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ISO 10993 Compliant Gasket Manufacturing & Distribution
At McDowell & Company, we specialize in manufacturing ISO 10993 compliant gaskets engineered for medical devices and biomedical applications. Our comprehensive range of biocompatible gaskets meets all relevant parts of ISO 10993 standards for biological evaluation of medical devices. When your application demands documented biocompatibility and risk assessment, selecting the right ISO 10993 compliant gasket manufacturer is essential. Our expertise ensures your gaskets meet international standards while delivering consistent sealing performance.
ISO 10993 Gasket Technical Aspects
Materials
- ISO 10993 tested silicones
- Biocompatible PTFE
- Medical-grade elastomers
- Validated compounds
- Custom formulations
- Implant-grade materials
- LSR (Liquid Silicone Rubber)
- High-purity fluoropolymers
Manufacturing Capabilities
- ISO Class 7 clean room
- Validated processes
- Particle-free production
- Bioburden control
- Custom molding
- Precision fabrication
- Contamination prevention
- Clean packaging
Quality Standards
- ISO 10993 series compliance
- ISO 13485:2016 certification
- USP Class VI testing
- FDA requirements
- EU MDR compliance
- Material certifications
- Risk assessment
- Full traceability
Industries Served
- Medical Device Manufacturing
- Implantable Devices
- Diagnostic Equipment
- Healthcare Products
- Biomedical Research
- Laboratory Systems
- Life Sciences
- Clinical Applications
End Applications
- Medical Devices
- Implantable Components
- Diagnostic Systems
- Patient Contact Devices
- Surgical Instruments
- Laboratory Equipment
- Drug Delivery Devices
- Clinical Equipment
ISO 10993 Compliant Gasket Frequently Asked Questions (FAQs)
1. What ISO 10993 testing is performed?
Our materials are tested according to applicable parts of ISO 10993
- Cytotoxicity (Part 5)
- Sensitization (Part 10)
- Irritation (Part 10)
- Systemic toxicity (Part 11)
- Genotoxicity (Part 3)
- Chemical characterization (Part 18)
- Relevant additional testing based on application
2. What documentation is provided for ISO 10993 compliance?
We provide comprehensive documentation including
- ISO 10993 test reports
- Biological evaluation reports
- Chemical characterization data
- Risk assessments
- Material master files
- Processing validation
- Sterilization validation
- Full lot traceability
3. How do you ensure ongoing ISO 10993 compliance?
We maintain compliance through:
- Regular material testing
- Process monitoring
- Change control systems
- Supplier qualification
- Material controls
- Documentation updates
- Quality system oversight
- Continuous validation
4. What sterilization methods are validated?
Our ISO 10993 compliant gaskets are validated for
- Steam sterilization
- Gamma radiation
- Ethylene oxide
- E-beam processing
- Multiple cycles
- Chemical sterilization
- Autoclave processes
- Dry heat
5. Can you help with ISO 10993 risk assessment?
Yes, we assist with:
- Material evaluation
- Chemical characterization
- Toxicological assessment
- Processing impact analysis
- Sterilization considerations
- Application review
- Documentation support
- Regulatory guidance
