Referenced Standards and/or "State of the Art"?

Mark Meer

Trusted Information Resource
#1
With regards to maintaining conformity to "generally acknowledged state of the art", how does one handle updates to standards referenced from the 60601 series?

For example, IEC 60601-1-2:2014 references CISPR 11:2009. However, the current version of CISPR 11 is a CISPR 11:2015(AM:2019).

Without getting into details of the differences (assume, for the sake of argument, that CISPR11:2015 is substantially different from CISPR11:2009), would the (generally accepted) expectation to demonstrate conformity to essential requirements be:
  1. Conformity to harmonized 60601-1-2 (and hence only to the referenced CISPR11:2009);
  2. Conformity to harmonized 60601-1-2 but with deviations to replace all instances of CISPR11:2009 with CISPR11:2015; or
  3. Conformity to both CISPR11:2009 (as referenced in 60601-1-2), AND CISPR11:2015 (because it's more reflective of state-of-the-art)?
I'm hoping that (1) is generally acceptable, as otherwise keeping up with continual updates to all referenced standards becomes quite a challenge...
Curious how others cope with continually updated standards.

MM.
 
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Marcelo

Inactive Registered Visitor
#2
The real problem here is how standards are written. If the standard has a dated normative reference, you have the use the dated reference to comply with the standard (even if a new version of the reference is published) because the standard used that specific version for reference. If the reference is undated, it means that you need to use the current version.
 

Mark Meer

Trusted Information Resource
#3
If the standard has a dated normative reference, you have the use the dated reference to comply with the standard (even if a new version of the reference is published) because the standard used that specific version for reference. If the reference is undated, it means that you need to use the current version.
Are there examples of when references are not dated in standards? Although standards may not be dated in the main text, they are (nearly always?) ultimately dated in a dedicated "references" section.

As such, it seems you are suggesting that option (3) of my original post is generally expected of manufacturers. If so, this is incredibly challenging. IEC 60601-1-2 alone has over a dozen normative references, many of which are now out-of-date. The amount of re-evaluations, re-testing, and documentation (multiplied by the organization's device catalogue) can get pretty burdensome.

Anyone have any strategies for managing this challenge?
 

Marcelo

Inactive Registered Visitor
#4
I'm not suggesting anything, I'm simply stating the rules related to how standards are written. It's in fact written in the "normative references"section:

"The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies."

Also, this means that from your examples, you have to use option (1), not (3).
 
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