Ikm Presentation New

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(EXCLUSIVE DISTRIBUTOR AGENT)FOR

INTERNATIONAL KOREAN COMPANY FOR

MEDICAL SYRINGES

DISPOSABLE SYRINGE TECHNICALDISPOSABLE SYRINGE TECHNICAL ANALYSISANALYSIS

100100% Made in Kingdom of Saudi Arabia% Made in Kingdom of Saudi Arabia



CONTENTS

1. PRODUCTS

2. DISPOSABLE SYRINGE ILLUSTRATION

3. OUR PRODUCTS

4. MATERILAS OF GASKET

5. DISCRIPTION FOR HYPODERMIC NEEDLE

.

7. HUB COLOR CODE AND SIZE STANDARDS FOR

NEEDLE

8. STANDARDS IN ACCORDANCE WITH ISO 7886

9. STERILIZATION

10.INDIVIDUAL PACKAGING

11.LABELLING

12.CERTIFICATES

13.QUESTION S

14.THNX 2



PRODUCTS

1. NAME OF PRODUCTSDISPOSABLE SYRINGE WITH DIFFERENT SIZES OF NEEDLES

2. TYPE OF PRODUCTIONFULL -AUTOMATIC PRODUCTION SYSTEM

.DISPOSABLE SYRINGE / Uni-Body / DISPOSABLE NEEDLES

3.1 DISPOSABLE SYRINGES1 cc / 3 cc / 5 cc / 10 cc

3.2 DISPOSABLE NEEDLESFROM 16Gauge TO 30Gauge, LENGTH : FROM 1/2" TO 1 1/2"



DISPOSABLE SYRINGE ILLUSTRATION

CAPP BARRELP GASKETP PLUNGERPNOZZLEP

WINGPBASE LINEPSCALE



OUR PRODUCTS

SYRINGE NEEDLE



MATERIALS OF GASKET

TPE COMPOUND ( COLOR: BLACK )

GRADE : SR-9000 ( SRG-2705 )

PROCESS OIL

MODIFIER ( POLYPROPYLENE )

ANTI OXIDANT

CARBON BLACK



DESCRIPTION FOR HYPODERMIC NEEDLE

APPEARANCE :

NO OBVIOUS SCRATCH, ROUGHNESS AND PARTICLES THERETO.

NEEDLE POINT :

NO BURR ON THE GRIND POINT AND SHOULD BE SHARP ENOUGH DUL

LENGTH :

SHOULD BE WITHIN THE FOLLOWING REQUIREMENTS WHEN THE LENGTHOF CANNULA IS MEASURED BY VERIFIER CALIPERS AND MICRO METER.

OUTER DIAMETER :WITHIN TO = 8%, TO -3% WHEN THE MEASUREMENT IS PERFORMED.



MATERIAL DESCRIPTION FOR NEEDLE PARTS TUBE :

AUTHENTIC STAINLESS STEEL 304 OF TYPE 10, 11, 16 IN ACCORDANCE

WITH ISO 683-13 ( STANDARDS : KSD-3698 )

HUB :

POLYPROPYLENE , MEDICAL INJECTION, VIRGIN GRADE

( STANDARDS : KSM-3010 )

CAP :POLYPROPYLENE , MEDICAL INJECTION, VIRGIN GRADE

( STANDARDS : KSM-3010 )



HUB COLOUR CODE & SIZE STANDARD

FOR NEEDLE

GAUGE HUB COLOR GAUGE HUB COLOR

18G PINK 19 G BROWN

20G LIGHT YELLOW 21 G GREEN

22G GREY 23 G SKY BLUE

25G ORANGE 26 G LIGHT BROWN

27G LIGHT GREY

[ Specification in accordance with ISO 594-2 , 6009 , 7864 , 9626 ]



STANDARDS

[ IN ACCORDANCE WITH ISO7886 ]1. APPEARANCE

AIR BUBBLES, CRACKS OR ANY OTHER DEFECT SHOULD NOT BE

DISTINCTLY FOUND IN BARREL PARTS.

2.DIMENSIONS :

THE LENGTH OF THE BARREL SHALL BE SUCH THAT THE SYRINGE HAS A

NOMINAL CAPACITY.



STANDARDS

[ IN ACCORDANCE WITH ISO7886 ]3. FINGER GRIPS :

THE OPEN END OF THE BARREL SHALL BE PROVIDED WITH FINGER GRIPS

THAT SHALL ENSURE THAT THE SYRINGE WILL NOT ROLL MORE THAT 180°WHEN IT IS PLACED ON A FLAT SURFACE AT AN ANGLE OF 10° TO THE

HORIZONTAL.

FINGER GRIPS SHOULD BE OF ADEQUATE SIZE, SHAPE AND STRENGTHFOR THE INTENDED PURPOSE AND SHOULD ENABLE THE SYRINGE TO BE

HELD SECURITY DURING USE.



STANDARDS

[ IN ACCORDANCE WITH ISO7886 ]4. PRINTING ON BARREL

GRADUATED SCALES AND OTHER WORKING SHOULD BE PRINTED

CLEARLY AND NOT BE EARED EASILY.

CAPACITY OF THE SYRINGE AT THE GRADUATION LINE FURTHEST

FROM THE ZERO GRADUATION LINE.

MAXIUM USABLE CAPACITY : CAPACITY OF THE SYRINGE WHENTHE PISTON IS DRAWN BACK TO ITS MAXIUM USABLE CAPACITY :

FURTHEST FUNCTIONAL PISTON.

FIDUCIAL LINE : LINE CIRCUMSCRIBING THE END OF THE PISTON FOR

DETERMING THE FIDUCIAL LINE : CAPACITY CORRESPONDING TO ANYSCALE READING OF THE SYRINGE.



STANDARDS

[ IN ACCORDANCE WITH ISO7886 ]5. PLUNGER SEAL (GASKET)

THE GASKET SHALL NOT BECOME DISLODGED FROM THE PLUNGER

UNDER NORMAL CONDITIONS OF USE AND SHOULD NOT BE FOUNDDUST AND DREGS OF ITSELF.

6. ACCURACY OF CAPACITY

FULLY INSERT THE PLUNGER TO THE BOTTOM OF BARREL AND TAKEMEASURE THE SOLUTION EXPELLED FROM THE SYRINGE.

THE LINE OF CAPACITY SHALL BE IN ACCORDANCE WITH FOLLOWING1 cc TO 3 cc : +5%

5 cc TO 50 cc : +4%



STANDARDS

[ IN ACCORDANCE WITH ISO7886 ]7. DESIGN OF THE PLUNGER AND PISTON

THE DESIGN OF THE PLUNGER AND PUSH-BUTTON OF THE SYRINGE SHALL BE SUCH THAT,

WHEN THE BARREL IS HELD IN ONE HAND, THE PLUNGER CAN BE DEPRESSED BY THE THUMBOF THAT HAND, WHEN TESTED IN ACCORDANCE WITH ISO7886 AANNEX B, THE PISTONSHALL BE NOT BECOME DETACHED FROM THE PLUNGER .THE PLUNGER SHOULD BE OF A

LENGTH ADEQUATE TO ALLOW THE PISTON TRAVERSE THE FULL LENGTH OF BARREL, BUT ITSHOULD NOT BE POSSIBLE EASILY TO WITHDRAW THE PLUNGER COMPLETELY FROM

.

THE PROJECTION OF THE PLUNGER AND THE CONFIGURATION OF THE PUSH-BUTTONSHOULD BE SUCH AS TO ALLOW THE PLUNGER TO BE OPERATED WITHOUT DIFFICULTY.

WHEN THE FIDUCIAL LINE OF THE PISTON COINCIDES WITH THE ZERO GRADUATION LINETHE PREFERRED MINIMUM LENGTH OF THE PLUNGER FROM THE SURFACE OF THE FINGER

GRIPS NEARER TO THE PUSH-BUTTON SHOULD BE ;

8mm FOR SYRINGES OF NOMINAL CAPACITY UP TO BUT EXCLUDING 2ml ;

9mm FOR THE SYRINGES PF NOMINAL CAPACITY OF 2ml UP TO BUT EXCLUDING 5ml ;

12.5mm FOR THE SYRINGES OF NOMINAL CAPACITY OF 5ml AND GREATER.



STANDARDS

[ IN ACCORDANCE WITH ISO7886 ]8. FIT OF PISTON IN BARREL

WHEN THE SYRINGE IS FILLED WITH EATER AND HELD VERTICALLY WITHFIRST ONE END THEN THE OTHER END UP PERMOST, THE PLUNGER SHALL

NOT MOVE BY REASON OF ITS OWN MASS.



STERILIZATION

SHOULD BE ELIGIBLE WHEN TEST IS PERFORMED AS PER STERILITY TEST

METHOD IN ACCORDANCE WITH EN550 / DIN : 1994

GAS USED : ETHYLENE OXIDE GAS (20%)



INDIVIDUAL PACKAGING

SHOULD BE UNDAMAGED OR UNOPENED BEFORE USE.



LABELLINGTHE PRIMARY CONTAINER , SECONDARY CONTAINER AND STORGAE

CONTAINER APPEAR AS FOLLOW:

DESCRIPTION OF THE CONTENTS INCLUDING NOMINAL CAPACITYAND THE TYPE OF NOZZLE

THE WORD " STERILE "

THE WORDS : FOR SINGLE USE :

THE LOT NO. , PREFIXED BY THE WORD " LOT "

THE NAME, TRADE MARK, TRADE NAME OR LOGO OF THEMANUFACTURER

THE DATE OF STERILIZATION IN ACCORDANCE WITH ISO 8601

MANUFACTURING DATE OR STERILIZATION DATE

INFORMATION FOR THE HANDLING, STORAGE AND TRANSPORTATION OF THE

CONTENTS.



ISO CERTIFICATE

SWISS ISO 9001:2008

FOR DESIGN, PRODUCT,

SALES AND SERVICE OF

DISPOSABLE SYRINGES

.

19



SAFDA LICENSE

20

METMET 112112 Global Climate ChangeGlobal Climate Change



[email protected]



THANK YOU

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