Skip to main content
Welcome to the cutting edge of safety science—Learn more about our rebrand.
  • Regulatory Update

Publication of National Versions of 60601-1 Standards

In March 2022, the AAMI published relevant U.S amendments of the IEC 60601-1 Standards. These will be utilized into FDA’s recognized standards database and OSHA’s list of “Appropriate Test Standards.”

A nurse is attending to patient.

July 19, 2022

IEC 60601 is a widely accepted series of standards for the Basic Safety and Essential Performance of Medical Electrical Equipment.

On March 18, 2022, the Association for the Advancement of Medical Instrumentation (AAMI) published the relevant U.S. amendments of the following IEC 60601-1 Standards:

  • IEC 60601-1:2005/AMD2:2020
  • IEC 60601-1-2:2014/AMD1:2020
  • IEC 60601-1-8:2006/AMD2:2020
  • IEC 60601-1-11:2015/AMD1:2020
  • IEC 60601-1-12:2014/AMD1:2020

Amendments to the previously published AAMI standards* have been published as follows:

  • ANSI/AAMI ES60601-1: 2005/A2:2021
  • ANSI/AAMI/IEC 60601-1-2:2014/A1:2021
  • ANSI/AAMI/IEC 60601-1-8:2006/A2:2021
  • ANSI/AAMI HA60601-1-11:2015/A1:2021
  • ANSI/AAMI/IEC 60601-1-12:2016/A1:2021

*Note: All the above amendments are currently only published as an amendment to the IEC standard. Publication of the fully amended standard is forthcoming.  

 

These recently published standards will be utilized for inclusion into FDA’s recognized standards database as well as OSHA’s documented list of “Appropriate Test Standards.” 

A similar set of national standards updates were issued by the Canadian Standards Association (CSA) under the following Canadian national standards:

  • CSA C22.2 No. 60601-1:14 AMD2
  • CSA C22.2 No. 60601-1-2:16 AMD1
  • CSA C22.2 No. 60601-1-8:08 AMD2
  • CSA C22.2 No. 60601-1-11:15 AMD1
  • CSA C22.2 No. 60601-1-12:15 (Dated January 2022)
  • Additionally CSA has published CSA C22.2 No. 60601-1-6:11 (Dated January 2022)

*Note: All the above amendments are currently only published as an amendment to the IEC standard. Publication of the fully amended standard is forthcoming.  

Regulation updates

The U.S. FDA has recently updated the web-based directory of recognized consensus standards to include all of the above standards. The supplemental information sheets for all of the above standards indicate a required transition date for new submittals to the FDA of Dec. 17, 2023, after which all of the new standards will be required. Health Canada’s standards updates and transitional periods may be similar to the US FDA requirements.

The OSHA NRTL program currently includes all amendments to the base standard, therefore AAMI ES 60601-1 and its collaterals, including the above amendments are suitable for use for a product to bear an NRTL marking.

For EU market access, the EN versions of the standards have not been updated or published in the Official Journal of the European Union. However, under council directive 2017/745 (Medical Device Regulation), manufacturers must consider state of the art and typically compliance to, or a gap assessment and appropriate risk mitigations will need to be in place for compliance with the EU MDR.

Pathways to Certification and Regulatory Approval

With these standards updates, manufacturers should focus efforts and their engagement with UL Solutions to help confirm compliance with the most recent updates to the standards. The current publications of standards, regulatory requirements and national deviations clearly describe the transition periods for supporting regulatory approvals, NRTL Marking and issuance of CB Scheme reports.

The current CB Scheme for the above standards now includes U.S. National Differences. The previous version of the standard did include country deviations for Canada, U.K., Israel, Japan and Korea. We anticipate that these national differences are forthcoming during the next several months.

Our global network of laboratories have achieved scope expansions to cover the updated CB Scheme standards, and national differences will be applied as soon as they are available and as needed by manufacturers.

Since the publication of the IEC versions of the above standards in late 2020, our main testing laboratories have achieved CBTL status in the following locations:

Laboratory Name Laboratory Location Country NCB

UL Brea

Brea, CA

United States of America

UL (US)

UL Fremont

Fremont, CA

United States of America

UL (US)

UL India Pvt Ltd.

Whitefield

India

UL (Demko)

UL International Demko A/S

Ballerup

Denmark

UL (Demko)

UL International  Germany GmbH

Neu-Isenburg (Zeppelinheim)

Germany

UL (Demko)

UL International Italia S.r.l.

Carugate

Italy

UL (Demko)

UL International Polska sp. z o.o.

Warszawa

Poland

UL (Demko)

UL International-Singapore Pte Ltd

Singapore

Singapore

UL (Demko)

UL Japan, Inc.

Mie 516-0021

Japan

UL (US)

UL Korea Ltd. (Main Office)

Seoul

Korea, Republic of

UL (Demko)

UL Melville

Melville, NY

United States of America

UL (US)

UL Minneapolis

Mounds View, MN

United States of America

UL (US)

UL Northbrook

Northbrook, IL

United States of America

UL (US)

UL RTP

Research Triangle Park, NC

United States of America

UL (US)

UL VS Limited

Basingstoke

United Kingdom

UL (Demko)

UL-CCIC Company Limited

Suzhou

China

UL (Demko)

UL-CCIC Company Limited Guangzhou Branch

Guangzhou

China

UL (Demko)

Underwriters Laboratories Taiwan Co., Ltd

Peitou Taipei City

Chinese Taipei

UL (Demko)

Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and help you bring your products to market faster.

Our testing and compliance engineers work closely with standards committees to stay up to date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI) and the International Electrotechnical Commission (IEC). UL Solutions has several U.S. FDA ASCA-accredited testing laboratories across the U.S., Europe, and Asia.

To learn more, contact us. 
 

Get in touch

Have questions, need specifics? Let's get this conversation started.

Help and support

How can we help?