Standards for Medical Devices

 Standards is a document, that is prepared by subject matter experts and approved by a recognized body.

This provides guidance on the design, use or performance of materials, products, processes, services, systems or persons.

International Standardisation Bodies 

• ISO: International Standardization Organisation (www.iso.org )
• IEC: International Electrotechnical Commission (www.iec.ch )
• ITU: International Telecommunication Union (www.itu.int )

European Standardisation Bodies

• CEN: European Committee for Standardisation (www.cen.eu)
• CENELEC: European Committee for Electrotechnical Standardisation (www.cenelec.eu)
• ETSI: European Telecommunications Standards Institute (www.etsi.org)

International standards are developed by International Standardisation Bodies.

ISO 14971:2019 Medicaldevices — Application of risk management to medical devices. 

European standards are developed by European Standardisation Bodies.

EN 60601-1-6:2010/A2:2021 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

European Harmonised standards

European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation.

Harmonised standards are published in Official Journal of the European Union.

Devices that are in compliance with harmonized standards shall be presumed to be in conformity with the requirements of European Regulation. (Article 8)

US FDA Recognized Consensus Standards

FDA identify or recognize a standard established by a national or international standard developing bodies.Manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Guidance on Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices

US FDA Recognized Consensus Standards Database:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

 

References

REGULATION (EU) No 1025/2012

REGULATION (EU) 2017/745

REGULATION (EU) 2017/746

Standards and Conformity Assessment Program: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices