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iso-11137-chemical-resistance-of-sterilized-devices
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 11607 Material Compatibility with SterilizationISO 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 11137 Chemical Resistance of Sterilized Devices Laboratory Testing Service by Eurolab

ISO 11137 is an international standard that specifies the requirements for evaluating the chemical resistance of sterilized devices. This standard is developed and published by the International Organization for Standardization (ISO), which is a non-profit organization that brings together experts from various industries to establish common standards.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ISO 11137 testing service is governed by international and national standards, such as ISO 11137:2017, ASTM F1671-13, EN ISO 11137-2:2006, TSE EN ISO 11137-2:2006, and others. These standards outline the requirements for evaluating the chemical resistance of sterilized devices, including the testing conditions, sample preparation procedures, measurement and analysis methods, and reporting standards.

International and National Standards

The international standard ISO 11137 is a widely recognized and adopted standard globally. However, national standards may have specific requirements or variations based on local regulations and industry needs. Some notable examples of national standards include:

  • ASTM F1671-13 (USA)

  • EN ISO 11137-2:2006 (Europe)

  • TSE EN ISO 11137-2:2006 (Turkey)

  • AS/NZS 4815:2010 (Australia and New Zealand)

    • Standard Development Organizations

    The development of standards is a collaborative effort between industry experts, governments, and other stakeholders. Standard development organizations, such as the International Organization for Standardization (ISO), play a crucial role in establishing common standards and guidelines.

    Evolution of Standards

    Standards are constantly evolving to reflect new technologies, innovations, and changing regulatory requirements. The revision process involves revising existing standards or developing new ones to ensure they remain relevant and effective.

    Standard Numbers and Scope

    The following standard numbers and their scope are relevant to ISO 11137 Chemical Resistance of Sterilized Devices testing:

  • ISO 11137:2017 - Chemical resistance of sterilized medical devices (Sterilization of medical devices using ionizing radiation)

  • ASTM F1671-13 - Standard test method for evaluating the effects of steam sterilization on medical devices

  • EN ISO 11137-2:2006 - Sterilization of medical devices using ionizing radiation - Part 2: Validation requirements

    • Standard Compliance Requirements

    Compliance with international and national standards is mandatory in various industries, including:

  • Medical device manufacturers

  • Pharmaceutical companies

  • Food processing and packaging industry

  • Aerospace and defense industry

  • Automotive industry

    • Inadequate compliance can result in product recalls, fines, and damage to reputation.

    Consequences of Not Performing ISO 11137 Testing

    Not performing ISO 11137 testing can lead to:

  • Reduced product safety and reliability

  • Increased risk of contamination and infection

  • Regulatory non-compliance and associated penalties

  • Loss of market share and revenue

    • Industries and Sectors Requiring ISO 11137 Testing

    ISO 11137 testing is required in various industries, including:

  • Medical devices (e.g., implants, surgical instruments)

  • Pharmaceutical industry (e.g., packaging, equipment)

  • Food processing and packaging industry

  • Aerospace and defense industry

  • Automotive industry

    • Risk Factors and Safety Implications

    Performing ISO 11137 testing helps mitigate risks associated with chemical resistance of sterilized devices. Failure to perform this test can lead to:

  • Reduced product safety and reliability

  • Increased risk of contamination and infection

  • Regulatory non-compliance and associated penalties

    • Quality Assurance and Quality Control Aspects

    ISO 11137 testing is an essential aspect of quality assurance and control in various industries. The benefits include:

  • Improved product safety and reliability

  • Enhanced regulatory compliance

  • Reduced risk of contamination and infection

  • Increased customer confidence and trust

    • Competitive Advantages of ISO 11137 Testing

    Performing ISO 11137 testing provides competitive advantages, including:

  • Improved market positioning

  • Enhanced reputation and credibility

  • Increased customer loyalty and retention

  • Competitive edge in the market

    • Cost-Benefit Analysis of ISO 11137 Testing

    While performing ISO 11137 testing may involve costs, the benefits far outweigh them. The cost-benefit analysis includes:

  • Reduced risk of contamination and infection

  • Improved product safety and reliability

  • Enhanced regulatory compliance

  • Increased customer confidence and trust

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

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