surgical instruments market

Quality » Quality Control

 

Quality Procedures Requirements  

For manufacturing of surgical and dental instruments, LIFECARE first chooses the correct stainless steel grade for required instruments. LIFECARE takes the help of ASTM & DIN standards, DIN book, ISO's standard manual and other suitable literature for the manufacturing of surgical instruments.

For surgical instruments, mostly two types of stainless steels are used:-

  • AUSTINITIC STAINLESS STEEL (AISI 300 Series) Non-Magnet.
  • MARTENSITIC STAINLESS STEEL (AISI 400 Series) Magnet.

Mostly Martensitic stainless steel is used with AISI 410 & AISI 420 grades for the manufacturing of General Surgical Instruments.

Austenitic and Martensitic stainless steel are used for the manufacturing of Dental instruments.

AISI 410 Grade is used for manufacturing of NON-CUTTING Instruments.

AISI 420 Grade is used for the manufacturing of CUTTING Instruments.

AISI 304 is used for the manufacturing of the Tips of Scalars and Elevator Handles.

Other Stainless steel Grades are also used according to requirement of the instruments.

Quality Processes   
1. Hardness
  • Material shall conform to the mechanical property requirements as following:

Hardness Guidelines for Selected Class 4 Martensitic Stainless Steels in the Annealed Condition

Type

Brinell Hardness

Max (HB)

410

210

410X

220

416

262

416 Mod

262

420A

220

420B

235

420 Mod

255

420X

262

420C

262

420F

262

420F Mod

262

431

285

440A

285

440B

285

440C

285

440F

285

2. Corrosion Resistance  
There are two test methods are specified for determining corrosion resistance
Copper Sulfate Resistance Test and Boiled Water Resistance Test.

A-Copper Sulfate Resistance Test

Check that there is No copper deposit on the instruments. 
B-Boiled Water Resistance Test
Check that there is No blemishes on the instrument OR No visible signs of corrosion. 
3. Elasticity   
A-Function of needle holders & Haemostatic forceps 
The function of needle holders shall be tested in accordance with the following:
Place a plastics fiber (e.g. a suture filament) of a maximum diameter 0.2mm between the jaws of the instrument at a point within the third of the length nearest the tip. Fully close the instrument and apply a tensile force of 20N to the fiber. Record whether the fiber is pulled out from the jaws.
After the test, no distortion, cracks or any other permanent modifications shall be visible. 
B-Function of Haemostatic forceps 
Place a test wire in accordance with table 1 or 2 as appropriate between the tips of the instrument jaws. Fully close the instrument to the last ratchets position. Leave the instrument in this position for 3 h at room temperature. Examine the instrument for the presence of cracks and permanent deformation. 
Table 1 - Test wire for haemostatic forceps 
Dimensions in millimeters

Test wire

 

Diameter of test wire

 

Nominal length (overall length) of haemostatic forceps

Wire of stainless steel grade 11 in accordance with ISO 683-13 or other similar material

2

Up to 130

 

3

Over 130 to 150

 

4

Over 150 to 200

 

5

Over 200

Table 2 - Test wire for haemostatic forceps
Dimensions in millimeters

Test wire

 

Diameter of test wire

 

Nominal length (overall length) of needle holders

Wire of stainless steel grade 11 in accordance with ISO 683-13 or other similar material

0.8

Up to 160

 

1

Over 160

4. Cutting (for cutting instruments)
The cutting ability of the instruments shall be tested in accordance with the following:
The testing material in accordance with the table shall be cut non-stop three times along two-third of the blade without lateral pressure.
Table - Testing materials

Testing material

Number of layers

Category of instrument

Examples

Wetted tissue paper

 

1

Micro-spring

 

Barraquer scissors

Iridectomy scissors

De Wecker scissors

Gauze No.181)

 

2

Lightweight Bow-handled

 

Iris scissors

Strabismus scissors

Stevens tendon scissors

Kilner dissecting scissors

Potts-de-Martell scissors

Joseph scissors

 

5

Medium weight Bow handled

 

Mayo scissors

Metzenbaum scissors

Nail scissors

Sim uterine scissors

Dauphine dressing scissors

Tonsil scissors

 

8

Heavyweight

 

Lister bandage scissors

Smith bandage scissors

Bowel scissors

Doyen flesh scissors

  • The testing material shall be cut cleanly without tearing.
  • After the test, no distortion, cracks or any other permanent modifications of the instrument shall be visible.
5. Visual Inspection  

All Instruments should pass the following inspections:

  • The instruments shall have joints which move smoothly and shall be neither too loose nor too tight; it shall be possible to close and reopen the instruments easily with two fingers.
  • All surfaces shall be free from pores, crevices and grinding marks. The instrument shall be supplied free from residual scale, acid, grease and grinding and polishing materials. Compliance with these requirements shall be checked by inspection under normal vision, corrected, if necessary.
  • Check the instruments marking with Life Care trade mark & Code of the instruments.
  • Instruments having tungsten carbide inserts shall have gold-colored handles.
  • Check the instruments dimensions according to Catalogue.
6. Storage and sterilization  
Be sure that warranty & instructions for use card is included in each Pack for each instrument
7. Packaging  
  • The packing design should be fulfill protection of each instrument against damage and deterioration.
  • Check the instrument code with the packaging.

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Chairman Word
To our country, to the entire world and to the future, we founded lifeCare Surgical. Starting from where others ended, adding the value of 20 years experience in the field of instrumentation. Offering products with the best quality that appreciate health care and doctors needs.