Download Enquiry Form for Biocompatibility Studies 記入方法のご案内 ※ご記入

Enquiry Form for Biocompatibility Studies
1
Company’s Name
2
Company’s Address
3
Contact Person
4
Purpose of the testing
5
Test Item Name
GLP
6
Type of test item
7
Property of Test Item
(where appropriate)
8
Suitability
for
autoclave (please fill if the
sample is non-sterile when
sending to our lab)
20
20
9
Homogeneity of Test
Item
10
Test Item
Pictures
121
121
/unknown
/not applicable
ISO10993-12
of
7.
Please see attachment
11 Intended use of Test
Item
Version 01:01 June 2011
Enquiry Form for Biocompatibility Studies
12
Body Contact of Test
Item
13
Contact Duration
14
User Manual (if any)
Please see attachment
15
Application of Test
Extraction(
)
Direct contact (
)
Item
(Extraction
contact)
16
OR
Direct
Extraction Condition
(choose one)
*Only applicable to
extraction application
method
17
For Polymeric Test
Item Only (please
choose if use
Common extraction
method OR Organic
solvent extraction
method)
ISO 10993-10:2010
/
Version 01:01 June 2011
Enquiry Form for Biocompatibility Studies
18
Stability:
/
/unknown
/not applicable
19
Special instructions
regarding the
preparation of the
device
20
Other special
requirements by
sponsor
Version 01:01 June 2011