GB/T 44424-2024 Walking trolleys - Requirements and test methods
1 Scope
This document specifies the general requirements, materials, temperature, structure, strength, torque and durability, appearance, stability, force on human tissues, packaging and test report for walking trolleys, establishes ergonomic principles, provides information supplied by the manufacturer and describes the test methods.
The document is applicable to the walking trolleys as daily assistive products for walking, for a user mass of no less than 35kg.
Excluded are rollators specified in ISO 11199-2.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3746 Acoustics- Determination of sound power levels and sound energy levels of noise sources using sound pressure- Survey method using an enveloping measurement surface over a reflecting plane
Note: GB/T 3768-2017 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010, IDT)
ISO 8191-1 Furniture- Assessment of the ignitability of upholstered furniture- Part 1 : Ignition source : smoldering cigarette
Note: GB 17927.1-2011 Upholstered furniture - Assessment of the resistance to ignition of mattress and sofa - Part 1 : Smouldering cigarette (ISO 8191- 1:1988, NEQ)
ISO 8191-2 Furniture - Assessment of ignitability of upholstered furniture - Part 2 : Ignition source : match- flame equivalent
Note: GB 17927.2-2011 Upholstered furniture - Assessment of the resistance to ignition of mattress and sofa - Part 2 : Match flame equivalent (ISO 8191 -2:1988, NEQ)
ISO 9227 Corrosion tests in artificial atmospheres - Salt spray test
Note: GB/T 10125-2021 Corrosion tests in artificial atmospheres - Salt spray tests (ISO 9227:2017, MOD)
ISO 10993-1 Biologicalevaluation of medical devices - Part 1: Evaluation and testing with a risk management process
Note: GB/T 16886.1-2022 Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process (ISO 10993-1:2018, IDT)
ISO 12100 Safety of machinery- General principles for design- Risk assessment and risk reduction
Note: GB/T 15706-2012 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010, IDT)
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14971 Medical devices - Application of risk management to medical devices
Note: GB/T 42062- 2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019, IDT)
ISO 22442-1 Medical devices utilizing animal tissues and their derivatives - Part 1 : Application of risk management
IEC 60601-1:2005 Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance
Note: GB 9706.1-2020 Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance ( IEC 60601-1:2012, MOD )
IEC 60695-1-10 Fire hazard testing- Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines
Note: GB/T 5169.2-2021 Fire hazard testing for electric and electronic products - Part 2:Guidance for assessing the fire hazard - General guidelines (IEC 60695-1-10:2016, IDT )
EN 614-1 Safety of machinery- Ergonomic design principles - Part 1 : Terminologt and general principles
EN 1041 Information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
walking trolley
frames which can be moved by pushing and/or lifting that enable a person to improve stability and balance while walking and standing, with hand grips, without forearm supports and with four or more wheels
Note 1: AlI parts are placed in front of the user to guide his/her gait effectively (see Figure 1).
Example: Walking trolleys with a seat for resting, and/or a bag for carrying goods.
Note 2: The difference between a walking trolley and a rollator is described in Figure 1.
3.2
user mass
body mass of the person using walking trolleys
3.3
Maximum width
maximum outside dimension of a walking trolley when the width is adjusted at its maximum, measured horizontally at right angles to the direction of movement when the walking trolley is in normal use
3.4
handle height
vertical distance from the highest point of the handle to the ground surface
3.5
handgrip
part of the walking trolley which is specified by the manufacturer as normally held by the hand when the walking trolley is in use
Note: See Figure 2 and 3.
3.6
grip distance
distance between the upper surface of the handgrip and the lower surface of the brake lever measured vertically at the centre of the hand grip
Note: See Figure 3.
Standard
GB/T 44424-2024 Walking trolleys—Requirements and test methods (English Version)
GB/T 44424-2024 Walking trolleys - Requirements and test methods
1 Scope
This document specifies the general requirements, materials, temperature, structure, strength, torque and durability, appearance, stability, force on human tissues, packaging and test report for walking trolleys, establishes ergonomic principles, provides information supplied by the manufacturer and describes the test methods.
The document is applicable to the walking trolleys as daily assistive products for walking, for a user mass of no less than 35kg.
Excluded are rollators specified in ISO 11199-2.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3746 Acoustics- Determination of sound power levels and sound energy levels of noise sources using sound pressure- Survey method using an enveloping measurement surface over a reflecting plane
Note: GB/T 3768-2017 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010, IDT)
ISO 8191-1 Furniture- Assessment of the ignitability of upholstered furniture- Part 1 : Ignition source : smoldering cigarette
Note: GB 17927.1-2011 Upholstered furniture - Assessment of the resistance to ignition of mattress and sofa - Part 1 : Smouldering cigarette (ISO 8191- 1:1988, NEQ)
ISO 8191-2 Furniture - Assessment of ignitability of upholstered furniture - Part 2 : Ignition source : match- flame equivalent
Note: GB 17927.2-2011 Upholstered furniture - Assessment of the resistance to ignition of mattress and sofa - Part 2 : Match flame equivalent (ISO 8191 -2:1988, NEQ)
ISO 9227 Corrosion tests in artificial atmospheres - Salt spray test
Note: GB/T 10125-2021 Corrosion tests in artificial atmospheres - Salt spray tests (ISO 9227:2017, MOD)
ISO 10993-1 Biologicalevaluation of medical devices - Part 1: Evaluation and testing with a risk management process
Note: GB/T 16886.1-2022 Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process (ISO 10993-1:2018, IDT)
ISO 12100 Safety of machinery- General principles for design- Risk assessment and risk reduction
Note: GB/T 15706-2012 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010, IDT)
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14971 Medical devices - Application of risk management to medical devices
Note: GB/T 42062- 2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019, IDT)
ISO 22442-1 Medical devices utilizing animal tissues and their derivatives - Part 1 : Application of risk management
IEC 60601-1:2005 Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance
Note: GB 9706.1-2020 Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance ( IEC 60601-1:2012, MOD )
IEC 60695-1-10 Fire hazard testing- Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines
Note: GB/T 5169.2-2021 Fire hazard testing for electric and electronic products - Part 2:Guidance for assessing the fire hazard - General guidelines (IEC 60695-1-10:2016, IDT )
EN 614-1 Safety of machinery- Ergonomic design principles - Part 1 : Terminologt and general principles
EN 1041 Information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
walking trolley
frames which can be moved by pushing and/or lifting that enable a person to improve stability and balance while walking and standing, with hand grips, without forearm supports and with four or more wheels
Note 1: AlI parts are placed in front of the user to guide his/her gait effectively (see Figure 1).
Example: Walking trolleys with a seat for resting, and/or a bag for carrying goods.
Note 2: The difference between a walking trolley and a rollator is described in Figure 1.
3.2
user mass
body mass of the person using walking trolleys
3.3
Maximum width
maximum outside dimension of a walking trolley when the width is adjusted at its maximum, measured horizontally at right angles to the direction of movement when the walking trolley is in normal use
3.4
handle height
vertical distance from the highest point of the handle to the ground surface
3.5
handgrip
part of the walking trolley which is specified by the manufacturer as normally held by the hand when the walking trolley is in use
Note: See Figure 2 and 3.
3.6
grip distance
distance between the upper surface of the handgrip and the lower surface of the brake lever measured vertically at the centre of the hand grip
Note: See Figure 3.
