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

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S |

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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

www.pacelifesciences.com

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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