IEC 60601 Safety Training Seminar

Integrating IEC 60601 into the design process

IEC 60601, IEC/ISO 80601, Ed 3.2 Series, Medical Electrical Equipment, Basic Safety & Essential Performance

Objective

This course is an intense 3.5 day training course.  Presentation slides contain excerpts from the applicable safety standards, and frequent examples to illustrate how the safety requirements apply to typical medical device designs. Participants are broken into work groups where they put newly learned safety requirements into practice with assigned exercises. The groups review their answers with the class. The slides and a work book is given to each participant.  After the class, the work book with answers is given to participants. Our course continues to evolve to stay up to date with latest standards, interpretations, regulatory guidance, and feedback from over 1,600 past participants. Participants are encouraged to ask questions about the safety requirements, and how they apply to their products currently under development.

The goals of the course are:

Instructor, Frank O'Brien

Dates and times

The 3.5 day safety training course is:

Boston area, training room

TÜV Rheinland - North America Technology and Innovation Center

400 Beaver Brook Rd, Boxborough, MA 01719, United States

A large training room has been arranged for low density seating. Participants will be asked to participate in groups of 3 or 4 when doing work group exercises, but group size is flexible. Masks will be optional. We'll have a few Covid 19 test kits available, for anyone experiencing symptoms.

Your registration includes full catering for continental breakfast, morning break, lunch (on full days), and afternoon break.

There will be an optional tour of the TUV Rheinland medical test facility, during one of the evenings.

Boston area hotel

Boxboro Regency Hotel & Conference Center

242 Adams Pl, Boxborough, MA 01719, United States

This is closest hotel to TUV Rheinland facility. There are many others in area. 

Any needed travel and hotel accommodation are the responsibility of each participant.

For flight arrangements Boxboro is equi-distant between Boston Logan (BOS) and Manchester NH (MHT), although MHT can be faster depending on Boston traffic.

Content

A. Risk Management & Usability Engineering

We’ll look at the general Risk Management process. We’ll then focus on Risk Assessment, and Risk Controls. We’ll look at some RM examples. We’ll look at the changes with new 2019 release of ISO 14971.

We’ll look at the general Usability Engineering process. We’ll look at key similarities & differences between Risk Management and Usability Engineering. We’ll look at how to implement Usability Engineering for legacy devices. We’ll look at key updates with IEC 62366-1:2015 and A1:2020.

Both of these process standards seek improvement through production and post-market surveillance. We’ll look at general post market data with an eye towards assessing the medical industries’ general success with risk acceptability and good usability.

Work group exercise 1: complete hazard table

B. Standards & Test Reports

We'll look at the organization and scope of the general standard, understand its fit into its larger family of Collaterals and Particular standards. 

Consensus standards provide a generally acknowledged state of the art (GASOTA) of safety principles. Compliance provides the presumption of acceptable Risk. Standards can fall behind the GASOTA. There can be unforeseen Hazards. We'll look at examples of how consensus standards are identified for medical equipment. 

Compliance is documented with a Test Report. The most common format, which manufacturers use, as it travels well internationally, is the CB (Certification Body) test report form. The report can also be accompanied by a CB Certificate, which means CB procedures, practices, and interpretations were used.

Work group exercise 2: identify standards

C. Medical Equipment & General Philosophy

We'll look at the definitions and some of the characteristics related to Safety for Medical Electrical Equipment, Accessories, Medical Electrical Systems, users, and use environments

IEC 60601 is a "Single Fault Safe" standard. The product needs to be safe in Normal Condition and Normal Use; after any foreseeable misuse, or after Single Fault Condition; and over the Expected Service Life. 

IEC 60601 has gaps where Risk Management is required. The CB OD 2044 guidance calls these RM Results. The guidance outlines how RM Results are to be documented in the CB Test Report Form.

D. Essential Performance & Alarms

We'll look at the definitions for Safety, Basic Safety, and Essential Performance.

Essential Performance (EP) is identified with the RM process. The focus is on the clinical function and establishing “clinical limits”. Typically its clinical practitioners, such as doctors, who are needed to evaluate Risk acceptability. With an IV Pump as an example, we’ll see how EP is identified with a Hazard Table.

We'll look at 5 equipment examples and identify EP associated with their clinical function, and compare to the EP defined by their Particular standards. In many cases, EP is considered Basic Safety (BS), as BS includes the overlap. 

We'll attempt to answer the question, can any medical equipment have no EP (or BS) associated with its clinical function?

Last, we'll provide a brief summary of general Alarm requirements, IEC 60601-1-8, including A2:2020. Alarms are Risk Controls typically for loss of EP (or BS).

Work group exercise 3: Identify Essential Performance

E1. Electrical, insulation diagram specification

Insulation diagrams show how there's the required 2 means of protection (MOP) from Hazardous voltages, and for F-type (floating) Applied Parts, at least 1 MOP for Mains voltage. Insulation diagrams define for each MOP, the insulation type, Working Voltage, and parameters, Creepage, Clearance, and Dielectric Strength. 

We'll look at the process for creating insulation diagrams: a) categorize touch surfaces, b) classify Applied Part, c) Risk Assess Clause 4.6 Patient touch protection (e.g. MOPP or MOOP), d) specify insulation and insulation parameters, and e) establish test plan for insulation. We'll follow this process to specify insulation diagrams and test plans for 3 medical equipment examples -- A home use thermometer, therapeutic heater, and ECG monitor.

Work group exercise 4: Construct insulation diagram

E2. Electrical, verification

We'll look at electrical verification testing: Working voltage, CR, CL, cemented joints, PE testing, Humidity conditioning, Leakage current, Dielectric withstand, and Defibrillation-proof testing.

F. Mechanical, PEMS/Software, Thermal, Fire, O2 Rich

For mechanical Hazards, we'll focus on the Hazardous Situation called the Trapping Zone. We'll look at Motion control, Stability, Braking, and Support. 

Using motion control as an application, we’ll look at the PEMS/software development life cycle process requirements. 

For thermal Hazards, we'll focus on internal temperatures (e.g. insulation), surface temperatures, and typical normal and SFC and misuse testing. 

For fire Hazards, we'll look at the 3 Risk Control strategies, 1) limited power, 2) control flammability of materials, and/or 3) conduct Single Fault Condition testing. 

G. Liquids, Radiation, Enclosures, Components, Systems, Information for Safety & Recap

For liquids we'll look at Spillage, leakage, IEC 60529 ingress, and cleaning. 

For Radiation, we'll look at types ionizing, microwave, laser light, and intense incoherent light. 

Enclosures play a key Risk Control as they enclose and guard against all the energy related hazards (e.g. electrical, mechanical, thermal, radiation, fire). We'll look at the tests conducted, including for mechanical strength, and thermal resistance. We'll look at equipment types (e.g. Stationary, Mobile, Portable, Hand-held, Body-Worn), and the applicable enclosure testing.

We'll look at Safety Critical Components; how to identify, specify, and document in TRF, Table 8.10.

We'll look at Medical Systems, and how non-medical equipment can be used safety within medical systems.

We'll look at the Risk Control of last resort, Information for Safety, We'll briefly look at the prescribed markings and instructions.

Last, we'll do a recap, and review the process for integrating the IEC 60601 series into the design process.

Work group exercise 5: Prepare a test plan

Standards included

The course content includes an overview of these product standards:

and these process standards, which IEC 60601 requires and relies on:

Participant details

All participants get the slides, speaker notes, workbook, and workbook answers.

With full attendance, all participants receive a Certificate of Completion.

There are no course prerequisites, although some familiarity with quality management and risk management procedures is helpful.

Registration, IEC 60601 Safety

The course fee is 2,025 USD. There's a 15% discount for registering 6 weeks early (by 24 Mar 2024). There's a 10% discount for registering more than 1 participant from a company.

Before booking, please review our cancellation policy and other terms, and our privacy policy.

If you want to register 4 participants, separately register 2 participants twice. For 5 participants, separately register 2 participants, and then 3 participants. With groups, when combining registrations, in order to receive the group discount, avoid the 1 participant registration option.