Assistive products - Lifts for the transfer of persons with disabilities - Requirements and test methods (ISO 10535:2021); German version EN ISO 10535:2021
In March of this year, one of the most important standards for technical aids, that of lifts for transferring people with disabilities, was fundamentally updated. Among other things, an aspect that has long been demanded by many people, namely the compatibility assessment of lifts/body support systems, has finally been added.
If you search the vigilance databases of various regulatory agencies, you will find numerous reports of adverse events resulting from inappropriate selection and combination of lift booms (or other connectors) and body support systems that have led to injury and in some cases death of people with disabilities.
Examples of these incidents include:
- Errors when attaching or securing compliant body support systems
- Errors in the selection of the compliant body support system used
- Error in positioning the person in the body support system
- Errors during maintenance / repair of sling or clamp fasteners
- Errors during maintenance / repair of the joints
What has long been common practice for other technical aids and their accessories is now also available for lifts and lift accessories.
Combinations must be checked and approved:
- It must be stated for which type of lift the body support system is intended and vice versa
- The dimensions and type of stabiliser for which the body support system is intended and vice versa must be specified
- The type, size, dimensions, maximum load that can be applied and material of the lanyard and body support system must be specified
- and much more
These neuen Anforderungen bzw. das Wissen über die von den Hersteller*innen freigegebenen Kombinationen muss natürlich auch bei den Betreibenden ankommen. Here we refer to the regular training courses for medical device consultants. Manufacturers must keep their professional circles up to date with product training so that we can get the accidents described above and their avoidable consequences under control.
The update replaces EN ISO 10535:2006
Other significant changes are:
- Aspects of lifters with robotic properties have been added
- Guidelines have been added regarding the compatibility of lifts/body support systems, as explained above
- the informative annex to the inspection has been further developed
- Reduction of the minimum capacity of mobile lifts from 120 kg to 100 kg
- Added requirement for an emergency lowering device for mobile lifts and standing/raising lifts
Studies show that the nursing and care profession involves many physically demanding factors in the care and support of people with disabilities. A lift is a safe Assistive products for assisted lifting and moving. The new version specifies requirements and test procedures. The aim is to ensure essential aspects of safety for both the disabled person and the carer. At the same time, possible new developments in robot technology have been taken into account. Some of the requirements and test methods are general, while others only apply to certain types of mobile and stationary lifts.
Gerne können Sei uns zu Medizinprodukteberaterschulungen und anderen regulatorischen Themen contact us..
(1 Rating(s), average: 5.00 out of 5)
Loading...
