How to confirm Personal Protective Equipment (PPE) meets EU specifications?
COVID-19 has caused significant impacts on everyday life since early 2020. To prevent the infectious disease, selecting a Personal Protective Equipment (PPE) which is authorized with the global organization plays a crucial role for the distributors and buyers.
However, various PPE quality specifications in the global marketplace may cause confusion. For protective clothing, some might be only searching for EN 14126:2003 or ASTM 1670/1671 tested ones which would not be enough for the selecting standards. To be clarified, in the case of COVID-19 or infectious disease, the distributors shall select the PPE which satisfies the strictest requirement in the world, Category III of Regulation (EU) 2016 / 425.
In Category III, the authorized CE mark comes with four digital numbers of a Notified Body, and a CE certified PPE should be verified through the process of Module B and then either Module C2 or Module D. For instance, all ULTITEC series are certified as CE 0598 by the Notified Body of SGS Fimko Oy as the flow chart showed below.
Module B: EU Type-examination
EU type-examination is a part of a conformity assessment procedure. The Notified Body will examine the technical design of PPE to verify if the design meets the requirement of (EU)2016/425. When the type meets the applicable requirements, the notified body shall issue an EU Type-examination certification to the manufacturer.
Module C2: Internal production control plus supervised product check
The PPE product of the manufacturer shall be inspected and checked if it meets the type described in the EU Type-Examination annually at random intervals by the Notified Body.
Module D: Quality assurance of the production process
The production process at the manufacturer’s site shall be evaluated annually by the Notified Body to ensure if it satisfies the type described in the EU type-examination and complies with the applicable requirements of EU Regulation.
The key element of selecting an appropriate PPE will be examining whether if the product is fully CE marking. Honorably, all ULTITEC series are entirely CE marking as well as certified with Module B plus Module D, and we are consistently providing safety shield for comprehensive protection to the frontline heroes!