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isotr-17399-compatibility-and-stability-of-biocompatible-materials
Stability and Compatibility Studies ASTM D1308 Chemical Resistance and Stability TestingASTM D4056 Compatibility Testing of Polymers in ProductsASTM D4065 Dynamic Mechanical Analysis for StabilityASTM D4332 Environmental Chamber Testing for StabilityASTM D618 Accelerated Aging and Stability Testing of PolymersASTM D6940 Stability Testing of Adhesive CosmeticsASTM E1309 Compatibility of Ingredients in FormulationsASTM E1447 Thermal Compatibility Testing of Cosmetic IngredientsASTM E1980 Accelerated Aging of Skin Care ProductsASTM E2169 Microbial Stability Testing of CosmeticsASTM E2243 Microbial Challenge Testing for StabilityASTM F1980 Accelerated Stability Testing of Medical DevicesEN ISO 11348 Luminescent Bacteria Test for Stability AnalysisEP 2.2.16 Determination of pH for Stability EvaluationEP 2.2.28 Determination of Residual Solvents in Stability SamplesEP 2.2.29 Water Determination for Stability SamplesEP 2.9.12 Determination of Viscosity for Stability TestingEP 5.1.5 Microbial Quality Control in Stability SamplesFDA 21 CFR Part 211 Stability Testing RegulationsFDA Guidance for Stability Protocols in PharmaceuticalsFDA Guidance for Stability Testing of Topical ProductsFDA Guidance on Photostability Testing of ProductsFDA Guidance on Stability Testing in PharmaceuticalsICH Q1A(R2) Stability Testing of New Drug Substances and ProductsISO 10993-11 Toxicity Testing Related to Product StabilityISO 10993-17 Toxicological Risk Assessment for StabilityISO 10993-5 Cytotoxicity Testing for Stability AssessmentISO 10993-9 Biological Evaluation of Stability SamplesISO 11348-1 Luminescent Bacteria Test for StabilityISO 11607 Packaging Stability for Medical DevicesISO 11930 Preservative Effectiveness Testing in Stability StudiesISO 11987 Compatibility Testing of Plastics for StabilityISO 12732 Stability Testing of Personal Care ProductsISO 14502-1 Chemical Analysis of Cosmetics for StabilityISO 14516 Determination of Antioxidants in Stability StudiesISO 14644 Cleanroom Stability Conditions for ManufacturingISO 15193 Packaging Stability Testing of Personal Care ProductsISO 16128 Guidelines for Natural and Organic Cosmetic StabilityISO 16128-2 Calculation of Natural Content StabilityISO 16128-3 Natural Ingredients Stability AssessmentISO 16637 Compatibility Testing for Medical DevicesISO 16750 Environmental Conditions Testing for Electrical StabilityISO 16750-4 Electrical and Mechanical Stability TestingISO 17516 Microbial Quality Limits in StabilityISO 17516 Microbiological Limits for Stability StudiesISO 18852 Stability Testing of Textile TreatmentsISO 20252 Guidelines for Stability in Clinical InvestigationsISO 20252 Guidelines for Stability in Clinical TrialsISO 22514 Statistical Methods for Stability Data AnalysisISO 22514-2 Validation of Stability Testing MethodsISO 22611 Physical Compatibility Testing of Cosmetic ProductsISO 22716 GMP for Stability and Quality AssuranceISO 22716 Good Manufacturing Practices for StabilityISO 24367 Shelf Life and Stability Testing for CosmeticsISO/TR 10105 Evaluation of Cosmetic Product StabilityISO/TR 15961 Analytical Methods for Stability StudiesUSP <1086> Pharmaceutical Stability Validation ProceduresUSP <1220> Stability Testing of Drug ProductsUSP <1220> Stability Testing of Pharmaceuticals and CosmeticsUSP <1225> Validation of Stability-Indicating MethodsUSP <151> Stability Studies for Topical ProductsUSP <71> Sterility Testing for Stability StudiesUSP <71> Sterility Testing in Stability Protocols

ISO/TR 17399 Compatibility and Stability of Biocompatible Materials Laboratory Testing Service: A Comprehensive Guide

ISO/TR 17399 is a technical report that outlines the principles for evaluating the compatibility and stability of biocompatible materials. This document provides a comprehensive framework for assessing the safety and performance of these materials in various applications, such as medical devices, implants, and pharmaceutical packaging.

Relevant Standards

The following standards are relevant to ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing:

  • ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

  • ASTM F748-15 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

  • EN ISO 10993-11:2009 Biological evaluation of medical devices -- Part 11: Tests for irritation and skin sensitization

  • TSE EN ISO 10993-10:2015 Biological evaluation of medical devices -- Part 10: Tests for in vitro cytotoxicity

    • Legal and Regulatory Framework

    The use of biocompatible materials is subject to various regulations and laws, including:

  • Medical Device Regulation (EU) 2017/745

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

  • U.S. Food and Drug Administration (FDA) regulations for medical devices

    • Standard Development Organizations

    The following organizations are responsible for developing and maintaining standards related to biocompatible materials:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, and new scientific knowledge. The following table summarizes the evolution of relevant standards:

    Standard Year Description

    --- --- ---

    ISO 10993-1:2018 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

    ASTM F748-15 2015 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

    EN ISO 10993-11:2009 2009 Biological evaluation of medical devices -- Part 11: Tests for irritation and skin sensitization

    Standard Compliance Requirements

    Compliance with relevant standards is essential for ensuring the safety and performance of biocompatible materials. The following table summarizes standard compliance requirements:

    Standard Requirement

    --- ---

    ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

    ASTM F748-15 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

    EN ISO 10993-11:2009 Tests for irritation and skin sensitization

    Why is this specific test needed and required?

    The compatibility and stability of biocompatible materials are critical factors in ensuring the safety and performance of medical devices, implants, and pharmaceutical packaging. This testing service is essential for:

  • Evaluating the chemical and physical properties of biocompatible materials

  • Assessing the biocompatibility and cytotoxicity of these materials

  • Ensuring compliance with relevant standards and regulations

    • Business and Technical Reasons

    Conducting ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing is essential for:

  • Ensuring product safety and reliability

  • Meeting regulatory requirements

  • Protecting against liability claims

  • Maintaining market share and competitiveness

    • Consequences of Not Performing this Test

    Failure to perform this test can result in:

  • Product recalls and withdrawals

  • Regulatory fines and penalties

  • Damage to reputation and brand image

  • Increased costs and liabilities

    • Industries and Sectors Requiring this Testing

    The following industries and sectors require ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing:

  • Medical devices

  • Implants

  • Pharmaceutical packaging

  • Biomaterials

    • Risk Factors and Safety Implications

    Biocompatible materials can pose significant risks to human health if they are not properly evaluated for compatibility and stability. The following table summarizes risk factors and safety implications:

    Risk Factor Safety Implication

    --- ---

    Inadequate biocompatibility testing Toxicity, irritation, or allergic reactions

    Insufficient cytotoxicity testing Damage to tissues or organs

    Failure to assess chemical and physical properties Corrosion, degradation, or malfunction

    Quality Assurance and Quality Control Aspects

    Eurolabs quality assurance and quality control procedures ensure the accuracy and reliability of ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing. The following table summarizes key aspects:

    Aspect Description

    --- ---

    Standard operating procedures (SOPs) Well-defined SOPs for all testing activities

    Calibration and maintenance of equipment Regular calibration and maintenance to ensure accuracy and reliability

    Training and certification of personnel Ongoing training and certification to ensure expertise and competence

    Standard Operating Procedures

    Eurolabs standard operating procedures (SOPs) for ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing include:

  • Sample preparation

  • Testing protocols

  • Data analysis and reporting

    • Testing Protocols

    Eurolabs testing protocols for ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing include:

  • In vitro cytotoxicity tests (e.g., MTT assay)

  • Irritation and skin sensitization tests (e.g., Draize test)

    • Data Analysis and Reporting

    Eurolabs data analysis and reporting procedures ensure the accurate interpretation and presentation of results. The following table summarizes key aspects:

    Aspect Description

    --- ---

    Data validation and verification Rigorous validation and verification to ensure accuracy and reliability

    Statistical analysis Appropriate statistical methods to analyze and interpret data

    Reporting requirements Clear and concise reporting to ensure easy interpretation and understanding

    Testing Methods

    Eurolab employs a range of testing methods for ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing, including:

  • In vitro cytotoxicity tests (e.g., MTT assay)

  • Irritation and skin sensitization tests (e.g., Draize test)

  • Chemical and physical property assessments

    • Testing Equipment

    Eurolabs testing equipment for ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing includes:

  • In vitro cytotoxicity testers (e.g., MTT assay)

  • Irritation and skin sensitization testers (e.g., Draize test)

  • Spectrophotometers

  • Balances

    • Testing Personnel

    Eurolabs testing personnel for ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing include:

  • Experienced technicians

  • Trained and certified analysts

  • Qualified scientists and engineers

    • Quality Management System

    Eurolabs quality management system ensures the accuracy and reliability of ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing. The following table summarizes key aspects:

    Aspect Description

    --- ---

    Document control Effective document control to ensure access to up-to-date documentation

    Training and certification Ongoing training and certification to ensure expertise and competence

    Calibration and maintenance Regular calibration and maintenance to ensure accuracy and reliability

    Testing and Calibration Schedule

    Eurolabs testing and calibration schedule ensures the regular evaluation and validation of equipment. The following table summarizes key aspects:

    Aspect Description

    --- ---

    Testing frequency Regular testing to ensure accuracy and reliability

    Calibration frequency Regular calibration to ensure accuracy and reliability

    Maintenance frequency Regular maintenance to ensure equipment is in good working order

    Conclusion

    ISO/TR 17399 Compatibility and Stability of Biocompatible Materials testing is essential for ensuring the safety and performance of medical devices, implants, and pharmaceutical packaging. Eurolabs quality assurance and quality control procedures ensure the accuracy and reliability of this testing service.

    Recommendations

    To ensure compliance with relevant standards and regulations, we recommend:

  • Conducting regular testing and calibration

  • Maintaining up-to-date documentation and records

  • Ensuring proper training and certification of personnel

    • By following these recommendations, you can ensure the safety and performance of your products and protect against liability claims.

    References

    1. ISO/TR 17399:2014 Compatibility and stability of biocompatible materials -- Technical report.

    2. ASTM F748-15 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices.

    3. EN ISO 10993-11:2009 Biological evaluation of medical devices -- Part 11: Tests for irritation and skin sensitization.

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