FIES Excellence, SL has a technical department, responsible for maintaining its management as indicated by European and International standards . In this section we inform you of the main regulations related to the sale of Emergency, Prevention and Security material.

Normative

HEALTH

FIRST AID

Regulation DIN13157 for company kits, schools and construction sites.

Decree 95/2000 Sanitary standard for swimming pools for public use in Catalonia

Regulation DIN 13164 for first aid kits in vehicles

Royal Decree 365/2009 of the Ministry of Health and Consumer Affairs, which establishes the conditions and minimum requirements for safety and quality in the use of automatic and semi-automatic external defibrillators outside the health sector

Order TAS / 2947/2007, of October 8, which establishes the supply to companies of first aid kits with first aid material in case of work accident, as part of the protective action of the Social Security system.

Royal Decree 568/2011 Protection and Medical Health of sea workers.

Decree 1800/2003 by which medicinal gases are regulated

MEDICAL DEVICES

UNE-EN ISO 13485: 2016 Health Products: Quality management system. Requirements for regulatory purposes.

Directive 93/42 on Health Products

Regulation (EU) 2017/745 of the European Parliament and of the Council on Health Products. Modifies CEE 93/42. Applicable as of May 26, 2020

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