EU Commission Publishes Updated Harmonization Standards

The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation.

The standards are an update to those implemented by the European Council’s Directive 93/42/EEC in 1993.

In the directive, changes are listed under categories for implantable, medical and in-vitro devices. When standards have been updated, manufactures need to re-evaluate their products against the updated standards and provide an updated version of their Declaration of Conformity. The date of implementation is June 30 unless otherwise noted.

Here are some of the important updates:

Sterilization:

• An addition of Part 2 to EN 556-2:2015. Sterilization of medical devices — Requirements for medical devices to be designated sterile — Part 2: Requirements for aseptically processed medical devices.
• A new version of 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.
• A new version of EN ISO 11137-2:2015. Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose.

Aseptic:

• A new version of EN ISO 13408-1:2015. Aseptic processing of health care products — Part 1: General requirements.
• A new version of EN ISO 13408-7:2015. Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products.

Patient Handling:

• A new version of EN 1865-1:2010+A1:2015. Patient handling equipment used in road ambulances — Part 1: General stretcher systems and patient handling equipment.
• A new version of EN 1865-2:2010+A1:2015. Patient handling equipment used in road ambulances — Part 2: Power assisted stretcher.

In-vitro Diagnostics:

• A new version EN ISO 15197:2015. In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
• A new version of EN ISO 23640:2015. In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents.

Medical Electrical Equipment:

• A new version of 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.

Medical Equipment:

• A new version of EN ISO 3826-4:2015. Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features.

Read the updated EU Commission directive here: www.fdanews.com/05-16-16-OfficialJournalofEuropeanUnion.pdf. View the Harmonized Standards by category here: www.fdanews.com/05-16-16-EuropeanCommissionHarmonisedStandard.pdf. The 1993 directive can be found here: www.fdanews.com/05-16-16-1993CouncilDirective93_42_EEC.pdf. — Joya Patel