DIN 58953-1:2010-05

The DIN 58953 standard series "Sterile supply" supplements the DIN EN ISO 11607 and DIN EN 868 standard series on packaging for terminally sterilized medical devices by specifying requirements for logistics, describing the application and handling of these packagings in health care facilities; furthermore it provides a comprehensive overview of terms. The new edition of part 1 "Terminology" has been completely revised on the basis of the aforementioned standard series and contains a current compilation of all terms and definitions that apply to packaging necessary for medical devices which shall be terminally sterilized. This includes definitions of terms which relate directly to packaging materials and packaging systems (such as sterile barrier systems, microbial barrier, protective packaging), but also definitions of terms on the thematic complex regarding the validation of forming, sealing and assembly processes (such as installation qualification, operational qualification, performance qualification) and definitions of terms which are used during handling (such as disposal, packing area, storage area for sterilized materials). Terms which have been added or deleted with respect to the previous edition, are given for information purposes in an informative annex. Part 6 contains two test methods for the determination of the microbial barrier of packaging materials. When applying the method for the determination of the microbial barrier under wet conditions, microorganisms are applied in droplets on test specimens; after incipient drying of the droplets an investigation is carried out to determine whether microorganisms have penetrated through the test specimens. The principle of the determination of the microbial barrier by means of passage of air is based on the fact that an air flow is being sucked through a microbial barrier test device, which may carry particles containing germs through the spore earth coated packing material. With respect to the previous edition, both methods have been revised; in particular the procedure is described more precisely. A standardized European or international test method for the determination of the microbial barrier of packaging materials is not yet available. Part 7 applies to the packing, labelling and loading of the sterilization chambers with sterilizer load which has been packed in paper bags, sealable pouches or reels, in sterilization paper, nonwoven wrapping material or textile materials. The individual materials themselves are specified in the DIN EN 868 standard series. The packaging technique, filling of the containers and their arrangement in the sterilization chamber are described. The requirements are supplemented by examples of packaging and loading techniques. Part 8 contains specifications for the delivery, storage, commissioning, transport and supply of sterile medical devices for and within health care facilities. This includes for instance requirements for the equipment, packaging and labelling. The aim is to maintain quality of the delivered medical products delivered in a sterile state until they are used under aseptic conditions. Part 9 applies to the sterilization of non-industrially sterilized products which are packed into sterilization containers according to DIN EN 868-8:2009-09 "Packaging für terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2009". The standard covers the prerequisites for the application of sterilization containers, their processing, putting sterilizer loads into the sterilization containers, sterilization (for instance loading the sterilizer), measures for supporting drying, demonstration of the processing, control of the condition, and handling. Regarding the labelling and storage of sterilization containers, reference is made to DIN 58953-8 "Logistics of sterile medical devices". The Committee responsible for the standards is NA 063-04-04 AA "Sterilgutversorgung" ("Sterile supply") of NAMed.