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Sponsor Information
Billing Information
Same As Sponsor
Sample Id / Lot #: (To be included in final report)
If this field's content does not fit in your generated PDF, please add it to an additional page with your submission.
Test Parameters
Per ISO 10993-1, Biocompatibility testing should be performed on the final finished device or the “as-used” state defined by the manufacturer specification and/or labeling. The final device state should include all manufacturing, cleaning, and sterilization (where applicable). Please confirm the device or materials submitted for testing represent the final product.
Surface Area (per test sample):
cm
2
NL to calculate
Please select the extraction ration to be used for testing:
3cm
2
/mL
6cm
2
/mL
0.2g/mL
0.1g/mL
1.25cm
2
/mL
Note: Complement Activation and PTT are performed using 6cm
2
/mL per the study protocol.
Product Sterilization Method:
Non-sterile
EO
Radiation
Steam
Other
Please confirm if the samples can be cut as needed for testing:
Yes
No
Test Samples:
Number of Samples sent:
Number of Samples to test:
Sample Preparation (Attach a photo for additional instructions)
List Part(s) of the test article that should be excluded
If this field's content does not fit in your generated PDF, please add it to an additional page with your submission.
List Part(s) of the test article that should be tested
If this field's content does not fit in your generated PDF, please add it to an additional page with your submission.
Special Instructions
If this field's content does not fit in your generated PDF, please add it to an additional page with your submission.
Test Information
STAT Testing (Extra Charge)
Controlled Substance (Extra Charge)
GLP (Extra Charge)
Check One:
I
II
III
IV
V
Biohazard
SDS: Check one:
Yes, Include w/shipment
N/A
Sample Disposition
Discard Samples
Return Samples
Return Shipping Container
Pickup
Shipping Condition
Ambient
On Ice
On Dry Ice
Return Data Logger
Sample Storage Condition
Room Temperature
Refrigerated (2 to 8°C)
Freezer (-10 to -25°C)
Freezer (≤ -70°C)
Other
Test Selection
Test Code
Study Name
Protocol #
Extractions Specifications
Direct Contact
Condition
Vehicle(s)
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
Yes
No
37°C for 24 hrs
37°C for 72 hrs
50°C for 72 hrs*
70°C for 24 hrs
121°C for 1 hr
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
MEM
NaCI
CSO
DMSO
EtOH
PEG
Culture Media
Ham's F12
SWFI
PBS
I agree to the
Website Terms of Use
, accept the
Service Terms
, and accept the
Privacy Policy
.
Print and
SIGN
the generated PDF and ship with your samples.
Biocompatibility Sample Submission Guide
Biocompatibility Sample Submission Guide
Thank you for choosing us for your testing. This guide will walk you through how to fill out the sample submission form.
If you have additional questions, the Service Center is here to help you. Please contact us by phone at +32/16.40.04.84 or by email to:
infoeurope@nelsonlabs.com
.
Ship Samples To
Select the location that you will be shipping the samples to. There is site-specific information that will populate on the form.
P.O. #
Provide your Purchase Order number. This number will be listed on your invoice. The PO should reflect the quoted amount for the services you are requesting.
Quote #
Provide the quote number you received from your account representative. If you are requesting services different than what was quoted or if the quote has expired, please contact your account representative for a new quote.
Number of Test Codes
Please indicate the number of different test codes you plan to submit. This will populate the correct amount of test samples for each test code. Maximum number allowed is 10. You can find these codes on your quote or the Nelson price list on our website in the form of three alpha characters followed by three numbers, for example: ABC123.
Courier Name & Account #
Provide your preferred courier and your account number if you elect to have your samples and / or shipping container returned (extra charge).
Sponsor Information
The information you provide here will be listed on the final report of the study, and the contact will be used as the contact throughout the study.
Billing Information
This will be where the invoice will be sent for payment. If it is the same as Sponsor Information, check the “Same as Sponsor” box, and it will automatically populate the information.
Test Code / Item #
Enter the test code / item #. The test code is listed as item # on your quote.
Test Description
Provide a brief description of the testing or the test name.
# of Samples Sent
How many total samples you sent (including any extras).
# of Samples to Test
How many of the samples you sent that you would like us to use for testing purposes.
Test Individually
This will produce a separate result for each sample (affects pricing).
Test Pooled
We will pool your samples together and produce one result for all samples pooled together.
# in Each Pooled Set
Use this box to indicate the number of samples you would like tested in each pooled set. (Example: 6 total samples, tested in two sets of 3 – enter 3 in this box.)
CSS#
Customer Specification Sheet (CSS) is an approval form that indicates specific testing details that supplement the Standard Testing Protocol (STP). Include the CSS# if you have one. Please note that a CSS# is required for all GLP studies, whether there are specific changes or additions to the STP or not.
Sample ID / Lot#
List your sample ID number and / or lot number the way you want it listed on your final report. This must match the ID number denoted on the physical samples. If additional space is needed for more information, please include that information on a separate attachment. This field is paragraph formatted (not a column table, so we advise against using bullet points).
Test Parameters
Check the necessary boxes and fill in any fields applicable to your samples and requested testing. For help determining test, contact sales@nelsonlabs.com.
Sample Preparation
Provide an image/diagram/photo of the device portions to be included in testing. List any portions of the device or packaging that should be removed and excluded from testing, and which portions of the device should be included. Add any disassembly instructions.
Test Information
Check the necessary boxes applicable to your samples.
Safety Requirement
For chemical / hazardous material safe handling and disposal, include SDS with each shipment. Schedule I and II controlled substances cannot be sent without prior notice and consent.
Sample Storage Condition
Check the appropriate boxes to indicate how you would like your samples to be stored while at our lab.
Shipping Condition
Check the appropriate boxes to indicate the condition of how you shipped your samples.
Sample Disposition
Check the boxes to indicate how you would like us to handle your sample disposition. If Discard Samples is checked, your samples will be disposed. If “Return Samples” is checked, your samples will be returned to the person listed in the “Sponsor Information” section per the courier listed on the SSF form. If “Return Shipping Container” is checked, only the shipping container will be returned per the courier listed on the SSF form.
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