Achieving High Reliability Through Quality Conformance of Printed Circuit Boards for Medical Devices

Transcription

1 Achieving High Reliability Through Quality Conformance of Printed Circuit Boards for Medical Devices IPC Association Connecting Electronics Industries John Perry, Director, Printed Board Standards &Technology Julie Ellis, Field Applications Engineer, TTM Technologies Jan Pedersen, Senior Technical Advisor, Elmatica. Alfred Macha, Managing Director, AMT Integrated Systems February 2018, MD&M West

2 Presentation Agenda Introduction Overview: Printed Circuit Boards for Medical Devices Why the need for an IPC standard for the medical device industry? Reliability Requirements for Printed Circuit Boards Sampling Frequencies for Acceptance Testing Process to develop a standard addendum IPC D-33AM Task Group Involvement of Medical Device professionals

3 Early and Present Day Medical Devices

4 In Half a Century

5 Density Trends In Array Packages - Cross-Section Views Increasing I/O Density Chip Scale Packaging Flip Chip Packaging BGA 1.27 mm BGA Silicon Die PCB XeTel 0.50 mm PCB XeTel 0.20 mm 1.27 mm BGA package Localized via density 62/cm 2 (400/in. 2 ) 0.50 mm BGA package Localized via density 400/cm 2 (2580/in. 2 ) 0.20 mm Flip Chip Localized via density 2500/cm 2 (16,129/in. 2 ) 20 x x Increase in via density 6.25 x Increase in via density

6 *Meeting Agency & Industry Standard Requirements does not guarantee high reliability, which is also design-materials-environment dependent. Customer Concerns and Requirements *Long Term Reliability: Regulatory Agency Requirements FDA UL Safety Environmental Requirements System and Product Specification Design For Manufacturing and Test Supply Chain Audit and Qualification Process Capability/Control Material Requirements Validation and Documentation First Article Inspection and Audit

7 Who Is IPC? Background and History Founded in 1957 as the Institute of Printed Circuits with six Member Companies (Electralab, Photocircuits, Methode, Tingstol, Printed Electronics Corp. and Graphik Circuits) Strong Foundation as Technical Organization Dedicated to Meeting Industry Needs An Accredited SDO Focusing on Printed Board Design, Fabrication, Electronics Assembly and Test

8 Introduction to IPC IPC is a global industry association dedicated to furthering the competitive excellence and financial success for more than 4,200 member sites that make, use, specify and design printed boards and assemblies, as well as their suppliers and end-product manufacturers, including those in: advanced microelectronics aerospace and military automotive computer and business equipment industrial equipment medical equipment and devices telecommunications industries

9 Introduction to IPC Membership Composition

10 Introduction to IPC Membership Composition, cont d

11 Introduction to IPC Global Representation Member Companies located in 64 countries ROW Europe Asia North America 0% 10% 20% 30% 40% 50% 60% 70%

12 Introduction to IPC Multifaceted Services and Programs Standards Generation Training & Certification Industry Education Conferences & Exhibitions Management Programs Market Research Statistical Programs Public Policy Advocacy

13 Overview: Printed Circuit Boards in Medical Devices

14 Overview: Printed Circuit Boards in Medical Devices

15 Overview: Printed Circuit Boards in Medical Devices Increased Focus on Quality The industry is experiencing an advanced technological introduction of new medical device designs. There has been a higher trend of reportables since 2010.

16 Overview: Printed Circuit Boards in Medical Devices The cost of quality of electronics failures has impacted the largest Medical Device Manufacturers Recall of implantable defibrillators cost a fortune 500 company expected to lose $5 Million every day the devices are off the market. FDA ordered a company to recall and destroy volumetric infusion pumps costing the company $400 Million in recall costs FDA has received more than 56,00 complaints associated with infusion pumps; these complaints resulted in serious injuries and 500 deaths. Source: The Business case of Medical Device Quality, McKinsey Center for Government. Oct 2013

17 Why the need for an IPC standard for Medical Electronics? Standards used for Medical Device Electronics Standards Referenced by FDA IEC ; Electrical Safety IEC ; EMC testing Other Standards Commonly Used IEC 60812; Failure Modes, Effects, and Criticality Analysis ( FMECA) IEC ; Usability Safety Requirements IEC ; Alarm Systems in Medical Equipment ISO 14971; Risk Management ISO 13485; Quality Management Systems IEC ; Vibration Test ROHS Restriction of Hazardous Substances IPC Standards; Various for PCB Design, Manufacturing, Assembly, Test and Printed Circuit Boards

18 Why the need for an IPC standard for Medical Electronics? IPC Popular Standards by Market Segment

19 Why a standard for Medical Electronics? IPC 6012/ Medical Addendum We are creating a Standard specifically to address quality conformance requirements in printed circuit boards for Medical Devices. The medical device classification is not the same as the IPC classification. IPC class is based on requirements of product to function in its environment - not on medical device 510K or PMA classification.

20 Why a standard for Medical Electronics? Typical Medical Applications and Related PCB Technologies Medical Application Type of Printed Circuit Boards IPC Class Life Sustaining, Life Saving: Implantables, ventilators, defibrillators. Medical Imaging: Ultrasound, MRI, CT Scanners, X-ray equipment Treatment devices: infusion pumps, medical lasers, surgical machines Rigid, Rigid Flex, Flex Rigid Rigid, Rigid Flex Class III Class II Class II, Class III

21 The Medical IPC Class 3 Class 3 High Risk Medical Electronics Includes equipment and implantable devices where continued high performance or performance-on-demand is critical; handling/storage and operating environments may be harmful to the device, and product downtime cannot be tolerated, because product failure could result in loss of life or permanent bodily harm to a patient or equipment operator, or major hazard to the environment. = High requirements to Product Reliability!

22 What will the Standard Specify? The Medical Addendum will Specify (or cross-referenced) requirements such as: Micro PCBs: Normal PCB Technology, but still IPC class 3: Visual Examination Imperfections acceptability Pattern Accuracy Plating integrity Laminate Integrity Plated hole Integrity Soldermask Thickness Cleanliness requirements Acceptance Testing Frequency Test report Visual Examination Imperfections Acceptability Pattern Accuracy Plated Hole Integrity Soldermask Thickness Cleanliness requirements Acceptance Testing Frequency Test report

23 Requirement parameters.. Holes Wicking Tighter tolerances IPC6012D class 3 = 80 micron Automotive and Medical: 50 micron

24 Requirement parameters.. Wicking can lead to CAF Laminate, Drilling, Glass Coating Accelerates with Bias, moisture, heat. Result: Unwanted connection

25 Acceptability Testing and Frequency Process Verification - Microsections Small volumes: per production panel Large Volumes: Process control per order Target: Define a requirement for volume manufacturing Secure Zero Defect using customized test methods and frequency

26 Acceptability Testing and Frequency Reliability Parameters - Cleanliness Cleanliness of finished PCB What is clean, and how to test? ROSE Method? Ion Chromatography Control? SIR Validation? New test methods not yet adopted..

27 Acceptability Requirements Inspection and Test AOI of all layers Increased Requirements to Electrical Test

28 Acceptability Requirements Final Inspection Report Do medical companies require special inspection reports to be archived in their DMR ( Device Master Record)? The aerospace industry requires AS9102 FAR, First Article Reports The automotive industry requires PPAP, Production Part Approval Process.

29 C = 0 Acceptability Got Lost in Translation Outside N. America

30 Sampling Frequencies for Acceptance Testing IPC-6012D 4.2 Acceptance Tests IPC-6012D (rigid) and IPC-6013D (flex and rigid/flex) make use of a C=0 Zero Acceptance Number Sampling Plan specified in Table 4-2 of these specifications when Sample is indicated in Table 4-3. Acceptance testing shall be performed as specified in Table 4-3 to the requirements of this specifications and IPC-6011 using either test coupons and/or production printed boards. Optional IPC Video about using the sample plan.

31 Sampling Frequencies for Acceptance Testing, cont d C=0 Acceptance Number Sampling Plan The C=0 Acceptance Number Sampling Plan provided in Table 4-2 is derived from principles established within ASQ Z1.4. This plan provides greater or equal protection for the Lot Tolerance Percent Defective (L.T.P.D.) protection at the 0.10 consumer risk level. The Index Values at the top of each sample size column associates to the Acceptable Quality Level (AQL). For a lot to be accepted, all samples (per Table 4-2) shall conform to the requirements. Disposition of rejected lots shall be fully documented.

32 Sampling Frequencies for Acceptance Testing, cont d C=0 Acceptance Number Sampling Plan

33 Sampling Frequencies for Acceptance Testing, cont d Table 4-3 Acceptance Testing & Frequency

34 Sampling Frequencies for Acceptance Testing, cont d C=0 Acceptance Number Sampling Plan What does this really mean? Example 1: Turn to Table 4-3 and find the PTH Solderability test Lot size example of 10 panels with 10 boards per panel (also referred to as 10-up) Find the AQL value for Class 3 Is this per panel or per board? So what is the Lot size for this test? Go to Table 4-2 and determine the number of samples to be tested

35 Sampling Frequencies for Acceptance Testing, cont d C=0 Acceptance Number Sampling Plan Example 2: Lot size example of 10 panels with 10 boards per panel (also referred to as 10-up) On how many samples must Internal Annular Ring and Breakout evaluations be made, if it is Class 2 product? Note: Look at coupons specified and Notes 4 and 5 on the panel remark.

36 Sampling Frequencies for Acceptance Testing, cont d Table 4-3 Acceptance Testing and Frequency

37 Sampling Frequencies for Acceptance Testing, cont d Referee Tests Two additional microsection sets from the same panel may be prepared and evaluated for microsection defects that are considered to be isolated or random in nature or caused by microsection preparation. For acceptance, both referee sets must be defect free.

38 Progression of Document Generation/Revision Working Draft -Multiple Iterations by Originating Task Group (OTG) -Make use of Sub- Teams through Face-to-Face, Web Meeting and Comment Review Final Draft for Industry Review - Considered Complete by OTG - Distributed for wider, open review Proposed Standard for Ballot - Official vote within OTG - Negative Ballot Resolution Typesetting, Publication and Distribution

39 IPC Standards Addendums The need for addendums creating supplemental requirements to be used in addition to, and in some cases, in place of those published in the primary IPC standards first came to reality among industry segments for space flight and military avionics: J-STD-001FS Space Applications Electronic Hardware Addendum to J-STD-001F IPC-6012DS Space and Military Avionics Applications Addendum to IPC-6012D, Qualification and Performance Specification for Rigid Printed Boards

40 IPC Standards Addendums Other Industry dedicated Addendums IPC-6012DA Automotive Addendum (IPC-610 Automotive Addendum under development) IPC-6012DS Space and Military Avionics Applications Addendum J-STD-001FS Space Applications Electronic Hardware

41 IPC Standard Addendums for Medical Devices IPC- 6012M Current Focus Areas Classification of Application Criteria Development of Medical-specific Requirements Development of Test Parameters and Test Frequencies Tandem development: IPC-6012D Qualification and Performance Rigid PCB IPC-6013C Qualification and Performance Flexible PCB

42 IPC Standard Addendums for Medical Devices Group Task Group Established on Nov 9 th 2016 Members from: USA, Asia and Europe Ericsson, Boston Scientific, Philips Healthcare, TTM, Dyconex, Sanmina, Olympic, Hong Yuen, WUS, CTC Circuits, IFTEC, UL, MIT, Norbit, inemi, AMT Manufacturing, Calumet, DfR Solutions, Train Analytics, Kitron, Valtronic members today

43 Why Are We Here?

44 Involvement of Medical Professionals Get involved in the completion of this standard We are looking for the EXPERTISE of medical device professionals: Product owners and OEMs PCB Design engineers Quality engineers and managers (both QA and QC) Procurement Regulatory and compliance

45 Contact IPC To Get Involved! IPC Association Connecting Electronics Industries Thank You! John Perry Director, Printed Board Standards & Technology