Medical Device DirectiveMedical devices, including wheel-

chairs, walking aids and scoot mobiles,

must comply with the European Direc-

tive for medical devices 93/42/EEC.

These products may thus only be sold

in the Europe if they fulfi l the essential

requirements (Annex I of the MDD).

Because the MDD applies to a very

wide range of medical devices, medical

devices are classifi ed based on the risks

In Europe, wheelchairs, walking aids and scoot mobiles are subject to the European Medical

Devices Directive 93/42/EEC (MDD). These products can only be launched on the European

market if they fulfi l the essential requirements Annex I of the MDD. To show compliance with

the essential requirements out of the MDD, harmonized standards can be used. Products that

are in conformity with these standards are presumed to be in conformity with the correspond-

ing essential requirements of the MDD. TÜV Rheinland Nederland B.V. is your professional

partner for testing and inspecting wheelchairs, walking aids and scoot mobiles in accordance

with these harmonized product standards.

they present to their users (patients,

health professionals etc.). Wheelchairs,

walking aids and scoot mobiles are

class I products. Class I means that

manufacturers themselves need to

show that they are in compliance with

the MDD. A Notifi ed Body does not

need to be involved in order to, declare

that their product is in compliance

with the essential requirements of the

MDD 93/42/EEC. Once manufacturers

have compiled a technical dossier

(including a risk analysis and their

own Declaration of Conformity) and

applied to the Health Authority, they

need apply the CE mark to their pro-

duct and may launch their product on

to the European market.

With TÜV Rheinland Nederland B.V.

you will benefi t from over 30 years

of experience relating to testing and

assessing wheelchairs, walking aids

and scoot mobiles.

Safety standardsfor Wheelchairs and Scoot mobiles.

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TÜV Rheinland Nederland B.V. takes part of the standardization committee for wheelchairs

(scoot mobiles) and walking aids. We know the essence and the backgrounds of the tests that

have to be performed in order to comply to the standards. We are aware of possible changes in

new versions of these standards. Together with the client, we always try to examine whether

this cutting-edge knowledge can be implemented in the proposed testing program.

TÜV Rheinland is able to offer the most

complete in-house testing package.

TÜV Rheinland Nederland has labora-

tory facilities to perform tests in the

field of crash safety (for wheelchair

transport in motor vehicles); static and

dynamic stability for safety in use;

speed, braking distance, acceleration

and deceleration; strength and dura-

bility, driving performance; fire safety;

electrical safety, including EMC, etc.

Because all tests will be performed

within the TÜV Rheinland group, we

can easily accommodate our customers’

wishes to witness the testing processes

for their products.

Besides the ability of TÜV Rheinland

to perform valid tests in accordance

with international standards, we also

offer the opportunity to use our testing

set-up to perform customer-specific

R&D tests under the supervision of one

of our experts.

Applicable standards for verificationThe following standards (voluntary

agreements between parties) are used

for wheelchairs and scoot mobiles

and walking aids:

EN 12183 for manual wheelchairs

EN 12184 for electric wheelchairs

and scoot mobiles

ISO 7176-series – the internationally

accepted series of standards that

describe the various testing methods

for wheelchairs and scoot mobiles

IEC 60601-1: general safety

for medical electrical devices

EN 12182: technical aids for

disabled persons

Besides these specific standards for

wheelchairs and scoot mobiles, we are

also able to perform quality manage-

ment certification in accordance with

ISO 13485 and/or ISO 9001.

Unique combinationFrom our independent position,

TÜV Rheinland Nederland deals with

testing and inspection, assessment

of dossiers, manuals, user manuals

and other texts for wheelchairs and

scoot mobiles, risk analyses, etc. .

We identify all findings in clear and

comprehensive report for you.

Further informationVisit our website for a complete over-

view of our products and services.

If you would like further information

about the testing and inspection of

Wheelchairs and Scoot mobiles,

please contact us.

Why testing and inspection by TÜV Rheinland?

TÜV Rheinland Nederland B.V.Annette J. van Raamsdonk Sales & Expert Medical7300 AM ApeldoornTel. +31 88 8887888info@nl.tuv.comwww.tuv.com/nl