Medical Adhesives
What are Medical Adhesives?
Medical adhesives are adhesives specially developed for use in medical devices and applications that meet the highest safety and quality standards. These adhesives must be biocompatible and fulfill strict regulatory requirements for contact with the human body.
Properties of Medical Adhesives
- Biocompatibility according to ISO 10993 standards
- IBOA-free formulations for workplace safety
- Sterilization resistance (gamma, ETO, steam)
- Low outgassing for sterile environments
- Chemical resistance to disinfectants
- Skin-friendly properties for direct contact
Applications
- Disposable medical products: Syringes, catheters and infusion systems
- Diagnostic devices: In-vitro diagnostics and laboratory equipment
- Implants: Long-term stable connections in the body
- Wearable devices: Skin-close sensors and monitoring systems
- Hearing aids: Housing bonding and electronics protection
Regulatory Requirements
- FDA 21 CFR 175.105: US food contact standards
- ISO 10993: Biocompatibility testing for medical devices
- USP Class VI: Biological compatibility testing
- CE marking: European medical device regulation
Material Compatibility
- Medical plastics: PP, PE, PC and PEEK
- Elastomers: Silicone and thermoplastic elastomers
- Metals: Titanium, stainless steel for implants
- Glass: Borosilicate glass for laboratory equipment
Processing Requirements
- Dispensing Valves: Sterile and precise application
- Clean room compatibility: Low particle emission
- Controlled shelf life for quality assurance
- Validatable processes for GMP compliance
Testing and Certifications
- Cytotoxicity tests: Cell compatibility studies
- Sensitization tests: Skin reaction testing
- Implantation tests: Long-term compatibility in the body
- Aging tests: Lifetime predictions
DELO Adhesive Solutions
- Comprehensive portfolio of medical-qualified adhesives
- 1-Component Systems for easy processing
- Biocompatibility documentation according to international standards
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