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iso-25539-2-coronary-stents
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ISO 25539-2 Coronary Stents Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The International Organization for Standardization (ISO) has developed a series of standards to ensure the safety and performance of coronary stents, which are critical medical devices used in cardiac interventions. ISO 25539-2 is one such standard that outlines specific requirements for the laboratory testing of coronary stents.

Overview of ISO 25539-2

ISO 25539-2:2015(E) is a globally recognized standard that provides guidelines for the testing and evaluation of coronary stents. The standard specifies the methods for evaluating the physical, mechanical, and biocompatibility properties of coronary stents. The scope of this standard includes:

  • Physical properties (e.g., dimensions, weight)

  • Mechanical properties (e.g., tensile strength, fatigue resistance)

  • Biocompatibility (e.g., cytotoxicity, hemocompatibility)

    • International and National Standards

    Several international and national standards are relevant to ISO 25539-2 coronary stents testing:

  • ISO 10993-1:2009(E) - Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system

  • ASTM F1840-02(2014) - Standard Test Method for Measuring the Axial Compressive Strength (ACS) of Coronary Stents

  • EN ISO 10993-5:2009 - Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

    • Standard Development Organizations

    Several organizations contribute to the development and revision of standards related to coronary stents:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Electrotechnical Standardization (CENELEC)

    • Why This Test is Needed

    Coronary stent testing is essential for ensuring device safety, efficacy, and regulatory compliance. The consequences of not performing this test can be severe, including:

  • Device failure leading to patient harm or death

  • Regulatory non-compliance resulting in fines and reputational damage

    • Standard Requirements and Needs

    The standard requirements and needs for ISO 25539-2 coronary stents testing are driven by the need to ensure device safety, efficacy, and regulatory compliance. The business and technical reasons for conducting this test include:

  • Ensuring device performance meets regulatory requirements

  • Reducing risk of device failure and patient harm

  • Complying with international and national regulations

  • Maintaining product quality and reliability

    • Test Conditions and Methodology

    The following steps outline the testing procedure for ISO 25539-2 coronary stents:

    1. Sample Preparation: Coronary stents are prepared according to manufacturers instructions.

    2. Testing Equipment: Appropriate testing equipment is used, including mechanical testing machines and biocompatibility testing systems.

    3. Environmental Conditions: Testing is conducted in a controlled environment with specified temperature (23C 5C), humidity (50 10), and pressure conditions.

    4. Measurement and Analysis: Physical, mechanical, and biocompatibility properties are measured and analyzed according to standard methods.

    Test Reporting and Documentation

    The test report for ISO 25539-2 coronary stents testing includes:

  • Standard reference number

  • Test parameters and conditions

  • Measurement and analysis results

  • Interpretation of results

    • The reporting standards and formats include:

  • ISO/IEC 17025:2005(E) - General requirements for the competence of testing and calibration laboratories

  • ASTM E1753-10(2016) - Standard Guide for Writing Technical Specifications for Laboratory Tests

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