DRAFT INTERNATIONAL STANDARD ISO/DIS 14971
ISO/TC 210 Secretariat: ANSI
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2005-09-22 2006-02-22

Medical devices - Application of risk management to medical devices
[Revision of first edition (ISO 14971:2000) and ISO 14971:2000/Amd.1:2003]

processed under the CEN-lead mode of collaboration as defined in the Vienna
Agreement.

ISO/DIS 14971

Contents Page
Foreword
............................................................................
........................................................................ v
Introduction................................................................
............................................................................
.. vii
1 Scope
............................................................................
................................................................. 1
2 Terms and
definitions.................................................................
................................................... 1
3 General requirements for risk management
............................................................................
.... 5
3.1 Risk management
process.....................................................................
....................................... 5
3.2 Management responsibilities
............................................................................
............................ 6
3.3 Qualification of personnel
............................................................................
................................. 7
3.4 Risk management plan
............................................................................
...................................... 7
3.5 Risk management file
............................................................................
........................................ 8
4 Risk analysis
............................................................................
..................................................... 8
4.1 Risk analysis
process.....................................................................
............................................... 8
4.2 Intended use and identification of characteristics related to the safety
of the medical
device......................................................................
....................................................................... 8
4.3 Identification of
hazards.....................................................................
........................................... 9
4.4 Estimation of the risk(s) for each hazardous
situation............................................................... 9
5 Risk
evaluation..................................................................
.......................................................... 10
6 Risk control
............................................................................
..................................................... 10
6.1 Risk reduction
............................................................................
.................................................. 10
6.2 Risk control option analysis
............................................................................
........................... 10
6.3 Implementation of risk control measure(s)
............................................................................
.... 10
6.4 Residual risk evaluation
............................................................................
.................................. 11
6.5 Risk/benefit
analysis....................................................................
................................................ 11
6.6 Risks arising from risk control
measures....................................................................
.............. 11
6.7 Completeness of risk
control.....................................................................
................................. 12
7 Evaluation of overall residual risk
acceptability...............................................................
......... 12
8 Risk management report
............................................................................
................................. 12
9 Production and post-production information
............................................................................
12
Annex A (informative) Rationale for
requirements................................................................
................ 14
Annex B (informative) Overview of the risk management process for medical
devices.................... 22
Annex C (informative) Questions that can be used to identify medical device
characteristics
that could impact on
safety......................................................................
................................... 24
Annex D (informative) Risk concepts applied to medical
devices....................................................... 30
Annex E (informative) Examples of hazards, foreseeable sequences of events,
and
hazardous situations
............................................................................
....................................... 45
Annex F (informative) Risk management plan
............................................................................
.......... 50
Annex G (informative) Information on risk management
techniques.................................................. 52
Annex H (informative) Guidance on risk management for in vitro diagnostic
medical devices........ 56
Annex I (informative) Guidance on risk analysis process for toxicological
hazards ......................... 72
Annex J (informative) Information for safety and information about residual
risk ............................ 74
Bibliography................................................................
............................................................................
. 76

Tables
Table D.1 - Examples of qualitative severity
level.......................................................................
............. 35
Table D.2 - Simplified examples of qualitative probability levels
.............................................................. 35
Table D.3 - Example of five qualitative severity levels
............................................................................
. 36
Table D.4 - Example of Semi-Quantitative Probability Levels
.................................................................. 36
Table E.1 - Examples of
hazards.....................................................................
........................................ 47
Table E.2 - Examples of initiating events and circumstances
.................................................................. 48
Table E.3 - Relationship between hazards, foreseeable sequences of events,
hazardous situations and
the harm that may
occur.......................................................................
............................................. 49
Table H.1 - Examples of possible use errors and labelling risk controls
.................................................. 69
Figures
Figure 1 - A schematic representation of the risk management process for
illustration ............................. 6
Figure B.1 - Overview of risk management activities as applied to medical
devices................................ 23
Figure D.1 - Example of a risk chart
............................................................................
............................ 30
Figure D.2 - Example of a qualitative 3 x 3 risk evaluation
matrix............................................................ 35
Figure D.3 - Example of a semi-quantitative risk evaluation
matrix.......................................................... 37
Figure D.4 - Some examples of risk control measures
............................................................................
39
Figure E.1 - Pictorial representation of the relationship of hazard,
sequence of events, hazardous
situation and
harm........................................................................
.................................................... 45
Figure H.1 - A risk model for laboratory use IVD medical devices
........................................................... 57