On July 10, 2015, new harmonized standards under the Directive 93/42/EEC for Medical Devices were published for the first time.
These new standards include:
- EN ISO 11990-1:2014 and EN ISO 11990-2:2014 pertaining to laser resistance of tracheal tubes
- ISO 10993-3:2014 pertaining to genotoxicity, carcinogenicity and reproductive and developmental toxicity
- EN 13060:2014 on steam sterilizers
- EN 13748-2:2015 on air ambulances
- EN 60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012 on general safety electrical equipment
The European Commission has made new additions to the consolidated list of harmonized standards for medical devices. The consolidated list provides standards that can be followed for compliance and confers a presumption of conformity with the essential health and safety requirements drawn by the EU Legislation and in particular by the Medical Devices Directive (93/42/EEC).
The harmonized standards specify the basic requirements that medical devices must fulfill under the EU directives in order to gain market access in Europe. According to European regulators, the updated list replaces all previous lists published in the Journal. The full list of the applicable harmonized standards can be found on the European Commission website. Any information concerning the availability of the standards can be obtained either from the European standardization organizations or from the national standardization bodies.
Staying up-to-date with the latest changes is vital for manufacturers who want to affix the CE Mark and place their device on the EU market, as these standards specify the basic requirements that medical devices must fulfill under the EU directives. If you want to know more about the applicable standards for your device, please contact us.