[Company Name]

[Company Group, Division, Location]

Product Name: [Product Name]

Document Title: Hazard Analysis Plan
Document Number: [Document Number]
Document Filename: [Document Filename]

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Revision Revision DCO/ECO Revision

Level Date Number Description of Revision Author
DRAFT DD/MM/Y YY-00000 Draft Author Name
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1.00 DD/MM/Y YY-00000 Initial Release Author Name
Y

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Hazard Analysis Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

Table of Contents

1.0 Scope and Purpose........................................................................................................................................1

1.1 Intended Use.......................................................................................................................................1
1.2 Description of Hardware....................................................................................................................1
1.3 Description of Software.....................................................................................................................1

2.0 Hazard Analysis............................................................................................................................................2

Table of Figures
Table 1. System Hardware Requirements..........................................................................................1
Table 2. Potential Hazards.................................................................................................................2

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[Company Name] Hazard Analysis Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

1.0 Scope and Purpose

This document describes the hazards associated with the intended use, hardware, and software
associated with [Product Name].

1.1 Intended Use

The [Product Name] is intended to be used as a data collector and a data manager for the patient,
image and examination information captured during Endoscopic, Laprascopic and
Bronchoscopic surgical procedures.

1.2 Description of Hardware

The [Product Name] Software is deployed on off-the-shelf personal computer hardware. The
following table describes the system hardware requirements.

Table 1. System Hardware Requirements
Component Description
Operating System Microsoft ME version 4.90.3000
System Unit IBM PC/AT NetVista; IBM BIOS: Ver.
PIKT 33.0, Date: 3/30/01
Keyboard: Maxisound, Standard with
Speakers
Mouse: PS/2
Speed CPU Pentium IV
Memory 640 kB total conventional; 260492 kB total
extended
Ports Connect serial devices: None
Connect parallel devices: None
Connect USB devices: HP LaserJet Model
123
Storage -- Fixed Intel 82801 BA Ultra ATA Storage Controller
72 GB
Storage – Removable Media CD-RW Plextor CD-R PX-W1210A
Zip 250 Drive
Floppy 3.5”, 1.4M
Sound and Video Controllers Microsoft Kernel Audio Mixer
Microsoft Kernel System Audio Renderer
SoundMAX Integrated Digital Audio
Display Adaptor ABC 123 Pro AGP
ABC Multimedia Video Driver

1.3 Description of Software

[Insert a description of the software here.]

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[Company Name] Hazard Analysis Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

2.0 Hazard Analysis

The following potential hazards have been identified for all reasonably foreseeable circumstances.

Table 2. Potential Hazards
Hazardous Event Cause(s) Level of Method of Corrective Measures
Concern Control
Energy Hazards
Shock to the Faulty Ground Minor Design Hardware Meets UL
Operator or Patient Standards
Fire Flammable Minor Design Plastics have
Materials appropriate ratings
EMI Emissions – Minor Design Hardware Meets FCC
Radiated and IEC Standards
Susceptibility -
Conducted
Electricity
Heat Major Restrict the
period of use
Mechanical Force Moderate
Ionizing Radiation Major Safety
Shielding
Moving Parts
Suspended Masses
Patient Support
Device Failure
Pressure
Vibration
Biological Hazards
Bio-Burden
Bio-Contamination
Bio-Incompatibility
Incorrect output
Incorrect formulation
Cross-infection
Pyrogenicity
Hygienic Safety
Degradation

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[Company Name] Hazard Analysis Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

Hazardous Event Cause(s) Level of Method of Corrective

Concern Control Measures
Environmental Hazards
Electromagnetic Interference
Inadequate power supply or coolant
Restriction of cooling
Incompatibility w/other devices
Accidental mechanical damage
Contamination due to waste products
Hazards Related to the Use of the Device
Inadequate labeling
Inadequate operating instructions
Inadequate Specification of accessories
Inadequate specification of pre-use checks
Over-complicated operating instructions
Unavailable or separated operating instructions
Use by unskilled/untrained personnel
Reasonable foreseeable misuse
Insufficient warning of side effects
Inadequate warning of hazards likely with re-
use single use devices
Incorrect measurement or other metrological
aspects
Incorrect diagnosis
Erroneous data transfer
Misrepresentation of Results
Incompatibility with
consumables/accessories/other devices

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[Company Name] Hazard Analysis Plan
[Company Group, Division, Location] [Document Number]
[Product Name] Rev x.xx DD/MM/YY

Hazardous Event Cause(s) Level of Method of Control Corrective Measures

Concern
Hazards arising from Functional Failure, maintenance, or aging
Hardware Errors Video Processor Minor Desig All hardware is off-the-shelf
Failure n equipment. OEM warranties
Microphone Failure are in effect. Equipment failure
Speaker Failure may degrade system
Display Failure functionality but will pose no
Data Storage Failure hazard to the user.
Printer Failure
Software Errors Minor Desig
n
Operation Errors Minor Desig
n
No Service Support Telecommunications Minor Desig Customer Service unit available
system failure n to respond to service calls
Inadequacy of Minor Desig
performance n
characteristics for
the intended use
Inadequate Minor Desig
specification for n
maintenance
Inadequate Minor Desig Hardware is re-packaged in
packaging n original packaging
Inadequate Minor Desig OEM warranty applicable
maintenance n
Improper re-use
Loss of mechanical
integrity
Inadequate
determination of
device lifecycle

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