Hello All,
First, as Dan mentioned this is an IEC standard not an ISO standard. I even confirmed on the ISO website just now.
Second, as Michael said this standard applies to all medical devices - active and non-active, implantable and implantable.
Third, the most recently published version of the standard is IEC 62366-1:2015 has not been Harmonized under the EU MD or EU IVD Directives but if you follow what a lot of Notified Bodies are pushing you will want to use the state of the art (per Annex I of the MDD which is the Essential Requirements of the Directive). The state of the art many times means the most recent version of the standard. IEC and ISO are the source of many EN standards but not all. In this case the most recent EN version is more recent than the Harmonized Standard. The most current version of the IEC 62366-1 has been adopted by CENELEC and been approved to publish in each EU country thru the appropriate standards body of that country like in the UK it is BSI. BSI published the current version as BSI EN 62366-1:2015 in June of 2015. So, this version of the standard is an EN standard just not Harmonized thru the MDD currently. Dan mentioned that the current MDD Harmonized standard is '
EN 62366:2008, based on IEC 62366:2007'.
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Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 13-Feb-2017 08:07
From: Lee Leichter
Subject: ISO 62366-1:2015
Michael,
ISO 62366 applies to ALL devices. The standard defines a risk based HF Engineering program to integrate Human Factors into the design of the device, identify and address user needs and assess and mitigate all potential use errors throughout the life of the product. You seem to be focusing on a HF Summative Validation study, which may not be required in all cases. The US requirement is specific to the data that is need to be provided to the FDA, not whether a Human Factors Engineering process is required as part of the design effort.
In the EU (and I would hazard all in the USA also, although it is not clearly integrated into the USA GMPs outside of design Controls) all classes of device need to meet the essential requirements, of which HF is a key element. Compliance with ISO 62366 is the harmonized method of establishing that the use and ergonomic requirements have been met, regardless of the need for a Summative Validation study.
Lee
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Lee Leichter RAC
President
P/L Biomedical
Fort Myers FL
United States
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Original Message:
Sent: 12-Feb-2017 15:49
From: Michael Murphy
Subject: ISO 62366-1:2015
We are developing a "clinical sample concentrator" as defined by the FDA in its classification definitions. These types of products are currently listed as Class I medical devices. We are interested in taking this product into the EU as a CE-marked device. We were wondering if ISO 62366 applies to Class I devices or is it related more to Class II and Class III products? Any advice here is welcomed.
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Michael Murphy
Vice President
Akonni Biosystems, Inc.
Frederick MD
United States
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