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iso-10993-12-sample-preparation-for-preservative-testing
Preservative Efficacy Testing AOAC 2003.07 Challenge Testing for Preservative EffectivenessAOAC 2007.01 Microbial Challenge Testing for PreservativesAOAC 991.14 Microbial Contamination Analysis in Preserved ProductsAOAC 997.02 Challenge Test Method for Preservative EffectivenessASTM D4014 Preservative Testing for Creams and LotionsASTM D5412 Microbial Limits Testing in Preserved CosmeticsASTM D6422 Preservative Effectiveness in Personal Care ProductsASTM E2180 Antimicrobial Activity of Preservative SystemsASTM E2181 Preservative Efficacy Testing for CosmeticsASTM E2315 Preservation Challenge Test for Cosmetic ProductsASTM E2315 Time-Kill Method for Preservative AssessmentASTM E2315-16 Time-Kill Kinetics for Preservative EffectivenessASTM E2316 Microbial Assessment of Cosmetic PreservativesASTM E2317 Antimicrobial Efficacy of Cosmetic PreservativesASTM E2709 Challenge Tests for Preservative SystemsASTM E2799 Antimicrobial Effectiveness Testing for CosmeticsCOLIPA Guidelines for Preservative Efficacy in CosmeticsEN ISO 11930 Microbial Preservation Testing for Personal CareEN ISO 11930 Microbial Quality and Preservation AssessmentEP 2.6.12 Enumeration of Microorganisms in Preserved ProductsEP 2.6.13 Detection of Specified Microorganisms in Preserved ProductsEP 5.1.3 Challenge Test for Preservative EfficacyEP 5.1.4 Microbial Limits in Preserved IngredientsEP 5.1.5 Microbial Quality Control in Preserved FormulationsFDA 21 CFR 701.3 Microbial Contamination Limits in Preserved ProductsFDA 21 CFR Part 700 Microbial Limits for Preserved CosmeticsFDA BAM Chapter 23 Microbial Pathogen Detection in Preserved ProductsFDA Cosmetic Microbiological Testing GuidanceFDA Guidance on Preservative Testing for Topical ProductsISO 10993-10 Preservation Efficacy in Dermal ProductsISO 11930 Challenge Test of Preservatives in CosmeticsISO 11930 Evaluation of Preservative Efficacy in CosmeticsISO 11930-1 Preservative Challenge Testing for Rinse-off ProductsISO 11930-2 Preservative Testing of Leave-on CosmeticsISO 11932 Validation of Microbial Methods in Preservation TestingISO 11989 Validation of Microbiological Methods in Preserved ProductsISO 16128 Natural and Organic Cosmetic Ingredient PreservationISO 16128-2 Calculation of Natural Preservative ContentISO 16134-3 Testing of Preservative EffectivenessISO 16212 Detection of Yeasts and Molds in Preserved CosmeticsISO 16212 Mold and Yeast Quantification in Preserved CosmeticsISO 17516 Microbial Limits and Preservation TestingISO 18415 Microbial Challenge Test for Personal Care ProductsISO 18593 Microbial Sampling in Preserved ProductsISO 18593 Microbiological Sampling Methods for Preserved ProductsISO 21148 Detection of Anaerobic Microorganisms in Preserved ProductsISO 21148 Detection of Preservative-Resistant MicroorganismsISO 21149 Enumeration of Aerobic Bacteria for Preservative StudiesISO 21149 Enumeration of Microorganisms in Preserved FormulationsISO 21149-1 Enumeration of Aerobic Bacteria in Preserved FormulationsISO 21150 Detection of Pathogens in Preserved CosmeticsISO 21150-1 Microbial Contamination in Cosmetic Raw MaterialsISO 21404 Testing for Microbial Contamination in Preserved CosmeticsISO 21702 Antiviral Efficacy Testing of PreservativesISO 22176 Good Hygiene Practices for Preserved CosmeticsISO 22716 Good Manufacturing Practices for Cosmetic PreservationISO 24434 Enumeration of Aerobic Mesophilic Spores in Preserved ProductsISO 24441 SPF Testing for Preserved SunscreensISO 24442 Enumeration of Aerobic Microbial Spores in ProductsISO 24442 Microbial Spores Enumeration in Preserved ProductsISO 24444 Comparison of Microbiological Test ProtocolsISO 24475 Microbiological Assessment of Preserved Raw MaterialsISO 29621 Categorization of Cosmetic Products by Microbiological RiskISO/TR 19837 Guidelines for Microbiological Risk Assessment of PreservativesISO/TR 19838 Risk Management of Preservatives in CosmeticsISO/TR 19930 Microbiological Test Method Development for PreservativesISO/TR 24476 Selection of Microbiological Test Methods for PreservationISO/TR 29621 Guidelines on Risk Assessment for PreservativesUSP <1227> Validation of Microbial Recovery in Preservative StudiesUSP <1227> Validation of Microbial Recovery in Preservative TestingUSP <1229> Microbial Recovery in Preservative Efficacy TestsUSP <1231> Water Quality for Microbiological Control in Preservative TestingUSP <1625> Microbial Testing of Preserved Topical ProductsUSP <51> Antimicrobial Effectiveness Testing for PreservativesUSP <60> Microbial Limits in Preserved CosmeticsUSP <61> Microbial Enumeration Tests in Preserved Cosmetics

ISO 10993-12 Sample Preparation for Preservative Testing: Laboratory Testing Services

The ISO 10993-12 standard is a widely accepted international standard that governs the sample preparation and testing of preservatives in medical devices. This standard is developed by the International Organization for Standardization (ISO) in collaboration with other standard development organizations, such as the American Society for Testing and Materials (ASTM), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE).

Legal and Regulatory Framework

The ISO 10993-12 standard is a legal requirement for medical device manufacturers in many countries. The standard ensures that preservatives are tested to ensure their safety and efficacy in medical devices. Non-compliance with this standard can result in recalls, fines, and damage to reputation.

International and National Standards

The ISO 10993-12 standard is part of the ISO 10993 series of standards for biological evaluation of medical devices. The relevant national standards that apply to this testing service include:

  • EN ISO 10993-12:2012 (European Standard)

  • ASTM F748-14 (American Standard)

  • TSE EN ISO 10993-12:2012 (Turkish Standard)

    • Standard Development Organizations

    The standard development organizations involved in the development of the ISO 10993-12 standard include:

  • 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 are updated regularly to reflect new scientific knowledge, technological advancements, and regulatory requirements. The ISO 10993-12 standard has undergone several revisions since its first publication in 1997.

    Scope and Compliance Requirements

    The ISO 10993-12 standard applies to medical devices that require preservatives for their intended use. Manufacturers must comply with this standard to ensure the safety and efficacy of their products.

    Standard Numbers and Scope

    The following are some relevant standard numbers and their scope:

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

  • ISO 10993-2:1993 (Biological evaluation of medical devices - Part 2: Guidance on the application of ISO 10993-1)

  • EN ISO 10993-12:2012 (Biological evaluation of medical devices - Part 12: Sample preparation and reference materials)

    • Industry-Specific Examples and Case Studies

    The ISO 10993-12 standard is applicable to various industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • Why This Test is Needed and Required

    Preservatives are essential in medical devices to prevent microbial growth and contamination. However, preservatives can also pose risks to human health if they are not tested and validated properly.

    Business and Technical Reasons for Conducting ISO 10993-12 Testing

    Conducting ISO 10993-12 testing is necessary for several business and technical reasons:

  • To ensure the safety and efficacy of medical devices

  • To comply with regulatory requirements

  • To prevent recalls and fines

  • To maintain customer confidence and trust

    • Consequences of Not Performing This Test

    Failure to perform this test can result in:

  • Product recalls and damage to reputation

  • Fines and penalties from regulatory authorities

  • Loss of customer trust and confidence

    • Industries and Sectors that Require This Testing

    This testing is required for various industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • Risk Factors and Safety Implications

    The risks associated with preservatives in medical devices include:

  • Microbial contamination

  • Allergic reactions

  • Toxicity

    • Quality Assurance and Quality Control Aspects

    Conducting ISO 10993-12 testing ensures that quality assurance and quality control measures are implemented to prevent microbial contamination and other safety issues.

    Competitive Advantages of Having This Testing Performed

    Performing this testing provides several competitive advantages, including:

  • Improved product safety and efficacy

  • Compliance with regulatory requirements

  • Increased customer confidence and trust

    • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of performing this test is favorable, as it ensures compliance with regulatory requirements, prevents recalls and fines, and maintains customer confidence and trust.

    Step-by-Step Explanation of How the Test is Conducted

    Conducting ISO 10993-12 testing involves several steps:

    1. Sample preparation

    2. Testing equipment setup

    3. Testing parameters and conditions

    4. Data collection and analysis

    Testing Equipment and Instruments Used

    The following are some of the testing equipment and instruments used in this test:

  • Incubators

  • Microscopes

  • Spectrophotometers

    • Data Collection and Analysis

    Data is collected and analyzed using various software tools, including:

  • Statistical process control (SPC)

  • Data analytics

    • Test Results Interpretation

    The results of this test are interpreted to ensure that preservatives in medical devices meet the required safety and efficacy standards.

    ... (rest of the document will be provided upon request)

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