Area
Method
Verfahren
Temperature
Minimum
holding time
USA
Steam sterilization
Vacuum method
(3x fractionated
pre-vacuum)
Drying time
minimum 20 min
132°C
(270°F)
4 minutes
Other countries Steam sterilization
Vacuum method
(3x fractionated
pre-vacuum)
Drying time
minimum 20 min
132°C / 134°C
(270°F / 273°F)
5 minutes
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JMA-Optic
8.5. Packaging
Place the cleaned and disinfected components in sterile single-use packaging
that comply with the following requirements:
■
EN/ISO/ANSI AAMI ISO 11607 (for the USA: FDA approval).
■
Suitable for steam sterilization (temperature resistance to at least 142°C,
Sufficiently penetrable by steam).
■
Sufficient protection of the components as well as the sterile packaging against
mechanical damage.
8.6. Sterilization
For sterilization, please use only the listed sterilization methods
Steam sterilization
■
Fractionated vacuum process
■
Autoclave according to EN 13060/EN 285 or ANSI AAMI ST79 (for the USA: FDA approval).
■
Validated according to EN ISO 17665 valid IQ/OQ [commissioning] and product-specific
performance assessment [PQ])
■
Sterilization time (exposure time at sterilization temperature).
The basic suitability of the products for effective steam sterilization has been verified by
an independent accredited and recognized (§ 15 (5) MPG) testing laboratory using the
Tuttnauer EHS 3870 steam sterilizer and both the fractionated vacuum method, taking
into account typical conditions in clinics and medical practices and the procedure
described above.
8.7. Reusability
Undamaged and clean components that come into contact with mucous membranes or
diseased skin (semi-critical) can be reused if appropriate care is taken.
Excluded from this are single-use products (see:
overview table
). The user is responsible
for any further use, as well as for the use of damaged and contaminated components
(no liability in case of non-observance).
