To determine whether silicone is medical grade or industrial grade, you can make a comprehensive consideration from the following aspects:
1. Certification and standards
Check certification:
Medical grade silicone usually needs to pass ISO 10993 and other biocompatibility standards, and may be certified by authoritative organizations such as FDA (U.S. Food and Drug Administration) and CE (European Conformity Certification).
Industrial grade silicone may not need to meet such strict biocompatibility standards, but may need to meet other certifications such as ROHS (Directive on the Restriction of the Use of Certain Hazardous Ingredients in Electrical and Electronic Equipment) and UL (Underwriters Laboratories).
Reference standards:
The standards for medical grade silicone are usually more stringent, including requirements for material purity, processing technology, physical properties, etc.
The standards for industrial grade silicone may be relatively loose, focusing more on meeting the needs of specific industrial applications.
2. Uses and characteristics
Use:
Medical grade silicone is mainly used in medical fields such as medical devices, cosmetic repair, implants, etc., and requires good compatibility with human tissue.
Industrial grade silicone is widely used in electronics, machinery, construction and other fields, such as making seals, grease, shock pads, etc.
Features:
Medical-grade silicone usually has excellent biocompatibility, non-toxic and odorless, environmentally friendly and healthy characteristics, and will not release harmful substances even if it contacts the human body for a long time.
Industrial-grade silicone may pay more attention to high temperature resistance, anti-aging, waterproof and moisture-proof, chemical corrosion resistance and other properties.
3. Material composition and purity
Material composition:
The material composition of medical-grade silicone is usually purer and does not contain chemicals that are harmful to the human body.
Industrial-grade silicone may contain some chemicals that are harmless to industrial applications but harmful to medical applications.
Purity:
The purity of medical-grade silicone is usually higher to ensure compatibility with human tissue.
The purity of industrial-grade silicone may vary according to the needs of specific application scenarios.
4. Production environment and process
Production environment:
The production environment of medical-grade silicone is usually more stringent, requiring dust-free and sterile conditions.
The production environment of industrial-grade silicone may be relatively loose, focusing more on production efficiency and cost control.
Production process:
The production process of medical-grade silicone is usually more sophisticated, including strict requirements for raw material screening, molding, post-processing and other steps.
The production process of industrial-grade silicone may be more flexible and diverse to meet the needs of different industrial applications.
5. Price and Supplier
Price:
Generally speaking, the price of medical-grade silicone is higher than that of industrial-grade silicone because its material cost, production cost and certification cost are relatively high.
Supplier:
Choosing a supplier with good reputation and experience is also an important factor in judging the grade of silicone. Suppliers of medical-grade silicone usually have stricter quality control and more professional technical support.
In summary, judging whether silicone is medical-grade or industrial-grade requires comprehensive consideration of certification and standards, uses and characteristics, material composition and purity, production environment and process, price and supplier, etc. In practical applications, the appropriate grade of silicone can be selected according to specific needs and application scenarios.