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iso-11607-material-compatibility-with-sterilization
Chemical Resistance and Material Compatibility Testing ASTM D130 Copper Corrosion TestingASTM D130 Corrosion Testing of MetalsASTM D2240 Hardness Testing of Polymer MaterialsASTM D2240 Hardness Testing Post Chemical ExposureASTM D256 Impact Resistance After Chemical ExposureASTM D257 Electrical Resistivity Post Chemical ExposureASTM D2765 Thermal Analysis After Chemical ExposureASTM D3359 Adhesion of Coatings Post Chemical ExposureASTM D3359 Adhesion Testing After Chemical ExposureASTM D3762 Abrasion Resistance Post Chemical ExposureASTM D3985 Oxygen Transmission Rate After Chemical ExposureASTM D4216 Chemical Resistance of PolypropyleneASTM D471 Swelling Resistance in LiquidsASTM D4727 Resistance of Rubber to ChemicalsASTM D522 Flexibility Post Chemical ExposureASTM D543 Chemical Resistance of PlasticsASTM D543 Resistance of Plastics to Chemical ReagentsASTM D543-14 Chemical Resistance of Plastics and ElastomersASTM D570 Water Absorption of PlasticsASTM D570 Water Absorption of Polymer SamplesASTM D638 Tensile Properties After Chemical TreatmentASTM D638 Tensile Testing of Chemical-Exposed SamplesASTM D638 Tensile Testing Post Chemical ExposureASTM D648 Heat Deflection Temperature After Chemical ExposureASTM D7338 Chemical Resistance of PolyethyleneASTM D746 Low Temperature Impact Post Chemical ExposureASTM D7569 Resistance to Chemical ExposureASTM D792 Density of Plastics After Chemical ExposureASTM D882 Tensile Properties of Thin Plastic SheetingASTM E96 Water Vapor Transmission Post Chemical ExposureASTM F1515 Chemical Resistance of Medical PlasticsASTM F1522 Resistance to Chemicals in Medical DevicesASTM F1874 Chemical Resistance of ElastomersASTM F2026 Chemical Resistance of Polymeric MaterialsASTM F2028 Chemical Compatibility of Surgical InstrumentsASTM F2033 Chemical Resistance of Medical PolymersASTM F2299 Resistance to Bacterial PenetrationASTM F2397 Chemical Resistance of ElastomersASTM F739 Chemical Permeation TestingASTM F748 Resistance of Polymers to ChemicalsASTM F903 Liquid Penetration ResistanceASTM F904 Chemical Resistance of Polymers in Medical UseISO 10993-1 Biological Evaluation ProcessISO 10993-10 Biological Evaluation of MaterialsISO 10993-10 Irritation Testing Post Chemical ExposureISO 10993-11 Cytotoxicity Testing Post Chemical ExposureISO 10993-12 Chemical Resistance Sample PreparationISO 10993-13 Extraction Methods for Medical DevicesISO 10993-14 Degradation Products in Medical MaterialsISO 10993-15 Identification of Degradation ProductsISO 10993-16 Toxicokinetics of MaterialsISO 10993-17 Toxicological Risk AssessmentISO 10993-18 Chemical Characterization of Medical DevicesISO 10993-19 Chemical Characterization for Medical DevicesISO 10993-2 Animal Welfare Requirements in TestingISO 10993-20 Sensitization TestingISO 10993-21 Evaluation of Degradation ProductsISO 10993-22 Evaluation of Material InteractionISO 10993-23 Assessment of ToxicityISO 10993-24 Evaluation of Extractables and LeachablesISO 10993-25 Material Compatibility ValidationISO 10993-26 Chronic Toxicity TestingISO 10993-27 Immunotoxicology TestingISO 10993-28 Mutagenicity TestingISO 10993-29 Chemical Residue LimitsISO 10993-3 Genotoxicity Testing of Medical MaterialsISO 10993-30 Toxicological Risk AssessmentISO 10993-4 Blood Compatibility TestingISO 10993-4 Hemocompatibility TestingISO 10993-5 In Vitro CytotoxicityISO 10993-6 Local Effects after Chemical ExposureISO 10993-7 Ethylene Oxide Residue LimitsISO 10993-8 Material Compatibility with BloodISO 10993-9 Selection of Tests for Medical MaterialsISO 11135 Material Compatibility in EO SterilizationISO 11135-1 EO Sterilization Material CompatibilityISO 11135-2 EO Sterilization Effects on MaterialsISO 11137 Chemical Resistance of Sterilized DevicesISO 13485 Material Compatibility RequirementsISO 14644-1 Cleanroom Material CompatibilityISO 14644-3 Cleanroom Material CompatibilityISO 22442 Compatibility of Implants with Biological SystemsISO 22442-2 Biocompatibility TestingISO 22442-3 Evaluation of Material Safety

Comprehensive Guide to ISO 11607 Material Compatibility with Sterilization Testing Services by Eurolab

ISO 11607 is a widely recognized international standard that specifies the requirements for materials used in medical devices that are intended to be sterilized. The standard covers the compatibility of materials with various sterilization methods, including ethylene oxide, gamma radiation, and electron beam radiation. Eurolabs ISO 11607 Material Compatibility with Sterilization testing service is designed to help manufacturers ensure compliance with this critical standard.

Overview of Relevant Standards

The ISO 11607 standard is part of the International Organization for Standardization (ISO) family of standards, which are developed through a consensus process involving experts from around the world. Other relevant standards that govern ISO 11607 testing include:

  • ASTM F2405: Standard Practice for Materials for Use in Sterilization Processes Using Hydrogen Peroxide Gas Plasma Sterilization

  • EN 285: Medical equipment Steam sterilizers Requirements for the development, validation, performance, installation and maintenance of steam sterilizers

  • TSE 11607:2013: Sterilizasyon ile uyumlu malzeme istisnasız

    • These standards are developed by various organizations, including the American Society for Testing and Materials (ASTM), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE).

    International and National Standards

    ISO 11607 is an international standard that applies to medical devices intended for use in sterilized form. However, national standards may also apply depending on the country where the device will be used.

    In the United States, FDA regulations require manufacturers to comply with ISO 11607 testing as part of their quality system. In Europe, EN 285 and ISO 11607 are harmonized standards that must be met for medical devices intended for use in sterilized form.

    Standard Development Organizations

    The development of international and national standards is a collaborative effort between organizations from around the world. Standard development organizations (SDOs) play a critical role in this process by bringing together experts to develop, review, and approve standards.

    Some notable SDOs involved in ISO 11607 testing include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulatory requirements, and industry practices. The ISO 11607 standard has undergone several revisions since its initial publication in 1999.

    The latest edition of ISO 11607 was published in 2016 and includes new testing methods for evaluating material compatibility with sterilization processes.

    Standard Compliance Requirements

    Manufacturers must comply with the relevant standards governing ISO 11607 testing. This includes:

  • Performing regular testing to ensure materials are compatible with sterilization processes

  • Documenting testing results and maintaining records of compliance

  • Ensuring that all materials used in medical devices intended for use in sterilized form meet the requirements of ISO 11607

    • Standard Compliance Requirements by Industry

    Different industries have varying levels of standard compliance requirements:

  • Medical device manufacturers: Must comply with ISO 11607 testing as part of their quality system

  • Pharmaceutical companies: May be required to comply with ISO 11607 testing for certain products

  • Biotechnology firms: May need to comply with ISO 11607 testing for biocompatibility and sterilization purposes

    • ISO 11607 Material Compatibility with Sterilization testing is a critical requirement for manufacturers of medical devices intended for use in sterilized form. This section explains why this test is needed, the consequences of not performing it, and the industries that require this testing.

    Why ISO 11607 Testing is Required

    Manufacturers must perform ISO 11607 testing to ensure materials used in medical devices are compatible with sterilization processes. Inadequate material compatibility can lead to:

  • Device failure or malfunction

  • Patient injury or harm

  • Product recalls and regulatory actions

    • Consequences of Not Performing ISO 11607 Testing

    Failing to comply with ISO 11607 testing requirements can result in:

  • Regulatory fines and penalties

  • Loss of market share and reputation

  • Increased costs for rework, repairs, and product recalls

    • Industries that Require ISO 11607 Testing

    Medical device manufacturers, pharmaceutical companies, biotechnology firms, and other industries that use sterilized materials must comply with ISO 11607 testing.

    Risk Factors and Safety Implications

    Material incompatibility can lead to serious safety risks for patients, including:

  • Device failure or malfunction

  • Infection or contamination

  • Adverse reactions or toxicity

    • Quality Assurance and Quality Control Aspects

    ISO 11607 testing is an essential component of quality assurance and quality control programs. Manufacturers must ensure that materials used in medical devices are compatible with sterilization processes to maintain product safety, efficacy, and regulatory compliance.

    Standard Requirements and Needs by Industry

    Different industries have varying levels of standard requirements and needs:

  • Medical device manufacturers: Must comply with ISO 11607 testing as part of their quality system

  • Pharmaceutical companies: May be required to comply with ISO 11607 testing for certain products

  • Biotechnology firms: May need to comply with ISO 11607 testing for biocompatibility and sterilization purposes

    • Standard Requirements and Needs by Region

    Regulatory requirements vary by region:

  • United States: FDA regulations require manufacturers to comply with ISO 11607 testing as part of their quality system

  • Europe: EN 285 and ISO 11607 are harmonized standards that must be met for medical devices intended for use in sterilized form

    • Standard Requirements and Needs by Product Type

    Different product types have varying levels of standard requirements and needs:

  • Sterilizable medical devices: Must comply with ISO 11607 testing

  • Non-sterilizable medical devices: May not require ISO 11607 testing

  • Pharmaceutical products: May be required to comply with ISO 11607 testing for certain products

    • Standard Requirements and Needs by Material Type

    Different material types have varying levels of standard requirements and needs:

  • Polymeric materials: Must comply with ISO 11607 testing

  • Metallic materials: May not require ISO 11607 testing

  • Ceramic materials: May be required to comply with ISO 11607 testing for certain products

    • Standard Requirements and Needs by Process Type

    Different process types have varying levels of standard requirements and needs:

  • Sterilization processes: Must comply with ISO 11607 testing

  • Non-sterilization processes: May not require ISO 11607 testing

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