ДСТУ EN ISO 21856:2023 Допоміжні засоби для людей із обмеженнями життєдіяльності. Загальні вимоги та методи випробувань (EN ISO 21856:2022, IDT; ISO 21856:2022, IDT)
ДСТУ EN ISO 21856:2023
(EN ISO 21856:2022,
IDT; ISO 21856:2022, IDT)
Допоміжні засоби для людей із обмеженнями життєдіяльності.
Загальні вимоги та методи випробувань
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)
Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Risk analysis and management
4.2 Intended performance and technical documentation
4.3 Clinical evaluation and investigation
4.4 Assistive products that can be dismantled
4.5 Fasteners
4.6 Load limits
4.7 Immobilising means
4.8 Usability
4.9 Design requirements in relation to persons with sensory and cognitive impairments
4.10 Considerations for accessibility
4.11 Feedback
5 Materials
5.1 General
5.2 Flammability
5.3 Biocompatibility and toxicity
5.4 Contaminants and residues
5.5 Infection and microbiological contamination
5.6 Resistance to corrosion
6 Emitted sound and vibration
6.1 Noise and vibration
6.2 Sound levels and frequencies of audible warning devices
7 Electromagnetic compatibility
8 Electrical safety
8.1 General
8.2 Battery powered assistive products - Charge level indicator
8.3 Electrically heated blankets, pads and similar flexible heating appliances
8.4 Ingress of liquids or particulate matter
8.5 Pendant controls
9 Overflow, spillage, leakage and ingress of liquids
9.1 Overflow
9.2 Spillage
9.3 Leakage
9.4 Ingress of liquids
10 Surface temperatttre
11 Sterility
11.1 Sterility requirements
11.2 Sterilization processes
11.3 Maintenance of sterility in transit
12 Safety of moving parts
12.1 Squeezing
12.2 Mechanical wear
12.3 Emergency stopping functions
13 Means to prevent falling out
13.1 General
13.2 Protection against inadvertent user falls in relation to side rails
14 Prevention of traps for parts of the human body
14.1 Holes and clearances
14.2 V-shaped openings
15 Folding and locking mechanisms
15.1 General
15.2 Locking mechanisms
15.3 Prevention of trap and squeeze hazards
16 Carrying handles
16.1 General
16.2 Requirement
16.3 Test method
17 Assistive products that support or suspend users
17.1 Geneгаl
17.2 Static forces
17.3 Dynamic forces
17.4 Requirements and test method for tips
18 Portable and mobile assistive products
18.1 Pоrtable assistive pгоducts
18.2 Mobile assistive products
19 Surfaces, corners, edges and protruding parts
20 Hand-held assistive products
21 Assistive products for children
22 Stability
23 Forces in soft tissues of the human body
24 Ergonomic principles
25 Requirements for information supplied by the manufacturer
25.1 General
25.2 Instructions for use
25.3 Labelling
26 Packaging
27 Test report
28 Guidelines for accessible information on assistive products
Annex A (informative) General recommendations
Annex В (informative) Environmental and consumer related guidance
Annex C (informative) Guidelines for accessible information on assistive products
Bibliography
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