4. Regulatory framework
The normative aspect was quickly coupled with regulatory constraints . The regulatory and normative domains converged, with the law making the main standards concerning the sterilization of reusable medical devices enforceable.
The first measures were recommended in circulars. Circulars do not have regulatory status in their own right; however, they often define reference practices that can be used as a basis in court.
4.1 Decree on good hospital pharmacy practice of June 21, 2001
Good...
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Regulatory framework
Objectives of hospital traceability
Bibliography
- (1) - GOULLET (D.), ROZENBAUM (L.) - FD 98 135 Maîtrise des traitements appliqués aux dispositifs médicaux réutilisables - Fascicule de documentation Afnor Groupe d'experts Co-Présidents , (2004).
- (2) - ROZENBAUM (L.) - Encadrement réglementaire en stérilisation centrale - Afnor, Hygiène et sécurité...
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