BME3012: Clinically-Inspired Engineering Design: Patents/Standards/Regulations

Patents

US Patent for US9861800B2 for systems and methods for controlling balloon catheters.

Types of Patents

Patent websites vary in coverage. Some only have full text or images for recent years. Some have better quality images than others. In some search engines, keywords only work on recent years. If you are doing a full, deep, and serious search, be sure to identify and search on the patent classifications as well as keywords.

There are three types of U.S. patents:

1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof. Utility patents are the most common type of patent and protect an invention for 20 years. 
Example: Eye tracking apparatus configured for degrading iris authentication (US11079843B2) 

2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture. Design patent numbers start with D and are protected for 14 years.
Example: Wiper blade ornament (USD707612S1)

3) Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant. Plant patent numbers start with PP and are protected for 20 years.
Example: Blueberry plant called Emerald (USPP12165P2)

...and patents include definitions of terms used. Remember, though, that patents are written by attorneys and not by engineers!

FDA Regulations & Standards

FDA Medical Device Databases

This pages offers links to various tools including:

• Recognized Concensus Standards Database Locate the various standards associated with medical devices.
• Device Listing Includes medical device establishments registered with FDA and medical devices listed with FDA (not necessarily approved by the FDA).  Use the quick search to locate a device or company by keyword.  An advanced search is also available.

Finding Standards

Through UF subscription (use UF VPN to access when off-campus):

• ASABE standards via the ASABE Technical Library. TIP: select standards from the Categories pull-down menu to search or you can browse a list of the standards.
• ASME Boiler and Pressure Vessel Code, Section II - Materials (2017) online via Knovel.
• ASTM Standards are online.  
• IEEE standards are online through the IEEE/IEE Electronic Library (IEL). Under the drop down menu next to the search box, click on Standards.

Free View/Read Access Online:

• ANSI Standards (American National Standards Institute) Incorporated by Reference (IBR) portal provides access to standards that have been incorporated by reference in the U.S. Code of federal Regulations (CFR) are offered at no cost in “read only” format for online reading. There are no print or download options. 
• NFPA Standards (National Fire Protection Association).  Under codes and standards drop down menu, look for the link Free access.  
• UL Standards (Underwriters Laboratory). Under UL Alternative Documents link, you can read them for free online via the Digital View option (free account required).

Remember: most government standards are also free, such as NASA standards.