IEC 60601–1 Ed. 3.2 (Amendment 2)

Home Industries Medical Devices IEC 60601-1 Ed. 3.2

In 2020, the second amendment to the third edition of the product safety standard for active medical devices IEC 60601-1 was published with extensive changes. With the update of the basic standard, the associated “collateral standards,” such as electromagnetic compatibility (EMC), usability, and alarms, appeared almost simultaneously. 

The following table provides an overview of the significance of the changes:

Norm

Description

Degree of changes
IEC 60601-1-2 Amd. 1 Ed. 4.0 EMC Major
IEC 60601-1-3 Amd. 2 Ed. 2.0 X-ray Minor
IEC 60601-1-6 Amd. 2 Ed. 3.0 Usability Major
IEC 60601-1-8 Amd. 2 Ed. 2.0 Alarm systems Major
IEC 60601-1-9 Amd. 2 Ed. 1.0 Environmentally conscious design Minor
IEC 60601-1-10 Amd. 2 Ed. 1.0 Physiologic closed-loop controllers Major
IEC 60601-1-11 Amd. 1 Ed. 2.0 Home healthcare environment Minor
IEC 60601-1-12 Amd. 1 Ed. 1.0 Emergency medical services environment Minor

 

 

SGS supports you in the testing and certification of your medical devices and systems according to the above-mentioned standards and regulations.

Our services in connection with IEC 60601-1 Ed. 3.2 include:

  • Full-scale acceptance testing according to IEC 60601-1 Ed. 3.2 including the inclusion of the applicable Collateral (IEC 60601-1-xx) and Particular (IEC/ISO 60601/80601-2-xx) standards. An excerpt of our test spectrum can be found here
  • Gap analysis and gap testing for active medical devices and systems that already have evidence of compliance to IEC 60601-1 Ed. 3.0 or 3.1
  • Updating of existing tests and certifications according to IECEE-CB procedures
  • Customized workshops to identify new/changed IEC 60601-1 Ed. 3.2 requirements applicable to your product
  • Delta audits of the risk management file
  • Delta tests of the accompanying documentation (instructions for use)
  • Delta tests of the software documentation according to IEC 62304:2006+Amd1:2015
  • Analysis of the isolation concept with regard to the influence of IEC 62368-1:2018
  • Training courses and webinars on the latest standards content. Further information

What changes does IEC 60601-1 Ed. 3.2 bring?

  • Dated references to process standards: ISO 14971:2019, IEC 62366-1:2015+Amd1:2020, IEC 62304:2006+Amd1:2015
  • New references to component standards: IEC 62368-1:2018 (IT/AV), IEC 62133-2:2017 (Li batteries), IEC 60747-5-5 (optocouplers)
  • Chapter 3: New and adapted definitions of terms
  • Chapter 7: Clarification of symbols and markings to be used incl. their colors
  • Chapter 8: Adapted test procedures for touch current measurement at outputs and signal interfaces, partial reconsideration of insulation barriers due to the influence of IEC 62368-1:2018, regulation of the procedure for protective conductor impedance measurement, and new requirements for EMC coatings
  • Chapter 11, Chapter 13: New limits for contact temperatures in the first fault, clarification of requirements for fire protection enclosures, and limited power circuits
  • Chapter 16: New regulation of limits for protective conductor impedances in ME systems

Deadlines and application information:

  • FDA Recognized Consensus Standard Database: transition deadline 12/17/2023
  • ANSI/AAMI has published the versions identical to the IEC final in April 2022
  • IECEE CB Scheme has already published test report templates for all the above IEC-60601-1-xx standards
  • All above-mentioned IEC-60601-1-xx standards are already adapted by the IECEE CB Scheme, their application is regulated in OD-2055 (Ed. 2.3) and thus testable and certifiable

Contact

Armin Hudetz
T: +49 89 78 74 75-133
F: +49 89 12 50 40 64-133
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Customer Service Team
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