Personal Protective Equipment (PPE) comes under the European directive 89/686/EC. Depending on the nature of the PPE design, a classification category is applied.
Products of simple design, but seen as class 1 products, are exempt from the EC type examination that is carried out by Notified Bodies. PPE belonging to this category, protects the user against risks that have a very limited impact (the guideline describes the risks and factors and what kind of products are concerned).
On the other hand there is PPE of complex design. These so-called category 3 products must protect the user against hazards that may be fatal or may seriously or irreparably damage health and of which the user cannot recognize the acute effects in time. A list of these products is also in the directive.
Finally there are also category 2 products. These are all products that do not come under categories 1 or 3.
Article 11
For category 3 products there is something special under discussion:
The manufacturer or importer is required, but has the choice to employ one of the two procedures under Article 11 of the Directive for the EC guarantee system.
The manufacturer or importer chooses article 11A if he has a system aimed at quality supervision of the end product or for 11B if he wants a system focused on production supervision.
Applying the chosen EC guarantee system is however the initiative and the responsibility of the manufacturer or importer. They are therefore obliged to make agreements with a competent authority. For example, for practical reasons, importers of products from outside the EU usually choose the 11A system, while manufacturers with the 11B system are better connected, for example, to an existing ISO 9001 system.
With the EC guarantee system, the purchaser of PPE must obtain more assurance that the product meets all relevant demands and that all subsequent deliveries of a previously bought product have at least the same level of protection.
This is also an excellent opportunity for the national supervisory authorities to keep a finger on the pulse of this important product category. They can easily pick up on the findings of the notified body that has been brought in by the manufacturer or importer for the EC-guarantee system.
CMK, 2013-10
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