risk management report - onyx healthcaredemo.onyx-healthcare.com/product/112/certification/rm...

VITA Electronics Co., LTD.

Issue Date: 2015-11-10 Report No:RM1511051

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Risk Management Report

Organization’s Name ................ : VITA ELECTRONICS CO LTD

Address ..................................... : 5TH FL 101 CHOU TZE ST

NEIHU TAIPEI TAIWAN

Kind of Device ............................ Medical LCD Monitor

Model and/or Type Reference .. : MEDDP-515xxx-xx-xxxx, MEDDP-517xxx-xx-xxxx, MEDDP-519xxx-xx-xxxx (where x can be 0-9, A-Z for marketing purpose only, no technical difference)

Scope of the risk analysis ......... : 1. Intended use and identification of characteristics related to the safety of the medical equipment

2. Identification of hazards

3. Estimation of the risk for each hazardous situation

4. “Design, Development and Manufacture” of the product in question.

Prepared: Kevin Quality Assurance: Ken

Safety: Leo Sales: Kay

R&D: Kevin President: TK



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Version Description Date

1.0 Initial 2015-11-10



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Table of Content

1. Introduction ……………………………………………………………………..……4 2. Risk Management Policy ………………………………………………...… .…….4 3. Risk Management process…………………………………………………………4 4. Risk analysis ……………………………………………………………………..…105. Risk Evaluation…………………….………………………………………………..226. Risk Control …………………………………………………………………………267. Evaluation of overall residual risk acceptability …………………………………418. Risk management report ……………………………… …………………………41



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1. Introduction

This report specifies a process to identify the hazards associated with medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Bibliography:

Item Standard no. safety IEC60601-1: 2005+ A1: 2012

ANSI/AAMI ES60601-1 (2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)2012) CAN/CSA-C22.2 No. 60601-1:14 EN60601-1:2006+A11:2011+A1:2013+A12:2014

EMC IEC 60601-1-2 Risk Management ISO14971: 2007

2. Risk Management Policy

Criteria for risk acceptability has defined based upon applicable national or regional regulations and relevant International Standards, and taken into account available information such as the generally accepted state of the art and known stakeholder concerns. Based on the guidelines being set up by the company management the identified risks will be evaluated in the risk management worksheet and reported in annual risk management reports as follows (according to ISO 14971): In determining acceptable risk, we will research pertinent regulations, standards and associated literature to identify state of the art for power supply with medical and dental equipment. The criteria of risk acceptability were according to requirement of IEC 60601-1.



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3. Risk management process

3.1 Risk management process The risk management process will be conducted follow Standard ISO 14971 clause 3.1, in figure 1 as below.

Figure 1 – A schematic representation of the risk management process



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3.2 Management responsibilities Top management / President opened the meeting for risk management process for following item - Assignment of qualified personnel - Adequate Resources - Policy for determining criteria for risk acceptability

See “meeting record of risk management” for details.

3.3 Qualification of personnel Persons performing risk management tasks shall have the knowledge and experience appropriate to the tasks assigned to them

Assigned Responsibility

Name Responsibilities in the whole Process Qualification

Record Ref. No.

Engineering Representative (R&D)

Kevin

- Responsible for carrying out the RM report (The person shall be trained ISO14971 or with relevant working experience.)

ISO14971 Training Record

Safety section Leo - Responsible for reviewing the RM report.

(The person shall be trained ISO14971 or with relevant working experience.)


Sales department Kay - Responsible for collects data and from

customer and market ISO14971

Training RecordQuality Assurance (QA) Representative

Ken - Responsible for document any decisions

and actions taken. ISO14971

Training Record

President TK

- Responsibilities as below - Ensuring the provision of adequate resources - Ensuring the assignment of qualified personnel for risk management.




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3.4 Risk management plan Risk management activities was refer to Risk management plan (Document No “RP1511051”), include the following: a) The scope of the risk management plan is specified by the product LCD Monitor. And describing the medical device and the life-cycle phases for which each element of the plan is applicable. b) Assignment of responsibilities and authorities; See clause 3.3 for details. c) The review requirements of risk management activities was specified in Risk management plan (Document No “RP1511051”). d) The criteria for accepting risks shall considering the applicable national or regional requlations and relevant international standards, and take into account available information such as the generally accepted state of the art and known stakeholder concerns. The risk index matrix is disclosed in clause 3.4.1 e) The final verification of the risk control shall be performed on the prototype samples. The compliance reports according to IEC60601-1, IEC 60601-1-2 and qualification test report. f) Activities related to collection and review of relevant production and post-production information. See Attachment for Risk management plan for details.



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3.4.1 Evaluation System Based on the guidelines being set up by the company management the identified risks will be evaluated

A: Probability of Occurrence (Improbable/Remote/Occasional/Probable/Frequent) Probability (Likelihood of event occurrence) Definition Common term Rank (1=lowest)

Frequent 5 With a probability of occurrence more than 10-3, or occurs more than once a month

Probable 4 With a probability of occurrence less than 10-3 but greater than 10-4, or occurs more than once a season

Occasional 3 With a probability of occurrence less than 10-4 but greater than 10-5, or occurs more than once a year

Remote 2 With a probability of occurrence less than 10-5 but greater than 10-6, or occurs more than once a product life-cycle

Improbable 1 With a probability of occurrence less than 10-6, unlikely to occur, but possible.

B: Severity of Harm (Negligible, Minor, Serious, Critical, Catastrophic) Severity (Impact of event occurrence) Definition Common term Rank (1=lowest)

Catastrophic 5 Could result in death, or life-threatening injury

Critical 4 Could result in permanent partial disability, injuries

Serious 3 Could result in injury requiring professional medical intervention

Minor 2 Could result in temporary injury not requiring professional medical intervention

Negligible 1 Inconvenience or temporary discomfort, these do not require any medical treatment.



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The acceptance criteria are as following: Risk Index Matrix

Severity rank

Probability rank

1 2 3 4 5

4 Acceptable, Insignificant

risk

Unacceptable, moderate risk

Unacceptable, high risk


Unacceptable, extreme risk


risk

Acceptable, Insignificant

risk





risk


risk


risk




risk


risk


risk


risk


Risk (index) acceptability level :

Risk= Severity x Probability

Result: Risk=1 to 4 is acceptable; Risk = 5 to 25 is unacceptable

The criteria was refer form risk Management Plan (Doc: RP1507063)

3.5 Risk management file Records of risk management activities, including any significant changes, are maintained

Description and reference to (ref number of) existing documents

Product tests according to 設計及開發程式 PN:QP0702

Process input (goods, resources, design etc.)

製程管制程序 P/N:QP0707

成品檢驗規定 P/N:QP0805

Post–production information and product surveillance on the markets

客訴流程管理辦法 P/N: QP0709

設計變更作業規定 P/N: QP0703

Product Problem record P/N: QP0710



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4. Risk analysis 4.1 Risk analysis process Risk analysis performed as described according to ISO 14971, clause 4.2 to 4.4. The implementation of the planned risk analysis activities and the results of the risk analysis were recorded in the risk management file. 4.2 Intended use and identification of characteristics related to the safety of the

medical device (a) Questions: The following questions can aid the person in identifying all the characteristics of the medical

device that could affect safety. (Which according to ISO 14971)

Item Questions Answer / Comments

C.2.1 What is the intended use and how is the medical device to be used?

The LCD Monitor is intended to serve as a display-integrated computing platform for integration with hospital system. This device is designed for general purpose for hospital environment. For data collection and display for reference. It shall not be used for life-supporting system.

C.2.2 Is the medical device intended to be implanted? No, they are not intended to be implanted.

C.2.3 Is the medical device intended to be in contact with the patient or other person?

No applied part

C.2.4 What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device?

The materials & components used are listed in BOM (bill of material).

C.2.5 Is energy delivered to or extracted from the patient?

No energy delivered to or extracted from the patient.

C.2.6 Are substances delivered to or extracted from the patient?

No delivered to or extracted from the patient.

C.2.7 Are biological materials processed by the medical device for sub-sequent re-use, transfusion or transplantation?

No biological materials process used.

C.2.8 Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?

Not supplied sterile function or intended to be sterilized by the user.

C.2.9 Is the medical device intended to be routinely cleaned and disinfected by the user?

Not intended to be routinely cleaned and disinfected by the user.

C.2.10 Is the medical device intended to modify the patient environment?

No modify the patient environment function.

C.2.11 Are measurements taken? No measurement function.

C.2.12 Is the medical device interpretative? No data interpretative.

C.2.13 Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?

No, they are not.

C.2.14 Are there unwanted outputs of energy or substances?

Yes, they will bring about high temperature, leakage current and EMC.

C.2.15 Is the medical device susceptible to Yes, they may influence by temperature,



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environmental influences? humidity, vibrations

C.2.16 Does the medical device influence the environment?

Yes, they may influence temperature and EMC

C.2.17 Are there essential consumables or accessories associated with the medical device?

No

C.2.18 Is maintenance or calibration necessary? No

C.2.19 Does the medical device contain software? No

C.2.20 Does the medical device have a restricted shelf life?

No

C.2.21 Are there any delayed or long-term use effects? No

C.2.22 What mechanical forces will the medical device be subjected to?

This LCD Monitor is subjected to such mechanical hazards as gravity (or instability), impact and drop.

C.2.23 What determines the lifetime of the medical device?

The service life is based on previous records and feedback of marketing in previous models.

C.2.24 Is the medical device intended for single use? This device not intended for single use.

C.2.25 Is safe decommissioning or disposal of the medical device necessary?

Yes, This device needs safe decommissioning or disposal.

C.2.26 Does installation or use of the medical device require special training or special skills?

It has to read the instruction manual before installation.

C.2.27 How will information for safe use be provided? Product specification or product data sheet Safety instructions will be provided according to IEC 60601-1:2005.

C.2.28 Will new manufacturing processes need to be established or introduced?

No

C.2.29 Is successful application of the medical device critically dependent on human factors such as the user interface?

No, it shall be evaluated in the final system.

C.2.29.1 Can the user interface design features contribute to use errors?

No

C.2.29.2 Is the medical device used in an environment where distractions can cause errors?

No

C.2.29.3 Does the medical device have connecting parts or accessories?

No

C.2.29.4 Does the medical device have a control interface?

No

C.2.29.5 Does the medical device display information? No

C.2.29.6 Is the medical device controlled by a menu? No

C.2.29.7 Will the medical device be used by persons with special needs?


C.2.29.8 Can the user interface be used to initiate user actions?

No

C.2.30 Does the medical device use an alarm system? No

C.2.31 In what way(s) might the medical device be No



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deliberately misused?

C.2.32 Does the medical device hold data critical to patient care?

No

C.2.33 Is the medical device intended to be mobile or portable?

No, the device is a fixed installed equipment.

C.2.34 Does the use of the medical device depend on essential performance?


(b) Intended use and & most unfavorable maximum working load condition These Medical LCD Monitors are designed to use in displaying medical imaging data applications. These products cannot be used in patient vicinity. The LCD displays and the power supply must not be used outdoors or in areas where an explosion hazard may occur. They are intended to connect to specified power adaptor and equipped with VGA/HDMI/DP ports. The user has to make sure that requirements from IEC 60601-1 are fulfilled, especially in combination from monitor with other electrical equipment. It shall not be used for life supporting system.

The unit can only use with switching power adapter as following

Maximum operation temperature 40 degree C

The metal enclosure of LCD Monitor can be touched within 1 sec to 10 sec and plastic enclosure can be touched within 10 sec to 1 mins. Power adapter can be touched within 10 sec to 1 mins. Touch screen can be touched within 10 sec to 1 mins. Pollution degree of equipment: Pollution Degree 2 Operation altitude of equipment: 0-3000m

Power Adapter ADAPTER TECHNOLOGY CO LTD.

ATM065-P120 I/P: 100-240 Vac, 50/60 Hz, 1.6-0.7A O/P: 12 Vdc, 5A; 60W

Two MOPP insulation is provided between primary and secondary circuit in evaluated power adapter.



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Model MEDDP-515xxx-xx-xxxx (DC)

LCD Panel Size: Pixel Pitch: Brightness: Contrast Ratio: Response Time:

15”

0.297mm 450 cd/㎡

800:1(typ.) 8mS(typ.)

Maximum viewable size 15 inch (38.1cm)

Video Input Analog:15-pin, D-sub connector Digital: DVI,DP,HDMI connector

Display area 304.128mmx 228.096mm (H×V)

Input voltage: Consumption

12V DC / 2A

12 watts maximum

External controls Power-switch, VGA, DVI,DP,HDMI Brightness, Contrast, Volume, Color temperature (User,6500°K,9300°K),

Clock, Phase, H-position, V-position, OSD-control, Recall, Sharpness, Exit

Horizontal frequency 30-60KHz

Vertical frequency 50-75Hz

Dimensions(with carton) 410mm×140mm×420mm (W×D×H)

Max. Resolution 1920×1080 (Non-Interlaced)

Power Saving With EPA standard

Plug & Play DDC 1/2B

Weight N.W.:3.2 Kgs G.W.:4.0 Kgs

Ambient temperature Operation: Non-operating

5°C – 40°C

-10°C – 60°C

Humidity Operating: Storage:

20%-80% 10%-90%

*Specifications are subject to change without notice.



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Model MEDDP-517xxx-xxxxxxx (DC)


17”

0.264mm 350 cd/㎡

1000:1(typ.) 5mS(typ.)





12V DC / 3A

15 watts maximum











5°C – 40°C

-10°C – 60°C


20%-80% 10%-90%




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Model MEDDP-519xxx-xxxxxxx (DC)


19”

0.294mm 350 cd/㎡

1000:1(typ.) 5mS(typ.)





12V DC / 3A

19.7 watts maximum











5°C – 40°C

-10°C – 60°C


20%-80% 10%-90%




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The reasonably foreseeable misuse listed as below table.

Following list are on known and foreseeable hazards associated with the medical device in both normal and fault conditions.

Item Foreseeable misuse and hazards identification

A1 Output overload of power adapter

A2 Output short of power adapter

A3 Supply voltage mismatch

A4 Unit drop.

A5 Unit subjected to force.

A7 Premature unpacking, transport or storage

A8 Premature or excessive cleaning

4.3 Identification of hazards

Following list are identification of hazard for medical device, (Note: the evaluation of possible hazards by R/D engineer base on engineering judgment and ISO 14971)

Item hazards identification Hazards Type

B1 Line voltage from mains to cause hazard. Electromagnetic energy - Electric Shock

B2 Touch current (Enclosure leakage current) of accessible parts to cause hazard.

Electromagnetic energy - Leakage current

B3 Touch current (Output leakage current) of accessible parts to cause hazard.

Electromagnetic energy - Leakage current

B4 Stored energy to cause hazard. Electromagnetic energy - Electric Shock

B5 High temperature to cause hazard. Thermal energy – High temperature

B6 Input current of Label less than measured value of equipment may cause fire hazard.

Labelling - Inadequate description of

performance characteristics

B7 X capacitor connected between Line and Neutral may cause electric shock.

Electromagnetic energy - Electric Shock

B8 Fuse may not operate to cause fire hazard. Electromagnetic energy - Electric Shock

B9 Unsuitable rating of critical component to cause fire hazard.

Electromagnetic energy - Electric ShockThermal energy – High temperature

B10 Critical component fault to cause fire hazard Electromagnetic energy - Electric ShockThermal energy – High temperature

B11 High electrical voltage to cause insulating materials dielectric breakdown


B12 Critical component or wires displaced to cause hazard

Mechanical energy - Vibration

B13 Physically equipment unstable in normal use to cause hazard

Mechanical energy - falling



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Item hazards identification Hazards Type

B14 Overheat to cause thermoplastic materials shrinkage or distortion

Thermal energy – High temperature

B15 Openings of enclosure to cause fire hazard Thermal energy – High temperature

B16 Equipment expose at high humidity preconditioning treatment to cause electric shock.


B17 Markings of Label were not clearly readable to cause hazard.



B18 Instructions or technical description document not provided to cause hazard.



B19. Information of instructions not enough to cause hazard.



B20 The Instruction not included the disposal of waste products, residues, etc to cause hazard.



B21 User modified the ME equipment to cause hazard. Labelling - Inadequate disclosure of

limitations

B22 The resistance to heat of insulation material (plastic enclosure or bobbin etc) are not retained to cause hazard


B23 Components of equipment, the unwanted movement or vibration to cause hazard.


B24 The accidental detachment of wirings to cause hazard.


B25 Wiring contact with a moving part or from friction at sharp corners and edges to cause hazard

Mechanical energy – sharp, edges

B26 No fuses provided on each supply lead to cause hazard.


B27 Rough surfaces, sharp corners and edges of ME equipment to cause hazard.

Mechanical energy - Torsion, shear and tensile

B28 The equipment placed in a corner in normal used to cause fire hazard.


B29 Constructional of Fire Enclosure not meet IEC 60601-1, 3rd to cause hazard.


B30 Rating misused for Component Electromagnetic energy - Electric ShockThermal energy – High temperature

B31 Setting change of controls device Operational hazards - Function

B32 Indicator of power status Operational hazards – User error

B33 Arrangement of controls and indicators Operational hazards – User error

B34 SIO / SOP incorrect connected Operational hazards – User error



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4.4 Estimation of the risks for each hazardous situation The decision of each hazardous risk were referred to recommendation of ISO14971, requirement of IEC 60601-1 and IEC 60601-1-2.

Item Initial Risk Estimation

Risk Probability Severity of the harm

Risk level (refer to chapter 3.3 Risk Index Matrix for

details)

Date of Assessment

A1 Output overload of power adapter 4 4 16 2015-11-10

A2 Output short of power adapter 4 3 12 2015-11-10

A3 Voltage mismatch. 4 4 16 2015-11-10

A4 Unit drop. 4 4 16 2015-11-10

A5 Unit subjected to force. 4 4 16 2015-11-10

A7 Premature unpacking, transport or storage 3 3 9 2015-11-10

A8 Premature or excessive cleaning 4 4 16 2015-11-10

B1 Line voltage from mains 3 5 15 2015-11-10


3 5 15 2015-11-10


5 4 20 2015-11-10

B4 Stored energy 5 3 15 2015-11-10

B5 High temperature 5 2 10 2015-11-10


4 4 16 2015-11-10


4 4 16 2015-11-10

B8 Fuse may not operate to cause fire hazard. 3 3 9 2015-11-10

B9 Unsuitable rating of critical component (transformer, main transistor, Bridge Rectifier, wiring….) to cause fire hazard.

5 4 20 2015-11-10

B10 Critical component fault (transformer, main transistor, Photo coupler, Bridge Rectifier…..) to cause fire hazard

5 4 20 2015-11-10


5 4 20 2015-11-10


4 4 16 2015-11-10



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details)

Date of Assessment


3 3 9 2015-11-10


5 4 20 2015-11-10

B15 Openings of enclosure to cause fire hazard

5 3 15 2015-11-10


4 4 16 2015-11-10


4 3 12 2015-11-10


4 3 12 2015-11-10

B19 Information of instructions not enough to cause hazard.

3 3 9 2015-11-10


3 4 12 2015-11-10

B21 User modified the ME equipment to cause hazard.

3 3 9 2015-11-10


4 4 16 2015-11-10


4 4 16 2015-11-10


3 3 9 2015-11-10

B25 wiring contact with a moving part or from friction at sharp corners and edges to cause hazard

4 3 12 2015-11-10


4 3 12 2015-11-10


4 3 12 2015-11-10


4 3 12 2015-11-10



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details)

Date of Assessment

B29 Constructional of Fire Enclosure not meet IEC 60601-1 to cause hazard.

4 3 15 2015-11-10

B30 Rating misused for Component

4 4 16 2015-11-10

B31 Setting change of controls device

5 1 5 2015-11-10

B32 Indicator of power status 3 4 12 2015-11-10

B33 Arrangement of controls and indicators

3 4 12 2015-11-10

B34 SIO / SOP incorrect connected

3 4 12 2015-11-10

Note:



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5. Risk evaluation For each identified hazardous situation, the manufacturer shall decide, using the criteria defined in the risk management plan (Doc. No: P1006017), if risk reduction is required. If risk reduction is not required, the requirements given in 6.2 to 6.6 do not apply for this hazardous situation. The results of this risk evaluation were recorded as below.

Item Risk Risk level Risk=Severity x probability

Result: Risk=1~4, acceptable; 5~25, unacceptable

Date of Assessment

A1 Output overload. 16 (unacceptable, to be reduced) 2015-11-10

A2 Output short. 12 (unacceptable, to be reduced) 2015-11-10

A3 Voltage mismatch. 16 (unacceptable, to be reduced) 2015-11-10

A4 Unit drop. 16 (unacceptable, to be reduced) 2015-11-10

A5 Unit subjected to force. 16 (unacceptable, to be reduced) 2015-11-10

A6 Unit subjected to impact. 16 (unacceptable, to be reduced) 2015-11-10


9 (unacceptable, to be reduced) 2015-11-10



B1 Line voltage from mains 15 (unacceptable, to be reduced) 2015-11-10





B4 Stored energy 15 (unacceptable, to be reduced) 2015-11-10

B5 High temperature 10 (unacceptable, to be reduced) 2015-11-10





B8 Fuse may not operate to cause fire hazard.




B10 Critical component fault (transformer, main transistor,




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Date of Assessment

Photo coupler, Bridge Rectifier…..) to cause fire hazard

















B19 Information of instructions not enough to cause hazard.
















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Date of Assessment













B32 Indicator of power status 16 (unacceptable, to be reduced) 2015-11-10







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6. Risk control 6.1 Risk reduction Risk control activities was according to ISO 14971, clause 6.2 to 6.7 6.2 Risk control option analysis One of following risk control options apply: a) inherent safety by design; b) protective measures in the medical device itself or in the manufacturing process; c) information for safety

Item Risk Risk control option analysis

Note

A1 Output overload of power adapter

a) inherent safety by design

Used with IEC 60601-1 certificated power adapter.

The specified power adaptor were designed regulating network of OVP, OCP into circuit to Comply with IEC 60601-1, clause 13, single fault conditions test requirement.

A2 Output short of power adapter



The specified power adaptor were designed regulating network of OVP, OCP into circuit to Comply with IEC 60601-1, clause 13, single fault conditions test requirement.

A3 Voltage mismatch. a) inherent safety by design


The specified power adaptor were designed auto range (100-240Vac) for input circuit to Comply with IEC 60601-1, clause 13, single fault conditions test requirement.

And provided with polarized DC jack.

A4 Unit drop. a) inherent safety by design

Provided a solid and hard enclosure to covered unit to Comply with IEC 60601-1, clause 15.3, drop impact test requirement.

A5 Unit subjected to force. a) inherent safety by design

Provided a solid and hard enclosure to covered unit to Comply with IEC 60601-1, clause 15.3, enclosure mechanical strength test requirement.

A6 Unit subjected to impact. a) inherent safety by design

Provided a solid and hard enclosure to covered unit to Comply with IEC 60601-1, clause 15.3, drop impact test requirement.



The outside of packaging marked environmental conditions for transport and storage according to IEC 60601-1, ISO 780 and ISO15223..



Provided method of cleaning into user manual according to IEC 60601-1

B1 Line voltage from mains a) inherent safety by design


The specified power adaptor were provided a solid enclosure to covered unit. And provided Double/Reinforced insulation and two MOPP between primary and secondary according to IEC 60601-1.



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The touch current for the output of adapter were met require of IEC 60601-1.

B3 Touch current (Output leakage current) of accessible parts to cause hazard



The touch current for the outer enclosure of adapter were met require of IEC 60601-1.

B4 Stored energy a) inherent safety by design


The discharge of AC inlet pins were met require of IEC 60601-1

B5 High temperature a) inherent safety by design


And designed used with Low Power CPU.



Provided rating information on label drawing of unit to Comply with IEC 60601-1, clause 4.11, power input test requirement.



Provided rating information on label drawing of unit to Comply with IEC 60601-1, clause 8.4.3, voltage limitation test requirement.




The specified power adaptor provided with main fuse, the fuse with IEC60127 standard approved to Comply with IEC 60601-1, clause 13, single fault conditions test requirement.

B9 Unsuitable rating of critical component to cause fire hazard.


According to our QMS procedure, all component are used within their specified ratings.

B10 Critical component fault to cause fire hazard


According to our QMS procedure, all components and wiring are used within their specified ratings.

and AC power Adapter Comply with IEC 60601-1, clause 13, single fault conditions test requirement.



Insulation materials were used withstand voltage complies with standard requirement. And application was complying with IEC 60601-1 requirements.



The equipment designed provided two fixings (Mechanically securing, glue, soldering, physical fit…..) to prevent such movement. According to IEC 60601-1 requirement.

B13 Physically of equipment unstable in normal use to cause hazard


Designed steady and solid enclosure to covered unit. According to IEC 60601-1 requirement.



Used high thermal rating of thermoplastic enclosure with UL94 approved to meet with to IEC 60601-12 requirement.



Provided a solid and hard enclosure without openings to covered unit to Comply with IEC 60601-1 requirement.

B16 Equipment expose at high humidity preconditioning


Provided a solid, hard and tight enclosure to covered unit to Comply with IEC 60601-1, clause 5.7 requirement.



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treatment to cause electric shock.



Used Waterproof Labels material to Comply with IEC 60601-1, clause 7.1.3, durability of marking test requirement.



For packing, we will provide the instruction manual per one carton. There is showed as below in instruction manual.

B19. Information of instructions not enough to cause hazard.


The instructions shall be according to IEC 60601-1, clause 7.9.2.5 provided following information:

a. brief description of the ME equipment

b. how the ME equipment functions

c. the significant physical and performance characteristics of the ME equipment

d. conditions of safe operation, transport and storage



The user manual provided production recycling information to user.



The instructions shall be according to IEC 60601-1, clause 7.9.3.1 provided following information:

WARING: No modification of this equipment is allowed.



Used high thermal rating of plastic material with UL94 approved to meet with to IEC 60601-1, Ball pressure test requirement.



The movable components (with 10N) will provide two fixings (Mechanically securing, glue, soldering, physical fit…..) to prevent such movement to meet IEC 60601-1 requirement.



The internal wire provided with two fixings (Mechanically securing, glue, soldering, physical fit…..) to prevent such accidental detachment to meet IEC 60601-1 requirement.



Designed wire-way of internal wire shall be smooth and free form sharp edges. Wires shall be protected so that they do not come into contact with burrs, cooling fins, moving parts, etc to meet IEC 60601-1 requirement.



Designed fuses provided on each supply lead for equipment to meet IEC 60601-1 requirement.



- Designed slick chamfer and surfaces for outer enclosure to meet IEC 60601-1 requirement.



Provided a solid enclosure to covered unit

Designed Transformer to meet class B (130 deg. C) limited of IEC 60601-1



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Used flammability V-1 material for enclosure and designed on openings to meet IEC 60601-1, clause 11.3 requirement.



According to our QMS procedure, all components and wiring are used within their specified ratings and comply with components standard.



LED indicator used for controls status.

B32 Indicator of power status a) inherent safety by design

Provided a LED indicator for status of normal



Designed location of controls and indicators were easy and obvious to access by user.



Provided a polarized connector and install information in user manual.



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6.3 Implementation of risk control measure(s) All risk control measures were verified and effective. See below for details.

Item Risk verified Note

A1 Output overload. Provided with OVP, OCP circuit. Comply with IEC 60601-1, clause 13, single fault conditions test requirement.

A2 Output short. Provided with OVP, OCP circuit. Comply with IEC 60601-1, clause 13, single fault conditions test requirement.

A3 Voltage mismatch. Designed auto range (100-240Vac) for input circuit to

Comply with IEC 60601-1, clause 13, single fault conditions test requirement.

A4 Unit drop. Provided a solid and hard enclosure to covered unit

Comply with IEC 60601-1, clause 15.3, drop impact test requirement.


Provided a solid and hard enclosure to covered unit to

Comply with IEC 60601-1, clause 15.3, enclosure mechanical strength test requirement.

A6 Unit subjected to impact.

Provided a solid and hard enclosure to covered unit to

Comply with IEC 60601-1, clause 15.3, drop impact test requirement.


The outside of packaging marked environmental conditions for transport and storage

Comply with IEC 60601-1, clause 7.2.17 requirement.


Provided method of cleaning into user manual

Comply with IEC 60601-1, clause 7.9.2.12 requirement.

B1 Line voltage from mains


Comply with IEC 60601-1, Double/Reinforced insulation requirement.


Changed rating of Y cap. and Bridge Cap.

Comply with IEC 60601-1, clause 8.7, leakage current test requirement.


Changed rating of Y cap. and Bridge Cap.

Comply with IEC 60601-1, clause 8.7, leakage current test requirement.

B4 Stored energy Changed rating of X cap. and Bleeder resistor


B5 High temperature Provided a solid enclosure to covered unit

Comply with IEC 60601-1, Table 22, Table 23 requirement.


Provided rating information on label drawing of unit

Comply with IEC 60601-1, clause 4.11, power input test requirement.

B7 X capacitor connected between Line and

Provided rating information on label drawing of unit

Comply with IEC 60601-1, clause 8.4.3, voltage limitation test requirement.



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Neutral may cause electric shock.


Used fuse, the fuse with IEC60127 standard approved to



According to our QMS procedure to use within their specified ratings.

Comply with IEC 60601-1, clause 4.8 requirement.


According to our QMS procedure, all components and wiring are used within their specified ratings.



Insulation materials were used withstand voltage complies with standard requirement.

Complying with IEC 60601-1 clause 8.8 requirements.


The equipment designed provided two fixings (Mechanically securing, glue, soldering, physical fit…..) to prevent such movement.



Designed steady and solid enclosure to covered unit.

Complying with IEC 60601-1 clause 9.4.3 requirements.


Used high thermal rating of thermoplastic enclosure with UL94 approved



Provided a solid and hard enclosure without openings to covered unit to



Provided a solid, hard and tight enclosure to covered unit to Comply with IEC 60601-1, clause 5.7 requirement.



Used Waterproof Labels material Comply with IEC 60601-1, clause 7.1.3, durability of marking test requirement.

B18 Instructions or technical description document not provided to cause

Provided with instruction manual Comply with IEC 60601-1, clause 7 requirement.



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hazard.

B19.

Information of instructions not enough to cause hazard.

The instructions provided following information:

a. brief description of the ME equipment

b. how the ME equipment functions

c. the significant physical and performance characteristics of the ME equipment

d. conditions of safe operation, transport and storage

Comply with IEC 60601-1, clause 7 requirement.



- It was showed in the instruction manual, as “Do not dispose this product in the household waste, please, follow the respective national law for proper disposal.”

Comply with IEC 60601-1, clause 7 requirement.



WARING: Do not modify this equipment without authorization of the manufacturer.



Used high thermal rating of plastic material with UL94 approved to meet with to IEC 60601-1, Ball pressure test requirement.

Comply with IEC 60601-1, clause 7.9.3.1 durability of marking test requirement.


The movable components (with 10N) will provide two fixings (Mechanically securing, glue, soldering, physical fit…..) to prevent such movement to meet IEC 60601-1 requirement.

Comply with IEC 60601-1, clause 8.8.4.1 Ball pressure test requirement.


The internal wire provided with two fixings (Mechanically securing, glue, soldering, physical fit…..) to prevent such accidental detachment



Designed wire ways of internal wire shall be smooth and free form sharp edges. Wires shall be protected so that they do not come into contact with burrs, cooling fins, moving parts



Designed fuses provided on each supply lead.


B27 Rough surfaces, sharp corners and

- Designed slick chamfer and surfaces for outer enclosure requirement.




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edges of ME equipment to cause hazard.



Complying with IEC 60601-1 Table 22 requirements.


Used flammability V-1 material for enclosure



According to our QMS procedure to use within their specified ratings.



LED indicator used for controls status.


B39 Indicator of power status

Provided a LED indicator for status



Designed location of controls and indicators were easy and obvious to access by user.



Provided a polarized connector and install information in user manual.




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6.4 Residual risk evaluation According to procedure, all residual risks are judged acceptable. No further risk control measures shall be applied after the risk control measures are applied, See below table for details. Initial Risk Estimation

(Before Risk Control0

Risk control

measure

Risk Estimation (After Risk Control )

item Risk Probability Severity of the

harm

Risk level (refer to

chapter 3.3 Risk Index Matrix for details)

Probability Severity of the harm



A1 Output overload. 4 4 16 (unacceptable)

After risk control measure1)

2 2 4 (acceptable)

A2 Output short. 4 3 12 (unacceptable)

After risk control

measure1

2 2 4 (acceptable)

A3 Voltage mismatch. 4 4 16 (unacceptable)

After risk control

measure1

1 1 1 (acceptable)

A4 Unit drop. 4 4 16 (unacceptable)

After risk control

measure1

4 1 4 (acceptable)


4 4 16 (unacceptable)

After risk control

measure1

4 1 4 (acceptable)

A6 Unit subjected to impact.


After risk control

measure1

4 1 4 (acceptable)



After risk control

measure1

1 3 3 (acceptable)



After risk control

measure1

2 1 2 (acceptable)

B1 Line voltage from mains


After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 2 2 (acceptable)

B4 Stored energy 5 3 15 (unacceptable)

After risk control

2 2 4



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Initial Risk Estimation (Before Risk Control0

Risk control

measure



harm






measure1(acceptable)

B5 High temperature 5 2 10 (unacceptable)

After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 1 1 (acceptable)



After risk control

measure1

2

2 4 (acceptable)



After risk control

measure1

2 2 4 (acceptable)



After risk control

measure1

2 1 2 (acceptable)



After risk control

measure1

1 1 1 (acceptable)

B14 Overheat to cause 5 4 20 After risk control

2 2 4



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Risk control

measure



harm






thermoplastic materials shrinkage or distortion

(unacceptable) measure1(acceptable)



After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 4 4 (acceptable)



After risk control

measure1

1 3 2 (acceptable)



After risk control

measure1

1 1 1 (acceptable)

B19.

Information of instructions not enough to cause hazard.


After risk control

measure1

1 1 1 (acceptable)



After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 1 1 (acceptable)



After risk control

measure1

4 1 4 (acceptable)

B23 Components of equipment, the


After risk control

measure1

1 4 4 (acceptable)



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Risk control

measure



harm






unwanted movement or vibration to cause hazard.



After risk control

measure1

3 1 3 (acceptable)



After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

1 2 2 (acceptable)



After risk control

measure1

4 1 4 (acceptable)



After risk control

measure1

1 3 3 (acceptable)



After risk control

measure1

4 1 4 (acceptable)



After risk control

measure1

2 1 2 (acceptable)



After risk control

measure1

1 1 1 (acceptable)

B39 Indicator of power status


After risk control

measure1

1 4 4 (acceptable)



After risk control

measure1

1 4 4 (acceptable)

B34 SIO / SOP incorrect 3 4 12 After risk 1 4 4



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Risk control

measure



harm






connected (unacceptable)

control

measure1(acceptable)

Note: 1)

See chapter 6.2 for manner of risk control details and chapter 6.3 for evidence details.



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6.5 Risk/benefit analysis According to procedure, No need to risk/benefit analysis because all residual risk is judged acceptable after risk control. 6.6 Risks arising from risk control measures No new hazards or hazardous situations arising from risk control measures because all risk control measures are inherent design in equipment before process of risk management and result of these control measures are acceptable. 6.7 Completeness of risk control All identified hazardous situations have been considered. The results of activity are recorded by Quality Assurance department. 7. Evaluation of overall residual risk acceptability After all risk control measures have been implemented and verified, the overall residual risk posed by the equipment is acceptable using the criteria defined in the risk management plan. 8. Risk management report The report is intended to ensure that the risk management plan was properly implemented. The overall residual risk is acceptable and there are appropriate methods in place to collect and analyze production and post-production information.

Attachment - Risk Management Plan


Issue Date: 2015-06-04 Report No:RP1511051

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Risk Management Plan

Organization’s Name ....... : VITA ELECTRONICS CO LTD

Address ........................... : 5TH FL 101 CHOU TZE ST

NEIHU TAIPEI TAIWAN

Kind of Device .................. Medical LCD Monitor

Model and/or Type Reference ........................ :

MEDDP-515xxx-xx-xxxx, MEDDP-517xxx-xx-xxxx, MEDDP-519xxx-xx-xxxx (where x can be 0-9, A-Z for marketing purpose only, no technical difference)

Scope of the risk analysis : 5. Intended use and identification of characteristics related to the safety of the medical equipment

6. Identification of hazards

7. Estimation of the risk for each hazardous situation

8. “Design, Development and Manufacture” of the product in question.



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Document History

Version Description Date

1.0 Initial 2015-6-04



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4. Introduction This risk management plan was established in accordance with EN ISO 14971 and considers the recommendations of all informative attachments of this standard. This risk management plan is in accordance with all requirements listed in appendix F of ISO 14971. Its task is to describe the risk management process for the following product

Medical LCD Monitor Model: MEDDP-515xxx-xx-xxxx, MEDDP-517xxx-xx-xxxx,

MEDDP-519xxx-xx-xxxx (where x can be 0-9, A-Z for marketing purpose only, no technical difference)

to identify potential risks, evaluate them and to control them effectively. This risk management plan describes the risk management process of the medical device manufacturer

VITA ELECTRONICS CO LTD

for the above mentioned medical device. It covers all phases of the life cycle, starting with the concept (design and development control), production, storage / despatch up to decommissioning or waste disposal in accordance with EN ISO 14971 Appendix F.1 und F.2.

In this risk management plan the following areas are covered:

- Description of the medical device and designation of the performance properties

- Designation of personnel, responsibilities and competence within the risk management process

- Evaluation of the risk management process through the management

- Criteria for the acceptability of risks

- Flow chart of the risk management process



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5. Description of the Medical Device and Designation of Performance Properties Specific Properties and Intended Use These Medical LCD Monitors are designed to use in displaying medical imaging data applications. These products cannot be used in patient vicinity. The LCD displays and the power supply must not be used outdoors or in areas where an explosion hazard may occur. They are intended to connect to specified power adaptor and equipped with VGA/HDMI/DP ports. The user has to make sure that requirements from IEC 60601-1 are fulfilled, especially in combination from monitor with other electrical equipment. It shall not be used for life supporting system. Product Lifetime:

This equipment average lifespan has been determined with approximately 50,000 hours.

Performance properties in case of intended use:

Based on above mentioned purpose the following performance properties can be derived, which forcefully have to be achieved in intended effect and safety:

1. Electrical Safety according to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)

2. Electromagnetic Compatibility according to IEC 60601-1-2 Personnel and Responsibilities in the Risk Management Process



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3. Personnel and Responsibilities in the Risk Management Process Persons performing risk management tasks shall have the knowledge and experience appropriate to the tasks assigned to them

Assigned Responsibility

Name Responsibilities in the whole Process Qualification

Record Ref. No.

Engineering Representative (R&D)

Kevin

- Responsible for carrying out the RM report (The person shall be trained ISO14971 or with relevant working experience.)


Safety section Leo - Responsible for reviewing the RM report.

(The person shall be trained ISO14971 or with relevant working experience.)


Sales department Kay - Responsible for collects data and from

customer and market ISO14971

Training RecordQuality Assurance (QA) Representative

Ken - Responsible for document any decisions

and actions taken. ISO14971

Training Record

President TK

- Responsibilities as below - Ensuring the provision of adequate resources - Ensuring the assignment of qualified personnel for risk management.




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4. Criteria to Analyze and Evaluate the Acceptability of Risk Criteria for risk acceptability has defined based upon applicable national or regional regulations and relevant International Standards, and taken into account available information such as the generally accepted state of the art and known stakeholder concerns. Based on the guidelines being set up by the company management the identified risks will be evaluated in the risk management worksheet and reported in annual risk management reports as follows (according to ISO 14971): In determining acceptable risk, we will research pertinent regulations, standards and associated literature to identify state of the art for power supply with medical and dental equipment. The criteria of risk acceptability were according to requirement of IEC 60601-1. Based on the guidelines being set up by the company management the identified risks will be evaluated in the risk management worksheet and reported in annual risk management reports as follows (according to ISO 14971):

A: Severity of Harm (Negligible, Minor, Serious, Critical, Catastrophic) Severity (Impact of event occurrence) Definition Common term Rank (1=lowest)

Catastrophic 5 Could result in death, or life-threatening injury

Critical 4 Could result in permanent partial disability, injuries

Serious 3 Could result in injury requiring professional medical intervention

Minor 2 Could result in temporary injury not requiring professional medical intervention

Negligible 1 Inconvenience or temporary discomfort, these do not require any medical treatment.



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B: Probability of Occurrence (Improbable/Remote/Occasional/Probable/Frequent)

Probability (Likelihood of event occurrence) Definition Common term Rank (1=lowest)

Frequent 5 With a probability of occurrence more than 10-3, or occurs more than once a month

Probable 4 With a probability of occurrence less than 10-3 but greater than 10-4, or occurs more than once a season

Occasional 3 With a probability of occurrence less than 10-4 but greater than 10-5, or occurs more than once a year

Remote 2 With a probability of occurrence less than 10-5 but greater than 10-6, or occurs more than once a product life-cycle

Improbable 1 With a probability of occurrence less than 10-6, unlikely to occur, but possible.

Criteria for the Acceptability of Risks Risk Index Matrix

Severity rank

Probability rank

1 2 3 4 5

4 Acceptable, Insignificant risk




Unacceptable, extreme risk


Acceptable, Insignificant risk














Risk (index) acceptability level :

Risk= Severity x Probability




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Risk Acceptability Assessment Criteria

The following criteria will be used according to IEC 60601-1:1988, IEC 60601-1:2005+ CORR. 1 (2006) + CORR. 2 (2007), IEC 60601-1:2012 and IEC 60601-1-2

Electromagnetic Energy Hazards

Humidity, cleaning, harmful ingress of liquids could affect the integrity of electrical insulation. Assessment criteria in determining if the resulting risk is acceptable include:

- no signs of wetting the hazardous parts; or

- the leakage current measurements to evaluate the accessibility to the hazardous parts, the dielectric strength test to evaluate the integrity of electrical insulation and measurement of electrical insulation coordination such as creepage distance and air clearances.

Mechanical Energy Hazards

Mechanical stress (caused by pushing, impact and rough handling) of the product could affect the integrity of electrical insulation and assessment criteria in determining if the resulting risk is acceptable include:

- no structural damages; or

- the dielectric strength test to evaluate the integrity of electrical insulation and measurement of electrical insulation coordination such as creepage distance and air clearances.

Thermal Energy Hazards

Molding stress (during fabrication of enclosure) could affect the integrity of mechanical strength and assessment criteria in determining if the resulting risk is acceptable include:

- no deformation of enclosure; or

- the dielectric strength test to evaluate the integrity of electrical insulation and measurement of electrical insulation coordination such as creepage distance and air clearances.

Fire Hazards

Assessment criteria in determining if the resulting risk is acceptable include:

- not exceeding maximum temperature; or

- no emission of flames, molten metal, poisonous or ignitable substance in hazardous quantities (demonstrated by no ignition of the cheesecloth), or no deformation of enclosure

5. Controlling of the Management Process by the Management

The risk management will be achieved continuously, to analyse the experience achieved with the product in question, to evaluate the risk situation and to document this appropriately in the risk management worksheet. If necessary, or in case of special incidents, the management or its deputy will initiate an extraordinary meeting with responsible person. The management controls include the evaluation of actions taken as well as the success of these actions. It includes also the evaluation of available information about competitors' products.



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Verification Plan:

All risk control measures were verified and effective according to IEC 60601-1, IEC 60601-1: 2012.

6. Controlling of the

The below flow chart describes the levels of realization of the management process and designates single steps for the risk analysis, risk evaluation, action management and the risk controlling.

Flow Chart: Flow of the Risk Management Process see next page.



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After availability and release of the risk management plan the below mentioned steps will be followed:

No

Yes

No

Yes

No

Yes

Yes

No

No

Yes

Yes No

Yes

No No

Yes

No

Yes

Production and post-production

information

Overall residual

risk evaluation R

isk control R

iskevaluation R

isk analysis

Intended use / identify characteristics (4.2)

Identify known or foreseeable hazards (4.3)

Estimate risk(s) for hazardous situation(s) (4.4)

Start

Is risk reduction necessary? (5)

Identify appropriate risk control measure(s), record risk control requirements (6.2)

Is the residual risk acceptable? (6.4)

measures (6.3)

Implement, record and verify appropriate measures (6.3)

Is the risk reducible? (6 2)

Are new hazards or hazardous situations introduced or exiting risks affected? (6.6)

Are all identified hazards considered? (6.7)

Is overall residual risk acceptable? (7)

Do medical benefits outweigh the residual risk?

(6.5)

Do medical benefits outweighthe residual risk?(7)

Prepare risk management report (8)

Review production and post-production information (9)

Is reassessment of risk necessary? (9)

Unacceptable

Step 1

Step 2

Step 3

Step 4

Step 6

Step 5

Step 7

Step 9

Step 8

Step 10

Step 11

Step 13

Step 12



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Step 1: Intended Use and Identification of Characteristics Related to the Safety of the Medical Device

The intended use and each reasonably imaginable and foreseeable misuse will be described in the risk management plan together with the product performance properties, which may influence the safety of the medical device. Then, the performance properties will be taken over into the risk management worksheet and the risks will be evaluated which occur if these performance properties are not achieved. For describing the features of the medical device and its environment in which it is used, Appendix C of the current standard EN ISO 14971:2009 is applied.

Step 2: Identification of Hazards

All known and foreseeable failures / dysfunctions / hazards, which infringe the function and safety of the medical device, will be identified. For this the medical device will be analysed in its regular mode, failure mode, (also in case of reasonably foreseeable misuse). Moreover already earlier discovered hazards, incidents or situations will be considered.

Starting point is always the identified features mentioned in Step 1, as well as the hazards listed in the tables of ISO 14971. These tables are listed in the appendix of the risk management plan and are to be considered accordingly within the risk management worksheet.

Step 3: Estimation of the Risk(s) for Each Hazardous Situation

For each defined or assumed hazard of Step 2 the implied risk will be assessed. The expected physical damage or severity of harm, and probability of occurrence.

Reasonably foreseeable sequences or combinations of events that can result in a hazardous situation will be considered and the resulting hazardous situation(s) will be recorded.

Step 4: Risk Evaluation

After that each risk will be evaluated, whether it is acceptable or not and whether a risk reduction is required. The criteria to evaluate the acceptability are listed in the risk management plan.

Step 5: Risk Control Option Analysis

For risks which are within the acceptable area no actions of risk control will be taken. Risks, which are outside this area, will be treated case by case. Any risk control measures have the goal to reach at least the „ALARP acceptance level“ (As Low As Reasonably Practicable).

Step 6: Implementation of Risk Control Measures

The execution of the actions of Step 5, and the effectiveness of the risk control measures taken will be evaluated/verified and recorded in the risk management worksheet.

Step 7: Residual Risk Evaluation



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The residual risks will be evaluated and documented in the risk management worksheet. In case a residual risk is not acceptable, Step 5 will be repeated.

Step 8: Risk / Benefit Analysis

Not acceptable risks can be accepted in exceptional cases, if a particularly high benefit is to be expected for the patient, and alternative products or treatment measures with minor risks are not available.

Step 9: Risks Arising from Risk Control Measures

In this step whether the actions of risk control and/or risk reduction would introduce new hazards or hazardous situations will be evaluated. In this case Step 3 has to be repeated.

Step 10: Completeness of Risk Control

In this step, whether all relevant risks have been considered and whether the risk evaluation process is complete will be checked. In case the risk evaluation is acknowledged as complete, the term “no further action” is stated in the risk management worksheet (Risk Management Worksheet I) or if this is not true, appropriate descriptions of proposed risk control measures have to be stated (Risk Management Worksheet II).

Step 11: Evaluation of Overall Residual Risk Acceptability

After the completion of all risk control measures, the whole residual risks as well as the acceptability of the residual risks will be evaluated. The evaluation of the residual risks will be performed analogically to the evaluation of the basic risks.

Step 12: Risk Management Report

There will be a summarizing risk management report. It will summarize the risk analysis, risk evaluation and management of preventive respectively risk control measures. This risk management report will be set up and released at least once per year by the management or its deputy.

Step 13: Production and Post-Production Information

Experience and information, which are collected during production and during the post productionphase, are evaluated, starting with step 3.

In each case the insights obtained during the risk management process will be implemented in any applicable product-related documents (e.g. Risk Management Worksheet I and II, instructions for use, labels and packaging).

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