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IEC 60601-1
Medical Equipment Compliance,
Certification, and Regulatory Services and Information

Medical Equipment Compliance Associates, LLC

Useful Resources

The following links are provided to assist you in finding what you need.

Standards

 

Current IEC, ISO, and EN Standards List, With Publish Dates

 

IEC 60601-1-XX, -2-XX Standards

IEC/ISO 80601-2-XX Standards

ISO 80601-2-XX Standards

 

EN 60601 Standards Search Link
EN 80601 Standards Search Link


EN 80601 Standards Search Link (Enter "80601" in Standard Reference)

 

European Commission List of Harmonised Medical Device Standards and Due Dates

This is the European OJ (Official Journal) site. Scroll just over half way down to the EN 60601-1 standards


Medical Device Directive (MDD)
(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
UL standards - UL Store

TechStreet - Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards
IHS Engineering - Purchase IEC, ISO, UL, AAMI, CSA, EN, etc. standards

 

 

Component Certification Directories

The following are NRTL Certification directories for components and devices.

They are used to verify the compliance of components under the applicable standards by the specified NRTLs.

NOTE: Some now require setting up an account to access the directories.

 

UL Product IQTM Component Certification Directory - UL Recognized, Listed, Classified, Certified (now requires account and login)

Intertek - Certified Product Directory Search

TUV Rheinland - Certified Product Directory Search

CSA - Product Certification Directory Search

TUV SUD - Certificate Explorer Search

SGS - Certified Products Search

 

OSHA - Occupationa Safety and Health Administration list of Nationally Recognized Testing Laboratories (NRTL)

 

 

Associates

The following are associates that we have a long experience working with, and recommend for their high quality services

Test Equipment For Medical Devices

 

The following is test equipment that we use in our lab, and we have found to work exceptionally well.

whaleteq.com - Contact Brian Biersach (bb@60601-1.com) at MECA or service@whaleteq.com at WhaleTeq with questions.

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.

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 Inc. - Contact: Matt Cunningham

  Medical equipment design, development, manufacturing services

  Equipment conceptualization, design, commercialization, manufacturing, fulfilment, and sustaining services

 

MethodSense, Inc. - Contact: Russ King at rking@methodsense.com

  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.

 

Active Alliance - Contact: Dale Hallerberg at dh@activealliance.solutions

  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.

 

Regulatory Technology Services LLC - Contact: Mark Job (Buffalo, MN)

  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

PLEXUS

  Equipment conceptualization, design, commercialization, manufacturing, fulfillment, and sustaining services