Aseptisk behandling av medicintekniska produkter - Del 5: Sterilisering på plats (ISO 13408-5:2006)
1.1This part of ISO13408 specifies the general requirements for sterilization in place (SIP) applied to productcontact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processingand offers guidance on qualification, validation, operation and control.
NOTESIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steamsterilization in place, which is the most common method used, is given in AnnexA.
1.2This part of ISO13408 applies to processes where sterilizing agents are delivered to the internal surfacesof equipment that can come in contact with the product.
1.3This part of ISO13408 does not apply to processes where equipment is dismantled and delivered to asterilizer.
1.4This part of ISO13408 does not supersede or replace national regulatory requirements, such as GoodManufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regionaljurisdictions.
1.5This part of ISO13408 does not specify requirements for development, validation and routine control of aprocess for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovinespongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced inparticular countries for the processing of materials potentially contaminated with these agents.
NOTESee also ISO22442-1, ISO22442-2 and ISO22442-3.