IEC 60601 Safety Training Webinar

IEC 60601 & IEC/ISO 80601, Basic Safety & Essential Performance of Medical Electrical Equipment & Systems

An introduction for design, quality, and test staff

Training Objective

Gain an overview of the IEC 60601 & IEC/ISO 80601 safety standards, and their related Risk and Usability process standards. Knowledge that may help keep your medical equipment projects on track. We'll cover such topics as:

  • Identify applicable standards,

  • Practical application of requirements to typical medical device designs,

  • Understand the interdependence between Risk Management, Usability Engineering, and the Safety standards,

  • Construct insulation diagrams,

  • Identifying safety critical components and their requirements

  • Understand verification tests

Instructor, Frank O'Brien

  • Evaluated 1000’s of Medical Electrical Equipment

    • 17 years consulting, 24 years UL

  • Med TC 62 committee work

    • Last 24 years, 1906 award

  • Over 1,500 design & quality engineers trained

  • MS Tech Mgt SUNY Stony Brook; PE NY; BS EE Clarkson College

  • Lives in County Clare, previously Boston, San Jose, Frankfurt, LI NY

Content

15 hours of content, presented as 6 modules. 3 modules Tue-Wed-Thu per week, over 2 weeks, as described below.

A. Standards & Testing

17 May 2022, Tue, 2 hours

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.

B. General Philosophy

18 May 2022, Wed, 2 hours

We'll look at the definitions and some of the characteristics related to Safety for Medical Electrical Equipment, Accessories, Medical Electrical Systems, Patient, Operator, Service Personnel, Professional health care environment, Home Health Care Environment, Emergency Medical Services Environment

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.

C. Essential Performance & Alarms

19 May 2022, Thu, 3 hours

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).

D. Electrical Basic Safety, Part 1

24 May 2022, Tue, 3 hours

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.

This module D will be presented in 2 Parts; 3 h + 1 h.

D. Electrical Basic Safety, Part 2 (1 h)

E. Mechanical, Thermal, Fire, & Oxygen Rich Basic Safety

25 May 2022, Wed, 3 hours

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

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.

We'll look at Oxygen Rich definition, which comes into play with ventilators and air path accessories. We'll look at Risk Control strategies for controlling the fire Risk.

F. Liquids, Radiation, Enclosures, Components & Information for Safety

26 May 2022, Thu, 2 hours

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

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

Standards included

The course content includes an overview of these standards:

  • Medical Electrical Equipment -- General Requirements for Basic Safety and Essential Performance, IEC 60601-1:2005 + A1:2012 + A2:2020, Ed 3.2, including US, Can, and EU differences

  • Alarms, IEC 60601-1-8:2006 + A1:2012 + A2:2020, ed 2.2

  • Home Healthcare, IEC 60601-1-11:2015 + A1:2020, ed 2.1

  • Emergency Medical Services, IEC 60601-1-12:2016 + A1:2020, ed 1.1

  • How to document applicable "Risk Management Results" in IEC 60601 test reports, IECEE CB-OD 2044:2013, ed 2.2

Process standards covered briefly to stress how IEC 60601 requires and relies on these processes.

  • Risk Management, ISO 14971:2019, ed 3.0

  • Usability Engineering, IEC 60601-1-6:2006 + A1:2013 + A2:2020, ed 3.2; and IEC 62366-1:2015 + A1:2020, ed 1.1

  • Software development life cycle, IEC 62304:2006 + A1:2015 , ed 1.1

Participant Details

The webinar will be held with Google Meet. You don't need a Google Account to participate in Meet video meetings. If you don't have a Google Account, our instructor will grant you access to the meeting.

All participants get the slides and speaker notes at the start of the webinar.

With full attendance, all participants receive a Certificate of Completion at the end of the webinar.

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

Registration

This event held from 17 May to 26 May 2022 is closed. Thanks to those who signed up.

We'll consider offering on-line recorded sessions. If these would be of interest, let us know. To stay informed about future recorded and live events, please join our mailing list.