IEC 60601-1-9 Compliance mendatory or Not - CT Scan machine

[Kuldeep Singh]

Hi Everyone.

As we are manufacture of Medical X-Ray equipment and Manufacture the Computed tomography Scan machine. As i new to this product and Compliance testing for this product is all under to me. When i saw the compliance table of predicate devices there i notice IEC 60601-1-9 which is (Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design)

So i am bit confusing for testing of our CT Scan machine for this particular standard.Is it mandatory to compliance with this standard also?

Thanks in advance

 

[Ronen E]

It is a way to meet some requirements of IEC 60601-1 ("the general standard"). Refer to the attached snapshots.

 

[Jean_B]

For devices distributed/used in Brazil this is a mandatory standard (as given by reference to the Brazilian version).
It is not (at the time of this post) mandatory for the USA or Europe.

 

[Marcelo]

For devices distributed/used in Brazil this is a mandatory standard (as given by reference to the Brazilian version).

Parts of it, in fact.

 

[Kuldeep Singh]

Thanks a lot all of you for sharing your knowledge

 

[Kuldeep Singh]

We are at Design Verification stage for Computed Tomography machine (CT Scan Machine). As per its Harmonized standards, there is no mandatory requirement in order to comply with Environment testing. Can anyone suggest us how to verify all these below requirements:-

1. Packing stability of machine, Although some ASTM standards were followed in our company but we are not sure for its applicability on it (due to weight (3000Kg) . what are the factors shall we consider to verify the packaging stability.

2. There may be vibration impact during transport and storage , what are the acceptance criteria or standard we should consider to comply the vibration impact.

2. Our Machine is subjected to transport via different routes like sea, air and Road transport. How can we validate these transport routes. We can validate the road transport during this stage. But how can we sure that , our device with this verified packaging can survive in Air and Sea transport also.

 

[Ronen E]

We are at Design Verification stage for Computed Tomography machine (CT Scan Machine). As per its Harmonized standards, there is no mandatory requirement in order to comply with Environment testing. Can anyone suggest us how to verify all these below requirements:-

1. Packing stability of machine, Although some ASTM standards were followed in our company but we are not sure for its applicability on it (due to weight (3000Kg) . what are the factors shall we consider to verify the packaging stability.

2. There may be vibration impact during transport and storage , what are the acceptance criteria or standard we should consider to comply the vibration impact.

2. Our Machine is subjected to transport via different routes like sea, air and Road transport. How can we validate these transport routes. We can validate the road transport during this stage. But how can we sure that , our device with this verified packaging can survive in Air and Sea transport also.

Look at the ISTA website. You'll find all the answers there.

Harmonized standards are never mandatory (even where they do list requirements), and anyway currently the relevance of published harmonization is low, since the last published list is very old and relates to the MDD (rather than MDR).

 

[Kuldeep Singh]

Can you suggest where can i find these standard(s) for our reference or any Test report format to which should i follow to perform the testing as per ISTA.

 

[Ronen E]

Can you suggest where can i find these standard(s) for our reference or any Test report format to which should i follow to perform the testing as per ISTA.

Did you study ISTA's website closely? All the information you need is there.
Please send me a PM if you need more assistance.