DIN 58946-6:2002-04
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES
01-11-2006
12-01-2013
Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Definitionen
4 Anforderungen an das Personal
4.1 Personal für den Routinebetrieb
4.2 Personal für Leitung, Überwachungsaufgaben
und Schulung
4.3 Personalfür die Validierung
5 Einweisung
5.1 Allgemeines
5.2 Einweisung für den Routinebetrieb
5.3 Einweisung für die Instandhaltung
6 Betrieb
6.1 Bestimmungsgemässer Betrieb
6.2 Ausserordentlicher Betrieb
6.3 Voraussetzungen für den Routinebetrieb
6.4 Routinebtrieb
7 Dokumentation
7.1 Allgemeines
7.2 Protokoll der Validierung
7.3 Gerätebuch
7.4 Tagesprotokoll
7.5 Chargendokumentation
7.6 Freigabedokumentation
8 Prüfungen
8.1 Übersicht über die Prüfungen
8.2 Routineprüfungen
8.3 Prüfung der Mess-Steuer-Regel-(MSR)-technischen
Einrichtungen des Sterilisators
8.4 Prüfung auf Arbeitssicherheit
8.5 Prüfungen mit standardisierter Beladung
8.6 Prüfungen mit ausgewählten Konfigurationen
(repräsentative Beladungen)
9 Validierung
9.1 Allgemeines
9.2 Kommissionierung
9.3 Leistungsprüfung mit standardisierter Beladung
9.4 Rekommissionierung
9.5 Leistungsbeurteilung
9.6 Erneute Leistungsbeurteilung
9.7 Beurteilung und Nachweise
Literaturhinweise
This standard is included in DIN Handbook 169.
| DevelopmentNote |
Supersedes DIN 58946-3 (08/2002)
|
| DocumentType |
Standard
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| AAMI ST77 : 2013 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION |
| DIN 58946-8:1986-03 | STERILIZATION - STEAM STERILIZERS - SMALL STERILIZERS - EFFICIENCY TESTING |
| DIN 58946-1:1987-03 | STERILIZATION; STEAM FOR MEDICAL PRODUCTS; TERMINOLOGY |
| DIN 58946-2:1982-10 | STERILIZATION - STEAM STERILIZERS - BIG STERILIZERS - REQUIREMENTS |
| DIN 58946-4:1987-05 | STERILIZATION - STEAM-STERILIZERS FOR MEDICAL PRODUCTS - BIO-INDICATORS - CONCEPTS, REQUIREMENTS, TEST |
| DIN 58946-3:1981-11 | STERILIZATION - STEAM STERILIZERS - TEST OF EFFICACY |
| DIN EN 868-1:1997-05 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
| DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
| DIN EN 46001:1996-09 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| DIN EN 868-8:2009-09 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS |
| DIN EN 61010-1 : 2011 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| DIN EN 61010-2-041 : 1996 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-041: PARTICULAR REQUIREMENTS FOR AUTOCLAVES USING STEAM FOR THE TREATMENT OF MEDICAL MATERIALS AND FOR LABORATORY PROCESSES |
| DIN EN 867-4:2001-02 | NON-BIOLOGICAL SYSTEMS FOR USE IN STERILIZERS - PART 4: SPECIFICATION FOR INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK TEST FOR THE DETECTION OF STEAM PENETRATION |
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