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iso-10993-12-toxicity-screening-for-additive-related-compounds
Food Additives and Contaminants AOAC 2001.01 Determination of Sodium Benzoate in Soft DrinksAOAC 2009.01 Quantification of Sulfites in Dried FruitsAOAC 972.32 Residual Analysis of Propyl Gallate in Frying OilsAOAC 981.14 Analysis of Benzoates in Soft DrinksAOAC 991.31 Artificial Flavor Quantification in BeveragesAOAC 999.07 Quantification of Butylated Hydroxyanisole (BHA)AOAC 999.10 Determination of Preservative Residues in Fruit JuicesAOAC 999.10 Testing for Sulfite Concentration in WinesAOAC 999.11 Testing of Melamine Contamination in Dairy ProductsAOAC Method for Detection of Chlorates in Frozen VegetablesAOAC Method for Estimating Sodium Nitrate in Processed MeatsAOAC Official Method for Caffeine Residue in Energy DrinksAOAC Official Method for Detecting EDTA in Canned VegetablesAOAC Official Method for Determining Ethyl Carbamate in AlcoholAOAC Official Method for Formaldehyde Testing in Gelatin AdditivesAOAC Official Method for Quantifying Potassium Bromate in BreadAOAC Official Method Testing for BHA/BHT in Packaged SnacksAOAC Official Method Testing of Aluminum Levels in Leavening AgentsCodex Alimentarius Compliance for Food Color Additives in IcingCodex GSFA-Standardized Analysis of Emulsifiers in Ice CreamCodex Standardized Detection of Undeclared Additives in Organic FoodEFSA-Compliant Analysis of Residual Monomers in Additive ResinsEFSA-Compliant Residual Solvent Testing in Food AdditivesEFSA-Regulated Benzoic Acid Testing in BeveragesEFSA-Regulated Residue Testing for Perchlorate in Infant FormulaEU Commission Regulation 2006/141 Sweetener Analysis in Infant FoodsEU Food Safety Regulation-Based Paraben Detection in Food PackagingEU Regulation (EC) No 1333/2008 Tartrazine Dye Analysis in CandiesEU Regulation (EC) No 1881/2006 Heavy Metal Testing in Cocoa PowderEU Regulation 1333/2008 Testing of Artificial Colorants in DessertsEU Regulation 1935/2004 Migration Testing of Stabilizers in Packaged FoodsEU Regulation 2011/10 Testing for Additive Migration in Plastic FilmsEU Regulation 2018/213 BPA Residue Analysis in Additive PackagingEU Regulation 2018/213 Testing for Endocrine Disruptors in PackagingEU Regulation No 1169/2011 Verification of Additive Labeling ClaimsEU Regulation No 1334/2008 Testing for Flavor Enhancers in Instant SoupsEU Regulation No 1935/2004 Testing for Migration from Packaging to FoodFDA 21 CFR 170.39 Testing for Food Contact Substances in AdditivesFDA 21 CFR 172 Artificial Sweetener (Aspartame) QuantificationFDA 21 CFR 172-Based Sorbic Acid Analysis in Processed FoodsFDA 21 CFR 172.345 Phosphate Additive Quantification in CheeseFDA 21 CFR 172.345 Phosphates in Cheese ProductsFDA 21 CFR 172.365 Testing of Sucralose in Sugar-Free ProductsFDA 21 CFR 172.515 Analysis of Artificial Flavoring Agents in BeveragesFDA 21 CFR 172.515 Flavor Additive Testing in Processed MeatFDA 21 CFR 172.515 Testing of Flavoring Substances in SnacksFDA 21 CFR 172.580 Diacetyl Detection in Butter-Flavored ProductsFDA 21 CFR 172.800 Detection of Polysorbate 80 in DessertsFDA 21 CFR 172.830 Polyethylene Glycol Detection in Food AdditivesFDA 21 CFR 172.848 Testing of Calcium Disodium EDTA in SaucesFDA 21 CFR 173.25 Enzyme Residue Analysis in Baby FoodsFDA 21 CFR 173.280 Enzyme Residue Clearance in Baby FoodsFDA 21 CFR 173.280 Enzyme Testing in Dairy-Based AdditivesFDA 21 CFR 173.340 Hexane Residue Testing in Soy ProductsFDA 21 CFR 175.300 Leachability Testing for Food Packaging CoatingsFDA 21 CFR 178 Testing for Antioxidants in Edible OilsFDA Compliance Testing for Monosodium Glutamate (MSG) in SeasoningsISO 10540 Determination of Nitrate in Root VegetablesISO 10789 Testing of Anti-Caking Agents in Powdered AdditivesISO 11286 Color Additive Content Testing in Snack ProductsISO 11287 Determination of Sulfite Levels in Dried FruitsISO 11293 Testing of Preservative Levels in Fish ProductsISO 14502-1 Polyphenol Content Testing in Functional BeveragesISO 15320 Testing of Synthetic Antioxidants in Cooking OilsISO 15705 Analysis of Preservatives in Bakery FillingsISO 15705 Preservative Load Testing in Canned ProductsISO 15705 Sorbic Acid Concentration Testing in Preserved FoodsISO 16000 Testing for Formaldehyde Residues in Food PackagingISO 16000-11 Testing for Additive Off-Gassing in Food StorageISO 16000-27 Testing of Acrylamide in Baked GoodsISO 16000-3 Testing of Volatile Organic Compounds in Food StorageISO 16000-6 Contaminant Monitoring in Food Processing EnvironmentsISO 17025 Accredited Nitrosamine Detection in Cured MeatsISO 17025 Accredited Testing of BPA Migration from Food ContainersISO 17025 Compliant Testing of Aflatoxin Contamination in Nut ProductsISO 17294-2 ICP-MS Analysis for Arsenic in Rice-Based ProductsISO 17294-2 ICP-MS Testing for Heavy Metals in Bakery AdditivesISO 17338 Nitrate and Nitrite Testing in SausagesISO 18664 Quantitative Analysis of Nitrate in Leafy VegetablesISO 18664 Quantitative Testing for Nitrites in Processed FoodsISO 18857 Phthalate Residue Testing in Food-Grade Plastic WrapISO 19330 Testing of Artificial Sweeteners in Nutritional SupplementsISO 19332 Determination of Lead and Cadmium in CandyISO 19338 Detection of Phthalates in Food Contact MaterialsISO 21422 Screening for Pesticide and Additive Residues in CerealsISO 21438 Heavy Metal Contaminant Testing in Additive MaterialsISO 21469 Testing of Additive Safety in Food-Grade LubricantsISO 21527 Sorbic Acid Residue Testing in Preserved VegetablesISO 21528 Microbial Stability Testing of Chemical AdditivesISO 2166 Color Additive Testing in Food DecorationsISO 22000 Contaminant Management System Verification in Food LinesISO 22000 Verification of Allergen-Free Additive ClaimsISO 22184 Food Contaminant Testing in Combined Additive FormulationsISO 22184 Multi-Residue Pesticide and Additive Analysis in CerealsISO 22241 Contaminant Screening in Ready Meals for NitritesISO 3976 Testing for Preservatives in Pickled ProductsISO 5667 Sampling and Testing of Food Additive WastewaterISO 6579 Microbiological Testing for Nitrite-Producing AdditivesISO 6579 Preservative Efficacy Testing in Deli MeatsISO 6579-1 Microbial Contaminant Detection in Additive ProcessingISO 9237 Permeability Testing for Food Contact Materials

Comprehensive Guide to ISO 10993-12 Toxicity Screening for Additive-Related Compounds Laboratory Testing Service

ISO 10993-12:2012 is a standard published by the International Organization for Standardization (ISO) that outlines the requirements for toxicity screening of additives related to plastics and rubber. This standard is part of the ISO 10993 series, which deals with biological evaluation of medical devices.

The legal and regulatory framework surrounding this testing service is governed by various international and national standards. Some of the key standards include:

  • ISO 10993-12:2012 (Biological evaluation of medical devices Part 12: Toxicity)

  • ASTM F748-08 (Standard Practice for Selecting Generic Biological Test Methods for Materials and Products)

  • EN ISO 10993-12:2012 (Biological evaluation of medical devices Part 12: Toxicity)

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

    • The standard development organization responsible for developing and maintaining this standard is the ISO/TC 194 committee. This committee consists of experts from various countries who work together to develop standards related to biological evaluation of medical devices.

    Standards evolve over time as new technologies and research emerge. Updates are made to reflect changes in scientific understanding, regulatory requirements, or industry practices. The latest version of this standard is ISO 10993-12:2012, which supersedes the previous edition (ISO 10993-12:2009).

    The scope of ISO 10993-12:2012 covers the toxicity evaluation of additives related to plastics and rubber, including:

  • Plasticizers

  • Stabilizers

  • Fillers

  • Reinforcing agents

    • This standard is applicable to medical devices that come into contact with tissue or fluid, such as catheters, implants, and surgical instruments.

    ISO 10993-12:2012 toxicity screening for additive-related compounds testing is a critical requirement for medical device manufacturers. The business and technical reasons for conducting this test are:

  • Ensuring the safety of patients by evaluating potential toxic effects

  • Complying with regulatory requirements, such as those set forth by FDA (US), CE (EU), and MDR (EU)

  • Maintaining product quality and reliability

  • Reducing liability risks associated with defective products

    • Consequences of not performing this test can include:

  • Non-compliance with regulations, leading to fines or penalties

  • Product recalls due to safety concerns

  • Damage to reputation and brand image

    • This testing is required for various industries, including medical device manufacturing, pharmaceuticals, and cosmetics. The risk factors associated with these products make it essential to conduct thorough toxicity evaluation.

    The ISO 10993-12:2012 toxicity screening test involves the following steps:

    1. Sample preparation: Preparing a representative sample of the additive-related compound

    2. Testing equipment and instruments: Utilizing state-of-the-art equipment, such as spectrophotometers and chromatographs

    3. Testing environment requirements:

    Temperature: 20C to 25C (68F to 77F)

    Humidity: 40 to 60

    Pressure: Atmospheric pressure

    4. Sample preparation procedures:

    Weighing and mixing of samples

    Preparation of solutions or suspensions

    5. Testing parameters and conditions:

    Concentration: Typically in the range of 0.1 to 10 (w/v)

    Incubation time: Up to 72 hours

    6. Measurement and analysis methods:

    Spectrophotometry (UV, visible, or infrared)

    Chromatography (GC, HPLC, or LC-MS/MS)

    7. Calibration and validation procedures:

    Regular calibration of equipment

    Validation of test methods against reference standards

    8. Quality control measures during testing:

    Use of certified reference materials

    Participation in proficiency testing schemes

    The test results are documented and reported according to the following guidelines:

    1. Report format and structure:

    Introduction: Test purpose, scope, and methodology

    Results: Tabulated or graphical presentation of data

    Discussion: Interpretation of results and conclusions

    2. Certification and accreditation aspects:

    Accreditation to ISO 17025:2005 (General requirements for the competence of testing and calibration laboratories)

    3. Traceability and documentation requirements:

    Use of unique sample identifiers

    Maintenance of test records, including raw data and analysis results

    4. Reporting standards and formats:

    Use of standard report templates (e.g., ISO/IEC 17025:2005 Annex D)

    Compliance with regulatory requirements for reporting

    Persuasive Conclusion

    ISO 10993-12:2012 toxicity screening for additive-related compounds testing is an essential requirement for medical device manufacturers. The consequences of non-compliance can be severe, including product recalls and damage to reputation. Conducting thorough toxicity evaluation ensures the safety of patients, maintains product quality, and reduces liability risks.

    By understanding the standard requirements and methodology, medical device manufacturers can ensure compliance with regulations and maintain a competitive edge in the market.

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