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Connection between IEC 62304 and Chapter 14 of IEC 60601-1

Lorenzo

Starting to get Involved
#1
Hello, everyone,

I would like to understand the connection between chapter 14 and IEC 62304 in connection with CB testing

Is it true that the testing laboratory does not review the software documentation if chapter 14 is not applicable? (If Software does not affect Basic Safety or Essential Performance)
The software is documented anyway, but Chapter 14 is not applicable. But I thought that the IEC 62304 was part of the CB scheme?

Thank you.
 

yodon

Staff member
Super Moderator
#2
PEMS (IEC 60601-1 section 14) doesn't apply if the software doesn't provide support for basic safety or essential performance or if failure of the software doesn't lead to an unacceptable risk.

So if the software doesn't do that, it would not be normally assessed during the IEC 60601-1 assessment.

However, IEC 62304 is a harmonized standard so you can use compliance to that to establish a presumption of conformity to the relevant essential requirements (e.g., 12.1). If you do, the Notified Body might expect an independent and qualified source (like an accredited test lab) to confirm compliance or they may require additional review time to confirm compliance if not; i.e., they may not take your word for it. Even if PEMS doesn't apply, it may be more convenient to have the test lab conduct the assessment of compliance to IEC 62304.
 
#3
IEC 62304 is a process standard, which means there are no testable requirements in this standard. CB Scheme covers product standards such as 60601, 61010, etc.

No NCB will issue a stand alone CB certificate for IEC 62304. beside that, clause 14 of IEC 60601-1 states " When the requirements in 14.2 to 14.13 apply, the requirements in subclause 4.3, Clause 5, Clause 7, Clause 8 and Clause 9 of IEC 62304:2006 shall also apply to the development or
modification of software for each PESS. " This means test labs do not require to evaluate software document to all the requirements of 62304.

But as a manufacturer, you can use clause 4.5 of IEC60601-1 "Alternative RISK CONTROL measures or test methods for ME EQUIPMENT or ME SYSTEMS " which gives you the option to determine if full evaluation to 62304 requires per outcome of your RMF.
 
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