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82
Instandhaltung
Reinigung, Desinfektion und Sterilisation
Gassterilisation mit Ethylenoxid (EtO)
1. Alle Sterilisationszyklen müssen einen
Vorbehandlungszyklus umfassen
(Vorkonditionierung):
Temperatur: 54 ± 2 °C
Zeit: 30 Minuten
Luftfeuchtigkeit:
70 % (relative Feuchtigkeit)
Vakuum: 1.3 psia
2. KARL|STORZ hat die Sterilisation mit EtO für
folgende Werte validiert:
Gasgemisch:
100 % EtO
Temperatur:
Sollwert 55 °C
Relative Luftfeuchtigkeit:
70% RH
Einwirkzeit (Feuchtigkeit): 30-45 Minuten
Einwirkzeit:
180 Minuten
(kompletter Zyklus)
EtO-Konzentration:
735 ± 30 mg/l
3. Die Auslüftungszeit beträgt 12|Stunden in einem
Auslüftungsschrank bei einer Temperatur von
50 - 54 °C.
Zulässige Höchstwerte für Rückstände nach EtO-
Sterilisation (gemäß ANSI/AAMI/ISO 10993-7):
Ethylenoxid:
4 mg (< 24h)
Ethylenchlorhydrin: 9 mg (< 24h)
1
HINWEIS: Sterilisationsverfahren, die von
dem beschriebenen validierten Prozess ab-
weichen, müssen individuell validiert werden.
Dabei sind länder- sowie sterilisatorspezi sche
Voraussetzungen und Rahmenbedingungen
bezüglich der Effektivität der Sterilisation
sowie der gegebenenfalls erforderlichen
Auslüftungszeiten zu berücksichtigen.
Literatur zum Thema Reinigung und Sterilisation
• Gruendemann, B.J. and Meeker, M.H.
Alexander's Care of the Patient in Surgery,
7th edition. The C.V. Mosby Company,
St. Louis, Mo. 1983.
• Association for the Advancement of Medical
Instrumentation. Designing, Testing and Labeling
Reusable Medical Devices for Reprocessing
in Health Care Facilities: A Guide for Device
Manufacturers. AAMI TIR No. 12-1994.
• Descoteaux, J-G, Poulin, E.C., Julein, M.
and Guidoin, R. Residual Organic Debris on
Processed Surgical Instruments. AORN Journal,
Vol. 62, No. 1, pp. 23-29, 1995.
Maintenance
Cleaning, disinfection and sterilization
Ethylene Oxide (EtO) gas sterilization
1. All sterilization cycles must include a
preconditioning cycle:
Temperature: 54 ± 2°C (130 ± 5°F )
Time: 30 minutes, nominal
Humidity:
70% RH
Vacuum: 1.3 psia
2. KARL|STORZ has validated EtO sterilization
using the following parameters:
Gas mixture:
100% EtO
Temperature:
Set point of 55°C
Relative humidity:
70% RH
Humidity dwell time: 30-45 minutes
Exposure time:
180 minutes, (full cycle)
EtO concentration:
735 ± 30 mg/L
3. Aeration of the equipment can be accomplished
in any aeration chamber at a temperature of
50|-|54°C (120 - 130°F) for 12|hours.
Maximum acceptable levels of residues following
EtO sterilization are as follows (per
ANSI/AAMI/ISO
10993-7):
Ethylene oxide:
4 mg (< 24h)
Ethylene chlorohydrin:
9 mg (< 24h)
1
NOTE: Sterilization methods which deviate
from the validated processes described must
be validated individually. The country-speci c
and sterilization device-speci c requirements
and outline conditions concerning the ef-
fectiveness of the sterilization must be taken
into account, as must, where applicable, the
necessary airing times.
References for Cleaning and Sterilization
• Gruendemann, B.J. and Meeker, M.H.
Alexander's Care of the Patient in Surgery,
7th edition. The C.V. Mosby Company,
St. Louis, Mo. 1983.
• Association for the Advancement of Medical
Instrumentation. Designing, Testing and Labeling
Reusable Medical Devices for Reprocessing
in Health Care Facilities: A Guide for Device
Manufacturers. AAMI TIR No. 12-1994.
• Descoteaux, J-G, Poulin, E.C., Julein, M.
and Guidoin, R. Residual Organic Debris on
Processed Surgical Instruments. AORN Journal,
Vol. 62, No. 1, pp. 23-29, 1995.
,
1.
(
):
: 54 ± 2 °C
: 30
:
70 % (
.
: 1,3 psia
2.
KARL STORZ
: 100 %
:
55°|C
.
.
:
70% RH
(
):
30-45
:
180
(
:
735 ± 30
3.
12
50-54 °C.
(
ANSI/AAMI/ISO 10993-7):
:
4
(< 24 )
:
9
(< 24 )
1
:
,
,
,
,
:
• Gruendemann, B.J. and Meeker, M.H.
Alexander's Care of the Patient in Surgery,
7th edition. The C.V. Mosby Company,
St. Louis, Mo. 1983.
• Association for the Advancement of Medical
Instrumentation. Designing, Testing and Labeling
Reusable Medical Devices for Reprocessing
in Health Care Facilities: A Guide for Device
Manufacturers. AAMI TIR No. 12-1994.
• Descoteaux, J-G, Poulin, E.C., Julein, M.
and Guidoin, R. Residual Organic Debris on
Processed Surgical Instruments. AORN Journal,
Vol. 62, No. 1, pp. 23-29, 1995.
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