Sterilisers Sfplus/Snplus; Intended Use; Note In Accordance With Medical Devices Directive; Guidelines For Sterilisation - Memmert UN PLUS Series Operating Instructions Manual

Sterilisers SFplus/SNplus

8. Sterilisers SF

8.1 Intended use

The SF /SN appliance serves for sterilising medical material through dry heated air at
PLUS PLUS
atmospheric pressure.

8.2 Note in accordance with Medical Devices Directive

The product lifetime as intended by the manufacturer is eight years.

8.3 Guidelines for sterilisation

For hot air sterilisation, there are different guidelines on the temperature and sterilisation
time to choose, as well as on packaging the sterilisation load. The values to be chosen depend
on the type and characteristics of the load to be sterilised and on the type of germs to be
neutralised. Before beginning sterilisation, make yourself familiar with the sterilisation method
laid down for your application.
Process parameters for hot air sterilisers are temperature and minimum hold time. The
following process parameters have been defined in recognised standards:
►
According to WHO: 180 °C with a minimum hold time of 30 min
►
According to the European Pharmacopoeia: 160 °C with a minimum hold time of 120 min
For the inactivation of endotoxin (pyrogenes), dry heat of at least 180 °C can be applied. For
the depletion of pyrogenic substances, you have to keep a combination of temperature and
time going beyond the requirements of sterilisation.
Inactivation of endotoxin is possible using the following process parameters (data in
accordance with ISO 20857:2010):
►
180 °C with a minimum effective time of 180 min
►
250 °C with a minimum effective time of 30 min
Caution:
The temperature and time requirements normal for hot air sterilisation do not destroy
endotoxins.
Especially when the appliance is heavily loaded, using these parameters without checking
them will not be sufficient. For safe sterilisation, validation of the individual sterilisation
process is required. The requirements for the validation of sterilisation by dry heat are e.g.
defined in standard ISO 20857:2010. Also valuable is the "guideline on validation and routine
monitoring of sterilisation processes using dry heat for medical products" issued by the
German Society for Hospital Hygiene (DGKH).
Sterilisers SF /SN
PLUS PLUS
default sterilisation programmes saved in the
appliance, which cannot be changed or deleted. A
description of how to activate them is provided from
page 48, their use is described from page 27. We
recommend to always use these programmes for
sterilisation.
If the process parameters are set manually,
setpoint-dependent operation is automatically
selected.
52
/SN
PLUS PLUS
feature
PROGRAM
Activate Test 012
Delete Test 022
Test 013
Test 014
Steri 180 °C
Test 015