Quality Assurance

Quality Assurance

BRAZN Surgical continuously strives to improve all processes throughout the organizations facilities to achieve the quality required for our Customers Satisfaction. We will comply with all regulatory requirements for the products we provide to our Customers and we ensure the continuing effectiveness of our Quality System.

PRODUCTION:

BRAZN producing their instruments according to the requirement of customers and provide instruments as per approved samples or catalogue reference.             

PRICES:

BRAZN prices are very competitive, flexible and our motto is to keep customers satisfy.      

Guarantee:

Our instruments are being manufactured with ultimate care and keeping in view the value of Human Life, therefore 100% guaranteed.                  

Materials:

Our products are manufactured using the best quality stainless steel as ASTM and DIN standards, which is imported from USA, GERMANY and JAPAN.                   

Return Policy:

We have return policies in the following ways if the instrument may not be MISUSED:

comitment:

we are committed to achieve Excellence in:-                    

 

 

ü  Quality

 

 

ü  Customer Relations

 

 

ü  100% Customers Satisfaction

 

 

ü  Performance Management

     

Quality Control:

For manufacturing of instruments, BRAZN chooses the correct stainless steel grade for required instruments. BRAZN takes ASTM, DIN and ISO standard manual 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.

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

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

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

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

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

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. 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.

•   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.

4. 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.

•   Check the instruments dimensions according to Catalogue.

5. Packaging.      

•   The packing design should be full fill protected of each instrument against damage and deterioration.

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