Our labs are cGMP-compliant, FDA registered, DEA registered and ISO/IEC 17025:2005 accredited.
Pace Analytical Life Sciences • 1311 Helmo Ave. N • Oakdale, MN 55128 P: 651.738.2728 • F: 651.714.9360 • www.pacelifesciences.com
LIFE
SCI
ENCE
S |
EVA
LUAT
ION
OF
MED
ICA
L DE
VICE
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EVALUATION OF MEDICAL DEVICESPace Analytical Life Sciences (PLS) offers analytical chemistry and biocompatibility testing for the qualitative and quantitative chemical and biological evaluation of medical devices. We understand that bringing innovative medical device technology to the global marketplace is a major financial investment and high-risk venture. Pace provides comprehensive testing capabilities and reliable test data in a timely and cost-effective manner. PLS offers testing services to evaluate the safety, purity, performance and toxicology of medical devices.
Medical Device Tests• General ISO Compliance ........................................................................... ISO 10993-1
• Genotoxicity in vitro testing (coming in 2018) ......................................ISO 10993-3
• Hemocompatibility in vitro testing .........................................................ISO 10993-4
• Cytotoxicity in vitro testing ......................................................................ISO 10993-5
• Implantation in vivo testing ......................................................................ISO 10993-6
• Ethylene Oxide Sterilization Residuals .................................................. ISO 10993-7
• Irritation and Sensitization in vivo testing .......................................... ISO 10993-10
• Systemic Toxicity in vivo testing .......................................................... ISO 10993-11
• Sample extraction and preparation ..................................................... ISO 10993-12
• Degradation products from polymeric medical devices .................. ISO 10993-13
• Degradation products from metals and alloys ................................... ISO 10993-15
• Toxicokinetic study design ..................................................................... ISO 10993-16
• Toxicological assessment for leachable limits .................................. ISO 10993-17
• Material / Chemical Characterization .................................................. ISO 10993-18
• Extractables / Leachables Testing
• Drug Release / Elution / Dissolution Profiles
• Assay and Impurity Profiles
• Physical / Functional Testing
• Surface Cleanliness
- Total Particulates
- Bacterial Endotoxins
- Bioburden
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pace analytical life sciencesnew jersey laboratory
12 WORLDS FAIR DR SOMERSET, NJ 08873 P: 651.738.2728F: 651.714.9360
pace analytical life sciences minnesota laboratory
1311 HELMO AVE. N OAKDALE, MN 55128 P: 651.738.2728 F: 651.714.9360
wolfe laboratories a subsidiary of pace analytical life sciences
19 PRESIDENTIAL WAYWOBURN, MA 01801 P: 781.305.4940 F: 781.305.3780
Working Together to Protect Our Environment,and Improve Our Health.
Biocompatibility and Chemical Characterization Test Matrix:Medical device categorization by: Testing Endpoints
Nature of Body Contact
Phys
ical
and
/or C
hem
ical
Info
rmat
ion
Cyto
toxi
city
Sens
itiza
tion
Irrita
tion
or In
tracu
tane
ous
Reac
tivity
Mat
eria
l-Med
iate
d Py
roge
nici
ty
Acut
e Sy
stem
ic T
oxic
ity
Suba
cute
Tox
icity
Subc
hron
ic T
oxic
ity
Chro
nic
Toxi
city
Impl
anta
tion
Effe
cts
Hem
ocom
patib
ility
Geno
toxi
city
Carc
inog
enic
ity
Repr
oduc
tive/
Deve
lopm
enta
l Tox
icity
Degr
adat
ion
Prec
linic
al S
afet
y St
udy
(Lar
ge A
nim
al)
Category Contact Duration of contact*
Surface device
Intact skin
Limited
Prolonged
Permanent
Mucosal membrane
Limited
Prolonged
Permanent
Breached or compromised
surface
Limited
Prolonged
Permanent
External communicating
device
Blood path, indirect
Limited
Prolonged
Permanent
Tissue/bone/dentin
Limited
Prolonged
Permanent
Circulating blood
Limited
Prolonged
Permanent
Implant device
Tissue/bone
Limited
Prolonged
Permanent
Blood
Limited
Prolonged
Permanent
= Available at Pace now = In vitro available at Pace in future = Available through subcontractor = Prerequisite information needed for risk assessment
= Endpoints to be evaluated in the risk assessment
* Limited = ≤ 24 hours; Prolonged = ≥ 24 hrs to ≤ 30 days; Permanent = > 30 days
Primarily reproduced from the public review copy of proposed ISO 10993-1:2017 revision. www.standards.aami.org
Life Sciences_Evaluation of Medical Devices