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1、Document Description: Software Description Document for XXXXX Series of MonitorsPage 1 of 17Printed or electronic versions of this document not accessed directly from the designated XXXXX Controlled Quality Information System are For Reference Only.VITAL SIGNS MONITORXXXX SERIES(PROJECT:)SOFTWARE DE
2、SCRIPTIONDOCUMENTCopyright 2012 XXXXXAll rights reserved. This information is considered proprietary and confidential.4 .4 .5 .5 5. .6 .6 10 11 11 12220 0 0000 1 441 1 1111 1 11Document Description: Software Description Document for XXXXX Series of MonitorsPage 2 of 17Printed or electronic versions
3、of this document not accessed directly from the designated XXXXX Controlled Quality Information System are For Reference Only.Contents1. BASIC INFORMATION1.1 Product Identification 1.2 Software Safety Classification 1.3 Configuration and Functionality1.3.1 Isolation Block Diagram1.3.2 Interface to E
4、xternal 1.3.3User Interface 1.4 Hardware and Software Block Diagram 1.5Software Modules 1.6Operating Enviroment1.7Application Scope 1.8 Marketing History 2. PROCESS DESCRIPTION 2.1 Development general description 2.1.1 Development Environment: 2.1.2 Manpower2.2 Risk Management2.3 Software Requiremen
5、t Specification 2.4 Life Cycle2.4.1 Development Process Overview 2.4.2. Configuration Management Overview 2.4.3. Maintenance Process Overview 2.5Verification and Validation2.6Bugs/DefectsManagement2.6.1 Description of Bug Management (Change Management)2.6.2 Defects Management Document Description: S
6、oftware Description Document forXXXXX Series of MonitorsPage 3 of 17Printed or electronic versions of this document not accessed directly from the designated XXXXX Controlled Quality Information System are For Reference Only.2.7 Modification History172.8 Clinical Evaluation 193 ALGORITHM 16Document
7、Description: Software Description Document for XXXXX Series of MonitorsPage 4 of 17Printed or electronic versions of this document not accessed directly from the designated XXXXX Controlled Quality Information System are For Reference Only.1. Basic information1.1 Software identificationProduct Name:
8、Project Name:Model:Version number:Manufacturer: XXXXXManufacturing address:1.2 Software safety classificationThe overall software safety class of the XXXXX software is Class B according to IEC 62304:2006.MeaningiSoftware Safety ClassNo in jury or damage to health is possibleANon-serious injury is po
9、ssibleBDeath or serious in jury is possibleCTable 1 Major Level of Concern1. Does the Software Device qualify as Blood Establishment Computer Software?No2. Is the Software Device inten ded to be used in comb in ati on with a drug or biologic?No3. Is the Software Device an accessory to a medical devi
10、ce that has a Major Level of Con cer n?No4. Prior to mitigation of hazards, could a failure of the Software Device result in death or serious in jury, either to a patie nt or to a user of the device?Noa. Does the Software Device control a life supporting or life susta ining fun cti on?Nob. Does the
11、Software Device control the delivery of potentially harmful en ergy that could result in death or serious in jury, such1 Acc. to IEC 62304:2006 clause 4.3Document Description: Software Description Document for XXXXX Series of MonitorsPage 5 of 17Printed or electronic versions of this document not ac
12、cessed directly from the designated XXXXX Controlled Quality Information System are For Reference Only.as radiati on treatme nt systems, defibrillators, and ablati on gen erators?Noc. Does the Software Device control the delivery of treatment or therapy such that an error or malf un cti on could res
13、ult in death or serious in jury?Nod. Does the Software Device provide diagnostic information that directly drives a decisi on regard ing treatme nt or therapy, such that if misapplied it could result in serious in jury or death? Noe. Does the Software Device provide vital sig ns mon itori ng and ala
14、rms for potentially life threatening situations in which medical in terve nti on is n ecessary?YesTable 2 Moderate Level of Concern1. Is the Software Device an accessory to a medical device that has a Moderate Level of Con cer n?No2. Prior to mitigation of hazards, could a failure of the Software De
15、vice result in Minor In jury, either to a patie nt or to a user of the device? No3. Could a malf un cti on of, or a late nt desig n flaw in, the Software Device lead to an err on eous diag no sis or a delay in delivery of appropriate medical care that would likely lead to Mi nor Injury?Yes1.3 Configuration and functionality1.3.1 Isolation Block DiagramFigure 1 Isolation Block Diagram of PMP1.3.2 Hardware/Communication InterfacePlease refer to the Block Diagram under section 1.4.Document Description: Software Descript
