ISO 11199-2:2021 PDF

Scope: This document specifies requirements and test methods of rollators being used as assistive products for walking with wheels, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer including marking and labelling. The requirements and tests are based on every-day use of rollators as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes rollators specified for a user mass of no less than 35 kg. This document is not applicable to rollators with horizontal forearm supports, classified as walking tables, for which ISO 11199-3 is applicable.

ISO 11199-2:2021 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 13732-1 Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 20417 Medical devices — Information to be supplied by the manufacturer
ISO 7000 Graphical symbols for use on equipment — Index and synopsis
ISO 8191-2 Furniture; assessment of ignitability of upholstered furniture; part 2: ignition source: match-flame equivalent

2021 ISO 11199-2:2021 Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators
2005 ISO 11199-2:2005 Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators
1999 ISO 11199-2:1999 Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators