EN ISO 11199-2:2021, published by CEN and identical to ISO 11199-2:2021, specifies requirements and test methods for rollators - wheeled assistive products for walking manipulated by both arms. The standard covers safety, ergonomics, performance and information supplied by the manufacturer (including marking and labelling). It applies to everyday use conditions and to rollators designed for a maximum user mass as declared by the manufacturer (minimum user mass covered: 35 kg). It does not apply to rollators with horizontal forearm supports (see ISO 11199-3).
Key topics and technical requirements
The standard defines normative requirements and test procedures across product, material and performance domains, including:
- General safety & risk analysis: Manufacturer responsibilities for hazard identification and mitigation.
- Structure, static strength and stability: Tests for frame strength, resting seat strength, backrest strength and static stability in forward, rearward and sideways directions.
- Brakes and braking performance: Requirements for brake effectiveness and durability.
- Durability testing: Endurance tests to simulate everyday use.
- Folding, adjusting and locking mechanisms: Safety and locking integrity for collapsible rollators.
- Handgrips, carrying handles and ergonomics: Human factors, grip performance and user comfort.
- Materials & biocompatibility: Requirements for flammability, toxicity, cleaning/disinfection and resistance to corrosion.
- Ingress of liquids and temperatures: Safety of parts contacting skin and liquid resistance.
- Safety of moving parts & prevention of body traps: Protection against squeezing, mechanical wear and entrapment (holes, V-shaped openings).
- Surfaces, corners, edges and labelling: Prevention of sharp edges and required markings, instructions and user information.
- Packaging: Requirements for delivery and protection during transport.
Practical applications - who uses this standard
EN ISO 11199-2:2021 is used by:
- Manufacturers and designers of rollators to design compliant, market-ready products.
- Test laboratories and conformity assessors for performance and safety verification.
- Procurement officers and healthcare providers to specify safe, durable assistive devices.
- Rehabilitation professionals and clinicians to understand device capabilities and limitations.
- Regulators and standards bodies evaluating product compliance and market access.
Related standards
- ISO 11199-3 (rollators with horizontal forearm supports / walking tables)
- Previous edition: EN ISO 11199-2:2005 (superseded)
- Other assistive product standards and harmonized CEN/ISO documents referenced within the standard
Keywords: EN ISO 11199-2:2021, ISO 11199-2, rollators, assistive products for walking, requirements and test methods, safety, ergonomics, brake effectiveness, static stability, durability, manufacturer marking.