Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
Abstract
ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor. ISO 17664:2004 specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification.
Requirements are specified for processing that consists of all or some of the following activities:
a) preparation at the point of use;
b) preparation, cleaning, disinfection;
c) drying;
d) inspection, maintenance and testing;
e) packaging;
f) sterilization;
g) storage.
When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing. It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards. In this case, a reference in the instructions is all that is required. For those medical devices where instructions for use are not required to accompany the medical device, other means of communicating the information can be used, e.g. user manuals, symbols or wall charts supplied separately.
The principles of ISO 17664:2004 may be applied when considering the information to be supplied with medical devices which only require disinfection prior to re-use.
ISO 17664:2004 is not applicable to textile devices used in patient-draping systems or surgical clothing.
DIN EN ISO 17664:2004-07 (D)
Sterilisation von Medizinprodukten – Vom Hersteller bereitzustellende Informationen
für die Aufbereitung von resterilisierbaren Medizinprodukten (ISO 17664:2004);
Deutsche Fassung EN ISO 17664:2004
Inhalt Seite
Vorwort ………………………………………………………………………………………………………………………………………..3
Einleitung ………………………………………………………………………………………………………………………………………4
1 Anwendungsbereich ……………………………………………………………………………………………………….5
2 Begriffe …………………………………………………………………………………………………………………………..5
3 Vom Hersteller bereitzustellende Informationen ………………………………………………………………7
3.1 Anweisungen zur Wiederaufbereitung ……………………………………………………………………………..7
3.2 Begrenzungen und Einschränkungen bei der Wiederaufbereitung …………………………………..7
3.3 Vorbereitung am Gebrauchsort ……………………………………………………………………………………….7
3.4 Vorbereitung vor der Reinigung ………………………………………………………………………………………8
3.5 Reinigung ……………………………………………………………………………………………………………………….8
3.6 Desinfektion ……………………………………………………………………………………………………………………8
3.7 Trocknen ………………………………………………………………………………………………………………………..9
3.8 Kontrolle, Wartung und Prüfung ……………………………………………………………………………………..9
3.9 Verpackung …………………………………………………………………………………………………………………..10
3.10 Sterilisation …………………………………………………………………………………………………………………..10
3.11 Lagerung ………………………………………………………………………………………………………………………10
4 Darstellung der Informationen ……………………………………………………………………………………….10
5 Validierung der bereitgestellten Informationen zur Wiederaufbereitung ………………………….11
6 Risikoanalyse ……………………………………………………………………………………………………………….11
Anhang A (informativ) Häufig angewendete Verfahren der Aufbereitung ……………………………………….12
A.1 Allgemeines ………………………………………………………………………………………………………………….12
A.2 Matrix zur Identifizierung des Aufbereitungsverfahrens …………………………………………………13
Anhang B (informativ) Beispiel einer Aufbereitunganweisung für wiederverwendbare
Medizinprodukten ………………………………………………………………………………………………………….15
Anhang ZA (informativ) Abschnitte in dieser Europäischen Norm, die grundlegende
Anforderungen oder andere Vorgaben von EU-Richtlinien betreffen ………………………………20
Literaturhinweise ………………………………………………………………………………………………………………………….21