FOR WUXI APPTEC USE ONLY

 

 

PAYMENT METHOD (required)

A signed print copy of this form must be included in your shipment.
Be sure to complete all fields as appropriate. You will receive an
automatic warning if your form is incomplete when you try to print.
NOTE: Submitting an incomplete form will result in a testing delay.

 

WARNING:  This form is incomplete / missing required information.
Submitting an incomplete form to WuXi AppTec will delay your testing.

If you need assistance, contact your Account Manager or Project Manager.

 

To print/save, always use the Print/Save button at the bottom of this form.
This will help ensure your form is not incomplete/missing required information that could delay your testing.

 

QUOTE NUMBER (QUO - ##### - ###### - #)

 

QUO - - -

SHIP TO: WuXi AppTec • 2540 Executive Drive • St. Paul, MN 55120

(1) 651.675.2000 TOLL FREE 888.794.0077

 

CLIENT INFORMATION

 

Account Number (required):

COMPANY NAME • STREET ADDRESS • CITY / STATE / ZIP • COUNTRY

*EDITED*

CONTACT NAME

PHONE

EMAIL

 

 

REQUESTED TESTING

CLICK HERE to access our "Services for Medical Devices Catalog"

 

TEST CODE

TEST NAME

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

REQUESTED TESTING

CLICK HERE to access our "Services for Medical Devices Catalog"

 

TEST CODE

TEST NAME

NLI #

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

Check here if more space is needed to list requested testing. An additional page – with space for continued test listings – will be added.

 

FORM-01351.04

WuXi

• Page 1 of 4

Effective Date: 11.06.17

 

REQUESTED TESTING

 

 

TEST CODE

TEST NAME

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

REQUESTED TESTING

 

 

TEST CODE

TEST NAME

NLI #

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

 

   

 

 

FORM-01351.04

WuXi

• Page X of Y

Effective Date: 11.06.17

 

TEST ARTICLE INFORMATION

 

QUANTITY OF TEST ARTICLES SUBMITTED:

 

CLICK HERE for Sample Requirements Guide

TEST ARTICLE NAME [As to be described on the final report]

LOT NUMBER:
Various (LIST ATTACHED)               N.A.

Limit of 25 characters for lot number. To provide unique identifiers or other information that needs to be specified in test article information for the final report, enter in “Test Article Name” space above.

EXPIRATION DATE:

Various (LIST ATTACHED)

PHYSICAL DESCRIPTION [As to be described on the final report]

INTENDED USE / APPLICATION

PHYSICAL STATE

 

SAFETY PRECAUTIONS

 

CONTROLLED STORAGE CONDITIONS

 

STERILIZATION EXPOSURE

Has test article been exposed to a sterilization process?    Yes    No

  

STERILITY STATUS OF TEST ARTICLE

 

Select one of the four options shown.

 

NOTE:

Per ISO 10993-1, testing is to be performed on final product (including sterilization processing).

Test article submitted sterile. To be tested as is.

Test article consists of both sterile and non-sterile components. To be tested as is.

Test article is not sterile. To be tested non-sterile.

Test article is not sterile. WuXi AppTec to expose to a sterilization cycle. Additional fees apply.

       

 

For GLP studies (required by US FDA)

 

TEST ARTICLE CHARACTERIZATION

 

Sponsor affirms test article has been characterized or that characterization testing is planned.

 

Sponsor is solely responsible for all test article characterization data as required in Good Laboratory Practices (GLP) regulations (21CFR58) – identity, strength, stability, purity, and chemical composition. Sponsor is also responsible for ensuring that test article here submitted is representative of the final product that will be subjected to materials characterization.

 

TEST ARTICLE DISPOSITION

 

Courier and account # for shipping:

(Required for returns)

(NOTE: Additional fee may apply for returns.)

 

FORM-01351.04

WuXi

• Page 2 of 4

Effective Date: 11.06.17

 

TEST ARTICLE HANDLING & PREPARATION

 

Preparation Requirements / Instructions

N.A.

Can the test
article be cut?

 

 

 

NOTE: Hemocompatibility testing typically requires the test article to be cut.

Is test article

absorbent?

 

NOTE: Entire article will be tested unless information is provided here as to materials/components
to be included/excluded for testing.

 

 

 

EXTRACTION PARAMETERS

 

N.A.

 

If requested tests require extraction, this entire section must be completed by Sponsor. For assistance, call 651-675-2000, Option #5.

 

 

 

NS = Normal Saline

SO = Sesame Oil

AS = Alcohol Saline

PEG = Polyethylene Glycol

PBS = Phosphate Buffered Saline

DMSO = Dimethyl Sulfoxide

 

TYPE OF EXTRACT

EXTRACTION RATIO

 

 

 

 

 

 

Per ISO 10993-12, a surface area ratio should be used whenever possible rather than a weight ratio.

The “surface area” includes the combined areas of all sides of the test article and excludes indeterminate surface irregularities.

EXTRACTION CONDITIONS

 

Cytotoxicity: 37°C / 24 hrs

 

All other extraction testing:

 

Conditions recommended for most devices: 50°C / 72 hrs

 

 

Cytotoxicity: Culture Media

 

Sensitization • Irritation • Acute Systemic Toxicity • Mouse Micronucleus:

LLNA • Ames • Mouse Lymphoma • Chromosomal Aberration:

 

 

Extraction conditions are based on an exaggeration of product use. For insoluble materials, use highest temperature possible without causing degradation of material.

 

Select “NS & PEG” for materials incompatible with DMSO.

Select “NS & DMSO or NS & PEG” if DMSO compatibility unknown. WuXi AppTec to determine extract.

 

Subacute/Subchronic Toxicity:

 

 

 

FOR HEMOCOMPATIBILITY TESTS

(incl. Hemolysis, PTT, P&L Counts, IVT Hemo, PT and Complement Activation)

N.A.

 

Test blood-contacting portions ONLY (per ISO 10993-4)

 

NOTE: Entire article will be tested unless box is checked.

Specify blood-contacting components/materials to be tested:

 

 

PTT (Partial Thromboplastin Time):

RATIO:

Platelet & Leukocyte Count and
IVT Hemocompatibility:

RATIO:

 

Complement Activation and
PT (Prothrombin Time): 

RATIO:

 

ASTM Hemolysis

 

TYPE OF EXTRACT: PBS

 

RATIO:

 

CONDITIONS

 

Direct Contact: 37°C / 3 hrs

 

Extract Method: 

 

FOR MHLW (Japan) TESTS

 

N.A.

Extraction parameters for MHLW tests are the same as for ISO/ASTM except for the specific tests described here.

MHLW Genotoxicity and Sensitization

These tests are performed using exhaustive extraction method in methanol/acetone with terminal evaporation.

MHLW Cytotoxicity

 

Ratio:

MHLW Hemolysis

 

CONDITIONS:  

 

Check here if comparison/control article is being submitted. [If checked, you will see an additional section that must be completed.]

 

FORM-01351.04

WuXi

• Page 3 of 4

Effective Date: 11.06.17

 

COMPARISON / CONTROL ARTICLE

QUANTITY OF COMPARISON/CONTROL ARTICLES SUBMITTED:   

COMPARISON/CONTROL ARTICLE IDENTIFICATION [As to be described on the final report]

LOT NUMBER:
Various (LIST ATTACHED)               N.A.

Limit of 25 characters for lot number. To provide unique identifiers or other information that needs to be specified in test article information for the final report, enter in “Comparison/Control Article Identification” space above.

EXPIRATION DATE:

Various (LIST ATTACHED)

PHYSICAL DESCRIPTION [As to be described on the final report]

INTENDED USE / APPLICATION

PHYSICAL STATE

 

SAFETY PRECAUTIONS

 

CONTROLLED STORAGE CONDITIONS

 

SURFACE AREA       The “surface area” includes the combined areas of all sides of the article and excludes indeterminate surface irregularities.

Surface area of comparison / control article: cm2

STERILIZATION EXPOSURE

Has control article been exposed to a sterilization process?    Yes    No

  

STERILITY STATUS OF CONTROL ARTICLE

 

Select one of the four options shown.

 

NOTE:

Per ISO 10993-1, testing is to be performed on final product (including sterilization processing).

Control article submitted sterile. To be tested as is.

Control article consists of both sterile and non-sterile components. To be tested as is.

Control article is not sterile. To be tested non-sterile.

Control article is not sterile. WuXi AppTec to expose to a sterilization cycle. Additional fees apply.

       

 

COMPARISON / CONTROL ARTICLE HANDLING & PREPARATION

 

Preparation Requirements / Instructions

N.A.

Do NOT cut

Unless box is checked, article may be cut into sizes needed for testing.

 

NOTE: Hemocompatibility testing typically requires the article to be cut.

NOTE: Entire article will be tested unless info is provided here as to materials/components to be included/excluded for testing.

 

FOR HEMOCOMPATIBILITY TESTS

(incl. PTT, P&L Counts, IVT Hemo, PT and Complement Activation)

N.A.

 

Test blood-contacting portions ONLY (per ISO 10993-4)

NOTE: Entire article will be tested unless box is checked.

 

Specify blood-contacting components/materials to be tested:

 

PTT (Partial Thromboplastin Time):

RATIO:

Platelet & Leukocyte Count and
IVT Hemocompatibility:

RATIO:

 

Complement Activation and
PT (Prothrombin Time): 

RATIO:

 

COMPARISON / CONTROL
ARTICLE DISPOSITION

 

NOTE: Additional fee applies for returns.

Courier & account # for shipping:

(Required for returns)

 

FORM-01351.04

WuXi

• Page X of Y

Effective Date: 11.06.17

 

COMMENTS

 

 

 

Sponsor signature is required before testing will be initiated.

Services requested in this form will be governed in accordance with WuXi AppTec's “Standard
Terms and Conditions.” To the extent WuXi AppTec's Standard Terms and Conditions are in
conflict with an applicable agreement (Agreement) between Customer listed in this form and WuXi AppTec, such Agreement will govern.

 

 

 

To save an electronic
copy of this completed form, select Adobe PDF Writer or Microsoft XPS Document Writer in
your print dialog.

 

Always print a
hard copy to ship
with your samples.

TESTING AUTHORIZATION & PROTOCOL APPROVAL

 

 

 

 

SIGNATURE

 

PRINT NAME

 

DATE

 

Sponsor signature is required before testing will be initiated.

Services requested in this form will be governed in accordance with WuXi AppTec's “Standard
Terms and Conditions.” To the extent WuXi AppTec's Standard Terms and Conditions are in
conflict with an applicable agreement (Agreement) between Customer listed in this form and WuXi AppTec, such Agreement will govern.

 

 

 

To save an electronic
copy of this completed form, select Adobe PDF Writer or Microsoft XPS Document Writer in
your print dialog.

 

Always print a
hard copy to ship
with your samples.

TESTING AUTHORIZATION

 

 

 

 

SIGNATURE

 

PRINT NAME

 

DATE

 

 

For any test being conducted GLP:
By signing above, you acknowledge that you have reviewed the most
current version of the protocol(s) listed on this form and your signature constitutes
approval of the protocol(s). If you would like to review any or all of the protocols,
click here to email WuXi AppTec and indicate the protocol(s) you want to review.

 

 

An electronic copy of the report will be emailed to you after the study has been completed.

The PDF file of each report will be emailed to the contact name on this form after completion of each study.

 

FORM-01351.04

WuXi

• Page 4 of 4

Effective Date: 11.06.17