{"id":10565,"date":"2024-12-11T14:03:01","date_gmt":"2024-12-11T13:03:01","guid":{"rendered":"https:\/\/extali.eu\/docs\/3-krankenhausleitung\/3-6-dienste\/technisch-logistische-dienste\/3-6-36-sterilisation\/"},"modified":"2025-08-07T11:43:35","modified_gmt":"2025-08-07T09:43:35","slug":"3-6-36-sterilisation","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/3-krankenhausleitung\/3-6-dienste\/technisch-logistische-dienste\/3-6-36-sterilisation\/","title":{"rendered":"3.6.36 Central sterilisation"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"identifizierung\">Identification<\/h2>\n\n\n\n<p>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.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"bezeichnung_des_dienstes\">Name of the service<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"organigramm\">Organisation chart<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"leitung\">Management<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"kontaktpersonen\">Contact persons<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"aufgabenstellung_allgemein\">General task<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"wer_sind_die_kunden\">Who are the customers?<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"leistungskatalog\">Service catalogue<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"qualitaetspolitik\">Quality policy<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"vertragliche_vereinbarungen\">Contractual agreements<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"kommunikation\">Communication<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"bearbeitung_der_schnittstelle\">Editing the interface<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"ueblicher_ablauf_innerhalb_des_dienstes\">Usual procedure within the service<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"lieferzeitenreaktionszeiten\">Delivery times\/response times<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"berichtform\">Report form<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"reklamationsmoeglichkeit\">Complaints option<\/h3>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"verweise\">References<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notes and comments<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Applicable documents<\/h3>\n\n\n\n<p>Guidelines of the German Society for Hospital Hygiene (<a href=\"https:\/\/www.krankenhaushygiene.de\/informationen\/fachinformationen\/leitlinien\/\" target=\"_blank\" rel=\"noreferrer noopener\">DGKH<\/a>)<br>Requirements for the qualification of the persons carrying out the work (<a href=\"https:\/\/www.dgsv-ev.de\/fachinformationen\/leitlinien\/\" target=\"_blank\" rel=\"noreferrer noopener\">DGSV<\/a>)<br>Hygiene requirements for the reprocessing of medical devices of the&nbsp;<a href=\"https:\/\/www.rki.de\/DE\/Content\/Infekt\/Krankenhaushygiene\/Aufb_MedProd\/Aufb_MedProd_node.html\" target=\"_blank\" rel=\"noreferrer noopener\">KRINKO at the RKI<\/a><br>There are also further standards and guidelines<\/p>\n\n\n\n<p>SPECTARIS German Industry Association for Optical, Medical and Mechatronic Technologies e.V.&nbsp;<a href=\"https:\/\/www.spectaris.de\/medizintechnik\/themen\/hygiene-und-aufbereitung\/#c2721\" target=\"_blank\" rel=\"noreferrer noopener\">Recommendations for process validation<\/a> <\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h3>","protected":false},"excerpt":{"rendered":"<p>Identifizierung Wenn f\u00fcr Dritte sterilisiert wird, ist die Sterilisationsabteilung Medizinprodukte-Hersteller und muss die Norm DIN EN ISO 13485:2009 einhalten. Auch f\u00fcr den internen Betrieb soll der Standard eingehalten werden. Bezeichnung des Dienstes Organigramm Leitung Kontaktpersonen Aufgabenstellung allgemein Wer sind die Kunden? Leistungskatalog Qualit\u00e4tspolitik Vertragliche Vereinbarungen Kommunikation Bearbeitung der Schnittstelle \u00dcblicher Ablauf innerhalb des Dienstes Lieferzeiten\/Reaktionszeiten [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10561,"menu_order":32,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-10565","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10565","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=10565"}],"version-history":[{"count":2,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10565\/revisions"}],"predecessor-version":[{"id":14920,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10565\/revisions\/14920"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10561"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=10565"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=10565"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=10565"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}