DIN Standards Committee Health Technologies
DIN 58950-1
Sterilization - Steam sterilizers for pharmaceutical products - Part 1: Terminology; Text in German and English
Sterilisation - Dampf-Sterilisatoren für pharmazeutische Sterilisiergüter - Teil 1: Begriffe; Text Deutsch und Englisch
Overview
The standards of the DIN 58950 standard series apply to steam sterilizers for pharmaceutical products that are operated using saturated steam, a steam/air mixture or a steam/hot water/air mixture. They apply to horizontal steam sterilizers with nominal sizes of at least 6 dm×6 dm×6 dm (useable space ≤ 216 dm2). The Working Committee has established publishing the standard series in two languages. DIN 58950-1: The standard contains the terms and definitions required for the standards of the DIN 58950 standard series, taking into account the European and international terminology standards on sterilization. In addition to the definitions of F and F0, a calculation example has been incorporated in the informative annex. Process diagrams of exemplary sterilization processes are represented in another informative annex. DIN 58950-2: Specified are: - performance requirements for equipment with regard to the sterilizing temperature, sterilizing time, heat treatment of fluids with F0 value calculation, loading and unloading temperatures and waste water temperatures; - requirements for the mechanical construction of the apparatus, including materials, surfaces and thermal insulation; - safety devices and measurement and control equipment; - accompanying documents to be provided by the manufacturer. The requirements are supplemented by informative details, for example, on the appropriate combination of dimensions for the useable chamber space and on loading and unloading systems. DIN 58950-3: The standard specifies tests which shall be performed by the operating company and manufacturer before using the sterilizer for the production of sterile pharmaceutical products. Types of test, test sites, extent of testing equipment and auxiliary means to be used during testing are described. Detailed checklists for Installation Qualification, Operational Qualification, testing of safeguards and protective features and validation of the programme control were compiled in the normative annexes DIN 58950-6: The standard contains requirements which ensure the operation of steam sterilizers for sterile pharmaceutical products. This includes requirements for the personnel, qualification and re-qualification, execution of routine tests and documentation. Furthermore, it has been specified how to proceed in the case of modifications/changes on sterilizers and their decommissioning. Requirements for occupational safety are outside the scope of this standard. DIN 58950-7: The standard contains requirements for the services and discharge and constructional requirements. Requirements for the purity of the services steam, water and compressed air, whereby regarding the service with steam, a differentiation is made between heating steam, sterilizing steam and pharmaceutical pure steam. The services required for this purpose are also described. Information on safety devices, insulation and pipe run were taken into account. Connection and consumption values for the services to be reported by the manufacturer were also added. Constructional requirements contain information on foundations and ceilings and minimum clearances for walls and equipment. A form for the specification of the connection and consumption values for services and discharge and for the weights and the installation dimensions of a steam sterilizer for sterile pharmaceutical products has been incorporated in the informative annex. The standards have been prepared by Working Committee NA 063-04-05 AA "Sterilisatoren für pharmazeutische Sterilisiergüter" ("Sterilizers for sterile pharmaceutical products") of the Medicine Standards Committee (NAMed).
