traditional 510k application - polymeric surgical mesh
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Healthmatrixtm
Macroporous
Polypropylene surgical Mesh
510(k) Premarket notification
Traditional 510(k)
By: Group 2
Ganesh Balachandar
Adriana Gavrilciuc
Nikhil Khanna
Gaurav Molankar
Thinn Soe
Healthmatrix
H M T
TableoSection 1
Section 2
Section 3
Section 4
Section 5
Section 6
Section 7
Section 8
Section 9
Section 10
Section 11
Section 12
Section 13
Section 14
Section 15
Section 16
HealthMatrixT
MacroporousTraditional 51
ofConten– 510(k) Cove
– Indications
– 510(k) Sum
– Class III Sum
– Financial C
– Declaration
– Executive S
– Device Des
– Substantial
0 – Proposed
1 – Sterilizatio
2 – Biocompa
3 – Performa
4 – Package V
5 – Risk Analy
6 – List of App
TM Polypropylen10(k)
ntser Letter .......
s for Use State
mmary or 510
mmary and C
ertification o
ns of Conform
Summary ......
scription ........
l Equivalence
Labeling ......
on and Shelf
atibility .........
nce Testing a
Validations ....
ysis ...............
plicable Stand
ne Surgical M
.....................
ement ...........
(k) Statement
ertification ...
r Disclosure S
mity and Sum
.....................
.....................
Discussion ...
.....................
Life ...............
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nd Product C
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dards and Ref
Mesh
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Statement .....
mary Reports
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Company Confidential
H M T
ListofTable 1:
Table 2:
Table 3:
Table 4:
Table 5:
Table 6:
Table 7:
Table 8:
Listof
Figure 1:
Figure 2:
Figure 3:
Figure 4:
Figure 5:
Figure 6:
Figure 7:
Figure 8:
HealthMatrixT
MacroporousTraditional 51
TablesDevice Com
Biocompatib
Materials/B
Device Com
Substantial E
Package Va
Risk Analys
Risk Index T
Figures
: Microscopi
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tion ..............
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.... 24
Company Confidential
H M T
Section
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Section
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Company Confidential
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Tests Cytotoxi
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Company Confidential
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Section
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indirect HealthMprovidingframe althe prodalso be methods Polypropcut into preferenc
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H M T
Section
Date of P
Trade N
Common
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n9–Subs
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te:
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ed Use HPinrefaadnoafsprere
ess 25
ize 24
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TM Polypropylen10(k)
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ntended to aseinforcementascial defectdditional suponabsorbablfter wound hpecifically neconstructionepair and or
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Company Confidential
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Question
Is the necomparemarkete
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Are the dcharacteenough tsubstantequivale
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n
ew device ed to a ed device?
e new devicee same on statemen
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orous pylene
Company Confidential
H M T
Conclusi
The charour predimesh forcharacterBoth the Finally, tlabel is p
HealthMatrixT
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ion:
racteristics oicate VitaMEour product
ristics. Our ddevices hav
the packaginpresented in t
TM Polypropylen10(k)
f HealthMatESH™ in allt is the samedevice and pve passed all ng and labelithe followin
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trix™ Macrol of the abov as our prediredicate are the biocompng of our deg section alo
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gical mesh ahe knitting oiting equivalzed by EO (ests that were valent to our
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r predicate; ainsert.
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Company Confidential
H M T
Section 10.1 She10.2 She10.3 She10.4 Ove10.5 Pou10.6 Pack HealthMoverwrappackage 10.1 She
HealthMatrixT
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lf box – Fronlf box – Baclf box – Side
erall view of uch label kage insert
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abeling
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Company Confidential
H M T
10.2 She
10.3 She
HealthMatrixT
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lf box - Bac
lf box - Side
TM Polypropylen10(k)
ck part
Figure
e parts
Figure
ne Surgical M
4: Labeling
5: Labeling
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g on back pa
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rts of shelf
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Company Confidential
H M T
10.4 Ove
HealthMatrixT
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erall view of
TM Polypropylen10(k)
f the shelf b
Figure
ne Surgical M
box
e 6: Overall
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Company Confidential
H M T
10.5 Pou
HealthMatrixT
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uch label
TM Polypropylen10(k)
ne Surgical M
Figure
Mesh
7: Pouch laabel
Company Confidential
H M T
10.6 Pac
HealthMatrixT
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ckage insert
TM Polypropylen10(k)
ne Surgical M
Figure 8
Mesh
: Package IInsert
Company Confidential
H M T
Section
11.1 Ster
The steriRequiremDevices: Sterilizat“Sterilizavalidation
Since oudesigneddaily dos30 days, mg in fir
The EO sof 10-6 anintegrity,utilizing repeat exthe actua
The validThe biollimits oflevels areacceptanmade ava
11.2 She
HealthMdate of stF1980 “SA real tim
The valid
HealthMatrixT
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n11–Ste
rilization
ilization valments for m
Part 2: Ttion dose ation of healn and routin
ur HealthMad for permanese of EtO doand 2.5g lifst 24 hours,
sterilization nd three con, acceptable the most rea
xposure. Theal exposure le
dation reportlogical testinf biological e acceptablece criteria. Tailable upon
lf Life
MatrixTM Macterilization. TStandard Gume testing pr
dation report
TM Polypropylen10(k)
rilization
lidation is inmedical devTest of ster
has been lth care prod
ne control of
atrixTM Macent contact,
oes not exceefetime). For 60 mg in fir
validation cnsecutive full
residual levalistic simulae simulated-evel to patie
t is not inclung, Pyrogencontaminan
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croporous PoThe acceleraide for Accerogram will
t is not inclu
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nandShel
n accordancvices labeledrility perform
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rst 30 days, 5
consisted of l cycle runs vels, and noated challeng-use extractioents. All of th
uded in this sn testing andnts. Heavy mcluded in thf the test rep
olypropyleneated aging stelerated Aginbe conducte
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lfLife
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submission, b
N556- SteriliISO 11737-lidation of dance with-- Part 1: Reor medical d
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mg in first y dose does ne.)
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but will be mn were perf
ual and mann report, as bt included in
Mesh has a shperformed, i
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but will be m
ization of m-2: Steriliza
sterilizationh AAMI/ANequirements devices.”
Mesh is arate that the 24 hours, >6not exceed 2
cycle runs too confirm pr
sed simulaterder to calculdated in ordeable upon req
made availaformed to enufacturing rbased off ofn this submi
helf life of 5 in accordancstems for Meted results.
made availab
medical deviation of Men Process.”NSI/ISO 1for developm
a medical dpatient’s av60 mg in the2 mg per da
o confirm an roduct and p
ed-use extraclate the effecer to demonquest.
able upon reqensure accepreagents resf in-house teission but ca
years from tce with ASTMedical Devic
ble upon req
ices - edical
The 1135, ment,
device erage e first ay (12
SAL pouch ction, cts of strate
quest. ptable sidual esting an be
the M
ces.”
quest.
Company Confidential
H M T
Section
12.1 Gen
HealthMthereforeensure sathe bioco10993-12any toxic
The follo
Tests Cytotoxi
Irritatio
Sensitiza
Pyrogen
Haemoc
Genotox
Acute SyToxicity SubchroChronic Implanta
15.2 Test
All the bextract w
Cytotoxieffects ofcan be coreport ca
HealthMatrixT
MacroporousTraditional 51
n12–Bio
neral Descri
MatrixTM Mace it has directafety and effompatibility 2. This evaluc effects that
owing table s
icity
n
ation
icity
ompatibility
xicity
ystemic
onic and Toxicity
ation
t Details
iocompatibiwas prepared
icity – This tf mesh on groncluded than be provide
TM Polypropylen10(k)
ocompatib
iption
croporous Pot invasive co
ficacy. The bmatrix fromuation includt the device m
summarizes
MethodTest by
IntracutInjectioMagnuMaximLAL
y Extract
ChromoAberratTest usextract Test usextract Direct iof mesh
lity tests werat X degree
test is perforrowth of bodat our surgicaed upon requ
ne Surgical M
bility
olypropyleneontact with thbiocompatib
m U.S. FDA Bdes tests permay cause to
the tests per
d y direct conta
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mization Test
t test
osomal tion test ing fluid
ing fluid
implantationh
re done accoes Celsius for
rmed throughdy cells. Theal mesh is nouest.
Mesh
e Surgical Mhe patient. B
bility tests haBlue Book Mrformed on oo body cells
rformed, met
Animaact Cellula
Rabbit
an Guinea
In plate
Rabbit
Cellula
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Rat
n Rabbit
ording to ISOr Y hours, fr
h the direct ere was no sion-cytotoxic
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thods, and re
al Star IS
5:t IS
10a Pig IS
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6:IS11IS11
t IS6:
O 10993 stanrom cottonse
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manent surgbility has beerformed in com G95-1, ISypropylene mnt.
espective res
tandard SO-10993-:1999 SO-10993-0:2010 SO-10993-0:2010 SO-10993-1:2006 SO-10993-:2002 SO-10993-:2007 SO-10993-1:2006 SO-10993-1:2006 SO-10993-:2007
ndards. Our eed oil.
hod to evaluell damage, aells. The cop
gical implanten evaluated ompliance wO 10993-1 a
mesh to verif
sults:
Resulpass
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pass
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pass
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test sample
uate any toxiand thereforpy of the test
t and to
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Company Confidential
H M T
IrritatioSurgical observedresults inthe test re
Sensitizato determbody andThe resulreport ca
Pyrogen(endotoxnon-pyro
Haemoccaused byhaemogloupon req
Genotoxdetect visgenotoxi
Acute Syour deviclocation. hours aftmice; therequest.
Subchrothat our dextract inreport. Thtoxic. Th
Chronic device minjected iafter a sin
HealthMatrixT
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n – This waMesh. The e
d every 24 hondicate that oeport can be
ation – The Gmine potentiad body fluidslts indicate tn be provide
icity – This xin-mediatedogenic. The c
ompatibilityy our producobin, and theuest.
xicity – This sible aberratc. The copy
ystemic Toxce might havWe used a fer a single d
erefore, our p
onic Toxicitydevice mightnjected into rhe results in
he copy of th
Toxicity – Tmight have on
into rats. Thngle dose or
TM Polypropylen10(k)
s performed extract was iours for 72 hour macropo provided up
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test was perd) on our testcopy of the t
y – This testct extract. Reerefore is ha
test was pertions. The reof the test re
xicity – This ve on body ofluid extract
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cal tissue rea the rabbit ming injectionopylene mes
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action to Hemodel, whosens (scored fosh material is
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s Amebocytesults indicat
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rmine the degproduct causpy of the tes
ese hamster ations; therefpon request.
determine anre remote froAcute test ti
dicated no ace test report
mine any poall body phys90 days. Doe mice; thereequest.
ne any possibphysiology. er than 10% st report. Th
ealthMatrix Pe skin sampl
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(MEM) Tesect internal cskin sensitizaergenic. The
e Lysate) LAte that our suuest.
gree of red bed no cell ly
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ovaries (CHfore, our pro
ny possible aom the site oimeframe wcute systemican be prov
ossible subchsiology. Wesage is clarifefore, our pr
ble chronic tWe used a fof the anima
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Polypropylenle area was and edema).
nt. The copy
st was perforcontact with ation respone copy of the
AL method urgical mesh
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Company Confidential
H M T
chronic tbe provid
Implantaimplantatdirectly cpoints: 2 tissue reaevidencepolymers
Carcinogproduct i
12.3 Con
The biocdevice isthe tests Evaluatiosutures a
HealthMatrixT
MacroporousTraditional 51
oxicity in thded upon req
ation – Thistion of the mcorrelated toweeks, 8 we
action was sc of device ms at new anat
genicity – Tis non-genot
nclusion
ompatibility non-toxic aare in accordon of Medicand mesh hav
TM Polypropylen10(k)
he mice; therquest.
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This test was oxic.
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ne Surgical M
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rformed to dte for implanbdominal herweeks, in wur product wnew locationThe copy of
not required
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determine anntation was irnias. The te
which the testwas determinns in the bodf the test repo
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he material uological tissucompatibilitation and Tetory of safe
n-toxic. The
ny pathologicin the abdomest was condt site was cloned to be nondy, or the forort can be pr
notoxicity te
used in the dues consistenty guidance oesting.” Addclinical use
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est results ind
design and mnt with their on ISO 1099itionally, poas an implan
test report c
ons due to of the rabbitmultiple timeored. The lohere was alsnwanted n request.
dicated that o
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Company Confidential
H M T
Section
13.1 Gen
AccordinPremarkeand perfo
Charact
Compos
Pore size
Thickne
Rigidity/(Fmax NBall bur
Tensile Snormal (Tensile Sparallel Suture rnormal (Suture rcross (FmTear res(Fmax NCorrosio
Lifetime
HealthMatrixT
MacroporousTraditional 51
n13–Per
neral Descri
ng to guidaet Notificatioormance ben
eristics
ition
e (microns)
ss (microns
/Stiffness N)
st (Fmax N)
Strength (Fmax N) Strength (Fmax N)
retention (Fmax N) retention max N) sistance N) on testing
e Fatigue Te
TM Polypropylen10(k)
rformanc
iption
ance documon Applicati
nch tests wer
HealthMacropPolyprSurgicaKnit Po
2410
) 250
5.2
) 344.3
28.8
32.8
35.6
34.2
33.7
Pass
est Pass
ne Surgical M
eTesting
ment for surion for a Surre performed
MatrixTM porous opelene al Mesh olypropylene
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gandProd
rgical meshrgical Mesh”d. The results
VitaMMacSurg
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h, “Guidance” the follows are summa
MESHTM roporous P
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Biocompat. SO 10993-2010 6
of a ations able.
Company Confidential
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13.2 Test
Rigidity/
Rigidity/polypropMethod ftabulatedresults fo
(Data Ins
Ball Bur
Ball bursdesign, sto ASTMRate-of-Tthey are below:
(Data Ins
Tensile/S
Suture pudesign, toverify thaccordanSheeting
The sutuapparatusresults artest resul
(Data Ins
Tear Res
Tear RepolypropThis test Strength
HealthMatrixT
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t Details
/Stiffness Te
/Stiffness tepylene designfor Stiffnessd above, to or repeated it
serted Here)
rst Testing
st testing wince it exhib
M D3787 - 0Traverse (CRconsistent w
serted Here)
Suture Test
ull out testino ensure that
hat the fabrince to ASTM”.
ure test was s. It was alsore tabulated alts for repeat
serted Here)
sistance Tes
esistance Tepylene design
was performof Fabrics b
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esting
esting was n. The testin of Fabric byshow that t
terations are
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etermine thein accordan
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the ring anvidual fiber. y are consiste
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h of our knithe hernia areed in vivo. od for Tensi
nd the sutureThe tensile ent with our
he strength stand tearing - 11 “Standure (Constan
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macroporousting was dotrength of Ttabulated ablts for repea
t macroporouea. The test wThis test w
ile Propertie
e to failure strength and
r predicate’s
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knit macropo08 “Standardiffness resultrmation. The
us polypropyone in accordTextiles-Consbove, to showated iteration
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was performees of Thin P
in a tensiled suture reteinformation
nit macropoperienced in ethod for TeExtension Te
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Company Confidential
H M T
Testing Mconsisten
(Data Ins
Corrosio
Testing fwithin inoffers exaccordingin our rePart 13: Devices”oxidativeactivity. and testepasses thbelow:
(Data Ins
Lifetime
Lifetime surgical withstandASTM Etesting inrepeated
(Data Ins
13.3 Con
Bench tehas mechpredicate
HealthMatrixT
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Machine).” nt with our p
serted Here)
on Testing
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e device.
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to determinpropylene is tance, as wresistance prSO 10993-1antification at our produous environnce with ourosion whilend it is non-
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hat HealthMharacterizati
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mine the abith the other d in vivo. Tor Strain-Coct passes the
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Company Confidential
H M T
Section
TEST
Vibratio
Drop con
Compre
Impact T
Biocomp
HealthMatrixT
MacroporousTraditional 51
n14–Pac
on Testing
nditioning
ssion Testin
Testing
patibility Te
TM Polypropylen10(k)
ckageVal
ng
ests
ne Surgical M
idations
Table 6: P
PURPOSE
To evaluatevibrations opackaging ainside the p
To evaluatebox and its protecting tthe box from
To evaluatepackaging bcompressivits distribut
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ackage Vali
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e the effects on the interioand the comp
package
e the ability oinner materi
the componem a sudden f
e the ability obox to withse box forcesion
e the forces oountered durg or on of the d the ability protect its co
hat the mateaging doesnffect on the may make it
ompatible
idation
ST
of or of ponents
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of tand
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TANDARD
STM: D472or Random Vf Shipping C
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