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iso-11930-2-preservative-testing-for-leave-on-products
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Comprehensive Guide to ISO 11930-2 Preservative Testing for Leave-on Products Laboratory Testing Service Provided by Eurolab

ISO 11930-2 is an international standard that governs the testing of preservatives in leave-on products, such as creams, lotions, and gels. The standard specifies the test methods for evaluating the antimicrobial activity of these preservatives. In this section, we will provide comprehensive information about the relevant standards that apply to this specific laboratory test.

Relevant Standards

  • ISO 11930-2:2019 (E) - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic antimicrobial activity of chemical disinfectants and antiseptics
  • ASTM E2187-01(2020) - Standard Test Method for Determining the Antimicrobial Activity of Disinfectant Solutions Against S. aureus (ATCC 6538)
  • EN 12791:2019 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic antimicrobial activity of chemical disinfectants and antiseptics
  • TSE 1292-2020 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic antimicrobial activity of chemical disinfectants and antiseptics
  • These standards are developed by international organizations such as ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), EN (European Committee for Electrotechnical Standardization), and TSE (Turkish Standards Institution). They specify the test methods, equipment, and parameters required to evaluate the antimicrobial activity of preservatives in leave-on products.

    Standard Development Organizations

    The development of standards is a collaborative effort between international organizations, national standards bodies, and industry experts. The main standard development organizations involved in the development of ISO 11930-2 are:

  • ISO (International Organization for Standardization)
  • ASTM (American Society for Testing and Materials)
  • EN (European Committee for Electrotechnical Standardization)
  • TSE (Turkish Standards Institution)
  • Evolution of Standards

    Standards evolve and get updated to reflect changes in technology, industry needs, and scientific advancements. ISO 11930-2 has undergone several revisions since its first publication in 2006. The latest revision, published in 2019, includes updates to the test method, equipment requirements, and parameters.

    Scope and Compliance

    ISO 11930-2 applies to chemical disinfectants and antiseptics that are intended for use on surfaces or skin. It is essential for manufacturers of leave-on products to comply with this standard to ensure their products meet the required safety and efficacy standards.

    Industry-Specific Examples

    Compliance with ISO 11930-2 is mandatory for various industries, including:

  • Cosmetics: Creams, lotions, gels, and other leave-on products
  • Pharmaceuticals: Topical creams and ointments
  • Medical devices: Disinfectants and antiseptics for medical device cleaning
  • Standard Compliance Requirements

    Manufacturers must ensure their products comply with ISO 11930-2 requirements to:

  • Meet regulatory requirements
  • Ensure product safety and efficacy
  • Maintain customer confidence and trust
  • Facilitate international trade and market access
  • ISO 11930-2 Preservative Testing for Leave-on Products is a critical laboratory test that ensures the antimicrobial activity of preservatives in leave-on products. In this section, we will explain why this specific test is needed and required.

    Why This Test is Needed

    Preservatives are essential in leave-on products to prevent microbial growth and contamination. However, improper use or ineffective preservatives can lead to product spoilage, customer complaints, and even recalls.

    Business and Technical Reasons for Conducting the Test

    Conducting ISO 11930-2 Preservative Testing for Leave-on Products is essential for manufacturers due to:

  • Regulatory compliance requirements
  • Ensuring product safety and efficacy
  • Maintaining customer confidence and trust
  • Facilitating international trade and market access
  • Consequences of Not Performing This Test

    Not conducting this test can lead to:

  • Product recalls and reputational damage
  • Customer complaints and loss of business
  • Regulatory non-compliance and fines
  • Safety risks for consumers and users
  • Industries and Sectors Requiring This Testing

    The following industries and sectors require ISO 11930-2 Preservative Testing for Leave-on Products:

  • Cosmetics: Creams, lotions, gels, and other leave-on products
  • Pharmaceuticals: Topical creams and ointments
  • Medical devices: Disinfectants and antiseptics for medical device cleaning
  • Risk Factors and Safety Implications

    Failure to comply with ISO 11930-2 can lead to:

  • Microbial growth and contamination of products
  • Product spoilage and customer complaints
  • Regulatory non-compliance and fines
  • Safety risks for consumers and users
  • Test Methodology and Parameters

    ISO 11930-2 specifies the test method, equipment requirements, and parameters required to evaluate the antimicrobial activity of preservatives in leave-on products. The standard includes:

  • Test organisms: S. aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 9027)
  • Test medium: Mueller-Hinton agar
  • Incubation period: 18-24 hours
  • Zones of inhibition: Measured in mm
  • Standard Parameters

    The standard specifies the following parameters:

  • Concentration range: 0.1-10 w/v
  • Incubation time: 18-24 hours
  • Zone size: Minimum 15mm diameter
  • Test Methodology and Equipment Requirements

    ISO 11930-2 specifies the test method, equipment requirements, and parameters required to evaluate the antimicrobial activity of preservatives in leave-on products. The standard includes:

  • Test organisms: S. aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 9027)
  • Test medium: Mueller-Hinton agar
  • Incubation period: 18-24 hours
  • Zones of inhibition: Measured in mm
  • Test Instrumentation and Calibration

    The standard requires the use of calibrated equipment, including:

  • Sterile loops and inoculators
  • Incubators and temperature controls
  • Spectrophotometers or zone measuring devices
  • Interpretation of Results

    The results of ISO 11930-2 Preservative Testing for Leave-on Products are used to evaluate the antimicrobial activity of preservatives in leave-on products. The standard includes guidelines for interpreting the results, including:

  • Zone size: Minimum 15mm diameter
  • Concentration range: 0.1-10 w/v
  • Incubation time: 18-24 hours
  • Test Report and Certification

    The test report must include:

  • Test method and parameters used
  • Results obtained
  • Conclusion drawn from the results
  • Date of testing and expiration date (if applicable)
  • Certification Requirements

    Manufacturers must ensure their products comply with ISO 11930-2 requirements to obtain certification. The certification process involves submitting a test report to a recognized certification body, such as:

  • ISO/IEC 17025:2017 (E) - General requirements for the competence of testing and calibration laboratories
  • IEC 17065:2020 (E) - Conformity assessment - Requirements for assessing whether processes for conformity assessment, including certification, satisfy requirements
  • Conclusion

    ISO 11930-2 Preservative Testing for Leave-on Products is a critical laboratory test that ensures the antimicrobial activity of preservatives in leave-on products. Manufacturers must comply with this standard to ensure their products meet regulatory requirements, maintain customer confidence and trust, and facilitate international trade and market access.

    Test Methodology and Parameters

    ISO 11930-2 specifies the test method, equipment requirements, and parameters required to evaluate the antimicrobial activity of preservatives in leave-on products. The standard includes:

  • Test organisms: S. aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 9027)
  • Test medium: Mueller-Hinton agar
  • Incubation period: 18-24 hours
  • Zones of inhibition: Measured in mm
  • Test Instrumentation and Calibration

    The standard requires the use of calibrated equipment, including:

  • Sterile loops and inoculators
  • Incubators and temperature controls
  • Spectrophotometers or zone measuring devices
  • Interpretation of Results

    The results of ISO 11930-2 Preservative Testing for Leave-on Products are used to evaluate the antimicrobial activity of preservatives in leave-on products. The standard includes guidelines for interpreting the results, including:

  • Zone size: Minimum 15mm diameter
  • Concentration range: 0.1-10 w/v
  • Incubation time: 18-24 hours
  • Test Report and Certification

    The test report must include:

  • Test method and parameters used
  • Results obtained
  • Conclusion drawn from the results
  • Date of testing and expiration date (if applicable)
  • Certification Requirements

    Manufacturers must ensure their products comply with ISO 11930-2 requirements to obtain certification. The certification process involves submitting a test report to a recognized certification body, such as:

  • ISO/IEC 17025:2017 (E) - General requirements for the competence of testing and calibration laboratories
  • IEC 17065:2020 (E) - Conformity assessment - Requirements for assessing whether processes for conformity assessment, including certification, satisfy requirements
  • Conclusion

    ISO 11930-2 Preservative Testing for Leave-on Products is a critical laboratory test that ensures the antimicrobial activity of preservatives in leave-on products. Manufacturers must comply with this standard to ensure their products meet regulatory requirements, maintain customer confidence and trust, and facilitate international trade and market access.

    To learn more about ISO 11930-2 and how it can benefit your organization, please contact us at Your Company Email or visit our website at Your Company Website.

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