1.4. Manufacturer’s instructions and information (PPE Regulation)

In addition to the name and address of the manufacturer, the instructions that must be supplied with the PPE must contain all relevant information on:

(a) instructions for storage, use, cleaning, maintenance, servicing, and disinfection. Cleaning, maintenance, or disinfectant products recommended by manufacturers must have no adverse effect on the PPE or the user when applied in accordance with the relevant instructions;

(b) performance as recorded during relevant technical tests to check the levels or classes of protection provided by the PPE; 31.3.2016 L 81/76 Official Journal of the European Union EN

(c) where applicable, accessories that may be used with the PPE and the characteristics of appropriate spare parts;

(d) where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use;

(e) where applicable, the month and year or period of obsolescence of the PPE or of certain of its components;

(f) where applicable, the type of packaging suitable for transport;

(g) the significance of any markings (see point 2.12);

(h) the risk against which the PPE is designed to protect;

(i) the reference to this Regulation and, where applicable, the references to other Union harmonization legislation;

(j) the name, address, and identification number of the notified body or bodies involved in the conformity assessment of the PPE;

(k) references to the relevant harmonized standard(s) used, including the date of the standard(s), or references to the other technical specifications used;

(l) the internet address where the EU declaration of conformity can be accessed.

The information referred to in points (i), (j), (k), and (l) need not be contained in the instructions supplied by the manufacturer if the EU declaration of conformity accompanies the PPE.

9 Information supplied by the manufacturer (EN 17353)

For garments, the requirements for information supplied by the manufacturer shall be in accordance with EN ISO 13688:2013. The following sentences shall be included in the information supplied by the manufacturer (if applicable):

  1. a) “When relevant, the stated maximum number and type of cleaning cycles is not the only factor related to the lifetime of the garment.

The lifetime depends on usage, care storage, and also, if relevant, on the number of cleaning cycles.”

  1. b) “For B1 devices, in order to achieve 360° visibility (visibility from all sides) at least two B1 devices shall be used; these shall be used on the left and the right side of the torso.”
  1. c) “For B2 devices, in order to achieve 360° visibility (visibility from all sides) at least two B2 devices shall be used; these shall be used on the left and the right side of the torso.”
  1. d) “Any alterations of the product such as printing of logos may compromise the minimum areas and performance of the product”

If the color after the Xenon test changes from one color box to another, this shall be mentioned in the instructions for use.