What is our requirement for maintaining the EMC series of standards? IEC 61000

[Bunny]

We are a medical device designer/manufacturer. We do not perform any EMC testing in house. What is our requirement for maintaining the EMC series of standards? IEC 61000-4-2, 4-3, 4-4, 4-5. I would have to spend >$1000 to obtain the latest versions if we do not need to.

 

[Pads38]

We are also manufacturers; I "look after" the EMC side of things. We use an external test house, but have on occasion hired test gear to do some in-house pre-compliance and development work.

The only standard we maintain is 60601-1-2.
Sometimes it would be useful to have access to details within the source standards (the 61000 series and CISPR etc). But usually the information can be found on-line in guidance documents or technical articles.

We also benefit from a good professionally friendly relationship with our usual EMC test house. They can also provide background information when needed, and they of course keep all the standards.

 

[Bunny]

I should add that we maintain compliance certificates to ISO 9001 & 13485.

Alright, I will not plan to purchase the revised 61000 series.

Thanks.

 

[J0anne]

We are a medical device designer/manufacturer. We do not perform any EMC testing in house. What is our requirement for maintaining the EMC series of standards? IEC 61000-4-2, 4-3, 4-4, 4-5. I would have to spend >$1000 to obtain the latest versions if we do not need to.

There is no requirement for this.
Standards are mandatory.