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iso-18562-7-testing-of-plasticizers-in-medical-devices
BPA, Phthalates, Plasticizer ASTM D6318 Testing of Phthalate Plasticizers in PolymersASTM D6414 Plasticizer Content in PVCASTM D6572 Phthalate Content in Plastic FilmsASTM D6886 Plasticizer Content in PVC MaterialsASTM D6955 Testing of BPA MigrationASTM D7333 Identification of BPA in PolymersASTM F2030 Migration Testing of BPAASTM F2031 Testing of BPA in Food PackagingASTM F2268 Testing of Plasticizer MigrationASTM F2299 Plasticizer Migration TestingASTM F2392 Testing of Plasticizer MigrationASTM F2393 Plasticizer Migration TestingASTM F2646 Identification of Phthalates in PolymersASTM F2678 Phthalate Content TestingEN 13130-13 Phthalate Release from Plastic MaterialsEN 13130-14 BPA Migration in Food PackagingEN 13130-15 Plasticizer Migration TestingEN 13130-16 Testing of Plasticizers in Food ContactEN 13130-17 BPA and Phthalate Migration TestingEN 13130-18 Phthalate and BPA Migration TestingEN 13130-19 Testing of Plasticizer MigrationEN 14372 BPA and Phthalate TestingEN 14372 Migration Testing for PhthalatesEN 14372 Phthalate and Plasticizer TestingEN 14372 Phthalate Content in Plastic PackagingEN 14372 Phthalate Testing in Food PackagingEN 14372 Plasticizer Content TestingEN 14372 Testing of Phthalates in Plastic Food ContactEPA 3540B Extraction for Plasticizer TestingEPA 3545 Extraction of BPA and PhthalatesEPA 3545 Extraction of PlasticizersEPA 8270B Analysis of PhthalatesEPA 8270C Semi-Volatile Organic Compounds TestingEPA 8270D GC-MS Phthalate AnalysisEPA Method 3535A Extraction of PhthalatesEPA Method 3536 Extraction of PhthalatesEPA Method 3540C Extraction for Phthalate TestingEPA Method 3540C Extraction of PlasticizersEPA Method 8061A Phthalates AnalysisEPA Method 8270D Analysis of Phthalates by GC-MSEPA Method 8270E GC-MS Phthalate TestingEPA Method 8270F Phthalate TestingEU Regulation 10/2011 Specific Migration of BPAFDA Guidance on BPA in Food PackagingISO 11443 Specific Migration Limits for PlasticizersISO 1186 Migration Testing for PlasticizersISO 1186-6 Migration Testing of PlasticizersISO 11885 ICP-OES Detection of PlasticizersISO 11885 ICP-OES Detection of PlasticizersISO 11885 ICP-OES Plasticizer DetectionISO 14372 Testing of Phthalates in PackagingISO 14389 BPA Analysis in PolymersISO 14389 BPA Testing in Plastic MaterialsISO 14389 Determination of BPA in Food Contact MaterialsISO 14389-2 Analysis of BPA in Polymeric MaterialsISO 14389-3 BPA Detection in PackagingISO 15819 Detection of Plasticizers in PackagingISO 18254 Detection of Plasticizers in Food Contact MaterialsISO 18254-2 Determination of PlasticizersISO 18254-3 Plasticizer DeterminationISO 18562 Testing of Phthalates in Medical DevicesISO 18562-5 Testing of Volatile Organic Compounds Including PhthalatesISO 18562-6 Testing of Plasticizers in Medical DevicesISO 18562-8 Plasticizer Testing in Medical DevicesISO 18562-9 Plasticizer Testing in Medical DevicesISO 18752 Determination of PhthalatesISO 18752 Determination of PlasticizersISO 18752 Testing of Plasticizers in Food Contact PlasticsISO 18843 Migration Testing of PlasticizersISO 18843-1 Determination of PlasticizersISO 21790 BPA and Analogues TestingISO 8124-6 Phthalates in Toys and Food Contact Materials

Comprehensive Guide to ISO 18562-7 Testing of Plasticizers in Medical Devices

ISO 18562-7 is a laboratory testing standard that governs the assessment of plasticizers in medical devices. This standard is developed by the International Organization for Standardization (ISO) and is part of a broader series of standards focused on biocompatibility testing.

Legal and Regulatory Framework

The use of plasticizers in medical devices is regulated by various international and national laws, including the Medical Device Regulation (MDR) in the European Union. The MDR requires manufacturers to ensure that their products comply with specific requirements related to biocompatibility, including the assessment of plasticizers.

International and National Standards

Several international and national standards apply to ISO 18562-7 Testing of Plasticizers in Medical Devices, including:

  • ISO 18562-1:2018 (Biological evaluation of medical devices Part 1: Evaluation and testing for biocompatibility)

  • ISO 10993-17:2002 (Biological evaluation of medical devices Part 17: Tests for cytotoxicity: In vitro methods)

  • EN ISO 10993-17:2019 (Medical devices Biological evaluation Part 17: Tests for cytotoxicity in vitro)

    • Standard Development Organizations and Their Role

    The International Organization for Standardization (ISO) is responsible for developing the ISO 18562 series. Other standard development organizations, such as the American Society for Testing and Materials (ASTM), also contribute to the development of standards related to biocompatibility testing.

    Evolution of Standards and Update Cycle

    Standards evolve over time as new technologies and research emerge. The update cycle typically ranges from 5-10 years, with revisions incorporating new scientific evidence, regulatory requirements, or industry feedback.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope include:

  • ISO 18562-7:2019 (Biological evaluation of medical devices Part 7: Assessment of degradation of polymeric materials and its potential effects on the biological environment)

  • EN ISO 10993-17:2019 (Medical devices Biological evaluation Part 17: Tests for cytotoxicity in vitro)

    • Standard Compliance Requirements

    Manufacturers must comply with relevant standards when developing medical devices containing plasticizers. Failure to do so can result in regulatory non-compliance, product recalls, and damage to reputation.

  • The use of plasticizers in medical devices is subject to specific regulations and requirements.

  • Manufacturers must ensure that their products comply with relevant standards, including ISO 18562-7.

  • Standards are developed by organizations such as the ISO and ASTM.

  • Standards evolve over time to incorporate new scientific evidence and regulatory requirements.

    • Business and Technical Reasons for Conducting ISO 18562-7 Testing of Plasticizers in Medical Devices

    The testing of plasticizers in medical devices is essential due to the potential risks associated with their use. These risks include:

  • Toxicity: Plasticizers can leach into the body, potentially causing harm.

  • Degradation: Over time, plasticizers may degrade, releasing toxic substances.

    • Consequences of Not Performing this Test

    Failure to test for plasticizers in medical devices can result in regulatory non-compliance, product recalls, and damage to reputation. Manufacturers must ensure that their products meet relevant standards to avoid these consequences.

    Industries and Sectors Requiring This Testing

    The following industries and sectors require ISO 18562-7 testing of plasticizers in medical devices:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • Risk Factors and Safety Implications

    Plasticizers can pose significant risks to human health, including:

  • Toxicity: Exposure to toxic substances can lead to serious health problems.

  • Degradation: Over time, plasticizers may degrade, releasing toxic substances.

    • Quality Assurance and Quality Control Aspects

    Manufacturers must ensure that their products meet relevant standards through rigorous quality assurance and control measures. This includes:

  • Regular testing for biocompatibility

  • Compliance with regulatory requirements

    • Contributions to Product Safety and Reliability

    ISO 18562-7 testing of plasticizers in medical devices contributes significantly to product safety and reliability by:

  • Ensuring compliance with regulatory requirements

  • Reducing the risk of product recalls

  • Protecting human health

    • Competitive Advantages of Having This Testing Performed

    Performing ISO 18562-7 testing of plasticizers in medical devices can provide manufacturers with competitive advantages, including:

  • Enhanced reputation and credibility

  • Improved market access and trade facilitation

  • Increased customer confidence and trust

    • Cost-Benefit Analysis of Performing this Test

    The cost-benefit analysis of performing ISO 18562-7 testing of plasticizers in medical devices is favorable due to the potential savings from:

  • Reduced risk of product recalls

  • Compliance with regulatory requirements

  • Protection of human health

  • Manufacturers must ensure compliance with relevant standards, including ISO 18562-7.

  • Failure to test for plasticizers in medical devices can result in regulatory non-compliance, product recalls, and damage to reputation.

  • The testing of plasticizers is essential due to potential risks associated with their use.

    • Industries and Sectors Requiring This Testing

    The following industries and sectors require ISO 18562-7 testing of plasticizers in medical devices:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Biotechnology firms

    • Risk Factors and Safety Implications

    Plasticizers can pose significant risks to human health, including:

  • Toxicity: Exposure to toxic substances can lead to serious health problems.

  • Degradation: Over time, plasticizers may degrade, releasing toxic substances.

    • Quality Assurance and Quality Control Aspects

    Manufacturers must ensure that their products meet relevant standards through rigorous quality assurance and control measures. This includes:

  • Regular testing for biocompatibility

  • Compliance with regulatory requirements

    • Contributions to Product Safety and Reliability

    ISO 18562-7 testing of plasticizers in medical devices contributes significantly to product safety and reliability by:

  • Ensuring compliance with regulatory requirements

  • Reducing the risk of product recalls

  • Protecting human health

    • Competitive Advantages of Having This Testing Performed

    Performing ISO 18562-7 testing of plasticizers in medical devices can provide manufacturers with competitive advantages, including:

  • Enhanced reputation and credibility

  • Improved market access and trade facilitation

  • Increased customer confidence and trust

    • Cost-Benefit Analysis of Performing this Test

    The cost-benefit analysis of performing ISO 18562-7 testing of plasticizers in medical devices is favorable due to the potential savings from:

  • Reduced risk of product recalls

  • Compliance with regulatory requirements

  • Protection of human health.

    • ...

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