DIN EN 415-3:2025-03

This standard includes safety requirements. This standard contains specifications which give detail to the essential requirements set out in Annex I of the "Machinery Directive", Directive 2006/42/EC, which apply to machines that are first placed on the market within the EEA. This standard serves to facilitate proof of compliance with the essential requirements of this directive. Once this standard is cited in the Official Journal of the European Union, it is deemed a "harmonized" standard, and thus a manufacturer applying this standard may assume compliance with the requirements of the Machinery Directive ("presumption of conformity"). This document establishes safety requirements for the main types of form, fill and seal machines, fill and seal machines and the filling machines which are frequently fitted to these machines. Form fill and seal machines within the scope of this document are: - flow wrapping machine; - vertical form, fill and seal machine; - horizontal sachet form, fill and seal machine; - thermoform, fill and seal machine; - tubular bag form, fill and seal machine; - mandrel form, fill and seal machine. Fill and seal machines within the scope of this document are: - pre-made bag, erect, fill and seal machine; - cup or tub fill and seal machine; - sack fill and seal machine. Filling machines commonly fitted to form, fill and seal machines and fill and seal machines within the scope of this document are: - auger filler; - volumetric cup filler; - nett weigher; - multi-head weigher. Other types of form, fill and seal machine which are described in 3.3 have similar hazards to these machines and Clause 4 indicates which clauses of this document are applicable to these machines. This document covers the safety requirements for machine design, construction and all phases of life of the machines including installation, commissioning, operation, adjustment, maintenance and cleaning. This document applies to machines manufactured after the date of publication of this document. This document does not apply to: - blow mould fill and seal machines; - bulk container fill and seal machines; - cartoning machines; - food depositors, including volumetric piston depositors in the scope of EN 15180; - thermoforming machines in the scope of EN 12409. This document does not consider: - hazards due to the products packed in these machines, but does consider the hazards caused by dusts, modified atmosphere gases, and flammable products; - hazards resulting from the operation of the machines in a potentially explosive atmosphere. This standard differs from DIN EN 415-3:2010-07 as follows: a) the Scope now includes fill and seal machines and multi-head weighers; b) cartoning machines have been removed from the Scope; c) safety requirements have been rewritten so they are in line with EN 415-10:2014; d) normative references have been changed to reflect the many changes that have been made to B1 and B2 standards. This document (EN 415-3:2021) has been prepared by Technical Committee CEN/TC 146 "Packaging machines – Safety”, the secretariat of which is held by UNI. The national interests during preparation were represented by Working Committee NA 060-18-25 AA "Form-, Füll- und Verschließmaschinen prEN 415-3 (SpA CEN/TC 146/WG 2)" ("Form, fill and seal machines (national mirror committee for CEN/TC 146/WG 2)”) of Section "Machinery intended for use with foodstuffs and feed and packaging machinery" at DIN Standards Committee Mechanical Engineering. Representatives of manufacturers of "Form, fill and seal machines", and of the employers' liability insurance associations contributed to this standard.