ISO 15883-6-2011 pdf free download

ISO 15883-6-2011 pdf free download.Washer-disinfectors Part 6:Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
Laveurs désinfecteurs — Pat-tie 6: Exigences et essais pour les laveurs dOsinfecteurs utilisant
une désinfection thermique pour les disposit ifs médicaux non invasifs, non critiques et pour I’équipement de soins de sante.
5 Mechanical and control requirements
5.1 Control systems
5.1.1 Means shall be provided to pre-set the washing temperature over a range between room temperature and an upper limit. The upper limit shall not be less than 60 ‘C. Adjustment shall be by means of a code, key or tool.
5.1.2 Either the WD shall be provided with a system to indicate when there is insufficient process chemical available for the next cycle or the supply shall be visible to the operator in order to permit manual verification that sufficient process chemical is present.
5.1.3 Either the WO shall be fitted with means to ensure that a fault is indicated when insufficient process chemical has been admitted or it shall be possible for the operator to visually verify that the required amount of process chemical has been used.
5.1.4 Means shall be provided to pre-set the disinfection temperature over a range between 65 ‘C and an upper limit. The upper limit shall not be less than 90 ‘C. Adjustment shall be by means of a code, key or tool.
5.1.5 Means shall be provided to pre-set the disinfection time over the range from I mm to at least 60 mm. Adjustment shall be by means of a code, key or tool.
WDs of the pass-through type should be employed when practicable, to provide separation of cleaned and disinfected items from those awaiting processing.
5.2 Process verification
5.2.1 The WD shall be equipped with a means to visibly disp’ay the temperature attained in the chamber or the load or a means to visibly display that the required temperature has been attained. This means shall be independent from the controller in order to provide verification of achievement of the programmed disinfection temperature (see ISO 15883-1:2006, 5.11.4 a)].
5.2.2 Provision shall be made for the installation of a temperature recorder when specified by the purchaser. When a recorder is fitted in accordance with ISO 15883-1:2006, 5.11.4 b), this shall be deemed to meet the requirement of 5.2.1.
6 Testing for conformity
6.1 General
Testing for conformity shall be carried out in accordance with ISO 15883-1. See also Annex A.ISO 15883-6-2011 pdf free download.