Interpretation of EU Directive on New Personal Protective Equipment EU2016/425

- Jun 27, 2019-

Interpretation of EU Directive on New Personal Protective Equipment EU2016/425


The new European Personal Protective Equipment Regulations 2016/425 was launched in the official journal on April 21, 2016, and a two-year transition period was initiated to replace the current 89/686/EEC Directive.

Directive 89/686 / EEC has been repealed since April 21, 2018. Approved 89/686/EEC EC Type Inspection Certificates (Article 10) are valid until April 21, 2023, unless they expire before that date.


Redefined the requirements of the Technical Document (Annex III):

(a) A complete description of the PPE and its intended use;

(b) assess the risks that personal protective uses are intended to protect;

(c) A list of basic health and safety requirements applicable to personal protective equipment;

(d) drawings and schemes for the design and manufacture of personal protective equipment and its components, subassemblies and circuits;

(e) understand the plans and plans described in point (d) and the explanations and explanations required for the operation of personal protective equipment;

(f) References to the harmonized standards referred to in Article 14 have been used to design and manufacture personal protective equipment. If part of the application of the uniform standard, the document should indicate the part that has been applied;

(g) If the harmonized standard has not been applied or is only partially applied, the other technical specifications used to meet the applicable basic health and safety requirements; 2 April, 2016, page 2 of 3

(h) the results of design calculations, inspections and inspections to verify that personal protective equipment meets the applicable basic health and safety requirements;

(i) Reporting tests to verify that personal protective equipment meets the applicable basic health and safety requirements and, where appropriate, the relevant level of protection;

(j) a description of the method used by the manufacturer in the PPE production process to ensure that the PPE produced meets the design specifications;

(k) A copy of the manufacturer's description and information contained in point 1.4 of Annex II;

(l) PPE produced as a single unit is suitable for individual users, and all necessary instructions for the manufacture of such PPE are based on the approved basic model;

(m) PPE for tandem production, where each project is suitable for individual users, describing the measures that the manufacturer should take during assembly and production to ensure that each PPE project meets the approved type and applicable basic health and safety requirements. . 31.3.2016 L 81/85 EU Official Gazette EN SGS recommends that this list be used in the submission of new technologies that you submit, which will make subsequent renewals easier to handle.


The definition of PPE is modified as follows:

(a) equipment designed and manufactured for the wear or possession of a person to prevent the person's health or safety from being exposed to one or more risks;

(b) The interchangeable parts of the equipment referred to in point (a), which are essential for their protective function;

(c) the connection system of the device described in point (a), which is not held or worn by a person, designed to connect the device to an external device or a reliable anchor point, rather than being designed for permanent fixation and No fastening work is required before use.


The definition of Class I products has been improved to include the following minimum risks:

(a) surface mechanical damage;

(b) cleaning materials that are in contact with weak or prolonged exposure to water;

(c) contact with a hot surface not exceeding 50 ° C;

(d) damage to the eyes when exposed to sunlight (except when observing the sun);

(e) Non-extreme atmospheric conditions.


Class III products have also been redefined to include only risks that may cause serious consequences, such as death or irreversible damage to the following health:

(a) substances and mixtures that are hazardous to health;

(b) an atmosphere of lack of oxygen;

(c) harmful biological agents;

(d) ionizing radiation;

(e) High temperature environment, the impact of which is comparable to the environment with a temperature of at least 100 ° C;

(f) Low temperature environment, the impact of which is comparable to the temperature of -50 ° C or below;

(g) falling from a height;

(h) electric shock and live working;

(i) drowning;

(j) cutting with a portable electric saw;

(k) high pressure jets;

(l) bullet wounds or stab wounds;

(m) Harmful noise.


Authentication mode:

Class II: EU Type Inspection (Module B) is specified in Annex V, followed by internal production control (Module C) type compliance as specified in Annex VI;


Class III: EU Type Inspection (Module B) is specified in Annex V, and either of the following:

The type of compliance based on internal production controls and regulated random product sampling (C2 module) as specified in Annex VI (this is equivalent to the previous Article 11A).

The type compliance based on the quality assurance of the production process (d module) as specified in Annex VIII (this is equivalent to the previous Article 11B).

Due to damage, for a PPE that is produced as a single product to meet the needs of a single user and classified according to Class III, the process referred to may follow the flow of the Class II product.