Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
The collateral standard for electromagnetic disturbances. FDA recognizes it for testing of non-implantable devices within its scope.
The text of this standard is sold by IEC and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Recognized | Edition 4.1 2020-09 (consolidated version) | - | Recognition number 19-36. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| United Kingdom | Recognized | EN 60601-1-2:2015 | - | Recognition number List row 210. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: YY 9706.102-2021, ISO 14117, JIS T 0601-1-2, IEC 61326-2-6, IEC 61326-1. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| Japan | Adopted | IEC 60601-1-2:2014 with amendment 1 (2020), identical JIS version | JIS T 0601-1-2:2023医用電気機器―第１－２部：基礎安全及び基本性能に関する一般要求事項―副通則：電磁妨害―要求事項及び試験 | Effective February 25, 2023. Transition until February 24, 2026. Until the end date either the previous JIS edition (2018) or the 2023 edition could be used. The end date has passed.. Since 25 February 2026 the EMC conformity of marketed devices is judged against the 2023 JIS edition, unless another suitable international EMC standard is justified. |
| China | National equivalent | - | YY 9706.102-2021Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Effective May 1, 2023. Mandatory industry standard in the group of mandatory standards for active devices named by a provincial regulator. |
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used. |
| Australia | Referenced | - | - | Voluntary. The TGA treats it as a way to show compliance with the Essential Principles but does not require it. The TGA expects EMC testing to be done by an accredited test laboratory. |