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

MECA Help Site

Medical Equipment Compliance Associates, LLC

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Useful Resources

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

MECA Useful Links
Useful Links Graphics



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)


IEC Standards
ISO Standards
IEC Standards
CEN Standards
Official Journal
Medical Device Directive
CENELEC Standards



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.


Method Sense

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

Regulatory Technology Services


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



FDA - Food and Drug Administration Home page

FDA  - FDA recognized consensus standards search

FDA - 60601 Series of Recognized Consensus Standard
FDA - 80601 Series of Recognized Consensus Standard
FDA - Guidance document search page

IEC - International Electrotechnical Commission Home page

IEC Working Group TC 62 - Electrical equipment in medical practice

IEC Working Group 62A - General standard writing committees

IEC Working Group 62B - Imaging standards writing committees

IEC Working Group 62C - Nuclear/Radiation standards writing committees

*IEC Working Group 62D - Particular standards writing committees

IECEE - International Electrotechnical Commission for Electrical Equipment Home page

IECEE CB Scheme - List of IECEE CB Scheme Members

IECEE CB Scheme - MECA CB Scheme CBTL member information and scope

AAMI - Association for the Advancement of Medical Instrumentation (Home page)

AAMI - Standards


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Experts in the field of medical certification and regulatory compliance with a commitment to quality service
Founded  2002

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