List European Harmonized Standards for the Medical Devices Directives (93/42/EEC, 90/385/EEC, and 98/79/EC) Updated

On Friday 27 April 2012, the European Commission published updated lists of the European harmonized standards that pertain to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive.

The updated list are important to all manufacturers of CE marked medical devices, active implantable medical devices and in vitro diagnostics that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, re-evaluate your products against the updated standards and update your Declaration of Conformity.

On the list for the Medical Devices Directive (93/42/EC), the following standards are amended:

  1. EN ISO 1135-4:2011 Transfusion equipment for medical use – Part 4: Transfusion sets for single use (ISO 1135-4:2010). This standard replaces the 2010 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  2. EN ISO 14602:2011 Non-active surgical implants – Implants for osteosynthesis – Particular requirements (ISO 14602:2010). This standard replaces the 2010 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  3. EN ISO 15001:2011 Anaesthetic and respiratory equipment – Compatibility with oxygen (ISO 15001:2010). This standard replaces the 2010 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  4. EN ISO 15747:2011 Plastic containers for intravenous injections (ISO 15747:2010). This standard replaces the 2010 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  5. EN 1642:2011 Dentistry – Medical devices for dentistry – Dental implants. This standard replaces the 2009 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  6. EN ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011). This standard replaces the version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.

On the list for the Active Implantable Medical Devices Directive (90/385/EEC), the following standards are amended:

  • EN ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2011). This standard replaces the version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.

On the list for the In Vitro Diagnostics Directive (98/79/EC), the following standards are amended:

  1. EN ISO 18113-1:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements (ISO 18113-1:2009). This standard replaces the 2009 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  2. EN ISO 18113-2:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009). This standard replaces the 2009 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  3. EN ISO 18113-3:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009). This standard replaces the 2009 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  4. EN ISO 18113-4:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009). This standard replaces the 2009 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.
  5. EN ISO 18113-5:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009). This standard replaces the 2009 version with the same number. By 30 April of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity.

The updated list of standards can be found in our Library shortly.