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BS EN ISO 20342-1:2022

BS EN ISO 20342-1:2022

$189.07

Assistive products for tissue integrity when lying down – General requirements

Published By Publication Date Number of Pages
BSI 2022 46
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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
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 Scope
10 2 Normative references
11 3 Terms and definitions
15 4 General requirements and safety
4.1 General requirements
16 4.2 Intended use
4.2.1 General requirements
4.2.2 Consideration regarding intended use
4.2.3 Intended use statement
17 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
18 4.9 Lifting and carrying means
5 Safety requirements
5.1 Requirements for information supplied by the manufacturer
5.1.1 General
19 5.1.2 APTI traceability
5.1.3 Education and training
5.1.4 Pre-sale information
20 5.1.5 User information
21 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
22 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
23 5.6 Default indicators
24 5.7 Feedback
6 Flammability
6.1 General
6.2 Flammability
25 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
27 7.3 V-shaped openings
7.4 Surfaces, corners, edges and protruding parts
7.5 Folding and adjusting mechanisms
7.6 Instability hazard
28 7.7 Temperature of parts that come into contact with human skin
29 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
30 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
31 8.6 Emergency stop functions
9 Biocompatibility
9.1 Biocompatibility and toxicity
9.2 Animal tissue
10 Contamination
10.1 Liquid ingress
32 10.2 Cleaning and disinfection
10.3 Cross infection and microbial contamination
34 Annex A (informative) General information
38 Annex B (informative) Environmental and consumer related guidance
42 Annex C (informative) Periodic inspection
43 Bibliography

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BS EN ISO 20342-1:2022
$189.07