SGS, the world’s leading provider of testing,
verification and certification services, offers a comprehensive range of
services to help manufacturers of products aimed at assisting the elderly
ensure they are safe and comply with the relevant regulations.
We live in a world with an aging population. Currently
there are an
estimated 143 million people over 80, but this
figure is expected to triple to 426 million by 2050. These people want to live
independently, maintaining a self-sufficient lifestyle for as long as possible.
To cater to an aging population, industry is developing products
specifically to help them live independently – for example, adult diapers and
radar fall detectors. These products must be high
quality and safe; they must also comply with the right regulatory standards.
What standards the product must conform to depends,
very often, on whether it is classed as a personal care item or a medical
device.
Medical devices are defined as
an instrument, apparatus, implement or piece of software that is principally
intended for the purposes of diagnosis, prevention, monitoring, treatment, or
alleviation of a disease, injury or handicap, on a human being.
This wide and diverse definition does not, however, cover all products aimed at
elderly people. For example, it would not include adult diapers, but it would cover
blood pressure monitors – both products that can easily be bought online.
Medical device also covers products that are not for use by the end consumer.
Instead, they are to be used only by Healthcare professionals.
Manufacturers need to be certain which category their product falls under so
they can ensure it complies with the correct standards. The standards that are
applied to personal care items, such as adult diapers and personal hygiene
wipes, are very different to those that apply to medical devices.
Manufacturer need to also work out which standards
they need to conform to within a product category. This is not always easy, as
there can be a wide variety of standards that can apply. For example, in one of
the fastest growing segments in the healthcare industry – wheelchairs and
walking aids – what standard is enforced will depend very much on the market
and the particular attributes of the product.
This sector – ‘wheelchairs and walking aids’ – includes walking frames,
rollators, sticks and crutches, with each having its own standard to which it
must conform. Electric wheelchairs, for example, are governed by the ISO 7176
series of standards. Manual wheelchairs, for a user who weighs less than 250kg,
must conform to EN 12183 in the European Union (EU). However, if the wheelchair
is electrically powered with a maximum speed not exceeding 15 km/h and is not intended
for use by a person weighing in excess of 300kg, the EU standard is EN 12184. EN
12184 also covers electrically powered scooters with three or more
wheels.
Walking aids that are manipulated using both arms – for example, a walking
frame or rollator – should comply with ISO 7176 for safety. In the EU, the
following standards can also be applied to test for static stability, braking
capabilities, static strength and fatigue:
- EN 11199-1 –
walking frames
- EN 11199-2 –
rollators being used as walking aids with wheels
- EN 11199-3 –
walking tables with three or more wheels
For walking aids that are manipulated by one arm –
walking sticks and crutches – these standards can be used to demonstrate safety:
- ISO 11334-1 –
elbow crutches
- ISO 11334-4 –
walking sticks with three or more legs
- BS 4997 – wooden
axilla crutches
- BS 5205 –
adjustable metal sticks
- BS 5181 – wooden
walking sticks
Manufacturers might also consider:
- ISO 24415-1 – for
testing the friction between the tips of walking aids on a (dry/flat)
walking surface
- ISO 24415-2 – for
durability of crutch tips
Deciding
whether a product is defined as a medical device or personal care item is just
the first step towards ensuring it complies with the right regulatory standards
for the target market. It is often wise to partner with an experienced service
provider, such as SGS, who can help to guide the manufacturer through the
regulatory process. This not only ensures against incorrect categorization; it
will also speed up the time to market for a product.
SGS
Solution
SGS offers a comprehensive range of services to manufacturers offering products
to the elderly. Our global network of experts and testing facilities have the
expertise to ensure your products are safe and comply with the correct
regulations.
Learn
more about SGS
Medical
Device
Services
Learn more about SGS Personal Care Services.
For more information, please contact:
Pierre-Jean
Cavaroc
Packaging and Medical Strategic Expert
Consumer and Retail
Email: crs.media@sgs.com
Website: www.sgs.com/medicaldevices
About SGS
SGS is the
world’s leading inspection, verification, testing and certification company.
SGS is recognized as the global benchmark for quality and integrity. With more
than 94,000 employees, SGS operates a network of over 2,600 offices and
laboratories around the world.