopy (e.g., FTIR, NMR)

    Chromatography (e.g., GC, HPLC)

    Quality Control and Assurance

    Eurolab ensures the quality of its services through:

  • Regular calibration and validation of testing equipment

  • Participation in interlaboratory comparisons and proficiency testing programs

  • Implementation of quality management systems (QMS) in accordance with international standards (e.g., ISO 9001:2015)

    • Conclusion

    In conclusion, Eurolabs comprehensive range of testing services for ISO 10993-21 Evaluation of Degradation Products ensures compliance with regulatory requirements, protects patients from potential health risks, and improves product quality.

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