DIN EN 556-2:2015-11

Medical devices marked as "STERILE" must be manufactured using appropriate and validated procedures. Sterilization of these medical devices in their final packaging is not always possible. In this case aseptic production is an alternative method. The standard defines the requirements that an aseptically manufactured medical device must meet if it is to be marked as "STERILE". Requirements for the aseptic manufacturing process and for provision of the documentation and records needed to demonstrate compliance with the requirements are specified. Requirements for medical devices that are to be marked as "STERILE" but were manufactured by sterilization in their final packaging are specified in DIN EN 556-1. The comparison of clauses of the standard and the essential requirements of the EC Directives 93/42/EEC on medical devices, 90/385/EEC on active implantable medical devices and 98/79/EC on in vitro diagnostic medical devices are contained in informative annexes. This standard has been prepared by Technical Committee CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom) in collaboration with German experts. The committee responsible for this standard is Working Committee NA 063-04-07 AA "Sterilisation von Medizinprodukten" ("Sterilization of medical devices") at DIN Standards Committee Medicine.