SGS looks at the complexity associated with whether a product is classed as a medical device or personal care item.
Online PR News – 05-June-2020 – Geneva, Switzerland – 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 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. [http://www.sgs.com/en/consumer-goods-retail/medical-devices]
For more information, please contact:
Packaging and Medical Strategic Expert
Consumer and Retail
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.