Medical  Device   &  QA  Consultancy

Do I need Independent 3rd Party Accreditation of my IEC 601-1-4 compliance data? 

The short answer is No! A Company can generate the data themselves and provided that IEC 601-1-4's requirement for the compilation of a Risk Management File throughout the products design life cycle and a Risk Management Summary have been addressed, including all the Training and Record Keeping requirements, then the Company's Notified body would simply audit the above mentioned documents, in a similar fashion to auditing a Technical File or Process or Software Validation data. 

Alternatively, the Company could  "outsource" to a 3rd party Company to generate the data on their behalf. Provided that the "Outsourced" Company is 'competent' and 'accredited' to carry out the work, then the Notified Body would accept the Certificate of compliance, without having to spend additional time auditing the documentation.

The above scenario is similar to a Company conducting electrical safety testing In House, rather than "Outsourcing" the Electrical safety Testing (eg: UL2601) to an accredited Third Party Test House. 

It would take a Notified Body only one or two minutes to satisfy themselves that the 3rd Party Test House Certificate was a valid means to demonstrate compliance with the Essential Electrical Safety ER's. Whereas it might take the Notified Body half a day or more to audit the Company's own In House Data, and there would be the potential for omissions or errors, which could lead to delays in accreditation.          

What are the Standards that comprise the IEC 601 Series?

IEC 601-1 is "top of the hierarchy" and is titled "GENERAL REQUIREMENTS FOR SAFETY"

IEC 601-1, UL 2601 and EN 60601-1 are almost identical.

What are Collateral Standards?

Next in the hierarchy come the COLLATERAL STANDARDS. These are;

IEC 601 1-1-1 - Safety of medical systems

IEC 601-1-2 - EMC safety

IEC 601-1 3 - Safety of X-Ray equipment

IEC 601 -1-4 - Programmable electrical medical systems (PEMS) 

IEC 601-1 -5 - Currently in draft

IEC 601-1 -6 - Currently in draft

IEC 601-1-7 - Currently in draft

IEC 601-1-8 - Currently in draft

What are Particular Standards?

Next in the hierarchy are Particular Standards.

IEC 601-2-xx.

These cover performance and additional safety requirements, particular to a type of medical device. For example IEC 601-2-24 cover the additional particular rqeuirements for Infusion Devices. Numbers are of the order 601-2-01 and range to in excess of 601-2-50 

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