Ortoalresa meets the following standards, directives and regulations in accordance with the quality commitment of their products:

 

COMPANY:

Standards
ISO 9001 Certified quality management system
ISO 13485 Certified quality management system for medical devices.
 

PRODUCTS:

Directives
2011/65/EU (ROSH) Restriction of the use of certain hazardous substances in electrical and electronic equipment.
2012/19/EU (RAEE) On waste electrical and electronic equipment.
2014/30/EU (CEM) On the harmonisation of the laws of the Member States relating to electromagnetic compatibility.
2014/35/EU (LVD) On the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits.
98/79/EC (IVD) On in vitro diagnostic medical devices.
93/42/EC Concerning medical devices.
Regulation nº
(EC) 1005/2009 On substances that deplete the ozone layer.
(EU)517/2014 On fluorinated greenhouse gases and repealing regulation.
Standards
EN-61010-1 Security requirements for electrical equipment for measurement, control and laboratory use. Part 1: General requirements.
EN-61010-2-020 Part 2-020: Particular requirements for laboratory centrifuges.
EN-61010-2-010 Part 2-010: Particaular requirements for laboratory equipment for the heating of materials.
EN-61010-2-040 Part 2-040: Particaular requirements for sterilizers and washer-desinfectors used to treat medical materials.
EN-61010-2-051 Part 2-051: Particular requirements for laboratory equipment for mixing and stirring.
EN-61326-1 Electrical material for laboratory use. Electromagnetic compatibility requirements (EMC). Part 1: General requirements.
EN-61326-2-6 Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment.
EN-13060 Small steam sterilizers.
 

PACKAGING:

ISPM 15 International standards for phytosanitary measures.
Directives
94/62/EC & 2004/12 EC Packaging and packaging waste.
 

GOODS TRANSPORT :

Regulation nº
(EC) 300/2008  Common rules in the field of civil aviation security.