Sterilization; Storage And Transport - KLS Martin group L1 Rib Gebrauchsanweisung

5.7

Sterilization

The following steam sterilization procedure must be used for sterilization; other sterilization procedures
are not permitted.
Steam sterilization:
• fractionated vacuum procedure (with sufficient product drying
• Steam sterilizer according to DIN EN 13060/DIN EN 285 or ANSI AAMI ST79 (for the US: FDA clearance)
• validated according to DIN EN ISO 17665 (valid IQ/OQ (commissioning) and product-specific
performance evaluation (PQ))
• maximum sterilization temperature 134°C (273°F; plus tolerance according to DIN EN ISO 17665)
Steam sterilization with fractionated pre-vacuum
Pre-va cuum cycl es
Medi um
Steri lization time
Steri lization temperature
Dryi ng ti me
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The proof of the general suitability of the products for an effective steam sterilization was provided by an
independent, accredited and recognized test lab (§ 15 (5) MPG [German Medical Devices Act]) using a
steam sterilizer HST 6x6x6 (Zirbus technology GmbH, Bad Grund), applying the fractionated vacuum process
and using a commonly available paraffinic-white-oil-based, additive-free instrument oi (greasing of joints
and friction surfaces). Typical conditions in clinics and physicians' practices as well as the procedure
described above were taken into account.
Do not use gravitational sterilization, lightning sterilization, hot air sterilization, radiation sterilization,
formaldehyde sterilization, ethylene oxide sterilization or plasma sterilization.
5.8

Storage and transport

Shipping contaminated products could result in the death of or serious injury to third parties!
When returning products, send only cleaned and disinfected products in sterile packaging.
• Keep clean during storage and transport.
• Avoid major temperature fluctuations.
• Protect from mechanical damage.
The actual drying time required depends directly on parameters which are the sole responsibility of the user (loading configuration and
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density, sterilizer condition, ...) and must therefore be determined by the user. Nichtsdestotrotz sollten Trocknungszeiten von 20 min nicht
unterschritten werden.
58
mi n. 3 x
s a turated water va por
3 mi n (or l onger)
132°C, pl us tolerance
10 mi n
)
3
L1 Rib
Instructions for Use
Revi sion 01