New milestone for the Medical Device Addendum.
Aiming for a medical standard recognized and used globally – members still wanted!
A year ago Elmatica initiated a task group for Medical Applications. IPC accepted the challenge and founded IPC-6012 and 6013 Medical Addendum with Jan Pedersen as chair.
The Addendum will strengthen the reliability and consistency of printed circuit board product qualification and acceptance for medical devices. The message from the group is clear: – Join us and impact the medical standards now.
– At APEX I sensed a new energy regarding standards. IPC has realised that the time it takes to create a standard needs to be shortened. It seems like the PCB industry might have realized the importance of clear and specific standards, down to PCB level, says Senior Technical Advisor at Elmatica, Jan Pedersen.
Not sufficient confidence of the durability in Class III
– The purpose of the IPC 6012 Medical Addendum Working Group is to determine an enhanced IPC Standard (6012 and 6013) for PCB fabrication beyond IPC Class III to demonstrate suitability for medical devices and provide a high degree of assurance of the reliability and durability of the PCB, says Steve Payne, European Manager of iNEMI Operations
FDA Class III medical devices, are those that ‘support or sustain human life. They are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury’.
Through reported actual field failures and potential field failures it has been determined that IPC 6012 Class III does not provide sufficient confidence of the durability of PCBs within these electronics devices.
Great opportunity to contribute
– The standard we are creating has a vital importance to the manufacturing value chain of medical electronics. It will secure that risk sensitive electronics are manufactured with appropriate requirements, to a globally recognized quality standard, says Pedersen.
– We look forward to work with industry design engineers and quality engineers as part of the IPC 6012 Medical Addendum Working group. Medical device design and product quality acceptance engineers have an opportunity to contribute in the development of the IPC 6012 Medical Device Addendum. This Addendum provides the industry a much needed printed circuit board qualification and performance standard that addresses specific board performance requirements needed for Class II and Class III Medical devices says Alfred Macha, Managing Director at AMT Integrated Systems.
The main tasks for the group is to define categorization of Medical Products based on risk level for the patient when errors occurs, and to specify requirements related to the categories.
Pedersen urges product owners of Medical Electronics to participate and create a standard that can be recognized and used globally, through the value chain all down to the PCB manufacturing.