DIN EN ISO 15883-4:2026-10 - Draft

Requirements for washer-disinfectors for thermolabile endoscopes

DIN EN ISO 15883-4 specifies requirements and test methods for washer-disinfectors used for the cleaning and chemical disinfection of thermolabile endoscopes. In addition, the standard describes requirements for testing, validation, routine control and monitoring of these devices and processes. Its aim is to support the safe and effective reprocessing of thermolabile endoscopes in healthcare settings.

What is DIN EN ISO 15883-4 about?

The standard defines performance requirements for washer-disinfectors for thermolabile endoscopes and specifies how their effectiveness can be demonstrated. The focus is on the cleaning and chemical disinfection of endoscopes, as well as requirements for process control, validation and regular performance testing. It also describes specifications for water treatment systems, process chemicals and process monitoring.

Topics covered

• Requirements for washer-disinfectors for thermolabile endoscopes
• Cleaning, chemical disinfection, rinsing and drying
• Performance requirements and conformity testing
• Validation and requalification of reprocessing procedures
• Process monitoring and process control
• Requirements for water treatment systems
• Use and monitoring of process chemicals
• Leak testing and channel flushing
• Routine testing and performance evidence

Practical relevance

The reprocessing of thermolabile endoscopes is one of the particularly sensitive processes in healthcare facilities. DIN EN ISO 15883-4 supports operators, manufacturers and validation bodies in reliably meeting high hygiene, quality and safety requirements. It provides a uniform basis for the assessment and monitoring of reprocessing processes, thereby contributing to patient safety.

Changes compared with DIN EN ISO 15883-4:2019-06

The current edition includes revised normative references and updated terms and definitions. Requirements for monitoring the reuse of disinfectants have been added, along with new annexes on the testing of flexible endoscopes, biofilm testing and the assessment of load dryness. In addition, the bibliography has been revised.

Target group

• Manufacturers of washer-disinfectors
• Operators of medical device reprocessing units
• Hospitals and outpatient healthcare facilities
• Hygiene officers
• Validation and testing organizations
• Quality management managers
• Manufacturers and operators of endoscopes