Understanding Food-Grade vs Biocompatibility for Medical Device Materials by StarFish Medical NPI Team Lead, Dana Trousil, is featured in the August 14 online edition of Medical Product Outsourcing. Sub-titled “Outsourcing food-safe in no way implies it is also biocompatible,” the article covers the essential requirements of food grade material to contrast those requirements against biocompatibility.
Trousil notes,”Materials have been under increasing scrutiny in recent years. Events like the Tylenol recall in 2010 (due to leaching of chemicals from packaging) have heightened awareness. REACH (European Union Registration, Evaluation, Authorisation and Restriction of Chemicals) has extended the original RoHS (Restriction on Hazardous Substances) program, with increasing numbers of chemicals making the list.”
The article explains and explores:
- Extractables and Leachables
- USP Materials
- ISO 10993 table
Trousil concludes “It’s possible that a material is food-grade, food-safe, USP Class VI, and ISO 10993 compliant. But just because something is food-safe in no way implies it is also biocompatible. Without going through ISO 10993 and determining use cases and risks, the material may not meet your needs.”
About Medical Product Outsourcing
Medical Product Outsourcing is the only global magazine (circulation of 25,000 Verified-qualified recipients) dedicated to the growing trend of medical device outsource manufacturing. Our in-depth coverage includes comprehensive feature articles, industry news, trends and other developments pertinent to the contract manufacturer-OEM relationship.
About StarFish Medical
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StarFish Medical is a full service Medical Device Design company offering design, development, and manufacturing services based in Toronto and Victoria. We use our Pathfinder™ process to reduce wasted effort and increase success for medical device product definition, technical engineering, and product development. Prototype and volume production are delivered within an ISO 13485 certified Quality Management System and an FDA registered manufacturing and clean room facility. www.starfishmedical.com
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