ChM STERILE VH202 Instrucciones De Utilizacion página 9

of 20+/-2 °C using 20g of the agent per 1 liter of water. Immerse
the implant in the solution, exposure time – 15min (follow the in-
formation contained in the instructions prepared by the manufacturer
of the agent, in respect of temperature, concentration, exposure time
and water quality).
h) After the exposure time, rinse the product thoroughly under running
water, paying particular attention to the holes and places difficult to be
cleaned. It is recommended to rinse with demineralized water.
i) Dry the device thoroughly. It is recommended to dry the implant
in a dryer at a temperature ranging from 90°C to 110°C.
j) Visually inspect the entire surface of the device.
4) The automated method using a washer - disinfector
a) Equipment and materials: a washer - disinfector, aqueous solutions
of cleaning agent.
b) CAUTION: The equipment used for washing/disinfection should meet
the requirements of ISO 15883. Procedure of washing in the washer-
disinfector shall be performed according to internal hospital pro-
cedures, recommendations of the washing machine manufacturer,
and Instructions for Use prepared by the washing-disinfecting agent
manufacturer.
c) The device should undergo a process of machine washing in the wash-
er-disinfector using the following cycle parameters: (1) - pre-washing
in cold tap water, duration – 2min; (2) - washing in an aqueous solu-
tion of cleaning agent at 55+/-2 °C and pH of 10.4 - 10.8, duration –
10min; (3) - rinsing under demineralized water, duration – 2min; (4)
- thermal disinfection in demineralised water at 90°C, minimal dura-
tion – 5min; (5) - drying at a temperature ranging from 90°C to 110°C,
duration - 40min.
7. Packaging
1) Washed and dried devices shall be packed in a packaging intended
for the recommended steam sterilization. The packaging and pack-
aging process have to meet the requirements of ISO 11607 standards.
The packaging procedure must be performed in controlled purity condi-
tions. The device must be packed in such a way that during its removal
from the packaging, when used, there is no risk for its re-contamination.
8. Sterilization
1) Washed, disinfected, and dried device shall undergo the sterilization
process in accordance with the applicable procedures of the customer.
The recommended method of sterilization is vacuum-type steam steril-
ization (with water vapor under overpressure):
a) temperature: 134°C,
b) minimum exposure time: 7 min,
c) minimum drying time: 20 min.
2) CAUTION:
a) The sterilization process must be validated and routinely monitored
in accordance with the requirements of EN ISO 17665-1.
b) Sterilization must be effective and in accordance with requirements
of the EN 556-1 standard to ensure the required level of guaranteed
sterility SAL 10
c) Implant must not be sterilized in the packaging in which it was deliv-
ered.
d) The method of sterilization using ethylene oxide, gas plasma and dry
heat should not be used, unless the Instructions for Use for the product
contains sterilization recommendations using these methods.
e) The above-mentioned principles for cleaning and sterilization must be
applied to all implants intended for implantation.
f) The surgical instruments used for implants insertion should also be
covered by cleaning and sterilization procedure.
10 PRECAUTIONS
1. Implant is intended for single use only. After removing the implant from
(where SAL stands for Sterility Assurance Level).
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