SGS
Test report
No.:CANEC2308505308 Date: July 4, 2023 Page 1 of 3
Customer Name: Guangzhou volfmen hose Co., Ltd. Customer address: Part of the first and second floors of Building B, No. 53, Yongning Road, Ningxi Street, Zengcheng District, Guangzhou City, Guangdong Province
Sample Name: Silicone steel wire tube The above samples and information are provided by customers.
SGS Job Number:
CP23-024208-GZ
Sample receipt date:
June 27, 2023
Detection cycle:
June 27, 2023 - July 4, 2023
Testing requirements:
Test according to customer requirements
Detection method:
See next page
Test results:
See next page
SGS工作编号: CP23-024208-GZ
样品接收日期: 2023年06月27日
检测周期: 2023年06月27日-2023年07月04日
检测要求: 根据客户要求检测
检测方法: 请参见下一页
检测结果: 请参见下一页 | SGS工作编号: | CP23-024208-GZ |
| :--- | :--- |
| 样品接收日期: | 2023年06月27日 |
| 检测周期: | 2023年06月27日-2023年07月04日 |
| 检测要求: | 根据客户要求检测 |
| 检测方法: | 请参见下一页 |
| 检测结果: | 请参见下一页 |
Summary of test results:
Testing requirements
in conclusion
FDA 21 CFR 177.2600 Total extracts
conform to
检测要求 结论
FDA 21 CFR 177.2600 一总提取物 符合 | 检测要求 | 结论 |
| :--- | :---: |
| FDA 21 CFR 177.2600 一总提取物 | 符合 |
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch Authorized Signature
Cai Jinfeng
Kim Cai蔡金丰 Approving Signatory
Test results:
Test sample description:
Sample number
SGS Sample ID
describe
Material
SN1
CAN23-085053.002
Translucent silicone tubing with white textile
(Customer provided) Silicone + Textile
(客户提供)
硅胶 + 纺织物 | (客户提供) |
| :---: |
| 硅胶 + 纺织物 |
样品编号 SGS样品ID 描述 材质
SN1 CAN23-085053.002 带白色纺织物的半透明硅胶管 "(客户提供)
硅胶 + 纺织物" | 样品编号 | SGS样品ID | 描述 | 材质 |
| :---: | :---: | :--- | :---: |
| SN1 | CAN23-085053.002 | 带白色纺织物的半透明硅胶管 | (客户提供) <br> 硅胶 + 纺织物 |
FDA 21 CFR 177.2600—Total Extracts
Test method: Refer to US FDA 21 CFR 177.2600.
Simulated fluid
time
temperature
Maximum allowable limit
Total amount of sample 002 extract
Comment
distilled water
7.0
hr
(
s
)
7.0
hr
(
s
)
7.0hr(s) 7.0 \mathrm{hr}(\mathrm{s})
Reflow temperature
20
mg
/
20
mg
/
20mg// 20 \mathrm{mg} / inch
2
2
^(2) ^{2}
<
0.5
mg
/
<
0.5
mg
/
< 0.5mg// <0.5 \mathrm{mg} / inch
2
2
^(2) ^{2}
conform to
After extraction
2.0
hr
(
s
)
2.0
hr
(
s
)
2.0hr(s) 2.0 \mathrm{hr}(\mathrm{s})
Reflow temperature
1
mg
/
1
mg
/
1mg// 1 \mathrm{mg} / inch
2
2
^(2) ^{2}
<
0.5
mg
/
<
0.5
mg
/
< 0.5mg// <0.5 \mathrm{mg} / inch
2
2
^(2) ^{2}
conform to
n-hexane
7.0
hr
(
s
)
7.0
hr
(
s
)
7.0hr(s) 7.0 \mathrm{hr}(\mathrm{s})
Reflow temperature
175
mg
/
175
mg
/
175mg// 175 \mathrm{mg} / inch
2
2
^(2) ^{2}
14.4
mg
/
14.4
mg
/
14.4mg// 14.4 \mathrm{mg} / inch
2
2
^(2) ^{2}
conform to
After extraction
2.0
hr
(
s
)
2.0
hr
(
s
)
2.0hr(s) 2.0 \mathrm{hr}(\mathrm{s})
Reflow temperature
4
mg
/
4
mg
/
4mg// 4 \mathrm{mg} / inch
2
2
^(2) ^{\mathbf{2}}
1.3
mg
/
1.3
mg
/
1.3mg// 1.3 \mathrm{mg} / inch
2
2
^(2) ^{2}
conform to
模拟液 时间 温度 最大允许限值 样品002提取物总量 评论
蒸馏水 7.0hr(s) 回流温度 20mg// inch ^(2) < 0.5mg// inch ^(2) 符合
萃取后 2.0hr(s) 回流温度 1mg// inch ^(2) < 0.5mg// inch ^(2) 符合
正己烷 7.0hr(s) 回流温度 175mg// inch ^(2) 14.4mg// inch ^(2) 符合
萃取后 2.0hr(s) 回流温度 4mg// inch ^(2) 1.3mg// inch ^(2) 符合 | 模拟液 | 时间 | 温度 | 最大允许限值 | 样品002提取物总量 | 评论 |
| :--- | :--- | :--- | :--- | :--- | :--- |
| 蒸馏水 | $7.0 \mathrm{hr}(\mathrm{s})$ | 回流温度 | $20 \mathrm{mg} /$ inch $^{2}$ | $<0.5 \mathrm{mg} /$ inch $^{2}$ | 符合 |
| 萃取后 | $2.0 \mathrm{hr}(\mathrm{s})$ | 回流温度 | $1 \mathrm{mg} /$ inch $^{2}$ | $<0.5 \mathrm{mg} /$ inch $^{2}$ | 符合 |
| 正己烷 | $7.0 \mathrm{hr}(\mathrm{s})$ | 回流温度 | $175 \mathrm{mg} /$ inch $^{2}$ | $14.4 \mathrm{mg} /$ inch $^{2}$ | 符合 |
| 萃取后 | $2.0 \mathrm{hr}(\mathrm{s})$ | 回流温度 | $4 \mathrm{mg} /$ inch $^{\mathbf{2}}$ | $1.3 \mathrm{mg} /$ inch $^{2}$ | 符合 |
Remark: (1)
mg
/
mg
/
mg// \mathrm{mg} / inch
2
=
2
=
^(2)= ^{2}= mg/square inch Note: The test results and photos in this report are quoted from report CANEC2308505306. Unless otherwise noted, compliance is determined using the binary rule of simple acceptance (
w
=
0
w
=
0
w=0 w=0 ) in accordance with ILAC-G8:09/2019. Unless otherwise noted, this report is solely responsible for the sample tested. This report may not be reproduced in part without the written permission of our company. This report is for internal reference only, for research, teaching, internal quality control, and product development purposes.
Sample photos:
This photo is only for use with the original SGS report