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New Zealand Clinical Blog / September 22, 2020

ISO Standards – what are they and why are they important?

ISO standards are a term many of us have heard of, and will be influenced by in our daily lives, but potentially do not know much about.

ISO is an independent, non-governmental international organisation, with membership of 164 national standards bodies.  The name ISO is derived from the Greek ‘isos’ meaning equal, with the name ISO being used in all countries around the world, regardless of what language is spoken.

ISO standards started with the essential question: what is the best way of doing this?  The first meeting to discuss international standards was in London in 1946, where 65 delegates from 25 countries met to discuss the future of International Standardisation, with ISO officially coming into existence in 1947 with 67 technical committees.   Today ISO is based in Geneva, Switzerland, with membership of 164 national standards bodies, 792 technical committees and sub-committees and over 23000 standards. 

Each technical committee is made up of independent experts nominated by ISO members, with the goal of each technical committee being to look at products and services with an eye towards ensuring safety, quality, reliability and effectiveness. 

Today the standards cover almost all aspects of technology and manufacturing, with each standard being drafted by a technical committee (TC) or sub-committee (SC) and taking approximately three years to confirm.  Each international standard is reviewed at least once every five years by all ISO member bodies, with the relevant TC/SC deciding whether the standard should be confirmed, revised or withdrawn.  Testing for each standard is reviewed by the technical committee to ensure they are appropriate and reasonable for a test lab or manufacturer to be able to apply, but also that they are meaningful for the end user.  Each standard is not intended to endorse specific solutions, just allow for a direct comparison of specific properties

ISO standards are present behind many aspects of our home and work lives, from the food we eat, the shoes we wear, the toys our children play with, the paper we use in our printers or the credit card we can use around the world.   One of the most popular standards is ISO 9001, this standard sets out the requirements for a quality management system, helping businesses and organisations be more efficient and improve customer satisfaction. 

ISO standards can also facilitate manufacturers working together to produce solutions that make our daily life safer and more convenient, for example, the use of ISOFIX to secure child car seats in vehicles.  Use of child car seats in vehicles is a solution that increases a child’s safety while travelling, however installing these car seats can be a challenge.  ISO 13216-1 relates to the the universal system for anchoring child restraint systems to vehicles, with the purpose of improving the safety of child restraints by making the installation of these seats easier and more reliable.  This standard has resulted in many car manufacturers installing ISOFIX anchor points in their cars (a metal loop hidden in the gap between the flat and upright parts of the seat) and child car seat manufacturers producing a product that installs into these anchor points.  For parents, using ISOFIX provides reassurance that they can install their child car seat correctly to maximise the safety benefits of the seat.  (This was a system that I used with both of my children and had no idea where the name derived from!) 

How does ISO standards relate to power wheelchairs?   The technical committee responsible for wheelchair standards is ISO/TC 173, Assistive products for persons with disability.   ISO/TC 173 was created in 1978, with the scope of standardisation in the field of assistive products and related services, to assist a person in compensating for reduced abilities.  This committee has developed numerous standards for persons with disability ranging from aids for ostomy (surgical opening for discharge of waste) and incontinence to assistive equipment helping people with a visual impairment use pedestrian crossings, to hoists for transferring.

From ISO/TC 173, Subcommittee SC 1 relates to wheelchairs.  This group is responsible development and maintenance of the ISO 7176 series, a 32 part series covering items such as static and dynamic stability, effectiveness of brakes, impact and fatigue strengths, obstacle climbing ability and wheeled mobility devices for use as seats in motor vehicles.

Each part of the standard is accompanied by a document that specifies the test methods and requirements for determining specified standard, for example ISO 7176-30: 2018, also known as Wheelchairs – Part 30: Wheelchairs for changing occupant posture – Test methods and requirements.  These guidelines specify the test methods and requirements for determining the safety and performance of a wheelchair that incorporates technology to alter the posture of the wheelchair user, for example a power wheelchair that offers power standing.

How do you find out what chairs have been tested to what standard?  The user manual of the chair will state what standards and regulations the chair meets the requirements of, including whether it has been tested to the ISO 7176 series.  Alternatively, the supplier or dealer who provide the chair should be able to tell you. 

This testing is often a big point of difference between high and lower cost power mobility options.  Mobility solutions that are lower cost are potentially manufactured from inferior materials or with an inferior design, where typically their user manuals will make little (or no) reference to any ISO testing.  This isn’t to say these mobility solutions are a poor choice, for a low cost mobility device may work well as a useful adjunct to a person’s mobility, for example a basic mobility scooter to allow a person to mobilise around a shopping mall independently.  However, this same device may not be safe or durable for a user who is dependant on a mobility device for their all-day mobility across multiple environments.  These users require a mobility solution that has been tested to ensure it is a safe and reliable device for everyday use, with ISO standards providing an independent means of establishing this. 

Next week we will take a closer look at ISO 7176-19:2008 - Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles.  We will look at what parameters this standard tests and what other factors need to be considered when a person is using their wheelchair as a seat in a vehicle.

References

https://www.iso.org/home.html

For more information on ISOFIX https://youtu.be/W0sTvpyKgKY

 

Rachel Maher 

Clinical Education Specialist

Rachel Maher graduated from the University of Otago in 2003 with a Bachelor of Physiotherapy, and later gained her Post Graduate Diploma in Physiotherapy (Neurorehabilitation) in 2010.   

Rachel gained experience in inpatient rehabilitation and community Physiotherapy, before moving into a Child Development Service, working with children aged 0 to 16 years.    

Rachel later moved into a Wheelchair and Seating Outreach Advisor role at Enable New Zealand in 2014, complementing her clinical knowledge with experience in NZ Ministry of Health funding processes.   

Categories: Complex Rehab, Power, Clinician

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