IEC 60601, ISO/IEC 80601, Basic Safety & Essential Performance of Medical Electrical Equipment & Systems
An introduction for design, quality, and test staff
Gain an overview of the IEC 60601/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
Course Modules & Schedule
15 hours of content, presented as 6 modules over 3 weeks.
Start date is 30 Nov 2021.
Finish date is 15 Dec 2021.
All modules start at 2 pm GMT = 3 pm central EU = 9 am US east = 6 am US west = 6:30 pm Bangalore = 10 pm Seoul = midnight Tokyo.
A. Standards & Testing
Tue, 30 Nov 2021, 2 pm to 4 pm GMT, 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
Wed, 1 Dec 2021, 2 pm to 4 pm GMT, 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
D. Electrical Basic Safety, Part 1 (1 h)
Tue, 7 Dec 2021, 2 pm to 5 pm GMT, 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.
Last we attempt to answer the question, can any medical equipment have no EP (or BS) associated with its clinical function?
D. Electrical Basic Safety, Part 2
Wed, 8 Dec, 2021 2 pm to 5 pm GMT, 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 3 Parts, over 3 sessions; 1 h + 3 h + 1 h.
D. Electrical Basic Safety, Part 3 (1 h)
E. Mechanical, Thermal, Fire, & Oxygen Rich Basic Safety
Tue, 14 Dec 2021, 2 pm to 5 pm GMT, 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
Wed, 15 Dec, 2021 2 pm to 4 pm GMT, 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, and how to document in Table 4.8.
Last we'll look at the Risk Control of last resort, Information for Safety, We'll briefly look at the prescribed markings and instructions.
All participants get the slides and speaker notes at the start of the webinar.
All participants will receive a certificate of participation at the completion of the webinar.
There are no course prerequisites, although some familiarity with quality management and risk management procedures is helpful.
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
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