Suzhou Yaxin Medical products Co.

, Ltd
No.12, Zhongta Road, Mudu Town, Suzhou 215101, Jiangsu province, China

Certificate of Analysis
Product Name Disposable Wound Drainage Reservoir

Lot No. 20211210 Specification 400ml

Manufacturing Expiration
20211210 20241209
Dtae Date
Sterilization
20211211 Sampling Place Parse library
Lot No.

Qty. 400 Sampling Date 2021.12.12

Sample Qty 5 Test Date 2021.12.12-2021.12.26

Test Standard CFDA /CE MDD / ISO 13485 Report Date 2021.12.26

Standard Clauses Standard requirement Test result Reference

2.1 Outer diameter of catheter 7.0±0.5mm YES

2.2 Catheter inner diameter 5.0±0.5mm YES

The surface of the negative pressure device, catheter

and joint of the drainage device should be smooth,
without obvious sharp edges or pit-shaped pits;
2.3 YES
there should be no foreign bodies or impurities in
the cavity; the side holes of the catheter should be
smooth and free of burrs.
The catheter of the drain should be resistant to
2.4 YES
bending.
The joint of the drainage device should be firmly ENISO13485：
2.5 YES 2003/AC:2007
bonded.

2.6 Drainer sealing performance should be good. YES

The drain should be shock resistant, and there

2.7 should be no liquid leakage at each connection after YES
the test.

The flow controller should be able to effectively

2.8 block and control the release of negative pressure YES
from the drain.

2.9 The negative pressure drain should be steriled. YES

 Sterilized with ethylene oxide, residual ethylene EN ISO10993-
2.10 4.52μg/g
oxide ≤10μg/g. 7：2002

Test Conclusion: After test, this batch of products ☑conformity □non-conformity

Tester： Checker : Approver: