What is ISO 15883-6 - Washer-disinfectors employing thermal disinfection about?
ISO 15883 is a European standard on washer-disinfectors. medical devices and healthcare equipment to enhance their performance.
ISO 15883-6 provides the requirements and test methods for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment to enhance their performance.
ISO 15883-6 is the sixth part of a multi-part series that outlines requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and it does not require an independent automated record of critical processes to be kept.
ISO 15883-6 is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this type can be used is restricted to devices and equipment that are non-invasive and non-critical (i.e., not penetrating the skin or contacting mucosal surfaces).
Note: Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or a combination of the two.
Who is ISO 15883-6 - Washer-disinfectors employing thermal disinfection for?
ISO 15883-6 on washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment is useful for:
- Manufacturers of washer-disinfectors
- Test centres
- Regulatory bodies
Why should you use ISO 15883-6 - Washer-disinfectors employing thermal disinfection?
Washer disinfectors are used for the automated cleaning and disinfection of instruments in practices, clinics, dental offices, medical centres, and hospitals. The non-invasive device does not penetrate inside the body, either through a body orifice or through the surface of the body.
ISO 15883-6 guideline assists you with performance requirements on cleaning and disinfecting for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment.
ISO 15883-6 guides on mechanical requirements and control requirements on control systems and process verification for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment.
ISO 15883-6 also guides on thermometric tests, tests for soil removal from chamber walls, tests for soil removal from load carrier, tests for soil removal from the load, information to be supplied by the manufacturer, and information to be requested from the purchaser by the supplier of the WD.
With compliance and obedience to ISO 15883-6, you can enhance the efficacy and standardise the performance of washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment.
