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iso-18562-testing-of-phthalates-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 18562-5 Testing of Volatile Organic Compounds Including PhthalatesISO 18562-6 Testing of Plasticizers in Medical DevicesISO 18562-7 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 Testing of Phthalates in Medical Devices Laboratory Testing Service

Provided by Eurolab: Experts in Laboratory Testing Services

ISO 18562 is a series of standards developed by the International Organization for Standardization (ISO) to provide guidelines for the testing and evaluation of phthalates in medical devices. Phthalates are a group of chemicals used as plasticizers in various medical devices, including tubing, connectors, and other components. The presence of phthalates in these devices can pose risks to patients, such as skin irritation, allergic reactions, and even cancer.

The ISO 18562 series consists of five parts:

1. ISO 18562-1:2017 - Medical devices - Biocompatibility evaluation of medical devices that include implants

2. ISO 18562-2:2018 - Medical devices - Biocompatibility evaluation of medical devices that include implantable materials in direct contact with the vascular system

3. ISO 18562-3:2019 - Medical devices - Biocompatibility evaluation of medical devices that include non-implantable, short-term, and reversible materials in contact with the skin

4. ISO 18562-4:2020 - Medical devices - Biocompatibility evaluation of medical devices that include implantable materials in direct contact with the tissue

5. ISO 18562-5:2021 - Medical devices - Biocompatibility evaluation of medical devices that include non-implantable, short-term, and reversible materials in contact with mucous membranes

These standards provide a framework for manufacturers to evaluate the biocompatibility of their medical devices, including phthalate levels. The testing process involves sampling from the device, extracting the phthalates, and analyzing them using various techniques.

Regulatory Framework

The regulatory framework surrounding ISO 18562 testing is governed by various national and international regulations. For example:

  • In the European Union (EU), the Medical Device Regulation (MDR) requires medical devices to comply with biocompatibility standards.

  • In the United States, the Food and Drug Administration (FDA) regulates medical devices under the Federal Food, Drug, and Cosmetic Act (FDC).

  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines for biocompatibility testing.

    • Standard Compliance Requirements

    Manufacturers must comply with these regulations by performing biocompatibility testing, including phthalate analysis. Failure to comply can result in regulatory penalties, product recalls, and damage to reputation.

    Industry-Specific Examples and Case Studies

  • A medical device manufacturer produces tubing for dialysis machines containing high levels of phthalates.

  • An implantable device manufacturer includes phthalates in their products packaging, which comes into direct contact with tissue.

  • A hospital purchases medical devices from a supplier that has not performed biocompatibility testing.

    • Standard Development Organizations and Their Role

    Standard development organizations (SDOs) play a crucial role in creating and maintaining standards. The SDOs involved in the creation of ISO 18562 are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These organizations work together to develop, maintain, and revise standards.

    Standards Evolution and Updates

    Standards evolve over time due to advances in technology, changes in regulations, or new research findings. The ISO 18562 series has undergone several updates since its initial publication.

    Technical Specifications and Parameters

    The following technical specifications are relevant to ISO 18562 testing:

  • Sampling: 1-10 of the devices total surface area

  • Extraction: Soxhlet extraction using a solvent like methanol or acetone

  • Analysis: High-performance liquid chromatography (HPLC) or gas chromatography-mass spectrometry (GC-MS)

    • Risk Assessment and Mitigation through Testing

    Phthalates in medical devices pose significant risks to patients, including:

  • Skin irritation and allergic reactions

  • Cancer and other health effects due to prolonged exposure

    • ISO 18562 testing helps mitigate these risks by ensuring that medical devices meet biocompatibility standards.

    Quality Assurance and Compliance Benefits

    Performing ISO 18562 testing provides manufacturers with several benefits, including:

  • Improved product safety and reliability

  • Compliance with regulatory requirements

  • Enhanced customer confidence and trust

    • Why This Test Should Be Performed

    Manufacturers should perform ISO 18562 testing to ensure compliance with regulations, protect patients health, and maintain a competitive advantage in the market.

    ---

    The need for ISO 18562 testing arises from several business and technical reasons:

  • Regulatory Compliance: Manufacturers must comply with biocompatibility standards set by regulatory agencies.

  • Product Safety and Reliability: Testing ensures that medical devices meet safety and performance requirements, reducing the risk of product recalls and liability.

  • Customer Confidence: Manufacturers can demonstrate their commitment to patient safety and product quality, enhancing customer trust and loyalty.

    • Industry-Specific Requirements

    Manufacturers in various industries require different types of testing:

  • Medical Device Manufacturers: ISO 18562 testing ensures compliance with biocompatibility standards for implantable, non-implantable, and reversible materials.

  • Pharmaceutical Manufacturers: Testing evaluates the compatibility of packaging materials with pharmaceutical products.

    • Testing Requirements

    The following testing requirements are relevant to ISO 18562:

  • Sampling: Devices must be sampled according to the standards sampling plan

  • Extraction: Extraction methods, such as Soxhlet extraction or liquid-liquid extraction, may be employed

  • Analysis: Analytical techniques like HPLC or GC-MS are used to determine phthalate levels

    • Why This Test Should Be Performed

    Manufacturers should perform ISO 18562 testing to ensure compliance with regulations, protect patients health, and maintain a competitive advantage in the market.

    ---

    The standard development organizations involved in creating and maintaining standards for biocompatibility evaluation are:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These SDOs work together to develop, maintain, and revise standards.

    Standard Evolution and Updates

    Standards evolve over time due to advances in technology, changes in regulations, or new research findings. The ISO 18562 series has undergone several updates since its initial publication.

    Technical Specifications and Parameters

    The following technical specifications are relevant to biocompatibility evaluation:

  • Sampling: 1-10 of the devices total surface area

  • Extraction: Soxhlet extraction using a solvent like methanol or acetone

  • Analysis: High-performance liquid chromatography (HPLC) or gas chromatography-mass spectrometry (GC-MS)

    • Risk Assessment and Mitigation through Testing

    Phthalates in medical devices pose significant risks to patients, including:

  • Skin irritation and allergic reactions

  • Cancer and other health effects due to prolonged exposure

    • ISO 18562 testing helps mitigate these risks by ensuring that medical devices meet biocompatibility standards.

    Quality Assurance and Compliance Benefits

    Performing ISO 18562 testing provides manufacturers with several benefits, including:

  • Improved product safety and reliability

  • Compliance with regulatory requirements

  • Enhanced customer confidence and trust

    • ---

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