DIN Standards Committee Quality Management, Statistics and Certification
DIN 58946-7
Sterilization - Steam sterilizers - Part 7: Edificial preconditions, requirements for the services and the operation of steam sterilizers used in health care facilities
Sterilisation - Dampf-Sterilisatoren - Teil 7: Bauliche Voraussetzungen sowie Anforderungen an die Betriebsmittel und den Betrieb von Dampf-Sterilisatoren im Gesundheitswesen
Overview
The present new edition of DIN 58946-7 specifies the requirements for the edificial preparations and services supply of small and large steam sterilizers. Regarding the edificial requirements, the standard includes, in particular, requirements for doors, passageways, clearances, foundations, heat dissipation and noise control. The specifications for the services cover the electrical supply as well as the quality of steam, water and compressed air. Furthermore, the standard contains information in regards to the installation of the pipework required for the services and discharge. After the withdrawal of DIN 58946-6, the essential requirements for the operation of small and large steam sterilizers have been included in Part 7. It covers, in particular, the requirements for the personnel, the preconditions for the operation, the sterilization and testing procedures and documentation. Furthermore, this standard provides explanations and assistance for the interpretation and implementation of DIN EN ISO 17665 (all parts) with regard to validation and requalification. This standard has been prepared by Working Committee NA 063-04-01 AA "Dampfsterilisatoren" ("Steam sterilizers") of the Medicine Standards Committee (NAMed).
