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BME 2600 / 3600 / 4600: BME Design - Fox (Fall 2023)

Researching 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) Check the FDA Consensus Standards.

(c) Searching the websites of relevant standards organizations, particularly ISO - (1) as another way of finding relevant standards (2) to get more information about a standard you have identified.


If you need to place an order for a specific standard:

(a) check the Standards in the UVM Libraries collections

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

Search steps

Screenshot of workflow for searching for standards

FDA Consensus Standards

Search individual organizations

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

Request a copy of a standard

(Some) questions about standards answered

Q: Something that is unclear for me is why there are different standards and not just one that satisfies all countries?

Q: Because there are so many organizations/companies that create standards, is there a straightforward way to know which organization would have the standards for a specific thing?

Q: What should someone do if a standard does not exist for their intended design?

Q: What are the consequences of missing a standard?

Q: If we wish to make standards more universal, and thus standardized, why can they be so complicated to get a hold of (via payment or convoluted processes to find) and thus not ideal for everyone to use?

Q: Why do engineers have to pay for ISO standards? Why aren't they free?

Q: If standard agencies like IEEE are private-sector companies, then how does the government validate these standards before implementing them in governmental agencies like the FDA?

Q: I want to know more about why the FDA does not issue their own standards, and if it has anything to do with bias?

Q: Do standards have patterns of bias to them? Are they created to work best for a certain race, gender, or ability?