2. Regulations and standardization

Depending on their field of activity, users of cleanrooms are subject to regulations requiring them first and foremost to control contamination. The following standards and/or regulations are potentially applicable to them, depending on their activities (non-exhaustive list):

• pharmaceutical Good Manufacturing Practices (GMP) ;

• European medical device regulations (MDR 2017/745);

• good preparation practices ;

• good hospital pharmacy practice ;

• the order of June 11, 2013 on the rules of good practice designed to guarantee biological safety and security;

• the decree of July 16, 2007 setting out the technical preventive measures, in particular containment, to be implemented in research,...