- Work With The Experts to Speed Your Device to Market -
Call Today
For answers to your questions
(262) 672-6901
IEC 60601-1
Medical Equipment Compliance,
Certification, and Regulatory Services and Information
MECA Help Site
Medical Equipment Compliance Associates, LLC
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
Deadlines For Medical Standards Compliance:
The deadline for the IEC 60601-1, Edition 3 + Amendment 1 standard (Edition 3.1) has passed for essentially all countries, except China.
The next deadline will be for the IEC 60601-1, Edition 3 + Amendment 2 standard (Edition 3.2), expected to be published in December of 2019.
The work on IEC 60601-1, Edition 4 is also in the works, and is currently expected to be published around 2025, but will likely be later.
This is NOT the 4th Edition of the IEC 60601-1-2 (EMC) Collateral standard, which had a deadline for most countries of December 31, 2018.
For the Base, Collateral & Particular standards, the required compliance date is generally 3 years after the IEC or national publication date.
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
List of IEC 60601-1 National Standards and Countries (Per IECEE CB Scheme)
Harmonized with IEC 60601-1:2015 + A1:2012 (Edition 3.1):
Albania SSH EN 60601-1:2006 + A1:2013 + AC:2014
Austria (AU) ÖVE/ÖNORM EN 60601-1: 2014 02 01
Brazil (BR) NBR IEC 60601-1:2010 + IEC 60601-1:2005/AMD1:2012
Bosna Hercegovina BAS EN 60601-1:2010 + A1:2015 + A12:2016
Bulgaria БДС EN 60601-1:2006 + A1:2013 + AC:2014
Canada (CA) CAN/CSA C22.2 No. 60601-1:2014 (has National Differences)
Denmark (DK) DS/EN 60601-1:2006 + A1:2013 + AC:2014
European Union (EU) EN 60601-1:2006 + A1:2013 + A12:2014
Finland (FI) SFS-EN 60601-1:2007 + A1:2016
Former Yugoslav Republic of Macedonia MCK EN 60601-1:2006 + A1:2016 + AC:2015
France (FR) NF EN 60601-1:2007 + A1:2014
Germany (DE) DIN EN 60601-1:2013; VDE 0750-1:2013-12
Hungary (HU) MSZ EN 60601-1:2017
Iceland IST EN 60601-1:2006 + A1:2013 + AC:2014
Ireland I.S. EN 60601-1:2006 + AMD1:2013 + AMD12:2014
Japan (JP) JIS T 60601-1:2012 + A1:2014 (has National Differences)
Latvia LVS EN 60601-1:2007 + A1:2014
Lithuania LST EN 60601-1:2007 + A1:2013
Luxembourg ILNAS-EN 60601-1:2006 + A1:2014
Montenegro MEST EN 60601-1:2010 + A1:2015 + A12:2015
Netherlands (NO) NEN-EN-IEC 60601-1:2006 + A1:2013 + A12:2014
Norway (NO) NEK EN 60601-1:2006 + A1:2013
Poland (PL) PN-EN 60601-1:2011 + +A12:2014 AC1:2015
Serbia SPRS EN 60601-1:2012 + A1:2014 + AC:2017
Slovenia (SL) SIST EN 60601-1:2007 + A1:2014 + AC:2015
Spain UNE-EN 60601-1:2008 + A1:2013 + A12:2014
Sweden (SE) SS-EN 60601-1:2006 + A1:2013 + A11:2014
Switzerland (CH) SN EN 60601-1:2010 + A1:2013 + Corr:2014
Turkey (TR) TS EN 60601-1:2007 + A12:2015 + AC:2017 + A12:2017 + A1:2017
United States of America (US) ANSI/AAMI/ES 60601-1:2005 + A2:2010 + A1:2012 (has National Differences)
United Kingdom (UK) BS EN 60601-1:2006 + A12:2014
Note:
Other countries may claim compliance to the IEC 60601-1 + Amendment 1 standard without a National publication of the standard.
China is currently accepting only IEC 60601-1 Edition 2.
Korea has the National Standard KS C IEC 60601-1, corresponding to IEC 60601-1, Edition 3 without Amendment 1.
List of Counties Participating in the IECEE CB Scheme for IEC 60601-1:
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
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
Experts in the field of medical certification and regulatory compliance with a commitment to quality service
Founded 2002
See us on
