Where should I start looking for BME standards?
Within BME, there are several commonly used standards that you'll want to consider for your project:
- ANSI/AAMI/ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
- ANSI/AAMI/ISO 14971 Medical devices - Application of risk management to medical devices
- ANSI/AAMI/IEC 62304 Medical device software — Software life cycle processes
- ANSI/AAMI/IEC 62366 Medical devices — Application of usability engineering to medical devices
- ANSI/AAMI/IEC 60601 Medical electrical equipment
- ANSI/AAMI/ISO 10993 Biological evaluation of medical devices
- ANSI/AAMI/ISO 11607 Packaging for terminally sterilized medical devices
Remember that BME standards often have multiple parts and those parts can be collateral and particular standards!
An important resource to search for possible BME standards is the US Food and Drug Administration (FDA) Recognized Consensus Standards database Links to an external site..
This database contains thousands of voluntary consensus standards that have been recognized by the FDA (wholly or in part).
In the BME industry, while most of these consensus standards are voluntary, they are heavily used because demonstrating conformity with them "facilitates the premarket review process" and "may reduce the amount of supporting testing documentation typically needed in a premarket submission." Source: FDA Standards and Conformity Assessment Program Links to an external site.
You can search this database many ways, including SDO name, standard identification number, keyword or speciality group area. Below are the twelve consensus standards for a keyword search on 'endovascular.'