ISO 14126 Blood Penetration Resistance Laboratory Testing Service: A Comprehensive Guide
ISO 14126 is an international standard that specifies the requirements for blood penetration resistance testing of medical devices. This standard is part of a series of standards developed by ISO/TC 194, Medical and Surgical Materials, to ensure the safety and effectiveness of medical devices.
Relevant Standards
ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 14126:2013 Biological evaluation of medical devices Part 19: Blood penetration resistance testASTM F739:2015 Standard Test Method for Water Penetration and Resistance of Protective Clothing Materials (Withdrawn)EN 14605:2009A1:2010 Medical gloves for surgery, general-purpose and procedure packs for surgical operationLegal and Regulatory Framework
The ISO 14126 standard is recognized by regulatory authorities worldwide, including the US FDA, EU Notified Bodies, and other national competent authorities. Compliance with this standard is mandatory for medical device manufacturers to ensure their products meet safety and performance requirements.
Standard Development Organizations
ISO/TC 194 is responsible for developing standards related to biological evaluation of medical devices, including ISO 14126. The organization consists of representatives from various countries, industries, and stakeholders who contribute to the development and maintenance of these standards.
Standards Evolution and Updates
Standards evolve over time as new research, technologies, and regulatory requirements emerge. The ISO/TC 194 committee regularly reviews and updates existing standards to ensure they remain relevant and effective in ensuring product safety and performance.
Standard Numbers and Scope
ISO 10993-1:2018 specifies the overall approach for biological evaluation of medical devicesISO 14126:2013 defines the requirements for blood penetration resistance testingASTM F739 (withdrawn) was a US standard that provided similar test proceduresIndustry-Specific Compliance Requirements
Compliance with ISO 14126 is mandatory for various industries, including:
Medical device manufacturersRegulatory authorities and competent bodiesTesting laboratories and certification bodiesHospitals, clinics, and healthcare institutionsThe ISO 14126 standard is essential for ensuring the safety and effectiveness of medical devices. This section explains why this test is required, the business and technical reasons for conducting it, and the consequences of not performing it.
Why ISO 14126 Blood Penetration Resistance Testing is Required
Medical device manufacturers must ensure their products meet regulatory requirementsRegulatory authorities require evidence that devices do not compromise patient safety or cause infectionThe standard ensures that medical devices do not allow blood to penetrate the material, reducing the risk of infection and promoting patient safetyBusiness and Technical Reasons for Conducting ISO 14126 Testing
Compliance with regulatory requirementsEnsuring product safety and performanceReducing liability risks associated with device failure or inadequate testingEnhancing product credibility and reputationSupporting innovation and research development in the medical industryConsequences of Not Performing ISO 14126 Blood Penetration Resistance Testing
Regulatory non-compliance and finesProduct recall or withdrawal from the marketLoss of customer trust and confidenceDamage to brand reputation and credibilityIncreased liability risks associated with device failure or inadequate testingIndustries and Sectors that Require ISO 14126 Testing
Medical device manufacturersRegulatory authorities and competent bodiesHospitals, clinics, and healthcare institutionsResearch and development organizationsEducational institutionsRisk Factors and Safety Implications
Infection transmission through device material failureDevice failure leading to patient harm or deathEconomic losses associated with product recall or withdrawalDamage to brand reputation and credibilityQuality Assurance and Quality Control Aspects
ISO 14126 testing is part of a comprehensive quality assurance programTesting laboratories must follow strict quality control proceduresRegulatory authorities require evidence of adherence to standard requirementsThis section provides detailed information on the test conditions, equipment, and methodology used for conducting ISO 14126 blood penetration resistance testing.
Step-by-Step Test Procedure
1. Sample preparation: Device materials are prepared according to the standards requirements.
2. Testing apparatus: A blood penetrating device is assembled and calibrated.
3. Blood specimen preparation: Fresh or preserved human blood is prepared according to the standard.
4. Testing: The blood penetrates through the device material, and the time-to-penetration is measured.
5. Data analysis: Results are analyzed, and a pass/fail judgment is made.
Testing Equipment and Instruments
Blood penetrating devices (e.g., needle puncture or vacuum chamber)Temperature control systemsHumidity control systemsPressure sensorsMeasurement and data acquisition softwareTesting Environment Requirements
Temperature range: 20-25C (68-77F)Humidity range: 40-60Air pressure: Normal atmospheric pressureTest Methodology
Device materials are tested according to the standards requirements.Blood penetrates through the device material, and time-to-penetration is measured.Results are analyzed, and a pass/fail judgment is made.Data Analysis and Reporting
Raw data is collected and processed using specialized softwareTime-to-penetration values are calculated and compared to standard requirementsA report is generated, stating the results of the testingPass/Fail Criteria
Time-to-penetration: 60 minutes (pass) or > 60 minutes (fail)Please note that this is a summary of the main sections.
