DANSK DSF/FPREN ISO 20342-1 PDF

This international standard applies to safety and performance of products intended to redistribute the load of the full body during periods of lying and to prevent and or treat pressure sores and injuries. This international standard will cover a range of different lying support surfaces intended to be used in combination with e.g. a medical bed, stretcher, trolley, operating theatre table or as a whole integrated system. This international standard also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position. This international standard does not apply to lying support surfaces used in combination with incubators. This international standard will also consider the combination of a full body support surface and an adjustable mattress support platform. The following aspects will be covered: ‐ safety, ‐ performance test methods and recommendations for clinical relevance ‐ protection against injuries to the patients/disabled persons. This international standard specifies requirements and test methods for assistive products within the following divisions of ISO 9999:2011: 04 33 06 Assistive products for tissue integrity when lying down, included are: ‐ Mattresses and mattress overlays for pressure‐sore prevention; ‐ Mattress coverings for pressure‐sore prevention mattresses; 12 31 03 Sliding boards, sliding mats and turning sheets. Only included are the following products intended to be used in a lying position and to 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 meter, cut as required for repositioning use; ‐ Powered turning products; This excludes: Sliding boards; Note: The title and explanation of 12 31 03 will be changed in the 2016 ed. of ISO 9999 to: Assistive products for sliding and turning. (Devices for changing position or direction of a person using sliding and turning techniques. Included are, e.g. sliding boards, sliding mats, turning sheets, turning cushions.) 18 12 15 Bedding, only included are: ‐ Leg positioners; ‐ Multi purpose body positioners; ‐ Arm positioners; ‐ Draw sheets; Note: In the 2016 ed. of ISO 9999 these products will be classified in 09 07 06 Positioning pillows, positioning cushions and positioning systems. Only draw sheets will remain in 18 12 15. This international standard only covers Part 1: General requirements. In order to ensure patient safety aspects. The intention is to develop a series of standards to cover the broad range of issues related to the mattresses, please see below for a non‐exhaustive list of areas to be covered. However, this part 1 only covers General requirements. ISO 20342‐1 Assistive products for tissue integrity when lying down; Part 1: General requirements ISO 20342‐2 Assistive products for tissue integrity when lying down; Part 2: Test methods for full body support surfaces for characteristics related to tissue integrity (immersion and heat and water vapor transmission characteristics) ISO 20342‐3 Assistive products for tissue integrity when lying down; Part 3: Property test methods