Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and

Thermal Soak Cycles

Verification Protocol VA 12-187-ST Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

Zimmer Manufacturing BV Mercedita, Ponce PR

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Approval Page Your signature indicates that you have reviewed this document and agree that it accurately and completely represents the process and the necessary validation activities. You also agree that this document complies with Zimmer Manufacturing BV validation procedures and instructions. PREPARED BY NAME / SIGNATURE Equipment/ System/ Process Owner / Project Lead APPROVED BY Carlos Ayala, Equipment/ System/ Process Owner Manager or Designee Jose Bagu, Quality Assurance/ Technical Services Manager or Designee Approval date is the last date of which above approvers signed this document. Protocol approvals must be completed PRIOR to initiation of ITP testing. DATE

Document Control Your signature indicates that you have received this protocol after final approval and are responsible for handling as per OCP 5.980-ZC. Printed Name Signature Date

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

Document Revision History Version No. Date Description of Change Rationale for Change Author

1.0

06/27/12

New document

Initial document Link to ZCAP 12011

Enrique Pomales

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Table of Content 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 PURPOSE ............................................................................................................................. 5 SCOPE .................................................................................................................................. 5 PROJECT BACKGROUND................................................................................................. 5 RISK ASSESSMENT ANALYSIS ....................................................................................... 6 PROCESS/ SYSTEM DESCRIPTION ................................................................................ 7 REFERENCES ..................................................................................................................... 9 DEFINITIONS AND SYMBOLS/ ACRONYMS .............................................................. 12 VERIFICATION STRATEGY ........................................................................................... 13 ROLES AND RESPONSIBILITIES ................................................................................. 24

10.0 GENERAL EXECUTION PROCEDURE ........................................................................ 24 11.0 INDIVIDUAL TEST PROTOCOLS (ITPS)/ TESTS CHECKLIST ................................ 28 12.0 VERIFICATION DISPOSITION...................................................................................... 34 13.0 PROTOCOL ATTACHMENTS AND APPENDIXES ..................................................... 35

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles 1.0 Purpose The purpose of this protocol is to determine whether the Trilogy cups/Acetabular products manufactured as per current processes OCP 17.008-ZC Rev 19 at ZMBV meet specifications for lot release, as outlined criteria for Pore size and Porosity per ZES 2A132. 2.0 Scope This protocol covers the Fiber Metal Diffusion Bonding Process of Trilogy/ Acetabular Cup product families, and the thermal cycle of HATCP/ Trilogy Spiked Cup product families, currently manufactured in cell 201/ 205, HIP Business Unit. Product families/ part numbers included in the scope of this protocol are listed in Table 1: Trilogy/ Acetabular Cup product families. Refer to Appendix 4 for a detailed list of part numbers per contract family (CF). Table 1: Trilogy/ Acetabular Cup Product Families
CF Identification CF Description U.S. Class III PMA Devices
HATCP CUPS (40-6200-XXX-XX) HATCP Trilogy Multi (40-6200-XXX-20) HATCP Trilogy Solids (40-6200-XXX-21) HATCP Trilogy Cluster (40-6200-XXX-22) HATCP Trilogy Spiked (40-6200-XXX-23) HATCP Trilogy Unit Hole (40-6200-XXX-24) AB CUPS (40-6400-XXX-XX) HATCP AB CUPS (40-6400-XXX-20) HATCP AB CUPS (40-6400-XXX-22) CUPS (00-6200-XXX-XX) Trilogy Multi (00-6200-XXX-20) Trilogy Solids (00-6200-XXX-21) Trilogy Spiked (00-6200-XXX-23) Trilogy Cluster (00-6200-XXX-22) Trilogy Unit Hole (00-6200-XXX-24) No

E31 E32 E33 E34 E35 E37 E38

Yes

G04 G05 G07 G09 G13

No

3.0

Project Background Two (2) vacuum furnaces are currently used for the Fiber Metal Diffusion Bonding Process of Trilogy/ Acetabular Cup product families, and the thermal cycle of HATCP/ Trilogy Spiked Cup product families.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

Diffusion bonding process in vacuum furnaces was last validated under VA 06-031/ 033. Product acceptance criteria included: tensile strength, microstructure and fiber metal chemistry. ZES 2A-60 Diffusion Bonding Parameters for Fiber Metal, Revision R, which was the effective specification by then, included the following requirements: oxygen content plus nitrogen content in monitoring coupons not to exceed 0.35 weight percent and bonding integrity evaluated on all fiber metal-coated implants according to ZES 4J-02 Laser Method Spec for Fiber Metal and Trabecular Metal Inspection. ZES 2A-60, Revision S was made effective on 07/24/07, and added the minimum tensile strength requirement of 20 MPa (2900 psi) to the quality requirements. ZES 2A-60, Revision T was made effective on 03/24/09, and added the following requirements: The porous coating shall have an average volume porosity of 30-70%. The porous coating shall have an average pore size between 100 and 1000 microns. ZES 2A-60, Revision T was made obsolete on October 2011 by ZES 2A-132, Trabecular Fiber Metal Diffusion Bonding Process Parameters. ZES 2A-132, Trabecular Fiber Metal Diffusion Bonding Process Parameters specification covers the process parameters for diffusion bonding for Titanium Fiber Metal (FM, ZES 2A-44) to Tivanium alloy (Ti-6Al-4V, ZES 2A-81, ZES 2A-82) for medical implants, as well as all of above listed product quality requirements. ZES 4L-02 Electron Beam Welding (EBW) Acetabular Shell specification covers the placement and electron beam welding (EBW) of Ti-6Al-4V spikes into Ti-6Al-4V Acetabular cups, as well as post weld processing, including the thermal cycle in the vacuum furnaces. ZES 4L-02 requires penetrant inspection be performed on all spiked cups using ZES 4H-01 Penetrant Inspection. 4.0 Risk Assessment Analysis Porosity and Pore size have been categorized as key quality attributes for these types of implants (Trilogy/Acetabular Cups) by the Code of Federal Regulations " 21CFR 888.3358" enacted by law and overseen by Federal Drug Administration . Porosity and Pore Size are indeed pivotal attributes for the market acceptability of these products.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Similar process were comparable with (Trilogy/Acetabular Cups) with the purpose of assigning criticality. The World cup FM shell FIP indicated that the Diffusion bonding process is a criticality of 5.

ZMBV has manufactured these Trilogy since 1995 and Trilogy Spike since 1997 for total of 510,394 units in the last three years. Nevertheless Harms Severity and Detection Levels associated with Hazard Conditions such as not meeting Patient/Customer Expectations, implant intended use and human factors are rated serious, these are considered negligible since failures are not likely to occur even in extreme conditions. As a consequence an assessment of "RPN" Risk Priority Number = Occurrence x Severity x Detectability of Hazardous Conditions per GSOP 15.903 (SOP 15.903) Process Failure Modes & Effects Analysis shows peril is reduced and no additional risk controls are required therefore is being deemed satisfactorily to set An Acceptance Quality Level of 1.0% comparable to the diffusion bonding process which resembles equivalent criticality 5.0 Process/ System Description The shells are machined from titanium alloy (Tivanium, Ti-6Al-4V) bar stock (refer to ZES 2A-81 Wought Ti-6Al-4V). A porous surface of commercially pure (CP) titanium fiber metal is metallurgical bonded to the outer surface of the shell, allowing for bone in growth or enhanced cement fixation. In some cases, hole patterns are machined on the semi-finished cup to use bone screws as additional form of fixation. Fixation screws can be inserted through the holes for additional fixation with the Acetabular bone. In the spiked design (where three spikes protrude from the outer surface) the spikes are impacted into the Acetabular for adjunctive fixation. Additionally, there is a series of shells coated with Calcicoat Ceramic Coating (HATCP) operations performed at Warsaw (not part of ZMBV Operations) for enhanced fixation to the bone. Diffusion Bonding Process: The intended function of the diffusion bonding process is to adhere a fiber metal hemisphere (porous material composed of Commercially Pure (CP) titanium interwoven wires) to a titanium or Tivanium (Ti-6Al-4V) alloy substrate by means of a metallurgical bond. Thermal Cycle for HATCP/ Trilogy Spiked Cups: The thermal cycle will encourage new grain growth to minimize the effect of electron beam welding (EBW) on the material (Ti-6Al-4V spikes placed into Ti-6Al-4V Acetabular cups). In addition the thermal cycle will remove the discoloration caused by welding.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Equipment: Currently used Vacuum Furnaces, as well as related Ancillary Equipment used in cell 205 for the preparation of the cups prior diffusion bonding, are listed in the following table.
Description Vacuum Furnace Asset No. Model Serial No.

ZC00196 ZC00496
25-1050-000-62X 25-1050-000-62Y 25-1050-000-62AA ZC00167

HL34BH HL34
SIWSBBP-1-3-H N/A N/A

2339 2159 (1386)

0026405791 0026405788 26405789 N/A 06347 262-90-012

Balances

Cut & Crimp ZC01565 ZC00212 Calibration ID: 25-1050-001-24B ZC00989 Calibration ID: 25-1050-001-24C ZC00214 25-1050-001-24A ZC01848 25-1050-001-24D ZC00198 Calibration ID: 25-1050-001-19B 25-1050-001-11P 25-1050-001-11S

Presotechnick Press (Bench Press)

MC 4.8 089-90-867 MC 9 DA 300-1818-SM MPI SMX 1212 300 Ton MC 01.02 LT30B-11C

Wabash Press

8999 8856 7E19007100269 9 H15753 H85781

Presotechnick Press Pneumatic Screwdrivers

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles 6.0 References The following references were consulted in the development of this document:

Qualification/ Validation Procedures, Specifications, and Related Documents Document Rev. Document Title Number OCP 5.980-ZC ZES 2A-44 ZES 2A-60 (Obsolete) ZES 2A-81 ZES 2A-132 ZES 2A-156 ZES 4H-01 ZES 4J-02 ZES 4L-02 ANSI/ASQ Z1.9 18 1 T R D A X AE B Validation Procedure Commercially Pure Titanium Wire for Fiber Metal Fabrication Diffusion Bonding Specification Parameters for Fiber Metal

Wrought or Forged Tivanium, TI-6AL-4V Alloy Trabecular/ Fiber Metal Diffusion Bonding Process Parameters Quality Requirements for Diffusion Bonded Fiber Metal Acetabular Cups Penetrant Inspection Specification Laser Method Spec for Fiber Metal and Trabecular Metal Inspection

Electron Beam Welding (EBW) Acetabular Shell Specification Sampling Procedures and Tables for inspection by Version: variables for percent nonconforming ANSI/ASQ Z1.92008 2008

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Operating Procedures, Instructions, and Forms Document Number OCP 4.260-ZC OCP 5.293-ZC OCP 5.294-ZC OCP 5.295-ZC OCP 5.296-ZC OCP 14.406-ZC OCP 17.034-ZC OCP 17.144-ZC OCP 17.147-ZC QCP 125-ZC ZWI 20.067-ZC ZWI 29.311
ZWI 29.401 ZWI 43.214

Rev. 20 11 15 12 25 13 12 4 2 3 1 6 5 10

Document Title ZMBV Maintenance Program Fiber Metal Cup and Crimp Operation Fiber Metal Product Compaction Assembly of Fiber Metal prior Diffusion Bonding Fiber Metal Diffusion Bonding Operation for Titanium Quantitative Determination of Oxygen and Nitrogen Content in CP Titanium and Titanium Alloys Nonconforming Material Report System, Manufacturing Bonding Operations Planned Deviation Report System Q.A. Parameters for Fiber Metal Devices Operation of ILT Laser Unit at Cell 205 Biomechanical Procedure Testing Laboratory Operating

The Determination of Pore Size, Porosity, and Voids of Modified Metallic Surfaces by Image Analysis Laser Method Inspection

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Previous Qualification/ Validation Related Documents Document Number VA 10-414 VA 07-070 VA 10-027 VA 08-157 VA 94-015 VA 06-033 VA 04-022 VA 95-009 VA 06-031 VA 04-023 VA 95-015 Document Title Installation, Operational, and Performance Qualification for Wabash MPI SMX 1212 300 Ton Press ZC01848 Installation and Operational Qualification for Wabash Fiber Metal Compaction Press ZC00214 Performance Qualification for Wabash Fiber Metal Compaction Press ZC00214 Installation and Operational Qualification for Cut & Crimp ZC01565 QV for Cut & Crimp ZC00167 Ti Fiber Metal Diffusion Bonding Process IQ/OQ/ PQ OQ/PQ Addendum

Equipment Qualification Ti Fiber Metal Diffusion Bonding Process IQ/OQ/ PQ OQ/PQ Equipment Qualification

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles 7.0 Definitions and Symbols/ Acronyms Definitions of terms, acronyms and symbols are included in the corresponding qualification/ validation plan VA 11-116-VP. This section presents additional definitions of terms in Table 2 and the symbols/ acronyms specific to this document in Table 3. Table 2: Terms Definitions Term Confidence Level Definition The confidence or risk level is based on ideas encompassed under the Central Limit Theorem. The key idea encompassed in the Central Limit Theorem is that when a population is repeatedly sampled, the average value of the attribute obtained by those samples is equal to the true population value. Furthermore, the values obtained by these samples are distributed normally about the true value, with some samples having a higher value and some obtaining a lower score than the true population value. A region of fiber metal which fails to completely bond to the surface of an implant. Indications for holography are depicted as solid black regions on holography monitor. A set of limits between which we can expect to find any given proportion of the population. A process by which metallurgical bonds are created at metal-to-metal contact sites under heat and pressure. A process that produces coalescence of metals by heat obtained from a concentrated beam of high velocity electrons impinging upon the surfaces to be joined. A predetermined amount of formed wire compacted into a predetermined volume of specified shape. Holography is a technique for recording and reconstructing the amplitude and phase distributions of a wave disturbance. It is widely used as a method for three-dimensional optical image formation by recording the pattern of interference between two mutually coherent light beams (Laser Method). The technique is accomplished by recording the pattern of interference between coherent light reflected from the object of interest (object beam), and light that comes directly from the same source (reference beam). Product Family Tivanium A grouping of products based on similar design. Ti-6Al-4V Alloy

Indication

Tolerance Limits Diffusion Bonding Electron Beam Welding Fiber Metal

Holography

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

Table 3: Acronyms and Symbols Acronym/ Symbol CP DB EBW GSOP MIS OCP SOP ZES ZMBV ZWI Commercially Pure Diffusion Bonding Electron Beam Welding Global Standard Operation Procedure Manufacturing/ Measuring Instruction Sheet Operating Control Procedure Standard Operation Procedure Zimmer Engineering Specification Zimmer Manufacturing BV, Ponce, PR Zimmer Work Instruction Associated Term

8.0

Verification Strategy Product families manufactured in HIP BU cells 201/ 205 have been evaluated to identify representative part numbers to be used for verification purposes. Evaluation process included the list of product part numbers and design characteristics. Key aspects are detailed below: All product families have the same geometry at the diffusion bonding furnace cycle step. Although different part numbers have different quantity of holes, such holes are made after the diffusion bonding process. Therefore, its not considered as a variable. Likewise, spiked shells includes three (3) spikes at the thermal furnace cycle. Therefore, its not considered as a variable. Same materials and surface finish apply to all product families.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Sampling Size and Acceptance Criteria Determination and Justification Samples will be withdrawn from available inventory of lots processed through all currently approved router steps, as defined on production work orders, up to last machining operation after processing in the vacuum furnace. NOTE: Sample/ test lots traceability must be clearly noted including lot number, part number, and protocol and ITP number. Specification limits for product cycles are established on ZES 2A-132: Pore size and porosity, per ZES 2A-132: The porous coating shall have an average volume porosity of 30-70%. The porous coating shall have an average pore size between 100 and 1000 microns. NOTE: Product samples will be sent to the Analytical Testing Services (ATS) Laboratory (ATS) in Warsaw, Indiana pore size, and porosity testing, using F-00517, Analytical Testing Services Metals/Spec Test Request form. Additional quality program requirements, not covered under this verification protocol, include: O2N2 monitoring coupons are analyzed at ZMBV, as per OCP 14.406-ZC. o Oxygen content plus nitrogen content shall not exceed 0.35 weight percent, per ZES 2A-132. Bonding integrity is evaluated on all diffusion bonded fiber metal coated products using holography per ZES 4J-02, as required in ZES 2A-132. Penetrant inspection is performed on all spiked cups using ZES 4H-01, as required in ZES 4L-02. All products subjected to this qualification protocol meet requirements above specified. 8.1. Verification Execution and Sampling Strategy

For verification purposes, samples will be withdrawn from inventory lots manufactured at ZMBV and collected from our Distribution Center at Warsaw. These samples were processed under normal (nominal) operating conditions, as detailed in applicable production routers, MIS and operating procedures. As per ANSI Z1.9 "Acceptance Variable Sampling Plan", Table A-2 below for a Total lot size of 8342 ( available size of cup sizes) with general inspection Level II code letter L is applied from Table B-3 with an AQL 1.0% , 75 parts must be sampled from Total Population. (Refer to Appendix 5 for Instructions/Flowchart for proper use of ANSI Z1.92008)

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

These parts will be sampled and tested per available cup size, for pore size and porosity. Sample Selection Strategy consisted of grouping lots within families (Refer to Table 4 Inventory Lots Manufactured). ANSI 1.9 was applied per lot families and samples determined to be pulled out from a random selected lot of each family (Pulled Qty by Part Size). The (75) seventy size parts were then selected from pulled samples. Refer to Table 6 below (Sample size by Lot).

Table A-2: ANSI Z1.9 Variable Acceptance Sampling Strategy

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Table B-3: ANSI Z1.9 Variable Acceptance Sampling Strategy (Cont.)

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles The following is a list of all part numbers and respective parts in stock. The total amount of parts adds up to 8356 an this is considered the total lot size. In case the lot of 8356 parts is rejected an examination of part numbers that resulted in outliers will be performed and further sampling with individual lot numbers/work orders carried out as per ANSI Z1.9. Table 4: Inventory Lots Manufactured
Part Number 00620003620 00620004220 00620004420 00620004620 00620004620 00620004620 00620004820 00620004820 00620004822 00620004822 00620004822 00620004822 00620004822 00620004822 00620004822 40640004822 40640004822 00620005020 00620005020 00620005020 00620005020 00620005020 00620005020 00620005020 00620005021 00620005022 00620005022 00620005022 Lot # 62001975 62099620 62099618 62094940 62099619 62105171 62105169 62105170 62091853 62050952 62091854 62091855 62094949 62096961 62096964 62094937 62099617 62063920 62063921 62063922 62076906 62076905 62096970 62096972 62094941 62086036 62086035 62086032 QTY 40 20 36 36 36 36 36 36 36 35 32 36 36 33 35 18 36 33 23 35 35 13 36 36 29 63 65 67 SIZE 36 42 20 44 36 46 46 46 108 48 48 48 48 48 48 48 48 48 48 48 369 50 50 50 50 50 50 50 50 50 50 50 Total per Family 40

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles
Part Number 00620005022 00620005022 00620005022 00620005022 00620005022 00620005022 00620005022 00620005022 00620005022 00620005022 00620005022 00620005022 00620005022 00620005023 40620005020 40620005020 40620005022 40620005022 40620005023 40640005022 40640005022 00620005220 00620005220 00620005220 00620005220 00620005220 00620005220 00620005222 00620005222 00620005222 00620005222 00620005222 00620005222 00620005222 00620005222 00620005222 00620005222 00620005222 Lot # 62043448 62050954 62050955 62096965 62096968 62096966 62096967 62043449 62065243 62059673 62099622 62113212 62114827 62076910 62086026 62113202 62073487 62113204 62038312 62072481 62079953 62076902 62010599 62091842 62043430 62105161 62105160 62099623 62086039 62043451 62086040 62086041 62099624 62094944 62091846 62094945 62096988 62096989 QTY 32 30 29 35 29 33 31 29 24 36 72 72 72 35 50 36 36 72 35 14 36 67 66 71 34 72 72 68 69 70 72 68 72 72 72 72 72 72 SIZE 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 Total per Family

1273

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles
Part Number 00620005222 00620005222 00620005222 00620005223 00620005223 40620005220 40620005222 40620005223 40640005222 40640005222 00620005420 00620005420 00620005420 00620005420 00620005421 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005422 00620005423 00620005423 40620005422 40640005422 00620005620 00620005620 00620005620 Lot # 62114822 62114823 62114824 62096993 62052791 62094933 62050959 62038316 62070116 62079951 62076899 62079954 62105165 62105166 62043437 62079962 62079964 62091844 62094942 62099649 62099650 62102516 62065248 62094943 62096987 62096996 62102514 62102517 62113213 62118980 62105176 62001308 62094935 62070117 62094939 62043432 62043433 QTY 72 72 72 36 36 72 68 36 36 36 67 67 72 72 35 70 63 70 71 71 63 68 60 69 72 72 72 72 72 72 36 20 72 36 69 67 72 SIZE 52 52 52 52 52 52 52 52 52 52 1697 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 54 1514 56 56 56 Total per Family

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles
Part Number 00620005620 00620005620 00620005620 00620005621 00620005622 00620005622 00620005622 00620005622 00620005622 00620005622 00620005622 00620005622 00620005622 00620005622 00620005622 40620005622 40640005622 40640005622 40640005622 00620005820 00620005820 00620005820 00620005820 00620005820 00620005822 00620005822 00620005822 00620005822 00620005822 00620005822 00620005822 00620005822 00620005822 00620005822 40620005823 40640005822 00620005823 Lot # 62105155 62105156 62113209 62043438 62073492 62091850 62094946 62094948 62096990 62091848 62091849 62099652 62096999 62099651 62113211 62043443 62070118 62079950 62079952 62076897 62050960 62102505 62105163 62105162 62060664 62086031 62046436 62060663 62091851 62091852 62086029 62086030 62113210 62114818 62038320 62073488 62105179 QTY 70 72 72 36 66 71 72 68 60 69 66 72 72 72 72 72 36 36 36 34 32 72 72 72 64 68 34 57 62 70 69 67 72 72 27 36 36 SIZE 56 56 56 56 56 56 56 56 56 56 56 56 56 56 56 56 56 56 56 58 58 58 58 58 58 58 58 58 58 58 58 58 58 58 58 58 58 1016 Total per Family

1398

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles
Part Number 00620006020 00620006020 00620006020 00620006020 00620006022 00620006022 00620006022 00620006022 00620006022 00620006022 00620006022 00620006022 00620006022 00620006022 00620006022 00620006022 00620006022 00620006220 00620006220 00620006222 00620006222 00620006222 00620006420 00620006420 00620006422 Lot # 62076904 62076903 62105158 62105159 62086038 62096991 62102513 62059676 62065256 62098945 62046435 62086037 62098944 62098946 62099621 62102511 62102512 62076901 62105157 62094950 62096992 62109945 62102509 62113207 62103685 Totals QTY 35 29 36 36 35 34 34 32 29 35 36 36 36 36 36 36 36 34 36 34 36 36 36 36 36 SIZE 60 60 60 60 60 60 60 60 60 60 60 60 60 60 60 60 60 62 62 62 62 62 176 64 64 64 108 8342 Total per Family

587

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Table 5: Pulled Quantities by Part Size
PART SIZE Pulled Quantity**

36 42 44 46 48 50 52 54 56 58 60 62 64 36 36 42

40 20 36 108 369 1273 1697 1514 1398 1016 587 176 108 40 40 20

**Collected from a random lot selected in each family. Lot Number information will be documented as part of the validation exercise.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

Table 6: Samples by Lot

Testing Recommended

QTY

Part SIZE

SAMPLE SIZE

40 20 36 108 369 1273 1697 1514 1398 1016 587 176 108 40 8342 8.2.

36 42 44 46 48 50 52 54 56 58 60 62 64 36 N/A

6 4 5 10 20 50 50 50 50 35 35 15 10 6 340

6 4 5 6 6 6 6 6 6 6 6 6 6 6 75

Change Management System and Product Disposition

HOLD Notification form (ZC-533) will be issued for each affected work order. Disposition of production lots on HOLD will be handled as per OCP 17.034-ZC Nonconforming Material Report System, OCP 7.819-ZC Corrective and Preventive Actions, and/ or OCP 17.147-ZC Planned Deviation Report System, as applicable.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

9.0

Roles and Responsibilities Roles and Responsibilities

Deliverables

Roles

Responsibilities Issue Hold Notice and planned deviation forms, and include with work orders affected by this study, as applicable.

Product Project Owner: Disposition Manufacturing (HIP BU Documentation Manager or designee) QC Manager Protocol, Execution and Report Technical Support Services

Issue protocol(s) and route for review and approval. Assure all protocol discrepancies are properly investigated and documented. Issue report(s) and route for review and approval. Reviewers/ Approvers: Review and approve protocol(s), Manufacturing, IT, QC Lab, discrepancy/ deviation forms, and and QA Technical Services summary report(s). Managers or designees Assure availability of required resources to complete the qualification/ validation study. Assure applicable regulatory and procedural requirements are covered. ATS, Biomechanical Test Process samples and provide test Lab results report per applicable test methods and procedures.

10.0

General Execution Procedure 10.1. Training Verification Protocol execution and review should be performed by trained and qualified individuals. Personnel executing ITPs should be trained in the applicable protocol section(s) prior execution. Verification of training/ certification of personnel involved in the execution of this protocol is documented in Pre-Requisite ITP-003. Procedure Objective evidence related to the execution of this qualification/ validation study is provided by completing the data collection (ITPs/ test) forms included in this protocol. Each data collection form includes:

10.2.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Test Number and Title: Unique identifiers for each ITP/ test form. Requirement Specification: A space to document source for requirement/ specification covered by the specific ITP/ test form. Test Objective: A statement on the objective/ purpose of the specific ITP/ test. Test Procedure: The actions and/or methodology required to execute the specific ITP/ test to meet the objective. Execution: A section (usually in table format) to document execution information. Expected and actual/ observed results columns are provided where applicable. For each ITP/ test step, actual/ observed results should match the corresponding expected results. Attachments: A space to indicate if attachments are included, and document the actual attachment number. Document N/A if no attachment is included. Acceptance Criteria: Each ITP/ test specific acceptance criteria is included in this section. NOTE: In case the ITP/ test is performed for baseline information purposes, it will be indicated in this section. Discrepancy/ Deviation Report (DR No.): A space to document any discrepancy/ deviation report related to the specific ITP/ test. Document N/A if no DR is included. Comments: A space provided to document any pertinent additional information specific to the ITP/ test form. Document N/A if no comment is needed. ITP/ Test execution is completed by the executor(s) who sign/ date the Recorded By, Performed By or Verified By space(s) in the form. Reviewed By and Date: A space provided to document test completion, including referenced attachments and DR forms, have been reviewed and are satisfactorily documented and completed. The reviewer(s) must be a person different than the executor.

10.3. Tests Acceptance Criteria If all test steps within the ITP/ test form are satisfactorily completed, the ITP/ test is accepted (Pass). If the result of any test step does not meet the expected result and/or test acceptance criteria, the ITP/ test is evaluated in order to determine whether the complete ITP/ test pass or fails, and whether qualification activities should be suspended until corrective actions are taken or not. If qualification activities are suspended, the entire ITP/ test is failed and must be repeated in its entirety. Refer to the Discrepancies/ Deviation Reports section below for detailed instructions. If the actual/ observed results do not match the expected results or acceptance criteria and the test step can be immediately corrected, the corrective action is recorded in the Comments section of the test case form. This action may be used only when there is an explainable error in the test procedure, in the expected results or the acceptance criteria (e.g., sequencing of procedure, formatting, grammar, typographical errors, etc.).

Page 25 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles 10.4. Discrepancies/ Deviation Reports (DR) If any discrepancy or deviation to protocol requirements are found (e.g., actual/ observed results do not match the expected results, and/or test acceptance criteria is not met) and immediate corrective action cannot be taken as mentioned in the previous section, document the actual result, document Fail in the applicable Pass/Fail section for the ITP/ test step. Initiate a Discrepancy/ Deviation Report (DR) describing the situation and include the DR No. in the DR Log, in sequential order. An individual Discrepancy/ Deviation Report form should be completed for each protocol related discrepancy or deviation. The failed ITP/ test or step should cross-reference to the corresponding DR. Each section of the DR report form should be completed, including: DR No. ITP/ Test Number and Step Description of the Incident Whether suspension of qualification/ validation is required or not Investigation and Corrective/ Preventive Actions Conclusions Whether DR is closed or not Required signatures and dates in each section In case additional space is required, a memo including the DR form sections may be issued, attached, and referenced in the actual DR form. Original DR forms, and any supporting documentation, should be attached to the executed protocol. Any needed changes to the equipment/ system/ process should be documented, as well as required re-execution of the ITP/ test or step(s) affected by the discrepancy/ deviation. The extent of testing to be repeated will depend on the error and should be justified within the DR report. In case a failed ITP/ test step is not required to be corrected and/or repeated, the decision must be justified in the DR report. In such case, the investigation/ conclusion should clearly state whether the original failed ITP/ test is considered as satisfactorily completed and accepted, including an appropriate rationale. After completion and review of the Investigation and Corrective/ Preventive Actions, and Conclusions sections, the DR report should be submitted to QA/ TS Management for final approval and disposition/ closure of the DR. Upon satisfactory completion of the protocol tests, any open DRs are summarized, evaluated, and resolved prior to completing the corresponding qualification/ validation report. In case, any DR needs to be kept open, it will be evaluated by QA/ TS Management in order to determine whether the DR affects or not the outcome of the qualification/ validation. Final resolution should be included in this protocol Disposition section(s), as applicable.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

10.5. Attachments All supporting documents and objective evidence pertaining to the execution of this protocol should be included in an attachment, and logged in the Attachments Log. Attachments should be properly identified, including at least: protocol number, ITP/ test number, quantity of pages, sign and date.

Page 27 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles 11.0 Individual Test Protocols (ITPs)/ Tests Checklist

Verification Testing ITP/ Test No. Item Description (ITPXXX) ITP-001 Verification Sampling/ Monitoring Lot Acceptability/Rejection ITP-002 Verification Test Results Required Test (Y/N) Y Y Comments (If No selected, document rationale)

Page 28 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

Page ___ of ___ ITP-001 Test Objective Verification Sampling/ Monitoring Provide objective evidence that product manufactured (Trylogy cups) manufactured as per current processes at ZMBV meet specifications, as outlined in ZES 2A-132 per OCP 17.008-ZC Rev 19 for Pore size and Porosity. Sample the required quantity of parts as established in this protocol. Document the information required in below tables. Test Procedure Send product samples to the Analytical Testing Services (ATS) Laboratory (ATS) in Warsaw, Indiana pore size, and porosity testing, using F-00517, Analytical Testing Services Metals/Spec Test Request form. Attach a copy of the filled form(s). NOTE: Sample/ test lots traceability must be clearly noted including lot number, part number, protocol, and ITP number. Attachments Yes Comments: No If Yes, list attachment number[s]:

Performed By/ Date Make copies of this page as needed.

Reviewed By/ Date

Page 29 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Page ___ of ___ ITP-001 Product Type:
Lot No. Lot Size Cup Size P/Ns QTY Performed by: Date:

Verification Sampling/ Monitoring

Total Quantity of Sampling/ Testing Parts: Attachments Comments: Yes No If Yes, list attachment number[s]:

Performed By/ Date Make copies of this page as needed.

Reviewed By/ Date

Page 30 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Page ___ of ___ ITP-001 Verification Sampling/ Monitoring (CONT) Required Samples per Cup Size per Type were withdrawn: See Table 6 Samples are properly identified, including lot number, part number, protocol, and ITP number. Acceptance Criteria Samples were submitted to the Analytical Testing Services (ATS) Laboratory (ATS) in Warsaw, Indiana for pore size, and porosity testing, and a copy of the corresponding form is attached F-00517, Analytical Testing Services Metals/Spec Test Request form. Information required in above tables was properly documented. If Fail, refer to the corresponding Discrepancy/ Pass Fail Deviation Report (DR No.): Yes No If Yes, list attachment number[s]:

Acceptance Criteria Met Attachments Comments:

Performed By/ Date Make copies of this page as needed.

Tables are Complete Yes No

Reviewed By/ Date

Page 31 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Page ___ of ___ ITP-002 Test Objective Lot Acceptance Criteria Verification Test Results Document and evaluate actual test results to provide objective evidence that product manufactured at target (nominal) process parameters for the product cycles/ recipes meet required specifications for pore size and porosity and access acceptability / rejection of lots per ANSI Z1.9 Document and evaluate test results, calculate the required statistics, and evaluate against acceptance criteria. Attach the corresponding Lab reports, as well as verified/ signed print-outs of any spreadsheet used to record the data and/or used for calculation purposes. Yes No If Yes, list attachment number[s]:

Test Procedure Attachments Comments:

Performed By/ Date Make copies of this page as needed.

Tables are Complete Yes No

Reviewed By/ Date

Page 32 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Page ___ of ___ ITP-002 Lot Acceptance Criteria Verification Test Results Pore size and porosity lot evaluated as per Acceptance/Rejection Criteria ANSI Z1.9 Flowchart on page 19 of 48 on protocol. Code- Letter & Sample Size (Inspection level II) B-3 C-4 D-5 E-7 F-10 G-15 H-20 I-25 J-35 K-50 L-75 M-100
M% Nonconformance as per ANSI Z1.9 (Accept P<M)

AQL%

Lot Size 2-15 16-25 26-50

1.49 1.49 3.33 3.54 3.27 3.06 2.93 2.86 2.66 2.47 2.27 2.18

Lot Acceptance Criteria

51-90 91-150 151-280 1.0% 281-400 401-500 501-1,200 1,201-3,200 3,201-10,000 10,001-35,000

Acceptance Criteria Met Attachments Comments:

Pass Yes

Fail No

If Fail, refer to the corresponding Discrepancy/ Deviation Report (DR No.): If Yes, list attachment number[s]:

Performed By/ Date Make copies of this page as needed.

Tables are Complete Yes No

Reviewed By/ Date

Page 33 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles 12.0 Verification Disposition

Item All tests were completed? Acceptance criteria met? Any test still open? If yes, explain below. All discrepancies were resolved satisfactorily, approved and closed? If not, explain below. Make copies of this page as needed.

Yes or No

Performed By / Date

Comments: ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________

_________________________________ System Owner _________________________________ QA/ TS

______________________ Date ______________________ Date

Page 34 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles 13.0 Protocol Attachments and Appendixes Appendix 1: Protocol Signature Identification Sheet Appendix 2a: Protocol Discrepancy/ Deviation Log Appendix 2b: Protocol Discrepancy/ Deviation Report Form Appendix 3a: Protocol Attachment Log Appendix 3b: Protocol Attachment Identification Sheet Appendix 4: Trilogy/ Acetabular Cup Product Families (Manufactured in Cell 201/ 205) Appendix 5: ANSI Z 1.9 Instruction/Flowchart for Double Side Test.

Page 35 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Appendix 1 Protocol Signature Identification Sheet The following is a record of each individual who signs or initials any page of this document in the process of system validation. Page ___ of ___ Name (Print) Title Signature Initials Date

Make copies of this page as needed.

Reviewed by: ______________________________________Date: _____/_____/______

Page 36 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Appendix 2a Protocol Discrepancy/ Deviation Log Log all discrepancies/ deviations created during the execution of this protocol, and recorded on a Discrepancy/ Deviation Report Form (DR). Page ____ of ____ Protocol Discrepancy/ Deviation Report No. Satisfactorily Investigated and Closed? (Y/N) Verified by/ Date

Incident

ITP No. and Step

Make copies of this page as needed.

Reviewed by: _________________________

Date: _______

Page 37 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Appendix 2b Protocol Discrepancy/ Deviation Report Form DR No._____001___ Section 1 Test Number and Step: ITP-002 Page __1_ of _1__

Description of Incident: VA-12-187-ST established that 75 samples of Trylogy cups would be tested for pore size and porosity to determine if they meet specifications as per ZES 2A-132. Two samples of cup size 048mm showed results below of the specification limits of 30% (29.2% and 29.5%) for porosity and one for size 046mm (29.4%) porosity. Performed By: Section 2 Investigation and Corrective/ Preventive Actions: Based on ANSI Z1.9 (Variable Acceptance Plan) an X bar and s Chart were ran in Minitab for porosity and pore size to assess outliers reflecting unsatisfactorily levels of porosity and pore (Refer to attachment 001 to Final Report for nonconformance of lots 048mm and 046mm). The other 63 parts showed adherence to protocol requirements, Porosity and Pore size were then assess to meet specification and all other lots released based on this results. Lots 62094940 size 46mm and lot 62094949 size 048mm that failed porosity criteria will be handled per OCP 17.034-ZC Nonconforming Material Report system for proper disposition as per 62094949 NCR 2012-1048 and 62094940 NCR 2012-1047. Performed By: Reviewed By: Section 3 Conclusions: Date: Date: Date:

DR requires suspension of qualification/ validation: Yes / No: ___No__

ANSI Z1.9 Acceptance for Variable Percent Non-Conforming was then applied to the 63 parts samples (representing all cup sizes except 46mm and 48mm) resulting in acceptable levels for porosity and pore size. Therefore it is concluded that all lots from cup sizes except 46mm and 48mm meet porosity and pore size requirements as per ZES 2A-132 and will be disposed for release. Performed By: Reviewed By: Section 4 Quality Assurance Signature: Make copies of this page as needed. Is the DR closed? Yes/ No: ________ Date: Date: Date:

Page 38 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Appendix 3a Protocol Attachment Log List all the documents used as objective evidence for the execution, specify number of pages and related ITP(s). Each sheet of the attached documentation must be properly identified with validation document number, ITP number, and attachment page number. Page ____ of ____ Attachment Number Attachment Title Number of Pages Related ITP(s)

Make copies of this page as needed.

Reviewed by:

Date:

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

Appendix 3b Protocol Attachment Identification Sheet

Attachment No: _____ No. of Pages: _____

Attachment for: _______________________________________ _______________________________________ Compiled and Stamped/ Identified by: _____ Date: _______

Page 40 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Appendix 4 Trilogy/ Acetabular Cup Product Families (Manufactured in Cell 201/ 205)
SIZE (mm) 36 38 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 72 74 76 78 80 FM DIAMETER Compaction FM (inches) Target Compaction (grams) Range (grams) 1.388 5.34 5.04-5.54 1.466 6.02 5.68-6.24 1.544 6.74 6.36-6.99 1.624 7.52 7.10-7.81 1.702 8.32 7.86-8.63 1.782 9.19 8.67-9.53 1.860 10.07 9.50-10.45 1.938 10.99 10.37-11.40 2.018 13.02 12.29-13.51 2.096 14.11 13.32-14.62 2.174 15.26 14.40-15.84 2.254 16.48 15.55-17.10 2.332 17.70 16.70-18.37 2.410 18.97 17.90-19.69 2.490 20.32 19.17-21.08 2.568 21.67 20.45-22.49 2.648 23.10 21.80-23.90 2.726 24.54 23.16-25.47 2.804 26.04 24.57-27.02 2.884 27.61 26.05-28.65 2.962 29.19 27.53-30.29 3.040 30.80 29.06-31.97 3.120 32.51 30.67-33.74 Fixture Base Size (inches) 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0"

CF

CF Name

Part Number CF
40-6200-036-20 40-6200-038-20 40-6200-040-20 40-6200-042-20 40-6200-044-20 40-6200-046-20 40-6200-048-20 40-6200-050-20 40-6200-052-20 40-6200-054-20 40-6200-056-20

CF Name

Part Number
00-6200-036-20 00-6200-038-20 00-6200-040-20 00-6200-042-20 00-6200-044-20 00-6200-046-20 00-6200-048-20 00-6200-050-20 00-6200-052-20 00-6200-054-20 00-6200-056-20

DF Fixture

E31

HATCP Trilogy Multi (-20)

40-6200-058-20 G04 40-6200-060-20 40-6200-062-20 40-6200-064-20 40-6200-066-20 40-6200-068-20 40-6200-070-20 40-6200-072-20 40-6200-074-20 40-6200-076-20 40-6200-078-20 40-6200-080-20

Trilogy Multi (-20)

00-6200-058-20 00-6200-060-20 00-6200-062-20 00-6200-064-20 00-6200-066-20 00-6200-068-20 00-6200-070-20 00-6200-072-20 00-6200-074-20 00-6200-076-20 00-6200-078-20 00-6200-080-20

25-3500-243-36 25-3500-243-38 25-3500-243-40 25-3500-243-42 25-3500-243-44 25-3500-243-46 25-3500-243-48 25-3500-243-50 25-3500-243-52 25-3500-243-54 25-3500-243-56 25-3500-243-58 25-3500-243-60 25-3500-243-62 25-3500-243-64 25-3500-243-66 25-3500-243-68 25-3500-243-70 25-3500-243-72 25-3500-243-74 25-3500-243-76 25-3500-243-78 25-3500-243-80

Page 41 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles
SIZE (mm) 38 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 48 50 52 54 56 58 60 62 64 66 68 70 FM DIAMETER Compaction FM (inches) Target Compaction (grams) Range (grams) 1.466 6.02 5.68-6.24 1.544 6.74 6.36-6.99 1.624 7.52 7.10-7.81 1.702 8.32 7.86-8.63 1.782 9.19 8.67-9.53 1.860 10.07 9.50-10.45 1.938 10.99 10.37-11.40 2.018 13.02 12.29-13.51 2.096 14.11 13.32-14.62 2.174 15.26 14.40-15.84 2.254 16.48 15.55-17.10 2.332 17.70 16.70-18.37 2.410 18.97 17.90-19.69 2.490 20.32 19.17-21.08 2.568 21.67 20.45-22.49 2.648 23.10 21.80-23.90 2.726 24.54 23.16-25.47 1.860 10.07 9.50-10.45 1.938 10.99 10.37-11.40 2.018 13.02 12.29-13.51 2.096 14.11 13.32-14.62 2.174 15.26 14.40-15.84 2.254 16.48 15.55-17.10 2.332 17.70 16.70-18.37 2.410 18.97 17.90-19.69 2.490 20.32 19.17-21.08 2.568 21.67 20.45-22.49 2.648 23.10 21.80-23.90 2.726 24.54 23.16-25.47 Fixture Base Size (inches) 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0"

CF

CF Name

Part Number CF

CF Name

Part Number
00-6200-038-21

DF Fixture

40-6200-040-21 40-6200-042-21 40-6200-044-21 40-6200-046-21 40-6200-048-21 40-6200-050-21 40-6200-052-21 E32 HATCP Trilogy Solids (-21) 40-6200-054-21 G05 40-6200-056-21 40-6200-058-21 40-6200-060-21 40-6200-062-21 40-6200-064-21 40-6200-066-21 40-6200-068-21 40-6200-070-21 40-6200-048-22 40-6200-050-22 40-6200-052-22 40-6200-054-22 40-6200-056-22 E33 HATCP Trilogy Cluster (-22) 40-6200-058-22 40-6200-060-22 40-6200-062-22 40-6200-064-22 40-6200-066-22 40-6200-068-22 40-6200-070-22 G09 Trilogy Cluster (-22) Trilogy Solids (-21)

00-6200-040-21 00-6200-042-21 00-6200-044-21 00-6200-046-21 00-6200-048-21 00-6200-050-21 00-6200-052-21 00-6200-054-21 00-6200-056-21 00-6200-058-21 00-6200-060-21 00-6200-062-21 00-6200-064-21 00-6200-066-21 00-6200-068-21 00-6200-070-21 00-6200-048-22 00-6200-050-22 00-6200-052-22 00-6200-054-22 00-6200-056-22 00-6200-058-22 00-6200-060-22 00-6200-062-22 00-6200-064-22 00-6200-066-22 00-6200-068-22 00-6200-070-22

25-3500-243-38 25-3500-243-40 25-3500-243-42 25-3500-243-44 25-3500-243-46 25-3500-243-48 25-3500-243-50 25-3500-243-52 25-3500-243-54 25-3500-243-56 25-3500-243-58 25-3500-243-60 25-3500-243-62 25-3500-243-64 25-3500-243-66 25-3500-243-68 25-3500-243-70 25-3500-243-48 25-3500-243-50 25-3500-243-52 25-3500-243-54 25-3500-243-56 25-3500-243-58 25-3500-243-60 25-3500-243-62 25-3500-243-64 25-3500-243-66 25-3500-243-68 25-3500-243-70

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles
SIZE (mm) 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 FM DIAMETER Compaction FM (inches) Target Compaction (grams) Range (grams) 1.544 6.74 6.36-6.99 1.624 7.52 7.10-7.81 1.702 8.32 7.86-8.63 1.782 9.19 8.67-9.53 1.860 10.07 9.50-10.45 1.938 10.99 10.37-11.40 2.018 13.02 12.29-13.51 2.096 14.11 13.32-14.62 2.174 15.26 14.40-15.84 2.254 16.48 15.55-17.10 2.332 17.70 16.70-18.37 2.410 18.97 17.90-19.69 2.490 20.32 19.17-21.08 2.568 21.67 20.45-22.49 2.648 23.10 21.80-23.90 2.726 24.54 23.16-25.47 Fixture Base Size (inches) 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0"

CF

CF Name

Part Number CF
40-6200-040-23 40-6200-042-23 40-6200-044-23 40-6200-046-23 40-6200-048-23 40-6200-050-23 40-6200-052-23 40-6200-054-23 40-6200-056-23 G07 40-6200-058-23 40-6200-060-23 40-6200-062-23 40-6200-064-23 40-6200-066-23 40-6200-068-23 40-6200-070-23

CF Name

Part Number

DF Fixture

00-6200-042-23 00-6200-044-23 00-6200-046-23 00-6200-048-23 00-6200-050-23 00-6200-052-23 00-6200-054-23 Trilogy Spiked (-23) 00-6200-056-23 00-6200-058-23 00-6200-060-23 00-6200-062-23 00-6200-064-23 00-6200-066-23 00-6200-068-23 00-6200-070-23

E34

HATCP Trilogy Spiked (-23)

25-3500-243-40 25-3500-243-42 25-3500-243-44 25-3500-243-46 25-3500-243-48 25-3500-243-50 25-3500-243-52 25-3500-243-54 25-3500-243-56 25-3500-243-58 25-3500-243-60 25-3500-243-62 25-3500-243-64 25-3500-243-66 25-3500-243-68 25-3500-243-70

Page 43 of 47

Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles
SIZE (mm) FM DIAMETER Compaction FM (inches) Target Compaction (grams) Range (grams) 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 1.544 1.624 1.702 1.782 1.860 1.938 2.018 2.096 2.174 2.254 2.332 2.410 2.490 2.568 2.648 2.726 Fixture Base Size (inches) 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.0" x 3.0" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0"

CF

CF Name

Part Number CF
40-6200-038-24 40-6200-040-24 40-6200-042-24 40-6200-044-24 40-6200-046-24 40-6200-048-24 40-6200-050-24 40-6200-052-24 40-6200-056-24 40-6200-058-24 40-6200-060-24 40-6200-062-24 40-6200-064-24 40-6200-066-24 40-6200-068-24 40-6200-070-24

CF Name

Part Number
00-6200-038-24 00-6200-040-24 00-6200-042-24 00-6200-044-24 00-6200-046-24 00-6200-048-24 00-6200-050-24 00-6200-052-24 00-6200-056-24 00-6200-058-24 00-6200-060-24 00-6200-062-24 00-6200-064-24 00-6200-066-24 00-6200-068-24 00-6200-070-24

DF Fixture

E35 HATCP Trilogy Uni Hole (-24) 40-6200-054-24 G13 Trilogy Uni Hole (-24) 00-6200-054-24

6.02 6.74 7.52 8.32 9.19 10.07 10.99 13.02 14.11 15.26 16.48 17.70 18.97 20.32 21.67 23.10 24.54

5.68-6.24 6.36-6.99 7.10-7.81 7.86-8.63 8.67-9.53 9.50-10.45 10.37-11.40 12.29-13.51 13.32-14.62 14.40-15.84 15.55-17.10 16.70-18.37 17.90-19.69 19.17-21.08 20.45-22.49 21.80-23.90 23.16-25.47

25-3500-243-38 25-3500-243-40 25-3500-243-42 25-3500-243-44 25-3500-243-46 25-3500-243-48 25-3500-243-50 25-3500-243-52 25-3500-243-54 25-3500-243-56 25-3500-243-58 25-3500-243-60 25-3500-243-62 25-3500-243-64 25-3500-243-66 25-3500-243-68 25-3500-243-70

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles
SIZE (mm) 48 50 52 54 56 60 62 64 66 68 70 48 50 52 54 56 58 60 62 64 66 68 70 FM DIAMETER Compaction FM (inches) Target Compaction (grams) Range (grams) 1.860 10.07 9.50-10.45 1.938 10.99 10.37-11.40 2.018 13.02 12.29-13.51 2.096 14.11 13.32-14.62 2.174 15.26 14.40-15.84 2.332 17.70 16.70-18.37 2.410 18.97 17.90-19.69 2.490 20.32 19.17-21.08 2.568 21.67 20.45-22.49 2.648 23.10 21.80-23.90 2.726 24.54 23.16-25.47 1.860 10.07 9.50-10.45 1.938 10.99 10.37-11.40 2.018 13.02 12.29-13.51 2.096 14.11 13.32-14.62 2.174 15.26 14.40-15.84 2.254 16.48 15.55-17.10 2.332 17.70 16.70-18.37 2.410 18.97 17.90-19.69 2.490 20.32 19.17-21.08 2.568 21.67 20.45-22.49 2.684 23.10 21.80-23.90 2.726 24.54 23.16-25.47 Fixture Base Size (inches) 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 3.5" x 3.5" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0" 4.0" x 4.0"

CF

CF Name

Part Number CF
40-6400-048-20 40-6400-050-20 40-6400-052-20 40-6400-054-20 40-6400-056-20

CF Name

Part Number

DF Fixture

E37

HATCP AB CUPS (40-64-20)

40-6400-060-20 40-6400-062-20 40-6400-064-20 40-6400-066-20 40-6400-068-20 40-6400-070-20 40-6400-048-22 40-6400-050-22 40-6400-052-22 40-6400-054-22 40-6400-056-22 40-6400-058-22 40-6400-060-22 40-6400-062-22 40-6400-064-22 40-6400-066-22 40-6400-068-22 40-6400-070-22

E38

HATCP AB CUPS (40-64-22)

25-3500-301-48 25-3500-301-50 25-3500-301-52 25-3500-301-54 25-3500-301-56 25-3500-301-60 25-3500-301-62 25-3500-301-64 25-3500-301-66 25-3500-301-68 25-3500-301-70 25-3500-301-48 25-3500-301-50 25-3500-301-52 25-3500-301-54 25-3500-301-56 25-3500-301-58 25-3500-301-60 25-3500-301-62 25-3500-301-64 25-3500-301-66 25-3500-301-68 25-3500-301-70

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles Appendix 5 Instructions/Flowchart ANSI Z1.9-2008 (Double Sided Test) B7. SUMMARY FOR OPERATION OFSAMPLING PLAN WHEN FORM 2 IS USED The following steps summarize the procedures to be followed: (1) Determine the sample size code letter from Table A-2by using the lot size and the inspection level. (2) Obtain plan from Master Table B-3 or B-4 by selecting the sampling size n and the maximum allowable per-cent nonconforming M. (3) Select at random the sample of n units from the lot inspect and record the measurement of the quality characteristic on each unit of the sample. (4) Compute the sample mean Xand the estimate of lot standard deviation s. (5) Compute the quality index (QU= (U X)/s ) if an upper specification limit U is specified for (QL= (X L)/s) if a lower specification limit L is specified (6) Determine the estimated lot percent nonconforming PU or PL from Table B-5. (7) If the estimated lot percent nonconforming PU or PL is equal to or less than the maximum allowable percent non-conforming M, the lot meets the acceptability criterion; if PU or PL is greater than M or if QU or QL is negative ,then the lot does not meet the acceptability criterion.

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Verification Protocol VA 12-187-ST, Version 1 Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

Appendix 5 Instructions/Flowchart ANSI Z1.9-2008 (Double Sided Test)-Continued

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