Overview
SIST EN ISO 8871-3:2004/A1:2019 is a European amendment to the international standard ISO 8871-3:2003/Amd 1:2018. It focuses on elastomeric parts used in parenteral and pharmaceutical devices, specifically detailing the method for the determination of released-particle count from these components. This standard is essential for ensuring the safety and quality of elastomeric components such as stoppers, seals, and other parts that come into contact with injectable drugs.
Produced under the coordination of the European Committee for Standardization (CEN), this amendment harmonizes testing procedures across European member countries, ensuring compliance with regulatory requirements for medical and pharmaceutical device manufacturers.
Key Topics
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Scope of Elastomeric Parts: Applies to elastomer components intended for parenteral use and various pharmaceutical device applications, highlighting their critical role in drug delivery safety.
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Released-Particle Count Determination: Specifies the standardized test methods for quantifying particles that may detach from elastomeric parts during handling or use. This addresses contamination risks related to injectable medications.
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Testing Methods Update: Amendment 1 introduces additional guidance, such as allowing the use of shaking machines with different horizontal circle parameters provided that comparability and equivalency can be demonstrated. This flexibility supports laboratory adaptability while maintaining test integrity.
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Harmonization and Compliance: Ensures consistent application across countries within the CEN network, facilitating market access and regulatory approvals of parenteral medical devices in Europe.
Applications
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Pharmaceutical Manufacturing: Manufacturers of injectable drugs rely on elastomeric parts that comply with SIST EN ISO 8871-3:2004/A1:2019 to minimize risks of particulate contamination, thus safeguarding patient health.
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Medical Device Production: Essential for producers of infusion sets, syringes, vial stoppers, and other non-active medical devices where elastomeric components interface with pharmaceutical substances.
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Quality Control Laboratories: Guidance on particle count testing supports rigorous quality assurance and control processes aimed at meeting stringent pharmaceutical industry standards.
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Regulatory Submissions: Provides a harmonized testing standard recognized by European regulatory bodies, facilitating smoother certification and market approval for medical devices and pharmaceutical packaging.
Related Standards
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ISO 8871 Series: This part (Part 3) is one segment of the broader ISO 8871 collection addressing elastomeric components for pharmaceutical use.
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CEN/TC 205 Standards: SIST EN ISO 8871-3:2004/A1:2019 corresponds with the work of CEN Technical Committee 205 on non-active medical devices, linking it to relevant quality and safety guidelines.
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ISO/TC 76: Developed under the ISO technical committee focusing on transfusion, infusion, injection, and blood processing equipment, ensuring broad international consensus.
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Pharmaceutical Quality Standards: Complements other pharmaceutical device standards addressing sterility, biocompatibility, and material suitability.
Keywords: elastomeric parts, parenteral devices, pharmaceutical use, released-particle count, SIST EN ISO 8871-3:2004/A1:2019, pharmaceutical packaging, particulate contamination, medical device standards, CEN, ISO 8871 series, quality control, injection equipment standards, pharmaceutical device testing.