GUIDE PPE - Cyprus Organization for the Promotion of Quality

Guide on PPE Directive
EuropeAid /114385/D/SV/CY
CEN/TC 211 Acoustics DS (Denmark)
CEN/TC 231/WG 3 Vibrations DIN (Germany)
More than 300 harmonised standards are already published and many of those are under revision. Lists of
PPE harmonised standards have been published by the OJEC under the following references:
Commission communication in relation to personal protective equipment - OJ C 203 of 28.8.2003. The list
of the harmonised standards can be found also at:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/ppe.html
INTERNATIONAL STANDARDISATION
In order to avoid the barriers to international trade, it has been accepted to give preference to the
international standardisation. Some ISO technical committees (like ISO TC 94/SC13, ISO TC 94/SC 14
and ISO TC 94/SC 15) are already drafting new standards.
CYPRUS STANDARDS BODY
Further information on standards and guidance information can be obtained from the Standards Body of
Cyprus:
CYS
Cyprus Organisation for the Promotion of Quality
At the Ministry of Commerce, Industry and Tourism
13-15, Andreas Araouzos Street
1421 Nicosia
RELATION WITH OTHER DIRECTIVES
GENERAL
If different aspects of a product are dealt with by more than one directive, it may only be placed on the
market and/or put into service when it complies with the requirements and the conformity assessment
procedures of all the directives applicable to it.
THE MEDICAL DEVICES DIRECTIVE (93/42/EEC)
This directive applies to devices, other than medicines, used in health care. It aims at protecting the
health and safety of patients and users of medical devices, and other exposed persons. The directive
states in Article 1.6 that it is not applicable to PPE. The decision as to which directive is applicable
depends on the principal use of the device. Thus surgical masks used principally to protect the patient are