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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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Information:
Medical Device FDA Requirements, IEC 60601-1 Standards

 

Help With Your Compliance Questions, FAQ

If you're on this page, you're likely trying to find specific information to answer a compliance question, or just trying to understand
the regulatory and standards requirements (FDA, CE Marking, etc.) to place your device on the US and international markets.
You should be able to find your answers here. We are continuously adding information to help assist you in your design, development, and preparing documentation for global marketing of your medical device.

Additional information is now provided on the new
IEC 60601-1 Help Site at MECAssociates.us

If you don't see the answers you need here, please email me the question.
I'll be happy to answer your question, and add it to this information page (if applicable).
Brian Biersach:
bb@60601-1.com

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Deadlines For Medical Standards Compliance:


The deadline for the IEC 60601-1, Edition 3 standard, including national harmonized standards, has passed for almost all countries, except China.
The next set of deadlines will be for the IEC 60601-1, Edition 3.1 standard (which includes Amendment 1), including national harmonized standards.
For the Collateral & Particular standards, the general rule for required compliance is 3 years after the IEC or national publication date of the standard.


US FDA deadline for compliance with AAMI ES 60601-1:2005(R)2012+A1:2012
    (Third Edition with Amendment 1) 2016-08-01, per FDA
    Required for new medical equipment and existing equipment requiring FDA re-submission


European Union deadline for compliance with EN 60601-1, Ed.3 + Am.1
    (Third Edition with Amendment 1) 2018-01-01, per EU OJ
    Required for all medical equipment on the market (no grandfathering)


Canadian Health Canada deadline for compliance with CSA C22.2 No. 60601-1:14
    (Third Edition with Amendment 1) Not yet specified, per Health Canada
   
Required for new medical equipment and existing equipment requiring re-submission


Deadline Passed

 

 

2018-01-01

 

 

Not yet specified


NEWS And Updates:



LinkedIn MECA Company page

Linkedin Group: IEC 60601-1 Edition 3.1 Compliance for compliance questions, news, and updates

Also see our Free document download page

MECA Linkedin Group


HELP With Your Medical Equipment (FDA, Certification, Regulatory Requirements)

This information is now provided on the new MECA IEC 60601-1 Help Site: MECAssociates.us

 

 

List of Countries Accepting The IEC 60601-1 Standards (Per IECEE CB Scheme)

 

ARGENTINA

AUSTRALIA

AUSTRIA

BAHRAIN

BELARUS

BELGIUM

BRAZIL

BULGARIA

CANADA

CHINA

COLOMBIA

CROATIA

CZECH REPUBLIC

DENMARK

FINLAND

FRANCE

GERMANY

GREECE

HUNGARY

INDIA

INDONESIA

IRAN, ISLAMIC REPUBLIC OF

IRELAND

ISRAEL

ITALY

JAPAN

KAZAKHSTAN

KENYA

KOREA, REPUBLIC OF

LIBYAN ARAB JAMAHIRIYA

MALAYSIA

MEXICO

NETHERLANDS

NEW ZEALAND

NORWAY

PAKISTAN

POLAND

PORTUGAL

ROMANIA

RUSSIAN FEDERATION

SAUDI ARABIA

SERBIA

SINGAPORE

SLOVAKIA

SLOVENIA

SOUTH AFRICA

SPAIN

SWEDEN

SWITZERLAND

THAILAND

TURKEY

UKRAINE

UNITED ARAB EMIRATES

UNITED KINGDOM

USA

VIETNAM


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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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