Report Reference No

20000710

Compiled by (+ signature)

Markus Weber

Reviewed by (+ signature)

Approved by (+ signature)

Date of issue

Verification laboratory

System Safety, Inc.

Address

10849 Penara Street

San Diego, CA 92126-5936

Verification location

Applicant

Address

Standard

ISO 14971:2000

Test Report Form No

03092000

Test procedure

Audit / Review

Procedure deviation

None

Non‑standard test method

None

Type of end product

End product Trademark

End product Model and/or type reference

End product Manufacturer

End product Address

See above

End product Rating(s)

PEMS/PESS Configuration Information:

No special hardware configuration necessary.

Software Designer (if different than end Product manufacturer).

NA

Address

NA

NA

Method of Identification of Software:

Revision

Particular Risks Addressed by Software:

As contained in hazard analyses

GENERAL INFORMATION

Particulars: verification item vs. verification requirements

As EN 60601‑1-4 is a collateral standard to EN 60601‑1, this report is to be used in conjunction with Test Report Reference No.: N.N.

Possible verification case verdicts

Verification case does not apply to the verification item---------------------------------------------------------- : N(ot)/A(pplicable)

Verification item is available------------------------------------------------------------------------------------------------- : N(oted)

Verification item does meet the requirement-------------------------------------------------------------------------- : P(ass)

Verification item does meet the requirement under the limited scope of this assessment----------- : P(ass) L(imited Scope)

Verification item does not meet the requirement-------------------------------------------------------------------- : F(ail)

Verification item does not meet the requirement under the limited scope of this assessment----- : F(ail) L(imited Scope)

Minor non-compliances are noted in regular case and font

Major non-compliances are note in ALL CAPS and / or BOLD

General remarks

‘’(See enclosure #)" refers to an enclosure appended to this report.

"(See appended table)" refers to a table appended to the report.

Throughout this report a period is used as the decimal separator.

The verification results presented in this report relate only to the item being verified.

This verification report shall not be reproduced except in full without the written approval of the verification laboratory.

SUMMARY OF CONTENTS:

The equipment has been evaluated according to standard ISO 14971:2000 First Edition.

All applicable verifications according to the above-specified standard(s) have been carried out, however the scope was limited to sub-system evaluation.

These verifications fulfil the requirements of standard EN 45001.

COTS

Commercial of the shelf software

DFU

Directions for Use

H&RA

Hazard and Risk Analysis

MDD

European Medical Device Directive

PEMS

Programmable Electronic Medical Devices

RMP

Risk Management Plan

SOP

Standard Operating Procedure

V&V

Verification and Validation

3.                     General requirements for risk management

3.2                     Risk management process

The manufacturer shall establish and maintain a process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and assessing the effectiveness of the control. This process shall be documented and shall include the following elements

a)       risk analysis;

b)       risk evaluation;

c)       risk control; and

d)       post-production information

Where a documented product design/development process exists, it shall incorporate the appropriate parts of the risk management process.

NOTE 1-A documented product design/development process can be used to deal with a systematic manner, in particular to enable the early identification of hazards in complex systems and environments.

NOTE 2-A schematic representation of the risk management process is shown in Figure 1

NOTE 3-See the bibliography.

3.3                     Management responsibilities

The manufacturer shall:

a)       define the policy for determining acceptable risk, taking into account relevant International Standards and national or regional regulations,

b)       ensure the provision of adequate resources,

c)       ensure the assignment of trained personnel (see 3.4) for management, performance of work and assessment activities, and

d)       review the results of risk management activities at defined intervals to ensure continuing suitability of the risk management process

The above shall be documented in the risk management file

3.4                     Qualification of personnel

The manufacturer shall ensure that those performing risk management tasks include persons with knowledge and appropriate to the tasks assigned to them. This shall include, where appropriate, knowledge and experience of the medical device and its use and risk management techniques.

Records of the appropriate qualifications shall be maintained

3.5                     Risk management plan

For the particular medical device or accessory being considered, the manufacturer shall prepare a risk management plan in accordance with the risk management process. The risk management plan shall be part of the risk management file.

The plan shall include the following:

a)       The scope of the plan, identifying and describing the medical device and the life cycle phases for which this plan is applicable;

b)       A verification plan

c)       Allocation of responsibilities

d)       Requirements for review of risk management activities; and

e)       Criteria for risk acceptability

NOTE The criteria for risk acceptability will do much to determine the ultimate effectiveness of the risk management process. Refer to annex E for guidance on establishing such criteria.

If the plan changes during the life cycle of the medical device, a record of the changes shall be maintained in the risk management file.

4.                      Risk analysis

4.1                     Risk analysis procedure

Risk analysis, as described in 4.2 to 4.4, shall be performed, and the conduct and results of the risk analysis shall be recorded in the risk management file.

NOTE-If a risk analysis is available for a similar medical device, it may be used as a reference provided it can be demonstrated that the processes are similar or that the changes that have been made will not introduce significant differences in results. This should be based on a systematic evaluation of the changes and the ways they can influence the various hazards present.

In addition to the records required in 4.2 to 4.4, the documentation of the conduct and results of the risk analysis shall include at least the following:

a)       a description and identification of the medical device or accessory that was analyzed;

b)       identification of the person(s) and organization which carried out the risk analysis;

c)       date of the analysis.

4.3                     Identification of known or foreseeable hazards

The manufacturer shall compile a list of known or foreseeable hazards associated with the medical device in both normal and fault conditions. Previously recognized hazards shall be identified. This list shall be maintained in the risk management file.

Foreseeable sequences of events that may result in a hazardous situation shall be considered and recorded.

NOTE 1-The examples of possible hazards listed in annex D and in clause B.2 for in vitro diagnostic medical devices can be used as a memory aid.

NOTE 2-To identify hazards not previously recognized, systematic methods covering the specific situation can be used (see annex F).

5.                     Risk evaluation

For each identified hazard, the manufacturer shall decide, using the criteria defined in the risk management plan, whether the estimated risk(s) is so low that risk reduction need not be pursued. In this case, the requirements given in 6.2 to 6.6 do not apply for this hazard (i.e., proceed to 6.7). The results of this risk evaluation shall be recorded in the risk management file.

NOTE 1-Guidance for deciding on risk acceptability is given in clause E.3.

NOTE 2-Application of relevant standards as part of the medical device design criteria might constitute risk control activities, thus necessitating application of the requirements given in 6.3 to 6.6

6.                      Risk control

6.1                     Risk reduction

When risk reduction is required, the manufacturer shall follow the process specified in 6.2 to 6.7 to control the risk(s) so that the residual risk(s) associated with each hazard is judged acceptable.

6.2                     Option analysis

The manufacturer shall identify risk control measure(s) that are appropriate for reducing the risk(s) to an acceptable level. Risk control shall consist of an integrated approach in which the manufacturer shall use one or more of the following in the priority order listed:

a)       inherent safety by design;

b)       protective measures in the medical device itself or in the manufacturing process;

c)       information for safety.

NOTE 1-Measures of risk control can reduce the severity of the potential harm or reduce the probability of occurrence of the harm, or both.

NOTE 2-Technical standards address inherent, protective, and descriptive safety for many medical devices. These should be consulted as part of the risk management process. See also annex G.

The risk control measures selected shall be recorded in the risk management file.

If, during option analysis, the manufacturer determines that further risk reduction is impractical, the manufacturer shall conduct a risk/benefit analysis of the residual risk (see 6.5); otherwise, the manufacturer shall proceed to implement the selected risk control measures.

6.4                     Residual risk evaluation

Any residual risk that remains after the risk control measure(s) are applied shall be evaluated using the criteria defined in the risk management plan. The results of this evaluation shall be recorded in the risk management file.

If the residual risk does not meet these criteria, further risk control measures shall be applied (see 6.2).

If the residual risk is judged acceptable, then all relevant information necessary to explain the residual risk(s) shall be placed in the appropriate accompanying documents supplied by the manufacturer.

Compliance is checked by inspection of the risk management file and the accompanying documents.

7.                      Overall residual risk evaluation

After all risk control measures have been implemented and verified, the manufacturer shall decide if the overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan. If the overall residual risk is judged unacceptable using the criteria established in the risk management plan, the manufacturer shall gather and review data and literature on the medical benefits of the intended use/intended purpose to determine if they outweigh the overall residual risk. If this evidence does not support the conclusion that the medical benefits outweigh the overall residual risk, then the risk remains unacceptable. The results of the overall residual risk evaluation shall be recorded in the risk management file.

8.                      Risk management report                                            

The results of the risk management process shall be recorded in a risk management report. The risk management report shall provide traceability for each hazard to the risk analysis, the risk evaluation, the implementation and verification of the risk control measures, and the assessment that the residual risk(s) is acceptable. The risk management report shall form part of the risk management.

NOTE-This report may be held on paper or on electronic media.