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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 16-238
Standard
ISO  11199-1 Second edition 2021-05
Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: Walking frames
Scope/Abstract
This document specifies requirements and test methods for walking frames used as assistive products for walking, 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 everyday use of walking frames as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes walking frames specified for a user mass of no less than 35 kg.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Kristen Gill
  CDRH/OPEQ/OHTV/DHTVB
  --
  Kristen.Gill@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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