BS EN ISO 20342-1:2019 - Assistive products for tissue integrity when lying down. General Requirements

BS EN ISO 20342-1:2019

Assistive products for tissue integrity when lying down. General Requirements

Status : Current   Published : July 2019



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?s ore 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

Standard NumberBS EN ISO 20342-1:2019
TitleAssistive products for tissue integrity when lying down. General Requirements
Publication Date17 July 2019
Normative References(Required to achieve compliance to this standard)ISO 554, IEC 60695-11-10, IEC 61000-3-3, ISO 14155, IEC 61000-4-3, IEC 61000-4-8, IEC 60601-1:2006, IEC 60601-1-6, ISO 9614-1, ISO 15223-1, IEC 61672-2, IEC 61000-3-2, IEC 60529, ISO 13732-1, IEC 61672-1, IEC 60601-1-8, IEC 60601-1-11, CISPR 11, ISO 10993-1, EN 1041, IEC 60601-1-2
Informative References(Provided for Information)ISO 9999:2016, ISO 14708-1:2014, ISO 21802, ISO 12952-2, EN 597-1, EN 614-1, ISO 14971, ISO 13850, ISO 5349-2, ISO 2631-1, IEC 62079, IEC/ISO Guide 71:2014, NFPA 701, ISO 11202, ISO 13485, ISO 12952-1, CGSB-4.2, EN 1021-2, ASTM E 1590, EN 894-3, ISO 21801, ISO/DIS 21801:2018, ISO 5349-1, EN 717-1, BS 7177, ISO 9227, EN 597-2, IEC 60601-2-52, EN 12182, EN 1021-1, UNI 9175, ISO 17966:2016, ISO 22523:2006, EN 1888:2012
International RelationshipsEN ISO 20342-1:2019,ISO 20342-1:2019
Draft Superseded By18/30324240 DC
DescriptorsPhysically-handicapped people, Testing, Disabled persons aids, Medical equipment, Health and safety requirements
Title in FrenchProduits d'assistance pour l'intégrité des tissus en position allongée Exigences générales
Title in GermanUnterstützende Produkte zur Gewebeintegrität im Liegen Allgemeine Festlegungen
ISBN978 0 580 90315 1
File Size1.462 MB

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