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 Directive
* MDD 93/42/EEC for CE marking – pdf document download
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
Comm2000 – UL standards Store
TechStreet – Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards
IHS Engineering – Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards
Test Equipment For Medical Devices
The following is test equipment that we use in our lab, and we have found to work exceptionally well.
Whale Teq
Test and measurement equipment for medical equipment, primarily ECG and Electrosurgical Test and verification. We use this test equipment in our lab for testing medical equipment for internationally accredited reports. There is nothing we’ve found on the market that does what these ECG and Electrosurgical testers do.
Associates
The following are associates that we have a long experience working with, and recommend for their high quality services.
Keystone Compliance
Keystone Compliance is an A2LA accredited test lab specializing in EMC, vibration, temperature, ingress protection and package testing. Keystone Compliance has a large scope of accreditation including significant experience working with manufacturers to receive IEC 60601-1-2 certification. With five EMC chambers and a large environmental testing lab, lead times for testing are short. Please visit www.keystonecompliance.com to learn more or to request a quote.
Minnetronix
Medical equipment design, development, manufacturing services. Equipment conceptualization, design, commercialization, manufacturing, fulfilment, and sustaining services.
Contact: Matt Cunningham
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
Active Alliance
Medical device regulatory assistance, specializing in risk management based on ISO 14971, usability based on IEC 62366, IEC 60601-1-6, and requirements for access to the European Union.
Contact: Dale Hallerberg at dh@activealliance.solutions
Regulatory Technology Services LLC
Accredited by the FDA to perform third-party reviews of FDA 510(k) submissions. More than 300 submissions averaging approximately 30 days from receipt of the submission to receipt of the Substantial Equivalence letter from the FDA.
Contact: Mark Job (Buffalo, MN)
PLEXUS
Equipment conceptualization, design, commercialization, manufacturing, fulfillment, and sustaining services.