Creo Drawing Practices

ER006 (QSD011329), Version A
Memphis Headquarters
Local Instruction CAD Drawing Practices
Introduction
Purpose This document defines the good drawing practices that will help ensure all users produce
and maintain CAD drawings in a consistent manner. Engineering and Commodity subject
matter experts may update and improve all content based on lessons learned, CAPAs, and
best practices.
Scope The information in this document applies to all production CAD drawings representing
Medtronic owned designs.
*Sites within scope of this document and other document attributes are noted within the QMS document change control
system.
Table of Contents
Introduction ................................................................................................................................................................1
Table of Contents .......................................................................................................................................................1
Roles/ Responsibilities ................................................................................................................................................2
Process Overview .......................................................................................................................................................2
1. General Guidelines .........................................................................................................................................2
2. Typical Process ...............................................................................................................................................2
Process Detail .............................................................................................................................................................2
3. Engineering Inputs ..........................................................................................................................................2
4. Process Outputs..............................................................................................................................................3
5. View Presentation ..........................................................................................................................................3
6. Scale ................................................................................................................................................................5
7. Drawing Notes ................................................................................................................................................5
8. Revisions .........................................................................................................................................................6
9. Numbering System .........................................................................................................................................7
10. Border/Format Specifications ....................................................................................................................8
11. Drawing Symbols ........................................................................................................................................9
12. Drawing Types ......................................................................................................................................... 10
13. Confidentiality Reminder......................................................................................................................... 11
References ............................................................................................................................................................... 11
Definitions ............................................................................................................................................................... 11
Records/ Reports ..................................................................................................................................................... 11
Revision History ....................................................................................................................................................... 12
CONFIDENTIAL - This document is electronically controlled. Printed copies are considered uncontrolled.
Page 1 of 12
ER006 (QSD011329), CAD Drawing Practices, Version A
Roles/ Responsibilities
Function/ Role: Responsibilities:
Product Development Engineer, Designer or  See Process Detail

Drafter
Product Development Checker (Must be  Review CAD data (drawings/models) prior to ER Processing
someone other than ECO Approver) submission.
Process Overview
1. General Guidelines
1.1. Tools: Primary Tools Employed
Tools Usage
PTC Creo Parametric 3D CAD models;
2D drawing creation and modification;
2D drawing PDF authoring;
Generation of ancillary CAD geometry files.
Windchill PDMLink (PTC) A Web-based, Product Data Management (PDM) system that
supports geographically dispersed teams while managing critical
processes such as content, change, and configuration management.
Agile (Oracle) A product lifecycle management (PLM) software product used by
Medtronic, Inc.
2. Typical Process
2.1. Engineers provide Designers (if applicable) with documentation, materials and direction necessary to
graphically define virtual 3D CAD models and 2D drawings.
2.2. An interactive and iterative development process is required.
2.3. Output Product Definition data are in the form of 3D CAD models and 2D Drawings. Product definition
data includes geometry, topology, relationships, tolerances, attributes, and features.
Process Detail
3. Engineering Inputs
3.1. To start the process of creating models and documentation, the Engineer receives and/or provides
sufficiently clear information and direction. Details may include:
 Project numbers
 Schedules
 Part numbers
 Descriptions
 Sketches
 Pictures
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 CAD models
 Similar parts/drawings
 Specifications
4. Process Outputs
Outputs Data Types Location

3D CAD Models .prt, .asm PDMLink
CAD Drawings Creo .drw / Visual confirmation that all drawing PDMLink
elements are complete and meet the intent of
the guidelines in this reference guide, and
checked in to PDMLink.
2D Drawing file formats PDF (*.pdf Acrobat files of 2D drawings) Agile
.dxf (data exchange file format)
Ancillary 3D CAD Geometry .stp, .igs,.stl Agile
4.1. All drawings shall comply with the rules and guidelines for dimensioning and tolerancing as shown in
the MSD-ES-102 specification document, referencing the ASME Y14.5 standard.
4.2. Commercially available components shall be used whenever possible. A separate specification control
drawing shall be created and shall include the following minimum information: Supplier identification,
sufficient component definition, applicable critical dimensions, material(s), applicable finishes, catalog
number(s), and description.
4.3. As a general guideline view orientation for final assemblies, single component instruments, and
implants, shall follow the “right-hand” rule. When practicable, component and sub-assembly
orientation should mimic assembly orientation.
4.4. Changes to existing drawings require they reflect current drawing standards. Complete information
on the ECO process may be found in work instructions CC128 (QSD008891), Production ECO Work
Instruction and RR071 (QSD002988), MSD Production ECO and Change Control Instruction.
4.5. Dimensions, texts, and notes shall be capitalized and placed horizontally.
4.6. Decimal numbers shall be used; fractions shall only be used when designating ANSI threads.
4.7. Drawings shall use the “Standard.dtl” data file for millimeters and the “Standard_in.dtl” data file for
inches. The “.dtl” files are located in: \\ent.core.medtronic.com\mit-mem01\Research and
Development Dept\pro_engineer\Libraries\pro_setup
5. View Presentation
5.1. Drawing views shall be third angle projection in accordance with MSD-ES-102; ASME Y14.3.
5.2. Section views shall be identified as “SECTION” followed by a pair of letters; for example, SECTION A-A.
(See Figure 1) Text shall be uppercase and bold. Letters should be used in alphabetical order
excluding I, O, Q, S, X, and Z. Only completely sectioned views shall be identified as sections.
5.3. Views containing one or more break-out sections shall not be labeled as section views, nor shall
section arrows be shown for break-outs in other views.
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Figure 1
5.4. Detail views shall be identified as “DETAIL” followed by an uppercase letter; for example, DETAIL B.
Text shall be uppercase and bold. (See Figure 1) View letters should be used in alphabetical order
excluding I, O, Q, S, X, and Z.
5.5. Auxiliary views shall be identified as “VIEW” followed by a pair of letters; for example, VIEW E-E. Text
shall be uppercase and bold. Letters should be used in alphabetical order excluding I, O, Q, S, X, and Z.
5.6. For multi-sheet drawings (3 or more sheets), when any view does not appear on the same sheet as its
reference, the appropriate sheet number shall be placed under the view name (DETAIL, VIEW, or
SECTION) and adjacent to one of its appropriate reference arrow letter designators (see Figure 2). For
this example, SECTION D-D would also contain the corresponding sheet number for this view directly
below the view name. Text shall be uppercase and bold. You may also abbreviate the word SHEET;
SHT or SH are commonly used.
Figure 2
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5.7. Best Practice Guideline: Drawings should not contain views, sections and details with the same
letter designation; for example, a SECTION D-D and a DETAIL D.
5.7.1. Isometric or Trimetric views may be depicted for clarity. (See Figure 3)
Figure 3
6. Scale
6.1. Drawings depicting exploded assembly views only should indicate “NTS” in the title block.
6.2. View scale text should be bold; decimal numbers shall be used in the format shown below.
 One trailing zero: (Example: SCALE 1.0)
 One leading zero: (Example: SCALE 0.5)
6.3. Predominate view scale shall be indicated in the border of all sheets. Differently scaled views shall be
appropriately identified.
7. Drawing Notes
7.1. There are two types of notes, general notes and local notes. Local notes apply to certain locations
only, not the entire part or assembly. Often time local notes are indicated by use of the delta symbol;
a corresponding delta is placed on the face of the drawing as an arrow note or in proximity to its
related object.
7.2. When practicable, General Notes shall be shown on sheet 1 in the lower left corner and shall be
numbered bottom to top. (See Figure 4)
Page 5 of 12
Figure 4
7.3. For general notes, individual notes are single spaced.
7.4. Best Practice Guideline: Double-space between general notes.

7.5. Notes shall be capitalized and should not be underlined.
7.6. For local notes defining laser marking requirements, text height shall be enclosed within parentheses.
8. Revisions
8.1. Changes to drawings are generally identified by use of the revision bubble, available from the standard
CAD symbol library.
8.2. Revisions shall be capital letters only and should be used in alphabetical order excluding I, O, Q, S, X,
and Z. (See Figure 5)
8.3. Drawings shall contain only the latest revision letter bubbles; previous revision bubbles shall be
completely removed.
8.4. For notes: Place the revision symbol adjacent to the note revised. (See Figure 5)
8.5. Notes shall not be renumbered. When removing a general note, the word “REMOVED” shall be added
in its place; the revision symbol is still placed adjacent. For subsequent revisions only, “removed”
notes may be replaced with new notes; i.e., note numbers may be re-used. (See Figure 5)
8.6. Item numbers shall not be renumbered. When removing an item number, the word “REMOVED” shall
be added to the “Part No.” field. For subsequent revisions only, “removed” items may be replaced
with new items; i.e., item numbers may be re-used.
8.7. For total “revise and redraw”, when more than 50% of the drawing is changed, revision bubbles are
not used.
Page 6 of 12
Figure 5
9. Numbering System
9.1. File names shall consist of numeric and/or alpha characters. Spaces shall not be used. Assemblies or
parts and their corresponding drawings shall always contain identical filenames.
9.2. For tabulated drawings, the file name includes numbers which bracket and identify the range (smallest
to largest) of parts; these file names necessarily contain more characters. The corresponding drawing
number is identical. The number in the title block for the drawing is identical except a forward slash is
placed between the two numbers representing the extremes. An example would be as follows:
 Filename: 87504100415.prt
 Drawing number: 87504100415.drw
 Title Block Drawing Number: 8750410/0415
9.3. Assemblies and components shall be formatted as follows: (NOTE: Specials “EX” item numbers shown)
 Top level items: EX0916015-A
 First tier level items: EX0916015-01-A
 Second tier level items: EX0916015-01-01-A
 For each subsequent tier, another dash followed by two digits
o An example modeling tree from Creo is shown in Figure 6 below.
Page 7 of 12
Figure 6
10. Border/Format Specifications

10.1. Drawings use B-size formats provided in Windchill and also located in: J:\Research and Development
Dept\pro_engineer\Libraries\formats
10.1.1. Millimeter drawings use the ERF003.frm format.
10.1.2. Inch drawings use the ERF004.frm format.
10.1.3. Subsequent sheets use the ERF003P.frm or ERF004P.frm respectively.
10.2. Generally, for components, material and finish information is provided in the notes. Therefore, “SEE
NOTES” is entered in the material and finish locations within the title block.
10.3. For assemblies, enter “SEE COMPONENT PRINTS” or “SEE SEPARATE DETAILS” within the title block
unless specific finish requirements apply to the top level drawing only.
10.4. Title Block Layout conforms to the ANSI Y14.1 standard (See figure 7)
Figure 7
 Block A: Third Angle Projection border callout

 Block B: Tolerance Block (Actual tolerance values may be different than values shown).
 Block C: Revision Block
Page 8 of 12
 Block D: Medtronic Logo (Conforms to the Medtronic Master Brand requirements).

 Block E: Date and Drawn by Fields (Initials of creator shown). These fields never change except
when totally “revised and redrawn”.
 Block F: Item Description
 Block G: Drawing and Part Number
 Block H: Sheet Size (standard B size format)
 Block J: Scale (predominate view scale, see 6.3)
 Block K: Finish and Material callout
 Block L: System Name (Product Family – Applies to Implants Only)
11. Drawing Symbols
11.1. Standard drawing symbols: These are located under the “Annotate” tab. Select the “Custom
Symbols” icon to access the Medtronic standard symbols library. Browse the library for the symbol
required. (See figure 8)
Figure 8
11.2. Weld symbols: From the “Browse” menu, select “System Syms” from the common folders location
(left column), then select weldsymlib\ansi_weld\simple. (See figure 9)
Figure 9
Page 9 of 12
12. Drawing Types

12.1. Assembly Drawings:
12.1.1. Assembly drawings are needed when two or more parts are assembled or joined; items may
be sub-assemblies as well. Weldments may be assemblies.
12.1.2. Assembly drawings shall contain the necessary drawing views and a Bill of Material (BOM)
with balloons (or bubbles) to represent each item in the BOM.
12.1.3. Only one balloon per item shall be shown on the drawing; for clarity, items already noted with
a balloon may be identified in other views using an arrow note with the text “ITEM XX”. For
quantities greater than 1, that quantity should be added adjacent to the balloon.
12.1.4. As a minimum, the BOM shall contain the following columns: ITEM No., QTY. REQ’D, PART
NUMBER, and DESCRIPTION. Generally the BOM is placed over the title block area; for multi-
sheet drawings it is placed on sheet 1. (See figure 10)
12.1.5. Item numbers shall be two-digits as follows: 01, 02, 03,. . . . . 10, 11, 12, etc.
Figure 10
12.2. Detailed Drawings:

12.2.1. Detail drawings display information necessary to fully define parts, including materials,
finishes, protective coatings, and processes.
12.2.2. Drawings shall contain only one item (detailed part).
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12.3. Tabulated Drawings:

12.3.1. Tabulated drawings define multiple parts or assemblies using one generic graphic and an
accompanying table. The table may include columns for nomenclatures, part numbers,
varying dimensions or qty. values, and sizes.
12.3.2. Pictorial differences not apparent in main views shown should be shown in separate views or
details and properly labeled.
13. Confidentiality Reminder
13.1. These drawings/documents contain sensitive Medtronic confidential information. Please make sure
that you protect this information by ensuring the appropriate legal agreements are in place before
you provide the drawings/documents to any outside parties.
References
 CC128 (QSD008891), Production ECO Work Instruction
 RR071 (QSD002988), MSD Production ECO and Change Control Instruction
 MSD-ES-102, Engineering Drawing Specification
Definitions
Agile
A product lifecycle management (PLM) software product used by Medtronic, Inc.
CAD
Computer Aided Design. Engineering drawings are typically created directly from 3 dimensional (3D) virtual solid
models within a CAD software application.
Engineering Change Order (ECO)
The process for generating, reviewing, and approving changes and new releases to documents and drawings.
NTS
The drawing is “Not To Scale” and does not represent the real world lengths or measures.
Windchill PDMLink
A Web-based, Product Data Management (PDM) system that supports geographically dispersed teams while
managing critical processes such as content, change and configuration management.
Records/ Reports
The following Quality records will be maintained according to the retention standards defined by regulatory
agencies, applicable Medtronic Corporate Policies, and record retention procedures.
 Records are not required for the activities described in this instruction.
The following reports are associated/ required by this process:
 Reports are not required for the activities described in this instruction.
Page 11 of 12
Revision History
Version Author Description of Changes Effective Date

Garrett Terry,
Jennifer
A Initial Release Mar 15, 2017
Trusler
Steve DeRidder
Page 12 of 12

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ER006 (QSD011329), Version A

Function/ Role: Responsibilities:

Product Development Engineer, Designer or  See Process Detail

Outputs Data Types Location

7.3. For general notes, individual notes are single spaced.

7.4. Best Practice Guideline: Double-space between general notes.

10. Border/Format Specifications

 Block A: Third Angle Projection border callout

 Block D: Medtronic Logo (Conforms to the Medtronic Master Brand requirements).

12. Drawing Types

12.2. Detailed Drawings:

12.3. Tabulated Drawings:

Version Author Description of Changes Effective Date

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