Geometrical Tolerancing in Medical Devices

Practical training in geometrical tolerancing, tailored for medical device design.

Course Description:

This intensive programme introduces the fundamental principles of geometrical tolerancing, with a focus on the aspects most relevant to medical device design and manufacture. The course can be delivered to either BS 8888 & ISO GPS or ASME Y14.5 standards, depending on client requirements.

Course Objectives:

By completing this course, participants will:

• Build a strong foundation - grasp the core principles that make the standards easier to understand

• Master the essentials - become fluent in the key terminology, rules, and most commonly used symbols from the standards.

• Apply with purpose - learn when and how to use tolerance symbols effectively, and how the standards are used, interpreted and applied across a part’s life cycle.

• Design for function - see how correct datum and tolerancing strategy enables a requirements-driven approach, ensuring fitness for purpose and unambiguous capture of design intent.

• Bridge textbook theory with practical application - Learn how tolerancing strategy is shaped by manufacturing and inspection realities.

• Gain practical confidence - work with real MedTech drawings and parts to see how the standards drive better design intent, clearer communication, and more efficient production.

Who it is for:

This course is designed to be accessible to newcomers to the standards as well as those with prior experience, within the MedTech sector.

The course is particularly valuable for:

• Design and Mechanical Engineers

• Inspectors and Inspection Planners

• Drafters

• Machinists, Operators, and Tooling Engineers

• Sales, Purchasing, and Quality personnel

• Managers, Supervisors, and Production Associates

• Anyone who needs to read, interpret, or work with the standards on engineering specification

  
  

Requirements:

• Participants should have some familiarity with engineering drawings and a background in design, production, or inspection, including the ability to interpret how parts are represented on drawings.

• Delegates don't need to bring materials, laptops etc. All materials are provided by GD&T Academy.

• Participants are welcome to supply drawings or components, which may be integrated into exercises to enhance course applicability.

• An upper limit of 10 delegates is advised to ensure effective learning.

Materials provided:

• Detailed course notes including drawing examples

• Workbook with exercises and other printable handouts

• Quizzes and knowledge checks to gauge progress throughout the course

• Certificate of course completion

Delivery Format:

• Onsite or online delivery

Duration:

• 3 days

Course Syllabus - BS8888 & ISO GPS:

Core Content:

• Foundations of Geometrical Tolerancing - Principles, benefits, and standards in context (ISO 8015, ISO 17450, BS 8888)

• Features & Size Control - Features of size, size tolerances and the Envelope Requirement (ISO 14405-1)

• Datums & Datum Systems - Defining, constructing, and selecting datums; controlling 6 degrees of freedom, datum feature indicator, datum targets, common datums (ISO 5459)

• Geometrical Tolerances - Characteristic symbols, tolerance indicators, tolerance features, modifiers and Theoretically Exact Dimensions (TEDs), tolerance characteristics & application, Profile Tolerances (ISO 1101, ISO 1660)

• General Tolerances: Linear & Angular tolerances, General geometrical specifications and general size specifications (ISO 2768, ISO 22081)

Industry Specific Content & Application:

• Datums based on complex surfaces (ISO 5459)

• Dimensional and geometrical tolerances for moulded parts (ISO 8062 Series)

• Plastic Moulded Parts: Tolerances and acceptance conditions (ISO 20457)

• Applying tolerances to non-rigid work-pieces (BS EN ISO 10579)

• Application on extruded parts, e.g. drug delivery and interventional Catheters

• Application on plastic moulded parts, e.g. inhalers, drug delivery devices, enclosures, insulin pen bodies

• Application on Surgical Robotic parts

• Application the standards on machined metal parts, e.g. prosthetic hip and knee replacements.
  

Course Syllabus - ASME Y14.5:

Core Content:

• Foundations of Geometrical Tolerancing - Principles, benefits, and standards in context

• Features & Size Control - Features of size, size tolerances and Rule #1

• Datums & Datum Systems - Defining, constructing, and selecting datums; controlling 6 degrees of freedom, datum feature indicator, datum targets, common datums

• Geometrical Tolerances - Characteristic symbols, Feature Control Frame, tolerance features, modifiers and Basic Dimensions, tolerance characteristics & application, Profile Tolerances

Industry Specific Content & Application:

• Datums based on complex surfaces

• Plastic Moulded Parts (ASME Y14.8)

• Applying tolerances to Flexible Parts

• Application on extruded parts, e.g. drug delivery and interventional Catheters

• Application on plastic moulded parts, e.g. inhalers, drug delivery devices, enclosures, insulin pen bodies

• Application on Surgical Robotic parts

• Application the standards on machined metal parts, e.g. prosthetic hip and knee replacements.

To book a course, discuss possible dates, or for further information:

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