Product and System Standards



  • ISO 14971: 2019          Medical devices — Application of risk management to medical devices

  

  • ISO 13485: 2016         Medical devices — Quality management systems — Requirements for regulatory purposes

  

  • ISO 9001: 2015 + ISO 9001:2015/Amd 1:2024          Quality management systems — Requirements

  

  • ISO 14001: 2015         Environmental management systems — Requirements with guidance for use

  

  • EN 12182: 2012          Assistive products for persons with disability — General requirements and test methods

  

  • ISO 17966: 2016          Assistive products for personal hygiene that support users — Requirements and test methods

  

  • ISO 11199-1: 2021         Assistive products for walking manipulated by both arms — Requirements and test methods — Part 1: Walking frames

  

  • ISO 11199-2: 2021EN ISO 111992:2021+A1:2024)    Assistive products for walking manipulated by both arms — Requirements and test methods — Part 2: Rollators

   

  • ISO 11199-3: 2005         Walking aids manipulated by both arms — Requirements and test methods — Part 3: Walking tables

  

  • ISO 11334-1: 2007         Assistive products for walking manipulated by one arm — Requirements and test methods — Part 1: Elbow crutches

  

  • ISO 11334-4: 2024         Assistive products for walking manipulated by one arm — Requirements and test methods — Part 4: Walking sticks with three or more legs  

  

  • ISO 24415-2: 2011         Tips for assistive products for walking — Requirements and test methods — Part 2: Durability of tips for crutches

  

  • ISO 24415-1: 2009        Tips for assistive products for walking — Requirements and test methods — Part 1: Friction of tips

  

  • EN 12520: 2024           Furniture — Safety, strength and durability — Requirements for domestic seating

 

  • EN 1970: 2014           Adjustable beds for disabled persons — Requirements and test methods 

  

  • IEC 80601-2-52: 2026          Medical electrical equipment-Part 2-52: Particular requirements for basic safety and essential performance of medical beds for adults

  

  • EN 12184: 2022           Electrically powered wheelchairs, scooters and their chargers — Requirements and test methods

 

  • EN 12183: 2022           Manual wheelchairs — Requirements and test methods

  

  • GB/Z 40836-2021          Wheelchairs for Wheelchair Basketball Game

  

  • ISO 7176-12014         Wheelchairs — Part 1: Determination of static stability

  

  • ISO 7176-22017         Wheelchairs — Part 2: Determination of dynamic stability of electrically powered wheelchairs

  

  • ISO 7176-32012         Wheelchairs — Part 3: Determination of effectiveness of brakes

  

  • ISO 7176-42008         Wheelchairs — Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range

  

  • ISO 7176-52008        Wheelchairs — Part 5: Determination of dimensions, mass and manoeuvring space

  

  • ISO 7176-62018         Wheelchairs — Part 6: Determination of maximum speed of electrically powered wheelchairs

  

  • ISO 7176-71998          Wheelchairs — Part 7: Measurement of seating and wheel dimensions

  

  • ISO 7176-82014          Wheelchairs — Part 8: Requirements and test methods for static, impact and fatigue strengths

  

  • ISO 7176-92009         Wheelchairs — Part 9: Climatic tests for electric wheelchairs

  

  • ISO 7176-102008         Wheelchairs — Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs

 

  • ISO 7176-112012         Wheelchairs — Part 11: Test dummies

  

  • ISO 7176-131989         Wheelchairs — Part 13: Determination of coefficient of friction of test surfaces

  

  • ISO 7176-142022 + Amd 1: 2025          Wheelchairs — Part 14: Power and control systems for electrically powered wheelchairs and scooters — Requirements and test methods

  

  • ISO 7176-151996           Wheelchairs — Part 15: Requirements for information disclosure, documentation and labelling

  

  • ISO 7176-192022          Wheelchairs — Part 19: Wheelchairs for use as seats in motor vehicles

  

  • ISO 7176-212025          Wheelchairs — Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers 

 

  • ISO 7176-222014           Wheelchairs — Part 22: Set-up procedures

  

  • ISO 7176-252022            Wheelchairs — Part 25: Lead-acid batteries and chargers for powered wheelchairs — Requirements and test methods

  

  • ISO 7176-262007            Wheelchairs — Part 26: Vocabulary

  

  • ISO 7176-282012            Wheelchairs — Part 28: Requirements and test methods for stair-climbing devices

  

  • ISO 7176-302018            Wheelchairs — Part 30: Wheelchairs for changing occupant posture — Test methods and requirements

  

  • ISO 7176-312023            Wheelchairs — Part 31: Lithium-ion battery systems and chargers for powered wheelchairs — Requirements and test methods

  

  • ISO 7176-322022           Wheelchairs — Part 32: Test method for wheelchair castor assembly durability