CERTIFICATE OF ANALYSIS

NO .:KJ2015071601

Product name Disposable Trocars

Model Type III (1) 10 Quantity 2000
Lot. No. 15070301
Test time 2015-07-07-2015-07-16
According to Product Standard published by Hangzhou Kangji Medical Instrument Co., Ltd

No. Item Standard requirement Result Conclusion

The outer surface should be smooth, no burr and
8/8 OK
1 Outward flaw, also unpolluted and no foreign matters. Pass
The tip of the optical needle should be transparent. 8/8 OK
OD: 012.5±1 mm 12.5012.52 Pass
2 Size(cannula (1)10) ID: (1)11±1mm 11.0011.02 Pass
L: 100+20mm 100 Pass
Size(optical needle OD: 010.7±1mm 10.70-4 0.71 Pass
Cr-)

(1)10) L: 145±20mm 145 Pass

The sealing valve and gas barrier valve should be
4 Flexibility(D10) open and closed flexible and no clamping 13/13 OK Pass
stagnation.
The sealing valve of the cannula should have good
Sealing
5 sealing performance and no leakage with 4kPa air 13/13 OK Pass
performance( 10)
pressure.
The gas barrier valve of the cannula should have
Gas barrier
6 good sealing performance and bubbles should be 13/13 OK Pass
performance( 10)
less than 20pcs in lmin with 4kPa air pressure.
Corrosion The metal parts should meet the requirements of
7 13/13 OK Pass
resistance(010) IS013402:1995
Matching The cannula and needle's matching space should be
8 13/13 OK Pass
performance(010) not more than 0.3mm and no clamping stagnation.
The product should be sterilized by a confirmed
9 Sterile OK Pass
sterile process.
10 EO residues <10 tig/g 8.87 [tg/g Pass