On March 9, 2016, the European Union adopted the Regulations (EU) 2016/425 and published in the Official Journal of the European Union. This regulation repeals and replaces existing Directive 89/686/EEC. The regulation summarizes several key changes that will be implemented.
Important date
â– The directive 89/686/EEC was withdrawn on April 21, 2018.
â– The EC type inspection certificate under the Directive 89/686/EEC (Article 10) is still valid if it has not expired before April 21, 2023.
EU type inspection certificate
The EC type inspection certificate issued under Article 10 of Directive 89/686/EEC is renamed as EU type inspection certificate and is issued in accordance with Module B of Annex V. This type of certificate is valid for 5 years.
The 2016/425 regulations require manufacturers to submit an application at the earliest 12 months and at the latest 6 months prior to the expiry of the EU type inspection certificate. At the expiration date NormalTCI Nomo Detection will make a suggestion and ask you whether the following applies:
â– Has the product been adjusted, which will affect the compliance of the product with the current basic health and safety requirements?
â– Has the current level of technology changed, such as the release of revised harmonized standards?
If the answer to the above question is "negative," the review will be simple (low cost) and a new certificate will be issued. Otherwise, a modified version of the technical document is needed. Our records show that many customers’ certificates under Article 10 are issued many years ago, so it is very important to review these products, and NormalTCI Nomo detects which products are no longer needed.
Technical documents
Technical documents (Annex III) requirements have been stipulated by the Center:
(a) A complete description of the PPE and its intended use;
(b) Risk assessment of PPE's attempt to protect the site;
(c) List of basic health and safety requirements applicable to PPE;
(d) PPE and its components, subcomponents, design drawings and plans for the design and circuit;
(e) Descriptive and explanatory information that must be provided in order to understand the drawings and plans mentioned in point (d) and to understand the operation of the PPE;
(f) A reference list of harmonized standards that has been applied in Article 14 of the design and manufacture of PPE. If only part of the harmonized standard is implemented, the document provided must specify what has already been implemented;
(g) Where harmonized standards are not implemented or are only partially implemented, descriptive information on other technical specifications implemented to meet current essential health and safety requirements needs to be provided; published on April 7, 2016, 3 pages ,page 2;
(h) Provide results of design calculations, observations and inspections to verify that PPE meets current essential health and safety requirements;
(i) Provide test reports confirming that the PPE meets current basic health and safety requirements, and determine the relative level of protection where applicable;
(j) A description of the method the manufacturer uses to ensure that the manufactured PPE meets the design specifications during the production process;
(k) A copy of the manufacturer's description and information as set out in Article 1.4 of Annex II;
(l) PPE produced as a single product to meet individual user needs, providing all necessary instructions for producing the PPE based on the approved basic model;
(m) For each product that is suitable for a single user's mass-produced PPE, the manufacturer will take some of the assembly and manufacturing process to ensure that each PPE product meets the approved model and the current basic health and safety requirements Measures to provide a description of these measures. NormalTCI Nomo Test recommends that you use the EU Official Gazette 31.3.2016 L 81/85 list in the new technical submission, which will make the next update easier.
Covered PPE Products
The definition of PPE was revised as follows:
(a) Dressing or hand-held equipment designed or manufactured to provide individuals with protection against one or more risks that compromise health or safety.
(b) Exchangeable parts mentioned in point (a) that are important for the protective function of PPE products.
(c) The connection system for non-wearing or hand-held equipment mentioned in point (a). Designed to connect the equipment and external equipment or to attach a fixed point, this part is a non-permanent fixed part and does not need to be fixed before use.
Under 89/686/EEC regulations, private heat-resistant PPE products (such as gloves) were not previously included. It is now covered.
The definition of Class I products has been improved to increase protection for the following minimum risks:
(a) Surface mechanical damage
(b) contact with ineffective cleaning materials or prolonged contact with water;
(c) contact with hot surfaces not exceeding 50°C;
(d) Injury to the eye due to exposure to sunlight (instead of observing the sun);
(e) Atmospheric conditions that are not extreme properties.
The definition of Class III products has also been refined to include risks that may cause very serious consequences, similar to death or irreversible health damage, related to the following:
(a) substances and mixtures that are harmful to health;
(b) An oxygen-deficient atmosphere;
(c) Pesticides;
(d) ionizing radiation;
(e) In high temperature environments, the effect may be compared with the effect of air temperature of at least 100°C;
(f) At low temperature, the effect can be compared with the effect of -50°C or even lower air temperature;
(g) falling from a high altitude;
(h) Electric shock and live operation;
(i) drowning;
(j) Hand chain saw cuts;
(k) High pressure injection;
(l) gunshot or knife wounds;
(m) Damage caused by noise.
As previously agreed, Class II products are product conformity assessment processes not included in Class I or Class III:
Category II: EU type inspection (Module B) is specified in Annex V, followed by compliance with internal production control (Module C) type as specified in Annex VI;
Class III: Annex V specifies the EU type inspection (Module B), and either of the following two:
(i) Type-compliance based on internal production controls and regulated random product spot checks (C2 modules) as specified in Annex VI (this is equivalent to previous Article 11A).
(ii) Type compliance based on quality assurance (D-Module) of the production process specified in Annex VIII (this is equivalent to the previous Article 11B).
Due to damage, for PPEs that are produced as a single product to meet individual user needs and are classified according to Category III, the mentioned process can follow the flow of the Category II product.
Manufacturer’s obligations
This is a new part but transfers the information in 89/686/EEC regulations to Article 8. It is important that there are additional requirements in the following clauses.
(4) When the risks presented by PPE are considered to be pertinent, in order to protect the health and safety of consumers and other end-users, manufacturers should conduct sample tests, investigations, and, if necessary, record complaints on the market for PPE. , Non-compliance PPE and PPE recall, and similar inspections are notified to the dealer.
(5) The manufacturer shall ensure that the listed PPE product has a model number, batch or serial number or other elements for identification, or that the PPE product is packaged or shipped with the PPE when the dimensions or attributes of the PPE product cannot be identified. Documents on the product provide the requested information.
(8) Manufacturers should furnish a PPE product with an EU declaration of conformity, or, in the instructions and information in Article 1.4 of Annex II, provide the URL for obtaining the EU Compliance Statement.
(9) If the manufacturer believes or has reason to believe that the PPE product it has provided to the market does not comply with the regulations, the manufacturer shall immediately take the necessary corrective measures to make the PPE product comply with the regulations, revoke the product or recall as appropriate. this product. Furthermore, when PPE products pose risks, in particular when a PEP product has been put on the market in a member country, the manufacturer should immediately inform the legally qualified national authority of the country that the product is illegitimate and inform it to take Any corrective action.
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