Medical Device Standards FAQ
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Standards FAQs


Below are the most common questions we receive about standards and standards development.

Explore our FAQs specifically about sterilization here.

What is a standard?
A standard is a document, established by consensus that provides rules, guidelines or characteristics for activities or their results (as defined in ISO/IEC Guide 2:2004).
How can I find out if my company is an AAMI member?
Please call AAMI at 1-800-332-2264, ext. 1214 or email membership@aami.org.
How can I join a standards committee?
AAMI does not require membership to participate on a standards committee. However, membership has its benefits! To learn more about membership options—whether as an individual, consultant, institution, or company—please contact membership@aami.org. Click here to learn more about standards committees.
How can I attend a Standards Meeting?
Check out our list of upcoming standards meetings to learn more about which committees are meeting in the coming months and whether they are open. Registration is ALWAYS required to attend.
I purchased a standard and have yet to receive it. Help!
Please contact our Customer Service department at customerservice@aami.org or 1-877-249-8226.
I’m having trouble accessing Committee Central.
If you can’t remember your username or password, please use this link to retrieve/reset. If you receive a message that says “Account Not Authorized” please contact standards@aami.org.
Can AAMI help with interpretation of a standard?
No. As a standards developing organization accredited under ANSI, AAMI is procedurally prohibited from providing interpretations of the standards and/or interpreting whether specific actions are in conformance with the standards. In addition, we do not have the technical expertise on staff to advise about specific practices. However, we can point you to content in the standards that might be helpful for your questions.
Can AAMI provide product recommendations or evaluations?
No. Please refer to the Buyers Guide for a list of subject matter experts that can assist you.
Can AAMI staff educate us on practices or products?
No. Please refer to the Buyers Guide for a list of subject matter experts that can assist you.
Can AAMI staff provide help on products or manufacturers?
No. Please contact the manufacturer directly.
Does AAMI offer certification on specific manufacturers/products?
No. Although AAMI Credentials Institute (ACI) does offer certification to healthcare professionals in other areas.
Can AAMI staff provide recommendations on specific manufacturers/products?
No.
Can AAMI staff help with questions on regulations?
No. You should contact the Centers for Disease Control and Prevention (CDC) or your local government bodies.
Can AAMI staff answer questions on ISO or IEC standards?
No. We can only point to content in these standards, but cannot give advice or interpretation.
Am I allowed to reproduce portions of a standard for our facility’s staff?
To learn about reuse permissions, click here. To request permission to reuse portions of a standard, go to the Copyright Clearance Center.
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