REVITAL HEALTHCARE (EPZ) LTD Doc No.

:Z/F/07/06
(EN ISO 13485 &ISO 9001 Certified Company) Issue Date: 01.01.2019
QUALITY CONTROL DEPARTMENT Rev.No.: 02
CERTIFICATE OF ANALYSIS
Product Name : SINGLE USE SYRINGE (2 PART) Report No. : FT / 2019 / 1209
Product : 10ml Syringe 21G X 1½” Lot / Lot size : 120919 / 25,000 Pcs
Brand : DCK Sterilizer M/c No. : 05
Mfg. : DEC. 2019 Sterilized On : 05 / 12 / 2019
Exp. : NOV. 2024 Sampling Date : 05 / 12 / 2019
Product Description: . A Sterile Hypodermic Syringe For Single Use With Stainless steel needle having GREEN
hub packed and sealed in a medical grade paper. The Syringe Barrel, Needle hub & cap are made up of P.P and
Plunger is of HDPE. The Syringe is sterilized by Ethylene Oxide Gas.
S.No TEST SPECIFICATION RESULT
01 Graduated capacity For 1 ml → 0.95 to 1.05, 10 ml→ 09.60 to 10.40
Graduation up to 2 ml → 1.90 to 2.10, 20 ml→ 19.20 to 20.80 10 ml
3 ml → 2.85 to 3.15, 50 ml→ 48.00 to 52.00
5 ml → 4.80 to 5.20
02 Dead Space Not more than 0.20 ml for 50 ml , 0.15 ml for 20 ml 0.09 ml
0.10 ml for 10 ml, 0.07 ml for 1,2,& 3ml
0.075 ml for 5 ml
03 Air Leakage Test No air leakage complies
04 Liquid Leakage Test No liquid leakage complies

05 O.D. of Needle For 27G → 0.40 to 0.42 mm. 26G → 0.44 to 0.47 mm.
25G → 0.50 to 0.53 mm. 24G → 0.55 to 0.58 mm. 0.80mm
23G → 0.60 to 0.65 mm 22G → 0.70 to 0.73 mm.
21G → 0.80 to 0.83 mm
06 Effective Length of For ½” → 12.70 mm (10.70 mm to 13.70 mm) 36.5 mm-38mm
Needle 1” → 25.40 mm (22.50 mm to 26.50 mm)
1 ¼” → 31.75 mm (29.50 mm to 33.50 mm)
1 ½” →38.00 mm (35.50 mm to 39.50 mm)
07 Sharpness Should Comply with sharpness complies
08 Blockage No blockages complies
09 Cleanliness Free from particles & extraneous matter complies

10 Acidity / Alkalinity Within one unit PH of the control fluid complies

11 Bond between Hub and Not less than complies
Cannula For 24G →3.400 Kgs. 23G → 3.400 Kgs.
22G → 4.000 Kgs. 21G → 4.400 Kgs.
12 Color of Hub 24G : MEDIUM PURPLE 23G : DEEP BLUE GREEN
22G : BLACK 21G: DEEP GREEN
13 INCOMPATIBILITY complies
TEST : Should comply with test.
a) visual (clarity, color,
presence of particles)
b) Organoleptic (odour) Should comply with test. complies
test
c) Ease of plunger Should comply with test. complies
movement
14 Sterility Should comply complies
Ref. STD: ISO.7886-1: 2000 & I.S.O. 7864:2009
DECLARATION: ON THE BASIS OF ABOVE RESULTS I DECLARE THAT ABOVE MENTIONED LOT
COMPLIES WITH THE PRESCRIBED STANDARDS FOR STERILE HYPODERMIC SYRINGES WITH NEEDLE.

18 / 12 / 2019

ANALYST DATE HEAD QUALITY

 REVITAL HEALTHCARE (EPZ) LTD Doc No.:Z/F/07/06
(EN ISO 13485 &ISO 9001 Certified Company) Issue Date: 01.01.2019
QUALITY CONTROL DEPARTMENT Rev.No.: 02
CERTIFICATE OF ANALYSIS
Product Name : SINGLE USE SYRINGE (2 PART) Report No. : FT / 2019 / 1207
Product : 10ml Syringe 21G X 1½” Lot / Lot size : 120719 / 50,000 Pcs
Brand : DCK Sterilizer M/c No. : 05
Mfg. : DEC. 2019 Sterilized On : 05 / 12 / 2019
Exp. : NOV. 2024 Sampling Date : 05 / 12 / 2019
Product Description: . A Sterile Hypodermic Syringe For Single Use With Stainless steel needle having GREEN
hub packed and sealed in a medical grade paper. The Syringe Barrel, Needle hub & cap are made up of P.P and
Plunger is of HDPE. The Syringe is sterilized by Ethylene Oxide Gas.
S.No TEST SPECIFICATION RESULT
01 Graduated capacity For 1 ml → 0.95 to 1.05, 10 ml→ 09.60 to 10.40
Graduation up to 2 ml → 1.90 to 2.10, 20 ml→ 19.20 to 20.80 10 ml
3 ml → 2.85 to 3.15, 50 ml→ 48.00 to 52.00
5 ml → 4.80 to 5.20
02 Dead Space Not more than 0.20 ml for 50 ml , 0.15 ml for 20 ml 0.09 ml
0.10 ml for 10 ml, 0.07 ml for 1,2,& 3ml
0.075 ml for 5 ml
03 Air Leakage Test No air leakage complies
04 Liquid Leakage Test No liquid leakage complies

05 O.D. of Needle For 27G → 0.40 to 0.42 mm. 26G → 0.44 to 0.47 mm.
25G → 0.50 to 0.53 mm. 24G → 0.55 to 0.58 mm. 0.80mm
23G → 0.60 to 0.65 mm 22G → 0.70 to 0.73 mm.
21G → 0.80 to 0.83 mm
06 Effective Length of For ½” → 12.70 mm (10.70 mm to 13.70 mm) 36.5 mm-38mm
Needle 1” → 25.40 mm (22.50 mm to 26.50 mm)
1 ¼” → 31.75 mm (29.50 mm to 33.50 mm)
1 ½” →38.00 mm (35.50 mm to 39.50 mm)
07 Sharpness Should Comply with sharpness complies
08 Blockage No blockages complies
09 Cleanliness Free from particles & extraneous matter complies

10 Acidity / Alkalinity Within one unit PH of the control fluid complies

11 Bond between Hub and Not less than complies
Cannula For 24G →3.400 Kgs. 23G → 3.400 Kgs.
22G → 4.000 Kgs. 21G → 4.400 Kgs.
12 Color of Hub 24G : MEDIUM PURPLE 23G : DEEP BLUE GREEN
22G : BLACK 21G: DEEP GREEN
13 INCOMPATIBILITY complies
TEST : Should comply with test.
a) visual (clarity, color,
presence of particles)
b) Organoleptic (odour) Should comply with test. complies
test
c) Ease of plunger Should comply with test. complies
movement
14 Sterility Should comply complies
Ref. STD: ISO.7886-1: 2000 & I.S.O. 7864:2009
DECLARATION: ON THE BASIS OF ABOVE RESULTS I DECLARE THAT ABOVE MENTIONED LOT
COMPLIES WITH THE PRESCRIBED STANDARDS FOR STERILE HYPODERMIC SYRINGES WITH NEEDLE.

18 / 12 / 2019

ANALYST DATE HEAD QUALITY

 REVITAL HEALTHCARE (EPZ) LTD Doc No.:Z/F/07/06
(EN ISO 13485 &ISO 9001 Certified Company) Issue Date: 01.01.2019
QUALITY CONTROL DEPARTMENT Rev.No.: 02
CERTIFICATE OF ANALYSIS
Product Name : SINGLE USE SYRINGE (2 PART) Report No. : FT / 2020 / 160
Product : 10ml Syringe 21G X 1½” Lot / Lot size : 016020 / 400,000 Pcs
Brand : DCK Sterilizer M/c No. : 05
Mfg. : JAN. 2020 Sterilized On : 26 / 01 / 2020
Exp. : DEC. 2024 Sampling Date : 26 / 01 / 2020
Product Description: . A Sterile Hypodermic Syringe For Single Use With Stainless steel needle having GREEN
hub packed and sealed in a medical grade paper. The Syringe Barrel, Needle hub & cap are made up of P.P and
Plunger is of HDPE. The Syringe is sterilized by Ethylene Oxide Gas.
S.No TEST SPECIFICATION RESULT
01 Graduated capacity For 1 ml → 0.95 to 1.05, 10 ml→ 09.60 to 10.40
Graduation up to 2 ml → 1.90 to 2.10, 20 ml→ 19.20 to 20.80 10 ml
3 ml → 2.85 to 3.15, 50 ml→ 48.00 to 52.00
5 ml → 4.80 to 5.20
02 Dead Space Not more than 0.20 ml for 50 ml , 0.15 ml for 20 ml 0.09 ml
0.10 ml for 10 ml, 0.07 ml for 1,2,& 3ml
0.075 ml for 5 ml
03 Air Leakage Test No air leakage complies
04 Liquid Leakage Test No liquid leakage complies

05 O.D. of Needle For 27G → 0.40 to 0.42 mm. 26G → 0.44 to 0.47 mm.
25G → 0.50 to 0.53 mm. 24G → 0.55 to 0.58 mm. 0.80mm
23G → 0.60 to 0.65 mm 22G → 0.70 to 0.73 mm.
21G → 0.80 to 0.83 mm
06 Effective Length of For ½” → 12.70 mm (10.70 mm to 13.70 mm) 36.5 mm-38mm
Needle 1” → 25.40 mm (22.50 mm to 26.50 mm)
1 ¼” → 31.75 mm (29.50 mm to 33.50 mm)
1 ½” →38.00 mm (35.50 mm to 39.50 mm)
07 Sharpness Should Comply with sharpness complies
08 Blockage No blockages complies
09 Cleanliness Free from particles & extraneous matter complies

10 Acidity / Alkalinity Within one unit PH of the control fluid complies

11 Bond between Hub and Not less than complies
Cannula For 24G →3.400 Kgs. 23G → 3.400 Kgs.
22G → 4.000 Kgs. 21G → 4.400 Kgs.
12 Color of Hub 24G : MEDIUM PURPLE 23G : DEEP BLUE GREEN
22G : BLACK 21G: DEEP GREEN
13 INCOMPATIBILITY complies
TEST : Should comply with test.
a) visual (clarity, color,
presence of particles)
b) Organoleptic (odour) Should comply with test. complies
test
c) Ease of plunger Should comply with test. complies
movement
14 Sterility Should comply complies
Ref. STD: ISO.7886-1: 2000 & I.S.O. 7864:2009
DECLARATION: ON THE BASIS OF ABOVE RESULTS I DECLARE THAT ABOVE MENTIONED LOT
COMPLIES WITH THE PRESCRIBED STANDARDS FOR STERILE HYPODERMIC SYRINGES WITH NEEDLE.

08 / 02 / 2020

ANALYST DATE HEAD QUALITY

 REVITAL HEALTHCARE (EPZ) LTD Doc No.:Z/F/07/06
(EN ISO 13485 &ISO 9001 Certified Company) Issue Date: 01.01.2019
QUALITY CONTROL DEPARTMENT Rev.No.: 02
CERTIFICATE OF ANALYSIS
Product Name : SINGLE USE SYRINGE (2 PART) Report No. : FT / 2020 / 216
Product : 10ml Syringe 21G X 1½” Lot / Lot size : 021620 / 275,000 Pcs
Brand : DCK Sterilizer M/c No. : 05
Mfg. : FEB. 2020 Sterilized On : 07 / 02 / 2020
Exp. : JAN. 2025 Sampling Date : 07 / 02 / 2020
Product Description: . A Sterile Hypodermic Syringe For Single Use With Stainless steel needle having GREEN
hub packed and sealed in a medical grade paper. The Syringe Barrel, Needle hub & cap are made up of P.P and
Plunger is of HDPE. The Syringe is sterilized by Ethylene Oxide Gas.
S.No TEST SPECIFICATION RESULT
01 Graduated capacity For 1 ml → 0.95 to 1.05, 10 ml→ 09.60 to 10.40
Graduation up to 2 ml → 1.90 to 2.10, 20 ml→ 19.20 to 20.80 10 ml
3 ml → 2.85 to 3.15, 50 ml→ 48.00 to 52.00
5 ml → 4.80 to 5.20
02 Dead Space Not more than 0.20 ml for 50 ml , 0.15 ml for 20 ml 0.09 ml
0.10 ml for 10 ml, 0.07 ml for 1,2,& 3ml
0.075 ml for 5 ml
03 Air Leakage Test No air leakage complies
04 Liquid Leakage Test No liquid leakage complies

05 O.D. of Needle For 27G → 0.40 to 0.42 mm. 26G → 0.44 to 0.47 mm.
25G → 0.50 to 0.53 mm. 24G → 0.55 to 0.58 mm. 0.80mm
23G → 0.60 to 0.65 mm 22G → 0.70 to 0.73 mm.
21G → 0.80 to 0.83 mm
06 Effective Length of For ½” → 12.70 mm (10.70 mm to 13.70 mm) 36.5 mm-38mm
Needle 1” → 25.40 mm (22.50 mm to 26.50 mm)
1 ¼” → 31.75 mm (29.50 mm to 33.50 mm)
1 ½” →38.00 mm (35.50 mm to 39.50 mm)
07 Sharpness Should Comply with sharpness complies
08 Blockage No blockages complies
09 Cleanliness Free from particles & extraneous matter complies

10 Acidity / Alkalinity Within one unit PH of the control fluid complies

11 Bond between Hub and Not less than complies
Cannula For 24G →3.400 Kgs. 23G → 3.400 Kgs.
22G → 4.000 Kgs. 21G → 4.400 Kgs.
12 Color of Hub 24G : MEDIUM PURPLE 23G : DEEP BLUE GREEN
22G : BLACK 21G: DEEP GREEN
13 INCOMPATIBILITY complies
TEST : Should comply with test.
a) visual (clarity, color,
presence of particles)
b) Organoleptic (odour) Should comply with test. complies
test
c) Ease of plunger Should comply with test. complies
movement
14 Sterility Should comply complies
Ref. STD: ISO.7886-1: 2000 & I.S.O. 7864:2009
DECLARATION: ON THE BASIS OF ABOVE RESULTS I DECLARE THAT ABOVE MENTIONED LOT
COMPLIES WITH THE PRESCRIBED STANDARDS FOR STERILE HYPODERMIC SYRINGES WITH NEEDLE.

20 / 02 / 2020

ANALYST DATE HEAD QUALITY