3.6.36 Central sterilisation Estimated reading: 1 minute 177 views Authors Identification If sterilisation is carried out for third parties, the sterilisation department is a medical device manufacturer and must comply with the DIN EN ISO 13485:2009 standard. The standard should also be complied with for internal operations. Name of the service Organisation chart Management Contact persons General task Who are the customers? Service catalogue Quality policy Contractual agreements Communication Editing the interface Usual procedure within the service Delivery times/response times Report form Complaints option References Notes and comments Applicable documents Guidelines of the German Society for Hospital Hygiene (DGKH)Requirements for the qualification of the persons carrying out the work (DGSV)Hygiene requirements for the reprocessing of medical devices of the KRINKO at the RKIThere are also further standards and guidelines SPECTARIS German Industry Association for Optical, Medical and Mechatronic Technologies e.V. Recommendations for process validation Attachments Technical-logistical services - Previous 3.6.35 Pick-up and delivery service Next - Technical-logistical services 3.6.37 Cleaning service