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AAMI ST 15883-2 pdf free download

AAMI ST 15883-2 pdf free download.Washer-disinfectors – Part 2: Requirements and tests for washer disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etC.
4.2 Cleaning
4.2.1 Cleaning shall be tested in accordance with the requirements of ISOANSI/MMI ST15883-1 using the test soils and methods specified in ISOITS 15883-5 or AAMIITIR3O that are pertinent to the loads to be processed.
The cleaning process shall meet the requirements of the test specified in 6.2.
4.2.2 During the washing stage:
the washing time shall start when the temperature at the control sensor of the WD reaches the specified washing temperature;
the washing temperature band shall have the lower limit defined by the washing temperature and an upper limit of the washing temperature +10°C (see ISQANSI!AAMI ST15883-1, 4.2.3).
4.2.3 Throughout the washing time the temperatures on any surface of the load, chamber walls, chamber drain and the load carrier shall:
be within the washing temperature band;
— not differ from one another by more than 5 K.
NOTE A washing stage can include two or more washing temperatures and washing temperature bands.
4.3 Disinfecting
4.3.1 Each operating cycle shall include a thermal disinfection stage for which the time at which the load is maintained at the disinfection temperature gives an 110 of at least 600 to provide at least intermediate-level disinfection on all surfaces of the load to be disinfected when tested in accordance with
6.3.
4.3.2 The cycle shall include a thermal disinfection stage giving an Ao of at least 600 to provide at least intermediate-level disinfection on all the internal surfaces of the chamber and on the load carrier when tested in accordance with 6.3.
4.3.3 The WD shall provide for disinfection times and temperatures to be set to provide the claimed level of disinfection give an Ao value up to a maximum value of not less than 3,000.)
5.1.2.2 When there is a common connection for fluid at the same supply pressure to more than one channel or device, evidence shall be provided that the flow through each of the channels meets the minimum that is required for effective cleaning, disinfection and rinsing of each device to be processed. 5.2 Control systems 5.2.1 Means shall be provided to pre-set the washing temperature over a range between room temperature and to 60 °C or higher. Adjustment shall be by means of a code, key or tool. 5.2.2 Means shall be provided to pre-set the disinfection temperature over a range between 75。C and not less than 95 °C. Adjustment shall be by means of a code key or tool. NOTE The manufacturer might need to adjust the_ minimum temperature for the_ specific operating characteristics of the installation location (e.g., high altitude location). 5.2.3 Means shall be provided to pre-set the disinfection time over the range from one minute to at least 60 min. Adjustment shall be by means of a code, key or tool.6.3.3 Temperature of internal surfaces of devices For internal surfaces of devices, the following additional test requirements apply. Insert one temperature sensor in each connector or in the pipe to the connector, as close to the connector as possible. (It might be necessary to modify the connector or the pipe to the connector in order to position the temperature sensor.) b) Install a flow meter in the pipe to each connector. c) Insert a temperature sensor in the discharge of process fluid from the device. The temperature sensor shall be shielded from heating by contact with process fluids within the chamber. The flow meter [see b)] should have a scale range from 0 to the maximum flow specified by the manufacturer of the WD +20 % and an accuracy of at least 5 % of the full scale over the temperature range 20 °C to 100 °C. For operational qualification and performance qualification testing, the four points identified during type testing as representing the range of temperatures shall be used.AAMI ST 15883-2 pdf download.

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