BELIMED WD290 - 2.5 Fields of application for the device; 2.6 Process validation

6/39 001 Instruction Manual WD290
10268 © Belimed
For your safety
2.5 Fields of application for the device
Cleaning and conditioning of:
• Surgical instruments
• Minimal-invasive instruments
• Instruments for anaesthesia and intensive care
• Baby bottles and teats
• Containers
• OP shoes
• Laboratory instruments from research and production
• Rigid endoscopes
• Eye instruments
• Neurosurgery
2.6 Process validation
The aim of process validation is to achieve a high level of safety in the recondi-
tioning of medical devices in order to afford the operators and patients the great-
est possible protection.
Process validation consists of:
a) Type testing / factory testing
b) Process validation consisting of:
• IQ - Installation Qualification
• OQ - Operational Qualification
• PQ - Performance Qualification
c) Routine testing / Annual requalification
(refer to appendix EN ISO 15883-1 November 2001, Chap. 6, Pages 35-37)
NOTE
Further information on process validation may be obtained from Belimed
Customer Service.
CAUTION!
Validation must only be carried out by authorised persons!
Devices must only be operated with processes validated in accordance with
regulations! Only use components (items to be washed, racks, programmes,
chemicals) which have been validated together.
The safety of operators and patients may be compromised if the devices
used are not validated in accordance with regulations.