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BME 3600 / BME 4600: BME Design - Fox (Fall 2024)

Standards

Standards: A standard is "a formula that describes the best way of doing something. It could be about making a product, managing a process, delivering a service or supplying materials – standards cover a huge range of activities." (ISO)

Required: standards tutorial

Note: the recommended browser for these tutorials is Chrome.

How to research standards

If you are doing a general search for standards that might apply to your project:

(a) Consult with experts and stakeholders who may be aware of relevant standards, e.g. faculty supervisor, research colleagues, or clients.

(b) Search the FDA Consensus Standards by keyword(s).

(c) Browse the FDA Consensus Standards by selecting the appropriate area in the "Specialty Task Group Area" dropdown menu.

(d) Prompt an AI tool for suggestions (but! keep in mind AI tools will return only a subset of possible matches and may return hallucinated information).

 

Once you have identified a standard that may be relevant, gather more information about the standard and how it is used:

(a) Look up the standard on the website of the standards development organization (e.g., ISO, IEEE, etc.). The SDO website should show an abstract and scope note.

(b) Search for academic or professional publications that describe the standard. Academic databases include PubMed and Google Scholar.

 

If you determine that a standard is relevant and you need a copy of the full text:

(a) Check the standards listing under Available now.

(b) If the standard you need is not listed there, skip to the Request a copy of a standard box to place an order.

 

FDA Consensus Standards

Search SDO websites

These are some (though not all) of the standards development organizations (SDOs) that maintain standards pertaining to biomedical engineering.

Available now

The standards and standards collections listed below are freely available from the UVM Libraries or from the SDO.

Request a copy of a standard

Some questions

  1. How do you know you've applied all the relevant standards? What is the procedure if you can't find a standard that relates to your project?
     
  2. How ethical is it that standards must be purchased? Doesn't that place limitations on who can innovate?
     
  3. What are the consequences of missing a standard?
     
  4. How are the "experts" that agree on the standards chosen?
     
  5. Do standards have patterns of bias to them? Are they created to work best for a certain race, gender, or ability?
     
  6. If we don’t know how to comply with a standard (we don’t know how to find/use a material needed for a sterilization standard), who can we go to?
     
  7. What if a company wants to make something that they think will outperform whatever the standard is? For example, using the Baltimore fire hydrant issue, what if the couplers were standardized and a company came along and said "I can make a better one, but it doesn't fit the standard."
     
  8. After graduating, how would you go about gaining access to these standards?

Librarian

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Graham Sherriff
(he/him)
Contact:
graham.sherriff@uvm.edu or MS Teams chat

Liaison to:
College of Engineering and Mathematical Sciences, US Patent and Trademark Office