EN ISO 15883

Area	Quality management
title	Washer-disinfectors - Quality management systems - Requirements for regulatory purposes
Latest edition	2009-09, 2011-07 (part 6)
ISO	15883

The EN ISO 15883 is a standard for cleaning and disinfection devices . It clarifies and describes the device requirements and the validation of the processes for processing. It is valid in Germany as the DIN standard DIN EN ISO 15883 .

Outline of the standard

The standard consists of seven parts:

Part 1 specifies general requirements, definitions and test methods laid
Part 2 describes the requirements and test methods for washer-disinfectors with thermal disinfection for surgical instruments , anesthesia machines, vessels, utensils, glass appliances, etc.
Part 3 specifies the requirements and test methods for washer-disinfectors with thermal disinfection for containers for human waste ( bedpan washer )
Part 4 Requirements and test methods for washer-disinfectors with chemical disinfection for thermolabile endoscopes
Part 5 test soiling and methods to demonstrate the cleaning effect, e.g. Z. draft CEN ISO / TS 15883-5: 2005
Part 6 specifies the requirements and test methods for washer-disinfectors with thermal disinfection for non-invasive, non-critical medical devices and accessories in the healthcare sector
Part 7 describes the requirements and test methods for washer-disinfectors with chemical disinfection for non-invasive, non-critical thermolabile medical devices and accessories in the healthcare sector

EN ISO 15883-1 General requirements, terms and test methods

Validation of cleaning / disinfection processes

There are 3 steps for the validation of washer-disinfectors :

The installation qualification (IQ) confirms that they are provided and installed according to the specification.
The operational qualification (BQ) confirms that, according to the manufacturer, they are performing the thermal disinfection properly and that they remain within the specified limit values.
The performance qualification (LQ) means that the performance of the cleaning effect and thermal disinfection of the cleaning and disinfection devices is checked using suitable test methods such as thermologgers, bio-indicators and test soiling.

EN ISO 15883-2 Requirements and test methods for cleaning and disinfection devices with thermal disinfection for surgical instruments, anesthesia devices, vessels, utensils, glass devices

The cleaning performance is tested with 50 ml sheep blood on cotton test pieces.

EN ISO 15883-3 Requirements and test methods for bedpan washers

Washer-disinfectors must meet the following requirements:

The program control must take place automatically.
Sensors to control and monitor disinfection must be available.
The process chemicals must be dosed automatically and this process must be controlled automatically.
The batches must be documented using a system.
The holding times and temperatures must be adjustable. The A0 value must be at least 600, for infectious diseases with viruses at least 3000. Let the D value of a disinfection process with moist heat be the time that is necessary at a certain temperature to reduce the germ count to 10%, and the -Value is the temperature increase necessary to reduce the D-value to 1/10. Then the A0 value of this process is the duration in seconds which, at a temperature of 80 ° C. transferred to the product by the process, leads to the killing of all those microorganisms for which the z value is 10.

EN ISO 15883-4 Requirements and test methods for endoscope cleaning devices with chemical disinfection

Endoscopes may be chemically disinfected due to the thermal instability of the endoscope tubes. There is a special test soil made of hep for the test. Blood + protamine and rinsing the endoscope tubes with NaCl and growing the germs on special culture media.

CEN ISO / TS 15883-5 test soils and methods

For bedpan washers, for example, stainless steel plates with a test soiling RAMS (cattle albumin , mucin , starch ) and Enterococcus faecium (bio-indicator) are used.

Instrument washers are tested with stainless steel screws in accordance with DIN 84M with E. faecium ATCC 6057 and contaminated mutton blood.

Endoscope washers are tested using the sponge test with the canal washing liquid (20 ml NaCl + inhibitor ). In addition, the last rinse water (250 ml) is examined or swabs are taken or bioindicators are used to arrive at a test result.