EN 285-2015 pdf download.Sterilization-Steam sterilizers – Large sterilizers.
8.2.2 Bowle and Dick test
When the sterilizer is tested as described in Clause 17 the indicator shalt show uniform colour change throughout the indicator in accordance with EN ISO 11140-3:2009 and the instructions for the use of the indicator.
8.2.3 Air leakage
When the sterilizer Is tested as described in Clause 18 the rate of pressure rise shall be within the specified limits (see 25.4 c)j and in any case shall be not greater than 0,13 kPa/min (1,3 mbar/min).
8.2.4 Air detector
8.2.4.1 General
If an air detector is fitted the performance requirements in 8.2.4.2 to 8.2.4.4 shall apply.
8.2.4.2 Air detector, small toad
When tested as described in 19.2 an air detector shall cause a fault to be indicated if the volume of air or other non-condensable gases retained or introduced into the sterilizer chamber during the air removal and steam admission of the operating cycle causes a difference in temperature of more than 2 K. This difference is evaluated between the lowest measured temperature in a standard test pack (see 23.1) or reduced pack (see 23.2) and the temperature measured at the reference measurement point of the sterilizer chamber at the commencement of the equilibration time.
8.2.4.3 Air detector, full load
When tested as described in 19.3 an air detector shall cause a fault to be indicated if the volume of air or other non-condensable gases retained or introduced into the sterilizer chamber during the air removal and steam admission of the operating cycle causes a difference in temperature of more than 2 K. This difference is evaluated between the lowest measured temperature in a standard test pack (see 23.1) and the temperature measured at the reference measurement point of the sterilizer chamber at the commencement of the equilibration time.
8.2.4.4 Air detector Function
When the sterilizer is tested as described in 19.4 the test result shall be regarded as satisfactory if a fault is indicated.
8.2.5 Hollow load test
When the sterilizer is tested in accordance with Clause 15, the indicator system shall have reached its specified pass-condition.
9.1.1 Noise emission from sterilizers shall be reduced by design and selection of components with low noise emission levels, particularly at source.
NOTE Guidance to reduce noise at source is provided in EN ISO 12100:2010, 6.2.2.2 and 6.3.4.2.
9.1.2 If equipment produces noise (except alarms) at a level which could cause a hazard, A-weighted sound power and emission sound pressure levels shall be determined and specified for each type of sterilizer. For testing and calculation EN ISO 3746:2010 shall apply.
NOTE 1 For limiting values see Directive 2003/10/EC on noise risk.
The noise emission tests shall be performed In normal use condition with empty sterilizer chamber.
If the emission sound pressure level is required it shall apply for the operator’s position in front of the sterilizer at a distance of 1 m and a height of 1,6 m. If the A-weighted emission sound pressure level at workstation is 70 dB (A) or less at least this fact shall be indicated in the equipment information,
If not evaluated different from dedicated tests, the standard deviation for the sound power and emission sound pressure levels shall be stated to be +5 dB (see EN ISO 3746:2010, Table D.1).
NOTE 2 For test and calculation other methods of demonstrated equivalence can be used. Guidance is provided in EN ISO 3740.
If changes or modification of tested equipment have previously been identified as not contributing to more than 3 dB (A) to the total sound power level, further testing and change of the specification may be omitted.
9.1.3 The sound power level for any additional devices supplied for use with the sterilizer shall be specified.
9.2 VIbration
Vibrations from sterilizers shall be reduced by design, selection of components and devices limiting vibrations, particularly at source.
NOTE Guidance to reduce vibration at source is provided in EN ISO 12100:2010. 6.2.2.2, 6.2.3; 6.2.6 and
6.3.4.3.
10 Rate of pressure change
The average pressure change for any 3 s interval during the operating cycle shall not exceed 1 000 kPa/min (10 bar/mm). Compliance shall be tested as described in Clause 22.
NOTE This level has been chosen to limit the risk for product and packaging integrity.EN 285-2015 pdf download.
EN 285-2015 pdf download
PS:Thank you for your support!
