ISO 11199-2:2021

Overview

ISO 11199-2:2021 - "Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators" is the international standard that specifies safety, performance, ergonomic and information requirements for wheeled rollators operated with both arms. The standard covers rollators used for everyday walking assistance, including models with resting seats, backrests and shopping bags, and applies to products specified for a minimum user mass of 35 kg. It is the third edition (2021) and replaces the 2005 edition.

Key topics and requirements

This standard defines practical test methods and design requirements across multiple technical areas:

• Scope and definitions for rollators manipulated by both arms (excludes rollators with horizontal forearm supports - see ISO 11199-3).
• Risk analysis and general safety requirements to address common hazards.
• Structure and static strength: tests and criteria for frame strength, seat strength and backrest strength.
• Static stability: forward, rearward and sideways stability tests based on everyday use and declared maximum user mass.
• Brakes: effectiveness, durability and general brake performance requirements.
• Durability testing to simulate repeated use and assess long-term integrity.
• Materials: flammability, biocompatibility/toxicity, infection control, cleaning/disinfection and corrosion resistance.
• Mechanical safety: guarding moving parts, preventing entrapment, mechanical wear and temperature limits for parts contacting skin.
• Folding, adjustment and locking mechanisms: safety and reliability tests for portable foldable designs.
• Ergonomics: handgrip design, carrying handles, and user interaction considerations.
• Marking, labelling and documentation: required product markings, instruction manuals and test-report expectations.
• Packaging and information supplied by the manufacturer covering safe use and maintenance.

Applications and who uses it

ISO 11199-2 is intended for:

• Manufacturers and designers of rollators for product development and compliance.
• Test laboratories and conformity assessment bodies performing safety and performance testing.
• Procurement teams, healthcare providers and occupational therapists evaluating rollator options for users.
• Regulators and standards committees who reference harmonized requirements for market access.
• Repair and maintenance services who need to understand durability and safety criteria.

Using ISO 11199-2 helps reduce fall risk, improve user safety and ensure clear labelling and instructions for end users.

Related standards

• ISO 11199 series (other parts): ISO 11199-3 covers rollators with horizontal forearm supports (walking tables).
• Developed by ISO/TC 173 (Assistive products) in collaboration with CEN/TC 293.

Keywords: ISO 11199-2, rollators, assistive products for walking, requirements and test methods, rollator safety, brake testing, static stability, ergonomics, manufacturer labelling.