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Than!"o for downloading the$ll %n &ne Template'
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T$829 & ,&.T9.TS
1 %ntrodction 1.1 Document overview 31.2 Scope 31.3 Abbreviations and Glossary 31.4 References 31.5 onventions 3
7 Proect (anagement ;2.1 !eam " #uman resources 52.2 Responsibilities 52.3 ustomer $%ser involvement 52.4 !as&s " 'lannin( $ )ilestones 52.5 *n(ineerin( environment 52.+ ,t#er Resources 5
2.- Software life cycle model 52. Reviews 52./ Software con0(uration mana(ement +2.1 Documentation mana(ement +2.11 eri0cation +
Speci6cations <3.1 States -3.2 'erformance -3.3 Safety security and privacy protection -3.4 %ser maintenance -3.5 %sability and #uman$factors en(ineerin( -3.+ System environment -3.- *ternal interfaces -
3. Resources 3./ nternal data 3.1 Adaptation 3.11 eri0cation 3.12 'ersonnel and trainin( 3.13 'ac&a(in( and installation
4 $rchitectre = ,onception > 4.1 Arc#itecture / 4.2 onception /
; Veri6cation 105.1 !est 'lan 15.2 !ests Description 1
? Tests )eslts 17+.1 Rationale for decision 12+.2 Results 12
< )e@irements tracea-ilit" 1
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1 %ntrodction
$ummary: This is the all-in-one template for soft#are de&elopment
This template doesnt co&er the ris" managementt is )lled incrementally during the proect. suggest incrementing the &ersion number #hen a chapter is full:
• 3e&1: chapter 1 4 2• 3e&2: chapter 5 4 • 3e&5: chapter • 3e&: chapter 6
Chapter , is )lled in re&ision 1 and re&ision 2.
1.1 Document overview
This document contains the organi7ation* the speci)cations* the conception* and&eri)cation tests of 888 soft#are de&elopment proect.t co&ers the follo#ing goals:
• 888.
1.2 Scope
171 %denti6cation
This document applies to the 888 de&ice9s de&eloped in the 888 proect.
177 &verview
'roect !&er&ie#
1.3 Abbreviations and Glossary
11 $--reviations
;dd here abbre&iations
17 Alossar"
;dd here #ords de)nitions
1.4 References
141 Proect )eferences
< %ocumentdenti)er
%ocument Title
=31> % ;dd your documents references.!ne line per document
147 Standard and reglator" )eferences
< %ocument
denti)er
%ocument Title
=$T% ;dd your references
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1>
1.5 onventions
3e?uirements listed in this document are constructed according to the follo#ingstructure:
)e@irement %d
Requirement title
3e?uirement description
3e?uirement &ersion
@Aample:
S)S!XXX!000
Title of XXX-000 requirement
%escription of 888-000 re?uirement
Bersion of 888-000
Typographical con&ention.;ny other con&ention.
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7 Proect (anagement
or each of the sub-sections* if you already ha&e a $!' in your DM$ that co&ersthe topic* add a reference to the $!'* and a little eAplanation if necessary.
The section describes the organi7ational structure of the 888 proect.
2.1 !eam " #uman resources
The team is described in the diagram belo#.
2.2 Responsibilities
The team of the proect has the follo#ing responsibilities:
• Technical (anager: 888
• Proect (anager: 888
• XXX
2.3 ustomer $%ser involvement
%escribe ho# the end user is in&ol&ed in the soft#are de&elopment: meetings*re&ie#s* and presentations of intermediate &ersions E
The customer may or may not be the end-user
2.4 !as&s " 'lannin( $ )ilestones
The planning belo# contains all tas"s of the proect and the lin"s bet#een tas"s.nsert a table or list or diagram describing the planning.
2.5 *n(ineerin( environment Fhat "ind of #or"station / ser&er do you use and e&ery other hard#are.
2.+ ,t#er Resources
f speci)c resources are need for the proect such as a calibrated measurementtool or a simulator* they shall be identi)ed* referenced and managed incon)guration.f not* add the follo#ing sentence
There is no particular resource needed for the proect such as a calibratedmeasurement tool or a simulator. +ence* no speci)c identi)cation of resources isneeded for the proect* the hard#are and soft#are resources are interchangeableC!T$.
2.- Software life cycle model
Faterfall / 3G' / ;gile* ?uote your model
2. Reviews
The proect begins #ith a launch re&ie# and ends #ith a )nal re&ie#. T#o types or re&ie#s occur during the proect:
• %esign 3e&ie#s
• Tests 3e&ie#s
2anch )eview is a formal* documented and systematic meeting during #hichthe proect team members get ac?uainted #ith the goals of the proect and allother information contained in the management plan.
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Design )eviews are formal* documented and systematic meetings during #hichthe current design of a product 9system* sub system etc. is re&ie#ed andcompared #ith the re?uirements. %esign 3e&ie#s are scheduled in the proectplanning. The obecti&e of %esign 3e&ie#s is to critically appraise the design and
de&elopment in accordance #ith the re?uirement* and to con)rm and appro&etechnical aspects.Test )eviews are formal* documented and systematic meetings during #hichthe current design of a product is tested. Tests re&ie#s are scheduled in theproect planning.inal )eview is a formal* documented and systematic meeting during #hich the'resident/'roect manager/any other &alidates the 888 product 9see &alidationprocess in soft#are ?uality assurance plan ref. 8. The re&ie# contains also a partde&oted to the return on eAperience on progress of the proect and on theprocesses used during the proect.
2./ Software con0(uration mana(ement %escribe con)guration management: #hat tool do you use. Fhat are therepositories 9eg:#or"* integration* deli&ery* )nal.
2.1Documentation mana(ement
%escribe ho# documents are identi)ed* managed* stored* archi&ed. +o# theirre&isions are managed%escribe also the appro&al cycle@ach proect technical or management document is &eri)ed:
• Technical #ise* by a member of the team*
• Hy the ?uality manager
; member of the team appro&es each document.'roect meeting reports are &eri)ed by the attendants of the meetings.
2.11eri0cation
%escribe ho# &eri)cation is done and managed. 3e&ie#s* documentation E $eealso chapter
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Speci6cations
This chapter is an eAtract of the $oft#are 3e?uirements $peci)cations template.+a&e a loo" at the $3$ template to see some eAamples of re?uirements.
3.1 States
!! soft#are #or"s in three states:
• $tarting: the soft#are loads its componentsI
• n use: all the functionalities of the soft#are are a&ailable to the usersI
• $topping: the soft#are is being stopped.
• Maintenance: the soft#are is in maintenance mode
• ;nd so on E
;dd a diagram #ith states and transitions if necessary
3.2 'erformance
This is the core of your $3$. t contains the purpose of your soft#are eApressed intechnical re?uirementsFhat are its functionsFhat are the algorithms usedE
3.3 Safety security and privacy protection
This section is about soft#are features li"e con)dentiality* integrity control*reliability* and a&ailability. $ee Cyber$ecurity re?uirements of %; and +';;re?uirements if necessary
3.4 %ser maintenanceMaintenance functions 9logs* archi&es* E
3.5 %sability and #uman$factors en(ineerin(
The re?uirements here may ha&e traceability #ith result of 62566 standardimplementation
;1 (an machine interface la"ot
The layout of 888 is E.nstead of a do7en of teAt re?uirements* a moc"-up of the soft#are JG is &eryappreciated
;dd only re?uirements for #hich a description of layout/beha&iour is necessaryand/or re?uested by a user.
;7 Belp
The user guide is al#ays &ery important for medical de&ices. t may be online* inthis case add re?uirements here about the online help E.;n about #indo# is a good #ay to identify soft#are &ersionE.
3.+ System environment
f soft#are is integrated in a speci)c system* describe brieKy the system and addspeci)c re?uirements to #hich your soft#are shall comply
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3.- *ternal interfaces
This section describes hard#are and soft#are interfaces of the soft#are in thesystem
<1 Bardware interfaces
or '@M$/@lectro-medical %e&ices* add re?uirements about integration of soft#are and hard#are.
<7 .etwor interfaces
;lso add here communication and net#or"s stu* li"e '* #ireless* Hluetooth E
< Data echange
f 888 soft#are is in interface #ith other soft#are* describe here there?uirements on data eAchanges.
3. Resources
n #hat en&ironment runs the soft#are
C1 Bardware resorces
+ard#are re?uirements
C7 Software resorces
!$* libraries* eAternal programs re?uirements
3./ nternal data
f speci)c re?uirements for internal data* li"e databases* binary )les* Aml E
3.1Adaptation
f speci)c re?uirements adaptability of con)guration of soft#are
3.11eri0cation
$pecial functions to test the soft#are* if necessary. or eAample a hidden functionto acti&ate a log )le during beta tests
3.12'ersonnel and trainin(
3e?uirements about the capabilities/"no#ledge of users* the training the shallha&e before using soft#are
3.13'ac&a(in( and installation
3e?uirements about pac"aging* install shield E
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4 $rchitectre = ,onception
4.1 Arc#itecture
ot mandatory for class ;
411 $rchitectre overview
Ji&e a general description of the system* from the point of &ie# of the user :• n #hat en&ironment it #or"s 9home* near patient bed* operating room E• Fho the users are• Fhat it is for*• The main functions*• The main interfaces* inputs and outputs.
417 2ogical architectre overview
%escribe the top le&el soft#are components and their interactions/relationships.
Gse GML pac"age diagrams and/or layer diagrams and/or interface diagrams.%escribe also the operating systems on #hich the soft#are runs.
41 Ph"sical architectre overview
%escribe the hard#are components on #hich soft#are runs and theirinteractions/relationshipsGse components diagrams* deployment diagrams* net#or" diagrams* interfacediagrams
4.2 onception
;bsolutely not mandatory for class ;.Hut* if you #ant to do a better ob:f there are some parts that deser&e a more detailed conception* describe it here.@g: a speci)c algorithm* memory cache management* details about the use of aframe#or"* of a library* of a communication protocol* of a database modelE
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; Veri6cation
This chapter is mandator"3arning this docment maes the assmption that there is onl" one
test phase
5.1 !est 'lan
;11 Test environment
This section describes the en&ironment of tests* from the point of &ie# of yourorgani7ation and logistics.%escribe #here is located the test platform.%escribe the hard#are used to test your soft#are
dentify accurately the soft#are used for test :• !$Ns and ser&ice pac"s• !$ dri&ers 9if speci)c for you• Hac"up / reco&ery tools• Feb* blogs* CM$* %atabases engines*• Memory* dis" usage* C'G* and net#or" analysers*• Test co&erage or test management tools• $imulator* data generator of soft#are or hard#are that you dont ha&e• ;ny tiny 9or big soft#are made by you to do the tests
or simple proects* most of these may be tools pro&ided #ith the !$ 9df* du* ps*top* dmesg* tas"manager* control panel E* or consumer products 9M$ !Oce*open oOce E.
%escribe the sets of data used during tests. Their identi)cation* structure*content* location* storage* 9structure and content may already be described inthe conception documents*
• input )les*• data )les*• scripts to generate data*• !utput )les* log )les
%escribe #hich documentation is deli&ered for the tests 9eg this document*nstructions or Gse E* if it is printed or online.
f speci)c hard#are is re?uired : paper in eAotic format* a stop#atch* a ruler* a
compass* a #illy #aller 2006;nd also pi77as* bier* red bull* champagne E
;17 ,stomer/ ield test site
f your product is tested in a health care centre* or if your customer is a medicalde&ice manufacturer* ha&e in mind that you may pro&ide your customer #ithhard#are* soft#are* data and documentation. (ou may install it and maintain it.+is opening hours may be constrained* his personnel shall ha&e speci)c?uali)cations Ef you #or" directly #ith praticians 9of your medical ad&isory board* for eAample*#ho are going to test your product in their oOces* describe ho# tests
input/output data are managed* ho# tests logs and bugs reports are collected.
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5.2 !ests Description
;71 Test identi6cation and content
@ach test is uni?ue and contains:
• ; uni?ue identi)er*
• ; teAtual description of test obecti&e*
• The traceability of the re?uirement9s in P5*
• The &eri)cation method 9* ;* %* T*
• %ata recording* post-processing and analysis procedure*
• ;ssumptions and constraints* if any
• $afety* security and pri&acy concerns* if any.
The identi)er has the follo#ing structure:• %e)ne your o#n uni?ue identi)ers.•
or eAample* concat the chars QT-Q* the P5 re?uirement % being tested*Q-R* and an incremental number 9if more than 1 test is need to &erify there?uirement.
;77 Tests description
The traceability bet#een tests and re?uirements in P5 and tests belo# is listed inthe P, 3e?uirements traceability.; re?uirement may re?uire more than one test to be &eri)ed. n this case* itappears in all tests* #hich &erify it.
%escribe each test #ith the pattern belo#.or most of tests* only a subset of )elds in the table is used* mar" /; 9non
applicable the unused )elds.
Test %D T!)9E!001 Testdescription
$mall description
Beri)ed3e?uirement
$3$-3@D-001 Beri)cation method: *;*%*T
nitialconditions
The state of soft#are beforetest
(ou may reference a procedureor it may be the result ofpre&ious test
Tests inputs nput data from any test tool*
input )les name and location
(ou may reference a procedure
to use the test tool%atacollectionactions
3ecording and post processingof output data
(ou may reference a procedureto record data #ith a test tool
Tests outputs !utput data )les names andlocation* logs E
Ji&e uni?ue name out outputdata )les.
;ssumptionsandconstraints
f any* may be limited accessto a tool* license E
@Apectedresults andcriteria
List here the results of test ;nd the criteria to e&aluate theresult
Testprocedre
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Stepnm-er
&perator actions 9pected reslt andevalation criteria
1 $tart foo oo is started
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? Tests )eslts
+.1 Rationale for decision
;fter eAecuting a test* the decision is de)ned according to the follo#ing rules:• &F: The test sheet is set to S!S state #hen all steps are in S!S state.
The real result is compliant to the eApected result.• .&F: The test sheet is set to S!S state #hen all steps of the test are set
to S!S state or #hen the result of a step diers from the eApected result.• .&T )G.: %efault state of a test sheet not yet eAecuted.• .&T ,&(P29T9D: The test sheet is set to Sot CompletedS state #hen at
least one step of the test is set Sot 3unS state.
+.2 Results
Ji&e a fe# information about tests. The 888 soft#are 9&ersion A.y.7 #as tested on the AAA test platform located in
AAA* from the yyyy/mm/dd to the yyyy/mm/dd. The tests of the test phase 9ref.soft#are test plan #here eAecuted.
Testers #here: Uohn %oe* Marc $mith
3epeat the list of tests* #ith one more column named QresultR.n result* add ! or ! or ot 3un. f !* add a bug id.
Test %D T!)9E!001 &V9)$22 )9SG2T &F Testdescription
$mall description
Beri)ed
3e?uirement
$3$-3@D-001 Beri)cation method: *;*%*T
nitialconditions
The state of soft#arebefore test
(ou may reference a procedureor it may be the result ofpre&ious test
Tests inputs nput data from anytest tool* input )lesname and location
(ou may reference a procedureto use the test tool
%atacollectionactions
3ecording and postprocessing of outputdata
(ou may reference a procedureto record data #ith a test tool
Testsoutputs
!utput data )lesnames and location*
logs E
Ji&e uni?ue name out outputdata )les.
;ssumptionsandconstraints
f any* may be limitedaccess to a tool*license E
@Apectedresults andcriteria
List here the resultsof test
;nd the criteria to e&aluate theresult
TestprocedreStepnm-er
&perator actions 9pected reslt andevalation criteria
)eslt
1 $tart foo oo is started !
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< )e@irements tracea-ilit"
This table gi&es the traceability bet#een re?uirements and tests* and the methodof test.
The &eri)cation methods of the re?uirements are de)ned belo#:• nspection 9: control or &isual &eri)cation• ;nalysis 9;: &eri)cation based upon analytical e&idences• %emonstration 9%: &eri)cation of operational characteristics* #ithout
?uantitati&e measurement• Test 9T: &eri)cation of ?uantitati&e characteristics #ith ?uantitati&e
measurement
or each re?uirement of the $3$* a &eri)cation method is de)ned. Method isabbre&iated * ;* % or T.
or each re?uirement* there shall be at least one test.
)e@ %D )e@ la-el Test %D Test desc (eth
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