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BS EN ISO 20342-1:2022 – TC

$246.62

Tracked Changes. Assistive products for tissue integrity when lying down – General requirements

Published By Publication Date Number of Pages
BSI 2022 102
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This document specifies general requirements and related test methods that are relevant to assistive products for tissue integrity (APTI) in the lying position in different application environments such as hospitals, home care and institutions. This document applies to the safety of APTI that are intended to 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 (adjustable included) or as a whole integrated system. This document does not apply to medical beds. 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 or operating/surgical tables. It also covers safety and performance test methods to ensure protection against injuries to the user. This document addresses the combination of a full body support surface and an adjustable mattress support platform. It also covers safety and performance test methods to ensure protection against injuries to the user. This document specifies requirements and test methods for APTI within the following classifications of ISO 9999:2022: 04 33 06 Assistive products for tissue integrity when lying down such as but not limited to —    mattresses and mattress overlays for pressure injury prevention, and —    mattress coverings for pressure injury prevention mattresses. 12 31 03 Assistive products for sliding and turning such as but not limited to the following: Devices for changing position or direction of a person using sliding or turning techniques. The only products included are those intended to be used in a lying position and remain in situ as part of the lying support surface. They are the following: —    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 unless the product is intended to be left in situ. 09 07 06 Positioning pillows, positioning cushions and positioning systems such as but not limited to —    leg positioners, —    arm positioners, and —    multipurpose body positioners. 18 12 15 Bedding such as but not limited to —    draw sheets.

PDF Catalog

PDF Pages PDF Title
1 30459968
57 A-30447040
58 National foreword
60 European foreword
63 Foreword
64 Introduction
65 1 Scope
66 2 Normative references
67 3 Terms and definitions
71 4 General requirements and safety
4.1 General requirements
72 4.2 Intended use
4.2.1 General requirements
4.2.2 Consideration regarding intended use
4.2.3 Intended use statement
73 4.3 APTI risk management
4.4 APTI usability
4.4.1 General
4.4.2 Design requirements in relation to persons with cognitive impairment
4.5 Design controls
4.6 Clinical evaluation
4.7 Foreseeable misuse
4.8 Test conditions
74 4.9 Lifting and carrying means
5 Safety requirements
5.1 Requirements for information supplied by the manufacturer
5.1.1 General
75 5.1.2 APTI traceability
5.1.3 Education and training
5.1.4 Pre-sale information
76 5.1.5 User information
77 5.1.6 Service information and inspection
5.1.7 Labelling
5.1.8 Marking of user weight and maximum load
5.1.9 Packaging
78 5.2 APTI that can be dismantled
5.2.1 General requirements
5.2.2 Small parts
5.2.3 Fasteners and connections
5.3 Resistance to corrosion
5.4 Noise and vibration
5.5 Sound audible acoustic energy
79 5.6 Default indicators
80 5.7 Feedback
6 Flammability
6.1 General
6.2 Flammability
81 6.3 Moulded parts used as enclosures for electrical equipment
7 Mechanical safety
7.1 Prevention of traps for the human body
7.2 Safety of moving and folding parts
83 7.3 V-shaped openings
7.4 Surfaces, corners, edges and protruding parts
7.5 Folding and adjusting mechanisms
7.6 Instability hazard
84 7.7 Temperature of parts that come into contact with human skin
85 7.8 Ergonomic principles
7.9 Additional consideration
8 Safety of electrical equipment
8.1 General electrical requirements
8.2 Electromagnetic compatibility
8.2.1 General
8.2.2 Emissions
8.2.3 Immunity
86 8.2.4 Power frequency magnetic field immunity
8.3 Liquid ingress
8.4 Interruption of power supply/supply mains to an APTI
8.5 Hold to run activation
87 8.6 Emergency stop functions
9 Biocompatibility
9.1 Biocompatibility and toxicity
9.2 Animal tissue
10 Contamination
10.1 Liquid ingress
88 10.2 Cleaning and disinfection
10.3 Cross infection and microbial contamination
90 Annex A (informative) General information
94 Annex B (informative) Environmental and consumer related guidance
98 Annex C (informative) Periodic inspection
99 Bibliography
BS EN ISO 20342-1:2022 - TC
$246.62