Regulation (EU) 2016/425 governs devices designed and manufactured to be worn or kept by a person to protect themselves from one or more risks to their health or safety and establishes the essential requirements to which they must meet.
Personal protective equipment is divided into three categories (I, II and III) which, depending on the risk, provide for a different conformity assessment procedure.
CATEGORY I (minimum risks): the manufacturer declares, under his sole responsibility, that the PPE satisfies the applicable requirements of the regulation (prepares the technical documentation and an adequate manufacturing and control process to ensure compliance).
CATEGORY II (PPE protecting from risks that are not minor but not fatal): a notified body examines the technical design of the PPE and verifies that it meets the requirements of the regulation. Specifically, the type examination involves the analysis of technical documentation and the execution of tests on a representative sample of the expected production.
CATEGORY III (serious risks): the conformity assessment procedure is the same as for category II, to which are added periodic factory visits to verify the conformity of the PPE to the certified type, by taking samples to be tested in the laboratory or by checking the quality system.
CSI, Notified Body No. 0497, is notified for the following Personal Protective Equipment:
CSI is also an accredited laboratory according to UNI EN ISO / IEC 17025 for various harmonized standards, including:
To check the complete list of accredited tests: https://www.accredia.it/
For information on the validity of certificates please write to prodotto@csi-spa.com.