Regulatory Focus™ > News Articles > European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

Posted 13 May 2016 | By Zachary Brennan 

European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

In the Official Journal of the European Union, the European Commission on Friday published a new list of the harmonized standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law.

The standards were published as part of the implementation of the European Council’s Directive 93/42/EEC from 1993, which deals with medical devices and their regulation.

Background

A harmonized standard is defined by the commission as a European standard developed by a recognized European standards organization, such as the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) or the European Telecommunications Standards Institute (ETSI).

The voluntary standards are created following a request from the European Commission to one of these organizations, and manufacturers or conformity assessment bodies can use them to demonstrate that products, services or processes comply with relevant EU legislation.

New List

For active implantable medical devices, the Journal included five standards with a first publication on Friday, all of which had a date of presumptive conformity of the superseded standard by 30 June, including:

  • EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices
  • EN ISO 11137-1:2015 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013);
  • EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013);
  • EN ISO 13408-1:2015 Aseptic processing of health care products — Part 1: General requirements (ISO 13408- 1:2008, including Amd 1:2013);
  • EN ISO 13408-7:2015 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012);

The list for medical devices includes (with a presumptive conformity date of 30 June 2016 unless indicated otherwise):

  • EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices;
  • EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances — Part 1: General stretcher systems and patient handling equipment;
  • EN 1865-2:2010+A1:2015 Patient handling equipment used in road ambulances — Part 2: Power assisted stretcher;
  • EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015);
  • EN ISO 11137-1:2015 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013);
  • EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013);
  • EN ISO 13408-1:2015 Aseptic processing of health care products — Part 1: General requirements (ISO 13408- 1:2008, including Amd 1:2013);
  • EN ISO 13408-7:2015 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); and
  • EN 60601-1-2:2015 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests IEC 60601-1-2:2014, which has a presumptive conformity date of  31 December 2018.

According to BSI, the standard on electromagnetic distrubances, published in 2015, is to help ensure medical equipment is not oversensitive to radio frequency interference. The standard specifies immunity test levels for the safety of medical electrical equipment and systems, covering equipment for use in healthcare facilities or the home. 

For IVDs, the list includes (with a presumptive conformity date of 30 June 2016 unless indicated otherwise):

  • EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices;
  • EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013);
  • EN ISO 13408-1:2015 Aseptic processing of health care products — Part 1: General requirements (ISO 13408- 1:2008, including Amd 1:2013);
  • EN ISO 13408-7:2015 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012);
  • EN ISO 15197:2015 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for selftesting in managing diabetes mellitus (ISO 15197:2013), with a presumptive conformity date of 30 June 2017;
  • EN ISO 23640:2015 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011), with a presumptive conformity date of 30 June 2017.

In addition to the published list, the EC notes that any information concerning the availability of the standards can be obtained either from the European standardization organizations or from the national standardization bodies.

Commission communication in the framework of the implementation of Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, medical devices and in vitro diagnostic medical devices

Harmonised Standards

Directive 93/42/EEC

 


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