Directives and standards

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: on usage restrictions applied to certain hazardous substances in electrical and electronic devices.
2012/19/EU WEE: on waste of electrical and electronic devices management.
2004/108/EC On electromagnetic compatibility.
2006/95/EC On voltage limits.
98/79/EC   On medical devices for in vitro diagnostic. 
Regulation  
1005/2009 On ozone-depleting substances .
842/2006 On certain fluorinated greenhouse gases.
Standards  
EN-61010-1 Security requirements for laboratory equipments.
EN-61010-2-020 Security requirements for equipments used in laboratories. Part 2-020: Special requirements for laboratory centrifuges. 
EN-61010-2-010 Security requirements for equipments used in laboratories. Part 2-010: Special requirements for laboratory devices used for heating materials.
EN-61010-2-051 Special security requirements for laboratory equipments used for mechanical mixing and stirring. 

EN-61326-1

Electrical material for laboratory use. Electromagnetic compatibility requirements (EMC). Part 1: General requirements.

 

PACKAGING:

 
   
ISPM 15 International standards for phytosanitary measures.
Directives  
94/62/EC & 2004/12 EC  Packaging and packaging waste.
GOODS TRANSPORT:  
Regulation  
300/2008  Common rules in the field of civil aviation security.

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