DIN Standards Committee Quality Management, Statistics and Certification
DIN SPEC 58929
Operation of small steam sterilizers in the health-care system - Guidance for validation and routine control of sterilization processes
Betrieb von Dampf-Klein-Sterilisatoren im Gesundheitswesen - Leitfaden zur Validierung und Routineüberwachung der Sterilisationsprozesse
Procedure
VN
Overview
The application of re-usable medical devices that are of low microbiological contamination or are sterile intended for direct use on patients assumes a previous processing of such medical devices. In order to be able to produce this condition and maintain it up until use, the total process of re-processing under use of extensive quality assurance measures is required to run in correspondence with the state of the art. Therefore, defined requirements shall be placed on the processing. The conditions under which a medical device may be designated as "sterile" are specified in DIN EN 556-1. It shall be specified in accordance with the "Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten" ("Requirements on hygiene during processing of medical devices") of the Robert Koch Institute (RKI) which medical devices shall be sterile.
All individual processing steps shall be coordinated with respect to the medical device, the previous processing and the previous as well as subsequent use of the medical device and shall always ensure the fulfilment in a consistently comprehensible and reproducible manner by the application of validated methods.
The basic requirements for the development, validation and routine control of a sterilization process for medical devices are specified in DIN EN ISO 17665-1.
DIN SPEC 58929 (pre-standard) provides guidance and specifies requirements for validation and routine control of steam sterilization processes used in small sterilizers. For application in Type N processes in accordance with DIN EN 13060 parts of this pre-standard can be used analogously.
With this pre-standard the user and the operator of small steam sterilizers are provided with approaches which allow them - also under use of justifiable simplifications if applicable - to verify the specification-appropriate execution of the sterilization method as a validated part of the process method in accordance with the state of the art and with the applicable rules and regulations.
Working Committee NA 063-04-01 AA "Dampf-Sterilisatoren" ("Steam sterilizers") at the Medical Standards Committee is responsible at DIN, the German Institute for Standardization e. V.
