Certification and Registration
Walking aid testing standards
Category:
Walker
Rollator for CE Certification (Reference BS EN 12182:2012)
BS EN 12182:2012 Assistive products for persons with disability-General requirements and test methods
BS EN 12182:2012 specifies the general requirements and test methods for assistive products for persons with disabilities. According to the definition provided in EU Directive 93/42/EEC, these products are classified as medical devices.
BS EN 12182:2012 does not apply to assistive products that achieve their intended purpose by administering medicinal substances to users.
This European standard applies when specific European standards exist for particular types of assistive products. However, some requirements of BS EN 12182:2012 may still apply and can be considered together with other relevant European standards.
It should be noted that not all products listed in EN ISO 9999 are medical devices. Contracting parties may consider whether this standard, or parts of it, can be applied to products outside the scope of EU Directive 93/42/EEC.
BS EN ISO 11334-1:2007 Walking aids manipulated by one arm—Requirements and test methods—Part 1 Elbow crutches
BS EN ISO 11334-1:2007 specifies the requirements and test methods for elbow crutches equipped with handgrips and tips. These methods cover tests for separation, static load capacity, fatigue resistance, and resistance to low-temperature embrittlement.
BS EN ISO 11334-1:2007 also specifies requirements related to safety, ergonomics, performance, and manufacturer-provided information, including labeling and marking requirements.
These requirements and tests are based on the maximum user weight specified by the manufacturer, assuming daily use of an elbow crutch during walking. BS EN ISO 11334-1:2007 applies to elbow crutches intended for users with a body weight of not less than 35 kg.
The requirements and test methods for friction between rubber tips and walking surfaces are addressed separately.
Note: The recommendations provided in Annex A supplement the requirements of BS EN ISO 11334-1:2007.
BS EN ISO 11334-4:1999 Walking aids manipulated by one arm—Requirements and test methods—Part 1: Walking sticks with three or more legs
BS EN ISO 11334-4:1999 specifies the requirements and test methods for evaluating the stability, static load capacity, and fatigue resistance of walking sticks with three or more legs equipped with handles and tips.
It also specifies requirements related to safety, ergonomics, performance, marking, and labeling.
These requirements and tests are based on the daily use of walking sticks with three or more legs, considering the user’s body weight during design and manufacture. They apply to users with a body weight of not less than 35 kg.
BS EN ISO 11334-4:1999 does not apply to walking sticks with three or more legs equipped with underarm or forearm supports.
Note: Annex A provides additional recommendations related to these requirements.
BS EN 1985:1999 (R2007) Walking aids- General requirements and test methods (for walking sticks)
BS EN 1985:1999 (R2007) Walking aids- General requirements and test methods (for metallic underarm/axillary crutch)
BS EN 1985:1999 (R2007) specifies the requirements and test methods for walking aids classified under EN ISO 9999:1998, including subclass 1203 and 1206. These include walking aids operated by one arm (used singly or in pairs and may incorporate upper body support) and walking aids operated by both arms.
BS EN 1985:1999 (R2007) does not apply to mobility aids specially designed or modified for specific persons with disabilities.
Note: Applicable parts of BS EN 1985:1999 (R2007) may also be applied to the above products and other mobility aids outside the scope of this standard.
ISO 24415-1: 2009 Tips for assistive products for walking — Requirements and test methods — Part 1: Friction of tips
ISO 24415-1:2009 specifies requirements and test methods for evaluating the friction between tips of walking aids and walking surfaces.
These requirements and test methods are based on normal walking conditions on dry, flat surfaces. Applicable walking aids include canes, elbow crutches, forearm crutches, walking sticks, walkers, rollators, and rollators with seats.
ISO 24415-1:2009 does not apply to tips manufactured for special purposes, such as use on ice and/or snow.
BS ISO 24415-2:2011 Tips for assistive products for walking — Requirements and test methods — Part 2: Durability of tips for crutches
BS ISO 24415-2:2011 specifies durability requirements and test methods for tips used on walking sticks and crutches, including elbow crutches, forearm-support crutches, and underarm crutches, as described in ISO 9999.
These requirements and test methods are based on normal walking conditions on dry and flat walking surfaces.
BS ISO 24415-2:2011 does not apply to cane tips manufactured for special purposes, such as walking on ice and/or snow.
ISO 10993-5 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
ISO 10993-5 specifies test methods for evaluating the in vitro cytotoxicity of medical devices.
ISO 10993-5 specifies the incubation of cultured cells in direct contact with the device and/or device extracts, either directly or through diffusion.
ISO 10993-5 aims to evaluate the biological response of mammalian cells in vitro using appropriate biological parameters.
ISO 10993-7:2008 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual medical devices sterilized using ethylene oxide.
It also specifies measurement procedures for ethylene oxide and ethylene chlorohydrin, as well as methods for verifying compliance with these requirements before product release.
Additional background information, including guidance and flowcharts illustrating the application of this standard, is provided in the informative annexes.
ISO 10993-7:2008 does not apply to ethylene oxide sterilization equipment that does not come into contact with patients, such as in vitro diagnostic devices.
EN ISO/ISO 11199-1:2021 Assistive products for walking manipulated by both arms — Requirements and test methods — Part 1: Walking frames
EN ISO 11199-1:2021 specifies requirements and test methods for walking frames operated by both arms, excluding attachments unless otherwise specified in particular test procedures.
EN ISO 11199-1:2021 also specifies requirements related to safety, ergonomics, performance, and manufacturer-provided information, including marking and labeling.
These requirements and tests are based on the daily use of walking frames as mobility aids designed for the maximum user weight specified by the manufacturer.
EN ISO 11199-1:2021 applies to walking frames intended for users with a body weight of not less than 35 kg.
EN ISO/ISO 11199-2:2021 Assistive products for walking manipulated by both arms — Requirements and test methods — Part 2: Rollators
EN ISO 11199-2:2021 specifies requirements and test methods for rollators operated by both arms without attachments, unless otherwise specified in particular test procedures.
EN ISO 11199-2:2021 also specifies requirements related to safety, ergonomics, performance, and manufacturer-provided information, including marking and labeling.
These requirements and tests are based on the daily use of rollators as mobility aids designed for the maximum user weight specified by the manufacturer.
EN ISO 11199-2:2021 applies to rollators intended for users with a body weight of not less than 35 kg.
EN ISO 11199-2:2021 does not apply to rollators equipped with horizontal forearm supports, which are classified as walking platforms.
SATISFY provides one-stop assistive device testing services, including preliminary assessment, preparation and submission of technical documentation, complete test monitoring, report interpretation, data analysis, and corrective action recommendations.
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