ISO 8536 is a multi-part international standard titled:
“Infusion equipment for medical use”
It consists of several parts, each focusing on a specific component of infusion systems. Examples include:
Each part defines design, dimensions, material compatibility, sterilization, mechanical strength, and fluid dynamics requirements, ensuring complete safety and interoperability of medical infusion systems.
In medical settings, intravenous (IV) infusion is a common and critical procedure. Faulty or non-compliant devices can result in:
❌ Inaccurate medication dosage
❌ Fluid leakage or contamination
❌ Unsafe pressure buildup
❌ Compatibility issues with other components
❌ Risk to patient life and regulatory rejection
ISO 8536 ensures that all infusion components meet stringent design, performance, and biocompatibility criteria—helping prevent adverse events and guaranteeing safe fluid delivery.
Implementing ISO 8536 ensures your infusion equipment is globally compliant, safe, and high-performing:
🧪 Standardized Dimensions and Interoperability
Enables safe connection and use with various global healthcare systems and accessories.
🛡️ Sterility and Biocompatibility Assurance
Designed for sterile, single-use medical applications to minimize infection risk.
🔍 Material and Performance Validation
Covers compatibility with medication, strength, flexibility, and leakage resistance.
🩺 Supports Safe Dosage and Infusion Control
Ensures reliable flow rate and delivery accuracy across infusion systems.
✅ Essential for Regulatory Approvals (CE, FDA, MDR)
A recognized baseline for product compliance and certification.
Adopting ISO 8536 with GMC’s guidance brings measurable value to medical device manufacturers and suppliers:
✅ Streamlined Market Access (EU, US, Asia, etc.)
Ensure infusion devices meet import and certification requirements worldwide.
✅ Enhanced Product Safety and Brand Reputation
Reduce product recalls and increase healthcare provider trust.
✅ Simplified Regulatory Submissions
Supports technical documentation for CE Marking, US FDA 510(k), or CDSCO in India.
✅ Compatibility with Global Supply Chains
Manufacture parts and components that integrate seamlessly with others on the market.
✅ Reduced Compliance Risk and Costly Retesting
Avoid issues during audits, tenders, or quality inspections.
✅ Strengthen OEM and Private Label Partnerships
Build trust with partners by demonstrating international standards compliance.
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Growth Management Corporation is a management consulting firm that provides consulting, training, implementation, and certification services and solutions to organizations of all sizes, and all domains.
