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Orthopedics,
Sports, and Rehabilitation: Personal
Protective Equipment Directive
Manufacturers of sports and leisure equipment that conduct business in
the European Union and around the globe must meet multiple safety requirements.
For example, in the European Union the Personal Protective Equipment Directive
has been in effect since 1995. Another example is fitness equipment where
specific European requirements may exist. For other areas of the globe,
there may be national, international, customer or purchasing agent specifications.
The Personal Protective
Equipment Directive 89/686/EEC has far reaching implication for manufacturers.
The import and sale of personal protective equipment in the EU is now
only possible if the legal requirements have been met and if the equipment
is marked accordingly. Personal protective equipment is classified into
3 categories, depending on complexity:
Category
I
This category is basic. For a manufacturer to import and market this category
of equipment in the EU a declaration of conformity is needed stating that
the product has been produced in line with the regulations. Examples of
Category I equipment would be gardening gloves or certain types of footwear.
Category
II
All equipment that is neither category I or category III is classified
as category II. In addition to the manufacturer's declaration of conformity,
category II equipment must also be tested by a Notified (or accredited)
Body. Examples of Category II equipment would be helmets, shin guards,
wrist guards, and elbow pads.
Category
III
The Personal Protective Equipment Directive describes protective objectives
that must be fulfilled for personal protective equipment in category III.
In addition to the manufacturer's declaration of conformity, category
III equipment must either be type tested annually by a Notified Body or
must be type tested once by a Notified Body and have a quality system
which is certified by a Notified Body. An example of Category III would
be mountaineering equipment such as harnesses and carabiners.
TÜV SÜD Product
Service can assist you during all phases of your compliance needs. We
offer the following services in our single source capabilities:
- ISO 9000 Registration
for Quality
- TÜV SÜD Product
Service Quality Certification Marks
- GS marks
- DIN marks
- Certification
marks for sports associations (e.g., UIAA, FIBA)
For more information,
contact us.
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