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Risk Management Concepts

Within IEC 60601-1 3rd Edition

Michael Howell, P.E., UL LLC

Outline

• Overview of ISO 14971

• Definitions of harms, hazards, risk

• Risk Acceptability Criteria

• IEC 60601-1 and Risk Management

• Summary and Questions

Slide 2

ISO 14971

Risk Management Precepts

• There is always risk associated with the use of a medical device

• Risk acceptability is determined by the manufacturer for each device

using the risk management policy

• Risk acceptability is influenced by the perception of risk.

Slide 4

ISO 14971 Overview

• ISO 14971 – a systematic “framework” for management of risks

• Includes well-defined terminology

• Lifecycle standard, not limited as a design standard

• ISO 14971 is an auditable standard

• Significant management responsibilities

Slide 5

ISO 14971 is a Management Standard

• It is compatible with ISO 13485 (Quality Management System):

• Management responsibilities

• Most Important - policy on acceptable risk

• Provide resources

• Provide trained personnel

• Provide oversight

• Critical documentation required for ISO 14971:

• Risk management file

• Risk management plan

• Risk management report

Slide 6

ISO 14971 Does Not Specify

• Device hazards

• Acceptable risk levels

• A risk analysis tool

• How to quantify risk

• A design life-cycle model

• ISO 14971 is a management standard that tells you what to do, not

how to do it

Slide 7

Risk Management per ISO 14971

Slide 8

Definition of Hazard and Harm

9

IEC 60601-1 3rd ed:

- Harm (3.38): Physical injury or damage to the health of

people or animals or damage to property or the

environment [ISO 14971:2000, def. 2.2 modified]

- Hazard (3.39): Potential source of HARM [ISO

14971:2000, def. 2.3]

ISO 14971:2000

- - Harm (2.2): Physical injury or damage to the health of

people or damage to property or the environment

- Hazard (2.3): Potential source of HARM

How to define the Hazards of your Medical

product?

ISO14971:2007 Annex E : Table E1

Slide 10

Hazards in IEC 60601-1, 3rd ed

Chapters related to Hazards in the standard:

• Cl. 7 -ME equipment identification, marking, and documents

• Cl. 8 - Protection against electrical hazards from ME equipment

• Cl. 9 -Protection against mechanical hazards of ME equipment and

ME systems

• Cl. 10- Protection against unwanted and excessive radiation hazards

• Cl. 11-Protection against excessive temperatures and other hazards

• Cl. 12 - Accuracy of controls and instruments and protection against

hazardous outputs

Slide 11

What is Risk?

Combination of:

- the probability of

occurrence of harm

- the severity of that

harm

12

Practice – What are the Risks?

• 3.102 RISK combination of the PROBABILITY of occurrence of

HARM and the SEVERITY of that HARM ISO 14971:2007, definition 2.16

Potential source of

harm?

Risk Acceptability Criteria Policy

• Risk Acceptability Policy will:

• Determine criteria for acceptability

• Guide product development

• Risk Acceptability Policy is based on:

• Application of international standards, national or regional regulations

• Available information on device

• State of the art

• Stakeholder concerns

Slide 14

Sample of a Risk Chart

Acceptable

Risk

Region

Unacceptable

Region

Manufacturer’s criteria for risk acceptability Frequent

Probable

Occasional

Remote

Improbable

Incredible

Negligible Minor Moderate Major

Severity of Injury

Pro

babili

ty o

f occurr

ence

Remember the scope of ISO 14971

- A procedure for MFR to identify

HAZARDS associated with

medical devices & their

accessories

- Estimate risks / Evaluate risks /

Control risks / Monitor the

effectiveness of the control.

- Apply for all stages of life cycle of

medical device

Slide 16

IEC 60601-1 and Risk Management

General Requirement for RM

• Clause 4.2 states:

“A RISK MANAGEMENT PROCESS complying with ISO 14971 shall

be performed.”

“The policy for determining acceptable RISK and the acceptability of

the RESIDUAL RISK(S) shall be established by the

MANUFACTURER.”

• Thus, one cannot comply with IEC 60601 without also complying with

ISO 14971.

• IEC 60601 contains common safety requirements and pass/fail

criteria as it always did. The RM process does not affect this.

Slide 18

How IEC 60601-1 Incorporates RM

• Applicability of specific requirements

• Options for risk control

• Modification of specific tests criteria

• Selection of particular tests criteria

• Alternative risk control (subject to clause 4.5)

• “Unacceptable Risk” determination

Slide 19

Specific Requirements

Numerous references to RM throughout. For example:

• Essential Performance determination (4.3)

• Expected Service Life (4.4)

• Applied Part requirements (4.6)

• Single Fault Condition determination (4.7)

Compliance is checked by inspection of the RISK MANAGEMENT

FILE.

Slide 20

Options for Risk Control

• Clause 11.2.2.1(b)... “The following configurations, alone or in

combination as appropriate (as determined by the application of the

RISK MANAGEMENT PROCESS), are considered to provide an

acceptable RESIDUAL RISK of fire in OXYGEN RICH

ENVIRONMENT:”

Slide 21

3. Information for safety

2. Protective

measures

1. Inherent safety by design

Modifications of Specific Test Criteria

• Clause 5.7….”Where RISK MANAGEMENT PROCESS suggests that

the ME EQUIPMENT can be exposed to high humidity for extended

periods (such as ME EQUIPMENT intended for out-door use), the

period is extended appropriately.”

(Note – Amendment 1 replaced the above with an actual requirement of

168 h)

Slide 22

Selection of Particular Test Criteria

• Clause 11.6.3 “…A quantity of liquid is poured steadily on a point on

top of the equipment. The type of liquid, volume, duration of the spill,

and location (point) are determined through Risk Analysis. Test

conditions that simulate the worst case for spillage shall be

documented in the RISK MANAGEMENT FILE.”

Slide 23

Alternative Risk Control

• Clause 4.5 (Alternative Risk Control Measures or Test Methods)

states:

• Where this standard specifies particular RISK CONTROL measure

or test method, an alternative RISK CONTROL measure or test

method is acceptable, provided that the MANUFACTURER can

demonstrate through scientific data or clinical opinion or

comparative studies that the RESIDUAL RISK that results from

applying the alternative RISK CONTROL measure or test method

remains acceptable and is comparable to the RESIDUAL RISK that

results from applying the requirements of this standard.

Slide 24

Unacceptable Risk

• The term “unacceptable risk” is used about 80 times in the standard,

e.g., in Clause 4.9:

- A COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS

shall be used when a fault in a particular component can generate

an unacceptable RISK.

• Who determines acceptable risk?

Slide 25

What Kind of Evidence Do We Need?

• Manufacturer’s Risk Management Process conforming to ISO 14971

• OD-2044, “Guidelines for Risk Management in Medical Electrical

Equipment” which was written to give clear guidance to certification

bodies

Slide 26

http://www.iecee.org/Operational_documents/od-cb_index.html

RM Report/ File

Summary

• A risk management process defined by ISO 14971 is necessary to

demonstrate compliance.

• Risk Management is intricately intertwined in the 3rd edition of IEC

60601-1.

• Although there are still baseline requirements, RM can be used to

tailor the standard to the device.

• The risk management process may add requirements/tests or may

eliminate or modify stated tests.

• Certifying compliance will require review of objective evidence of the

risk management process.

Slide 27

Questions

For more information:

Michael J. Howell, P.E.

Michael.J.Howell@ul.com

Slide 28