Mandatory Electrical Safety Tests - Regular Production Line

[karthika subramaniam]

What are the mandatory Electrical Safety tests which is to be performed in regular production line?

 

[Miner]

Please be more specific as this is a global forum. Is this in reference to a specific standard?

 

[karthika subramaniam]

Medical Device IEC standards Requirements
Like General safety standard - IEC 60601-1

 

[Pads38]

The full set of tests set out in 60601-1 are generally thought to be not suitable for routine production as some can be damaging. (The impact test dents panels, the dielectric strength test can, invisibly, damage insulation).

Instead have a look at IEC 62353, Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment, for a set of tests that can be safely applied.

 

[Marcelo]

In fact, IEC 62353 is for tests in the field. For production line routine tests, look at Annex H of iEC 62354.

 

[Aubrey Scott]

As I read it, 60601-1 has a note in CL: 5.1 suggesting the use of the standards already mentioned above (IEC 62354 and 62353).
Notes are not mandatory is my understanding. so, 60601-1 has no requirements for routine tests providing that all type tests have been adequately evaluated! Seems weird, right? Or am I really wrong?

At my company, the routine tests that have to be performed are Hi-pot and Earth Continuity. But then we are dealing with various other standards for our products and UL.

 

[Marcelo]

Notes are not mandatory is my understanding. so, 60601-1 has no requirements for routine tests providing that all type tests have been adequately evaluated! Seems weird, right? Or am I really wrong?

The standards is focused in the premarket, phase, so it does not need to require tests after device design.

 

[NickM]

Production line testing requirements are driven by 3rd party certifications such as UL, Intertek, TUV, etc., as well as specific country requirements for product registration.

 

[karthika subramaniam]

Thank you all for your inputs..

[FONT=&quot]My Advance Christmas and New Year Wishes....[/FONT][FONT=&quot][/FONT]

 

[swathi.sp]

Production line testing requirements are driven by 3rd party certifications such as UL, Intertek, TUV, etc., as well as specific country requirements for product registration.

Hi folks,

Since Electrical safety testing at production line is driven by 3rd party certifications body, is that possible to omit such destructive tests at production line and ensuring electrical safety at the same time.

On the grounds of,
1. Risk assessment and mitigation in place to avoid the workmanship error during production
2. Proper assembly checks at every stage of machine build to ensure the quality

Cable harnesss and wiring assembly checks, Assembly inspection will be in suffice to ensure electrical safety.

Please throw some light on this issue.