risk management concepts within iec 60601-1 3 edition...60601-1. •although there are still...
TRANSCRIPT
UL and the UL logo are trademarks of UL LLC © 2012
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
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
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
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
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