Performance Testing for 60601-4-2

[mattlol]

Hi all,

I was wondering if anyone here has run into issues testing for performance under standard 60601-4-2. We've already tested for safety under 60601-1-2, but have been instructed to go back and retest for 60601-4-2. The issue is, the device performance can only truly be quantified with equipment that would impede access to the device surface, thus not being able to use it during the testing. We wouldn't have any issues using the equipment at the lab after the testing (to comply with tests under performance criterion B), but we need to be able to verify performance for tests under criteria A as well.

Any suggestions?

 

[Al_Z1]

60601-4-2 is a guidance.
03. paragraph of it states, that:
"This document can be used in conjunction with IEC 60601-1-2 and testing for conformity to both documents can be done at the same time. This allows IMMUNITY testing of BASIC SAFETY, ESSENTIAL PERFORMANCE and performance of the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM during one test, concurrently or sequentially. The main difference is the use of performance criteria instead of pass/fail criteria, and differences can also include modes and configurations. For BASIC SAFETY and ESSENTIAL PERFORMANCE, the pass/fail criteria are determined as specified by IEC 60601-1-2. For performance, the criteria are determined by the specifications, instructions and information provided by the MANUFACTURER.
This document uses "recommend" and "should" in place of “shall" in most cases. "Shall" is used where an action is required by other standards or something needs to be done in a prescribed way in order to be effective. Also, this document has "normative" references."
You can, as a manufacturer, determine performance critera without it and specify it in your docs. It is supplement, not the mandatory standard.