ISO 11199-2:2021
Assistive products for walking manipulated by both arms — Requirements and test methods — Part 2: Rollators
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Apparatus
5 Test conditions
6 General requirements and test methods
6.1 Risk analysis
6.2 Rollators that can be dismantled
6.3 Fasteners
6.4 User mass/load limit
6.5 Structure requirements
6.6 Brakes
6.6.1 General requirements
6.6.2 Brake effectiveness
6.6.3 Durability of brakes
6.7 Handgrip
7 Materials
7.1 General
7.2 Flammability
7.2.1 General
7.2.2 Upholstered parts
7.3 Biocompatibility and toxicity
7.4 Infection and microbiological contamination
7.4.1 General
7.4.2 Cleaning and disinfection
7.5 Resistance to corrosion
8 Ingress of liquids
9 Temperatures of parts that come in contact with human skin
10 Safety of moving parts
10.1 Squeezing
10.2 Mechanical wear
11 Prevention of traps for parts of the human body
11.1 Holes and clearances
11.2 V-shape openings
12 Folding, adjusting and locking mechanisms
12.1 General
12.2 Folding mechanisms
12.3 Locking mechanisms
13 Carrying handles
13.1 General
13.2 Requirements
13.3 Test method
14 Surfaces, corners and edges
15 Static stability
15.1 Requirements for static stability
15.2 Test method for static stability
15.2.1 Forward-direction static stability test
15.2.2 Rearward-direction static stability test
15.2.3 Sideway-direction static stability test
15.2.4 Accessory equipment static stability test
16 Static strength
16.1 Static strength of resting seat
16.1.1 General
16.1.2 Requirements for static strength of resting seat
16.1.3 Test method for static strength of resting seat
16.2 Static strength of the rollator
16.2.1 General
16.2.2 Requirements for static strength of the rollator
16.2.3 Test method for static strength of the rollator
16.3 Strength of backrest
16.3.1 General
16.3.2 Requirement for strength of backrest
16.3.3 Test method for strength of backrest
17 Durability test
17.1 Requirement for durability
17.2 Test method for durability
18 Ergonomic principles
19 Packaging
20 Information supplied by the manufacturer
20.1 General
20.2 Information marked on the product
20.3 Instruction manual
20.4 Test report
Annex A (informative) Consideration items for hazards when designing the products
Annex B (informative) General recommendations
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Apparatus
5 Test conditions
6 General requirements and test methods
6.1 Risk analysis
6.2 Rollators that can be dismantled
6.3 Fasteners
6.4 User mass/load limit
6.5 Structure requirements
6.6 Brakes
6.6.1 General requirements
6.6.2 Brake effectiveness
6.6.3 Durability of brakes
6.7 Handgrip
7 Materials
7.1 General
7.2 Flammability
7.2.1 General
7.2.2 Upholstered parts
7.3 Biocompatibility and toxicity
7.4 Infection and microbiological contamination
7.4.1 General
7.4.2 Cleaning and disinfection
7.5 Resistance to corrosion
8 Ingress of liquids
9 Temperatures of parts that come in contact with human skin
10 Safety of moving parts
10.1 Squeezing
10.2 Mechanical wear
11 Prevention of traps for parts of the human body
11.1 Holes and clearances
11.2 V-shape openings
12 Folding, adjusting and locking mechanisms
12.1 General
12.2 Folding mechanisms
12.3 Locking mechanisms
13 Carrying handles
13.1 General
13.2 Requirements
13.3 Test method
14 Surfaces, corners and edges
15 Static stability
15.1 Requirements for static stability
15.2 Test method for static stability
15.2.1 Forward-direction static stability test
15.2.2 Rearward-direction static stability test
15.2.3 Sideway-direction static stability test
15.2.4 Accessory equipment static stability test
16 Static strength
16.1 Static strength of resting seat
16.1.1 General
16.1.2 Requirements for static strength of resting seat
16.1.3 Test method for static strength of resting seat
16.2 Static strength of the rollator
16.2.1 General
16.2.2 Requirements for static strength of the rollator
16.2.3 Test method for static strength of the rollator
16.3 Strength of backrest
16.3.1 General
16.3.2 Requirement for strength of backrest
16.3.3 Test method for strength of backrest
17 Durability test
17.1 Requirement for durability
17.2 Test method for durability
18 Ergonomic principles
19 Packaging
20 Information supplied by the manufacturer
20.1 General
20.2 Information marked on the product
20.3 Instruction manual
20.4 Test report
Annex A (informative) Consideration items for hazards when designing the products
Annex B (informative) General recommendations
Bibliography