Hjälpmedel för personer med funktionsnedsättning

Kommittébeteckning: SIS/TK 595 (Trycksårsprevention)
Källa: CEN
Svarsdatum: den 23 jul 2018
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This document applies to the safety of APTI, which make claims to redistribute the load of the full body, remain in situ during periods of lying, and to prevent and/or treat pressure injuries.

This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform or as a whole integrated system.

This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position.

This document does not apply to lying support surfaces used in combination with incubators.

This document will address the combination of a full body support surface and an adjustable mattress support platform. Safety and performance test methods to ensure protection against injuries to the user are the aspects that this document will cover.

This document specifies requirements and test methods for assistive products within the following divisions of ISO 9999:2016:

04 33 06 Assistive products for tissue integrity (APTI) when lying down:

— Mattresses and mattress overlays for pressure injury prevention;

— Mattress coverings for pressure injury prevention mattresses.

12 31 03 Assistive products for sliding and turning:

Devices for changing position or direction of a person using sliding or turning techniques. Only included are the following products intended to be used in a lying position and remain in situ as part of the lying support surface:

— Sliding products that glide one way and lock the other way;

— Sheets and underlays in flexible materials with low friction;

— Fabric sold by the metre, cut as required for repositioning use;

— Powered turning product;

This excludes sliding boards.

09 07 06 Positioning pillows, positioning cushions and positioning systems e.g:

— Leg positioners;

— Arm positioners;

— Multipurpose body positioners.

18 12 15 Bedding:

— Draw sheets

NOTE Through the use of this document, clinicians and manufacturers should consider the impact of other items (including additional APTI) used in conjunction with an APTI on tissue integrity and safety.