Standards
Current IEC, ISO, and EN Standards List, With Dates
- IEC 60601-1-XX, -2-XX Standards
* Note – at times, the IEC website can take up to several minutes to load - IEC/ISO 80601-2-XX Standards
* Note – at times, the IEC website can take up to several minutes to load - ISO 80601-2-XX Standards
- EN 60601 and 80601 Standards Search Link
- EN 80601 Standards Search Link
* Some not covered by CENELEC - European Commission List of Harmonized Medical Device Standards and Due Dates
* This is the NEW OJ (Official Journal) site (Scroll just over half way down to the EN 60601-1 standards) - Medical Device Regulation (MDR)
* Regulation (EU) 2017/745 for CE marking - Medical Device Directive (MDD)
* MDD 93/42/EEC for CE marking
Purchasing Standards
NOTE: Standards are copyrighted and not available in their published form for free.
We suggest searching each source below for the best price on the standards you need.
IEC Web Store – Purchase IEC standards
AAMI – Purchase AAMI standards
UL Standards Sale Site – UL standards Store
TechStreet – Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards
IHS Engineering – Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards
Associates
The following are associates that we have a long experience working with, and recommend for their high quality services.
MethodSense, Inc.
Risk assessment and Risk Management solutions/.consulting for Life Science Companies. Expertise includes IEC 60601-1, ISO 14971, ISO 13485, MDD 93/42/EEC, 21 CFR Part 820, AS/NZS ISO 31000, Annex 11, 21 CFR Part 11, and other regulations and standards. Expertise also includes FDA submission support, quality assurance management system development, medical device technology and software compliance, software validation, and business operations efficiency strategies for life science companies.
Contact: Russ King at rking@methodsense.com