EU Commission Publishes New Harmonized Standards for Devices, Implants, IVDs
European Commission on 27th May 16 presented a new list of the harmonized standards in Official Journal of the European Union. Manufacturers of medical, implantable and in vitro diagnostic devices can use these standards to show their products obey with EU law.
The standards were presented as part of the execution of the European Council’s Directive 93/42/EEC from 1993, which deals with medical devices and their regulation.
A harmonized standard is described by the commission as a European standard designed by an identified 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 specifications are designed after a request from the European Commission to one of these agencies, and manufacturers or conformity evaluation bodies can use them to show that products, services or procedures obey with appropriate EU legislation.
New List
For active implantable medical devices, the EU Journal provided 5 specifications with a first publication on 27th May, all of which had a date of presumptive conformity of the updated standard by 30 June, including:
- EN 556-2:2015 Sterilization of medical devices — Specifications for medical devices to be designated ‘STERILE’ — Part 2: Specifications for aseptically processed medical devices
- EN ISO 11137-1:2015 Sterilization of health care products — Radiation — Part 1: Specifications for development, validation and routine control of a sterilization procedure for medical devices (ISO 11137-1:2006, including Amd 1:2013);
- EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Setting up 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 procedures 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 suggested otherwise):
- EN 556-2:2015 Sterilization of medical devices — Specifications for medical devices to be designated ‘STERILE’ — Part 2: Specifications for aseptically processed medical devices;
- EN 1865-1:2010+A1:2015 Patient handling devices used in road ambulances — Part 1: General stretcher systems and patient handling devices;
- EN 1865-2:2010+A1:2015 Patient handling devices 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 incorporated features (ISO 3826-4:2015);
- EN ISO 11137-1:2015 Sterilization of health care products — Radiation — Part 1: Specifications for development, validation and routine control of a sterilization procedure for medical devices (ISO 11137-1:2006, including Amd 1:2013);
- EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Setting up the sterilization dose (ISO 11137-2:2013);
- EN ISO 13408-1:2015 Aseptic processing of health care products — Part 1: General specifications (ISO 13408- 1:2008, including Amd 1:2013);
- EN ISO 13408-7:2015 Aseptic processing of health care products — Part 7: Alternative procedures for medical devices and combo products (ISO 13408-7:2012); and
- EN 60601-1-2:2015 Medical electrical devices — Part 1-2: General specifications for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Specifications and tests IEC 60601-1-2:2014, which has a presumptive complying date of 31 December 2018.
With respect to BSI, the standard on electromagnetic disturbances, presented in 2015, is to assist make sure medical device is not oversensitive to radio frequency interference. The standard identifies immunity test levels for the safety of medical electrical devices and systems, covering devices for use in healthcare facilities or the home.
For IVDs, the list contains (with a presumptive conformity date of 30 June 2016 unless suggested otherwise):
- EN 556-2:2015 Sterilization of medical devices — Specifications for medical devices to be designated ‘STERILE’ — Part 2: Specifications for aseptically processed medical devices;
- EN ISO 11137-2:2015 Sterilization of health care products — Radiation — Part 2: Developing the sterilization dose (ISO 11137-2:2013);
- EN ISO 13408-1:2015 Aseptic processing of health care products — Part 1: General specifications (ISO 13408- 1:2008, including Amd 1:2013);
- EN ISO 13408-7:2015 Aseptic processing of health care products — Part 7: Alternative procedures for medical devices and combo products (ISO 13408-7:2012);
- EN ISO 15197:2015 In vitro diagnostic test systems — Specifications for blood-glucose monitoring systems for self-testing in handling diabetes mellitus (ISO 15197:2013), with a presumptive conformity date of 30 June 2017;
- EN ISO 23640:2015 In vitro diagnostic medical devices — Assessment of stability of in vitro diagnostic reagents (ISO 23640:2011), with a presumptive conformity date of 30 June 2017.
In addition to the presented list, the EC says that any information regarding the availability of the standards can be acquired either from the European standardization organizations or from the national standardization bodies.