IEC 60601 Safety Training Seminar

• Evaluated 1000’s of Medical Electrical Equipment

• 19 years consulting, 24 years UL

• 24 years, Med TC 62 committee work, 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

UMass Lowell Inn and Conference Center

50 Warren Street, Lowell, MA 01852, USA

umassiccfrontdesk@gmail.com

+1 978-934-6921

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.

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

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

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.

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

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

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.

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. 

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