Medical Device Packaging Testing & Validation
Ensure your sterile barrier systems and medical device packaging meet global regulatory standards. Our ISO 11607 and ASTM D4169-compliant testing services help you achieve safety, compliance, and market readiness.
Why Medical Device Packaging Testing Matters
- Protects patient safety by maintaining sterile integrity
- Required for FDA, EU MDR, and global regulatory compliance
- Prevents costly recalls and delays in product launch
- Supports sustainability and optimized packaging design
Key Standards
ISO 11607
- Governs packaging for terminally sterilized medical devices
- Requires:
- Performance testing (transport simulation, aging)
- Stability testing (shelf-life validation)
- Seal integrity and strength testing
- Mandatory for CE marking and FDA clearance
ASTM D4169
- Distribution simulation for medical device packaging
- Includes:
- Drop, vibration, compression, and atmospheric conditioning
- Hazard level selection based on shipping environment
- Often combined with ISO 11607 for full compliance
Our Testing Capabilities
- Transportation Simulation (ASTM D4169, ISTA protocols)
- Accelerated Aging & Shelf-Life Studies
- Seal Strength & Integrity Testing (ASTM F88, F1929)
- Microbial Barrier Testing
- Environmental Conditioning (temperature, humidity)
- Burts and Creep (ASTM F1140)
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Intertek supports Medical Device manufacturers in meeting all Safety and Quality requirements around the world
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