Risk Management File

Device name:

Document version number:

Version 1.0

Created by
Name and address of manufacturer:

Responsibility and Approval

Place and date:

Name of responsible person:

Signature:

Template Risk Management File V_2014-11-28

Table of contents

A. Device identification................................................................................................................. 1
Description .............................................................................................................................. 1
Assembly definition of the element .......................................................................................... 1
Assembly identification ............................................................................................................ 1
Specification ............................................................................................................................ 1
Involved people ....................................................................................................................... 1

B. General safety measures......................................................................................................... 2

C. Specific risks and failures, detection and preventing measures ............................................... 3

Critical Risk Priority Number .................................................................................................... 4
Factors of the Risk Priority Number (RPN) .............................................................................. 4
S – Severity ......................................................................................................................... 4
O – Occurance..................................................................................................................... 5
D – Detection ....................................................................................................................... 5

D. Detailed Risk Analysis ............................................................................................................. 6

Assembly 1 .............................................................................................................................. 6
Assembly 2 .............................................................................................................................. 6
Assembly ... ............................................................................................................................. 6
 A. Device identification
Description
Describe your device here. What is the purpose, how does it work, what can it do, how does it look like (picture, draw-
ing, etc…

Your text and pictures.

Assembly definition of the element

Describe individual assemblies and components here, suggested format as follows:

Element

Assembly 1 Assembly 2 Assembly 3

 Part 1  Part 4  Part 7
 Part 2  Part 5  Part 8
 Part 3  Part 6

Your chart and text.

Assembly identification
Identify assemblies and parts by images, sketches, etc.

Your images and text.

Specification
Specify each element in terms of size, weight, material, power requirement, power in-/output…

Your text.

Involved people
List involved people and their tasks.

Your text.

Risk Mananagement File Page 1

 B. General safety measures
Describe general precautions made to ensure safety of your device. Consider hardware, e.g. electronics or mechani-
cal components, and software.

In terms of safety of electroencephalographs, you may check IEC 60601-2-26 Ed. 3.0 b:2012, Medical electrical
equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalo-
graphs.

In terms of safety of FES bikes, you may check ASTM F2711-08(2012), Standard Test Methods for Bicycle Frames.

In terms of safety of a lower limb prosthesis, you may check ISO 10328:2006, Prosthetics - Structural testing of lower-
limb prostheses - Requirements and test methods.

Your text.

Risk Mananagement File Page 2

 C. Specific risks and failures, detection and preventing
measures
Each risk/failure should be listed in the “Detailed Risk Analysis” below. Describe the failure and possible resulting effects,
rate the probability of its occurrence, the severity, and the probability to detect the failure. Describe preventing measures
and rate the failure again.
The format of this risk/failure table has been adapted from:
http://www.npd-solutions.com/fmea.html,
http://www.harpcosystems.com/articles/Design-FMEA-Ratings-Part1/,
http://www.harpcosystems.com/articles/Design-FMEA-Ratings-Part2/,
http://www.harpcosystems.com/articles/Design-FMEA-Ratings-Part3/

Examples of possible hazards are listed below (based on ISO 14971):

Examples of biological Examples of operation- Examples of information

Examples of energy hazards
and chemical hazards al hazards hazards

Electromagnetic energy Biological Function Labelling

Line voltage Bacteria Incorrect or inappropriate Incomplete instructions for
Leakage current Viruses output or functionality use
 enclosure leakage current Other agents (e.g. prions) Incorrect measurement Inadequate description of
performance characteris-
 earth leakage current Re- or cross-infection Erroneous data transfer
tics
 patient leakage current Loss or deterioration of
Inadequate specification of
Electric fields Chemical function
intended use
Magnetic fields Exposure of airway, Inadequate disclosure of
tissues, environment or Use error limitations
property, e.g. to foreign Attentional failure
Radiation energy materials:
Ionizing radiation Memory failure Operating instructions
 acids or alkalis
Non-ionizing radiation Rule-based failure Inadequate specification of
 residues
Knowledge-based failure accessories to be used
 contaminates with the device
Thermal energy Routine violation
 additives or pro- Inadequate specification of
High temperature cessing aids pre-use checks
Low temperature  cleaning, disinfecting Over-complicated operat-
or testing agents ing
Mechanical energy  degradation products Instructions
Gravity  medical gasses
 falling  anaesthetic products Warnings
 suspended masses of side effects
Vibration Biocompatibility of hazards likely with re-
Stored energy Toxicity of chemical con- use of single-use medical
Moving parts stituents, e.g.: devices
Torsion, shear and tensile  allergenicity/irritancy
Force  pyrogenicity Specification of service
and maintenance
Moving and positioning of pilot

Acoustic energy
 ultrasonic energy
 infrasound energy
 sound

Risk Mananagement File Page 3

 Critical Risk Priority Number
During the risk analysis, each risk or failure is analyzed and rated with respect to its severity (S), probability of occur-
rence (O), and detection rate (D). The rating for each of the three aspects ranges from 1 (low security risk/failure, low
probability of occurrence, high detection probability) to 10 (severe injuries or death, high probability of occurrence, no/low
probability for detection). The product out of these three ratings is called Risk Priority Number (RPN). In case, the RPN is
greater than a critical threshold, preventing measures are required in order to reach a final RPN below or equal to the
critical threshold by means of reasonable and justifiable security measures.

Define a critical threshold in this section here – we recommend a critical RPN threshold of 75.

In case, the risk is greater than the critical threshold the risk must clearly be mentioned in the “declaration of agree-
ment” signed by the pilot and involved staff.

Your text.

Factors of the Risk Priority Number (RPN)

Find below a recommendation how to rate occurrence, severity, and detection. The “Risk Priority Number before” is a
mathematical product of the numerical Severity- (S), Occurrence- (O), and Detection-Ratings (D) obtained before apply-
ing any preventing measures to reduce the likelihood for dangerous incidents, thus: RPN before = (S1) x (O1) x (D1).
This “RPN before” should be set to prioritize items that require additional quality planning or action.

The “RPN after” is a mathematical product of the numerical Severity- (S), Occurrence- (O), and Detection-Ratings (D)
obtained after applying the preventing measures to reduce the likelihood for dangerous incidents, i.e. RPN after = (S2) x
(O2) x (D2). The “RPN after” has to be equal or below the predefined threshold in order to guarantee safe use of the
part/element/device.

Preventing measures are mechanisms that prevent the cause of the failure mode from occurring or that detect the failure
and stop the application before an incident can happen. It could also reduce the severity by e.g. designing softer and
rounder edges. Preventing measures could include specific inspection, testing or quality assurance procedures; selection
of other components or materials; de-rating; limiting environmental stresses or operating ranges; redesign of the item to
avoid the failure mode; monitoring mechanisms; performing preventative maintenance; or inclusion of back-up systems
or redundancy.

S – Severity

Rating S Criteria: Severity of effect Consequence Treatment

10 Death - -
Life-long medical care
9 Quadriplegia necessary / coma / Hospital stay
permanent damage
Amputations, paraplegia, blindness, deaf- Life-long medical care
8 ness, traumatic brain injury (severe), fourth- necessary / coma / Hospital stay
degree burns permanent damage
Complex fractures, open fracture, inner
Permanent damage
7 injuries, traumatic brain injury (severe), Hospital stay
possible
third-degree burns
Gash, fractures, torn muscles, articular
Permanent damage
6 cartilage injury, traumatic brain injury (mod- Hospital stay
possible
erate), second-degree burns
Gash, fractures, torn muscles, articular
Hospital stay or
5 cartilage injury, traumatic brain injury (mild), Reversible injury
ambulant treatment
second-degree burns
Severe cuts, severe scratches, severe con- Ambulant treatment
4 Reversible injury
tusions, strains, first-degree burns or self-treatment

Risk Mananagement File Page 4

 Minor cuts, minor scratches, minor contu- Discomfort during ap-
3 sions, stiff muscles, tension, blisters, exco- plication up to three Self-treatment
riations, sickness, first-degree burns days after application
2 Slight sickness, pressure marks Discomfort -
1 No harm - -

O – Occurance

Rating O Criteria: Probability of occurrence

10 Occurs or may occur very likely during every use of the session
9 Occurs or may occur likely during every use of the session
8 Occurs in 1 of 5 sessions (less than once a day)
7 Occurs in 1 of 10 sessions (less than once a day)
6 Occurs in 1 of 50 sessions (less than once half a month)
5 Occurs in 1 of 100 sessions (less than once a month)

4 Occurs in 1 of 500 sessions (less than once half a year)

3 Occurs in 1 of 1000 sessions (less than once per year)
2 Occurrence very unlikely
1 Occurrence nearly impossible

D – Detection

Rating D Criteria: Likelihood of detection by design control

10 No chance of detection
9 Very remote chance of detection

8 Remote chance of detection

7 Very low chance of detection by indirect methods (hardware or software)
6 Low chance of detection by indirect methods (hardware or software)
5 Moderate chance of detection by indirect methods (hardware or software)
4 High chance of detection by indirect methods (hardware or software)

3 High chance of detection by direct or indirect methods (hardware/software)

2 Direct and indirect detection: Hardware or software
1 Direct detection: Hardware or safe software (category 4, performance level e)

Risk Mananagement File Page 5

D. Detailed Risk Analysis
Assembly 1
Assembly Failure & Effect S1 O1 D1 RPN Preventing measures S2 O2 D2 RPN
before after
Part A

Part B

Part C

Assembly 2
Assembly Failure & Effect S1 O1 D1 RPN Preventing measures S2 O2 D2 RPN
before after
Part D

Part E

Assembly ...

Risk Mananagement File Page 6