Both USP Class VI and ISO 10993 are standards used to evaluate the biocompatibility of medical devices and materials, but they differ in scope, testing requirements, and regulatory application. Here’s a detailed comparison:
- USP Class VI
– Issuing Body: United States Pharmacopeia (USP)
– Scope: Primarily used for plastics and polymeric materials that come into contact with pharmaceuticals or medical products.
– Key Tests (per USP <88>):
– Systemic Injection Test (acute toxicity)
– Intracutaneous Test (irritation)
– Implantation Test (7-day muscle implantation for local reactivity)
– Applicability:
– Often required for pharmaceutical packaging (e.g., vials, syringes) and devices regulated by the FDA.
– Commonly referenced in FDA submissions for drug containers and delivery systems.
– Limitations:
– Less comprehensive than ISO 10993.
– Does not cover long-term or specialized biocompatibility endpoints (e.g., genotoxicity, carcinogenicity).
- ISO 10993 (Biological Evaluation of Medical Devices)
– Issuing Body: International Organization for Standardization (ISO)
– Scope: Broadly covers all medical devices (polymers, metals, ceramics, etc.) and evaluates their biocompatibility based on contact duration and nature (surface, external, or implantable).
– Key Tests (depends on device category):
– Cytotoxicity (ISO 10993-5)
– Sensitization & Irritation (ISO 10993-10)
– Systemic Toxicity (ISO 10993-11)
– Genotoxicity (ISO 10993-3)
– Hemocompatibility (ISO 10993-4)
– Implantation Effects (ISO 10993-6)
– Chronic Toxicity/Carcinogenicity (ISO 10993-3/11)
– Applicability:
-Global standard (used in EU, US, Asia, etc.) for medical device biocompatibility.
– Required for CE Marking (EU MDR) and FDA submissions (though FDA aligns with ISO 10993 but has additional guidance).
– Advantages:
– More comprehensive, covering long-term and specialized risks.
– Risk-based approach (tailored testing based on device type and contact duration).
Key Differences
| Aspect | UPS Class VI | ISO 10993 |
| Scope | Plastics for pharmaceuticals | All medical device materials |
| Testing Depth | Limited (acute toxicity/ irritation) | Comprehensive (varies by device risk) |
| Regulatory Use | FDA (pharmaceutical packaging) | Global (FDA, EU MDR, etc.) |
| Contact Duration | Short-term focus | Covers short/long-term & permanent |
| Specialized Endpoints | No (e.g., no genotoxicity) | Yes (genotoxicity, hemocompatibility) |
Which One to Use?
– USP Class VI: Best for pharmaceutical packaging (e.g., drug containers, stoppers) where FDA requires it.
– ISO 10993: Mandatory for medical devices (implants, surgical tools, IV sets) in most global markets.
FDA Perspective
– The FDA recognizes ISO 10993 but may require additional tests.
– For drug packaging, USP Class VI is often requested as a baseline.
EU/CE Marking
– Only ISO 10993 is accepted (USP Class VI alone is insufficient).
Summary
– USP Class VI is a limited, material-focused standard for pharma applications.
– ISO 10993 is a risk-based, comprehensive framework for medical devices worldwide.
If you’re developing a medical device, ISO 10993 is essential. For pharma packaging, USP Class VI may suffice (but check FDA requirements). Many manufacturers test to both standards for broader compliance.
Would you like help determining specific testing requirements for your product?