SOP on General Test Procedure for Device Testing
1. Dimension:
Measure the dimension of at least 5 test specimens & calculate the arithmetic mean
2. Flow Rate:
Measure the flow rate of at least 5 test specimens & calculate the arithmetic mean
3. Leak Test:
Observe the leakage of at least 5 test specimens.
4. Tensile Strength:
Measure the tensile strength of at least 5 test specimens & calculate the arithmetic mean
5. Other Performance Tests of Device:
Perform the other require test on at least 5 test specimen & calculate the arithmetic mean if
necessary.
SOP on Standard Test Procedure/Method for Device Testing:
Test Methods on each standard common test to be performed for approx all devices.
GB/T 14233.1-1998 Medical Infusion, Blood Transfusion, Injection Equipment Testing Methods,
Part1: Chemical Analysis Methods.
GB/T 14233.2 -2005 Test methods for infusion, transfusion, injection equipment for medical use-
Part 2: Biological test methods.
1. Physical Test Methods:
Dimension
Flow Rate
Leak Test
Tensile Strength/Firmness of Connection /Force at Break
Other Performance Tests: Shore, Hardness, Elongation , Needle Testing,
2. Chemical Test Methods: GB/T 14233.1(Chemical Analysis Methods)
Acidity or Alkalinity
Metal Ions (barium, chromium, copper, lead, and cadmium)
Residue on Evaporation
Ultraviolet Absorption
Acid Value
Safonification Value
Extractable Colour Test
Ethylene Oxide Residue
3. Biological Test Methods: GB/T 14233.2 (Biological Analysis Methods)
Sterility
Bacterial Endotoxins Test
Standard Operating Procedure:
On: every available instrument for analysis.
1. IV Cannula Needle, Hypodermic Needle & Infusion Needle Testers
Needle Penetration Force Tester
Needle Bending/Resistance to Breakage Tester
Needle Stiffness Tester
Needle Inspection Scope (Caltex Scientific USA)
2. Catheter & Tubing Breaking Force & Connection Fastness Tester
Tensile Strength & Force at break Tester
3. Medical Syringe Testers
Syringe Liquid Leakage Tester
Syringe Plunger Actuation Force Tester
4. Air Leakage Testers
Medical Device Air Leakage Tester (Rigid Devices)
Medical Device Air Leakage Tester (Soft Devices)
5. Conical Fitting Testers
Conical Fitting with 6% Luer Taper Tester
Male & Female Reference conical fitting gauges
6. Suture Needle Testers
Tester for determining Ductility & Elasticity of suture needles
Suture Needle Cutting Force Tester
Tester for determining Penetration Force and Strength of Suture Needle Point
Suture Diameter Gauge.
7. Stability Chambers
Accelerated Ageing of Sterile Barrier System
Accelerated Ageing of Medical Devices
Stability Study Protocol & Report Templates
ASTM F1980-7 (Standard guide on accelerated ageing of sterile barrier system for medical
device.)
1. Stability Study Protocols
Accelerated Ageing Stability Study Protocols
Real Time Stability Study Protocols
2. Stability Study Reports
Accelerated Ageing Stability Study Reports
Real Time Stability Study Reports
Accelerated Aging is a testing method used to estimate the useful lifespan of a product when
actual lifespan data is unavailable. This occurs with products that have not existed long enough
to have gone through their useful lifespan. A product can be released to market based upon
successful Accelerated Aging of the package/product that simulates the period claimed for
product expiration (1 year, 2 years, etc). Accelerated Aging data is recognized by regulatory
bodies as an acceptable means to generate data quickly, but is only accepted until those tests
can be repeated on "real time" samples.
An Accelerated Aging test is carried out by subjecting the product to unusually high levels of
stress (rapid, but controlled, changes in temperature, humidity, pressure, strain, etc.) designed
to mimic the effects of normal use. Mechanical parts are run at very high speed, far in excess of
what they would receive in normal usage. Polymers are often kept at elevated temperatures, in
order to accelerate chemical breakdown.
Accelerated Aging techniques are based on the assumptions that the chemical reactions
involved in the deterioration of materials follow the Arrhenius reaction rate function. This
function states that a 10° C increase or decrease in the temperature of a homogenous process,
results in approximately a two times or ½ time change in the rate of a chemical reaction. For
example, at 55°C, 6.5 weeks is equivalent to 1 year on-the-shelf, and at 55°C, two years would be
equivalent to 13.0 weeks and five years would be 32.5 weeks.
The primary reason for using Accelerated Aging techniques in the qualification testing of a
medical device is to bring the product to market at the earliest possible time. The goal is to
benefit both the patient-for example, through early availability of a life-enhancing device-and
the company-by generating additional sales and market share-without exposing either to any
undue risk. Although Accelerated Aging techniques are well documented in academic circles,
information on the use of these techniques in medical product testing is somewhat limited.
Packing Material Specification & Report Templates
1. Packing Material Specification
2. Packing Material Reports
1. ISO 5636-1 to 5 11. ISO 3689
2. ISO 2758 12. ASTM F1929
3. ISO 187 13. ASTM F1886
4. ISO 2233 14. ASTM F2338
5. ISO 9073-9 15. ASTM F2250
6. ISO 2493 16. ASTM F2252
7. ISO 6588-1/2 17. ASTM F88
8. ISO 1924-2 18. ASTM F1140
9. ISO 1974 19. ASTM F2054
10. ISO 534 20. ASTM D 1922
Preparation of Extract:
Immerse 5 Cannulae in suitable volume distilled water in suitable container made from
borosilicate glass. Ensure that all surfaces of the catheters & needles, including the inner surface
are in contact with water.
Close the flask by means of closure or close using pure aluminium sheet.
Heat in an autoclave at temperature of 121± 2 0C for 30 min.
Remove the catheters and needles and ensures that all water from the devices returned to the
container.
Prepare the control fluid by following the above procedure but omitting the product.
A. Acidity or Alkalinity:
Take 4 % volume from prepared extract.
Add 0.1 ml of phenolphthalein solution; the solution is colourless
Add 0.4 ml of 0.01M sodium hydroxide; the solution is pink
Add 0.8 ml of 0.01M hydrochloric acid and 0.1 ml of methyl red solution; the solution is orange-
red or red.
B. Oxidizable Matter/Reducing Substance:
To 20.0 ml of extract (B.1), add 1 ml of dilute sulphuric acid and 20.0 ml of 0.002 M
potassium permanganate. Boil for 3 minutes.
Cool immediately.
Add 1 g of potassium iodide and titrate immediately with 0.01 M sodium thiosulphate,
using 0.25 ml of starch solution as indicator.
Carry out the titration using 20 ml of control fluid as described in B.1
The difference between the titration volumes is not more than 1.5 ml.
C. Heavy Metals:
Extract: Cut test specimen of approximate 2 gm & mix with hydrochloric acid and ignite
in a silica crucible dish at 800 ±250C for 30 min. in muffle furnace. Dissolve the residue
in 10 ml of 1 M hydrochloric acid.
1. Barium:
Filter the prepared extract (B.2) and add 1 ml of 1M sulphuric acid to the filtrate.
Any turbidity produced is not greater than that produced on adding 1 ml of 1 M
sulphuric acid to a mixture of 10 ml of barium standard solution (10 ppm Ba) and 10 ml
of 1M hydrochloric acid.
2. Cadmium:
Add 2 ml acetate buffer pH 3.5 add 1.2 ml of thioacetamide reagent in prepared extract
(B.2), mix immediately and allow to stand for 2 minutes.
Any yellow colour in solution is not more intense than the yellow colour obtained by
repeating the operation using 10 ml of cadmium standard solution (10 ppm cd).
3. Lead:
Add 2 ml acetate buffer pH 3.5 add 1.2 ml of thioacetamide reagent in prepared extract
(B.2), mix immediately and allow to stand for 2 minutes.
Any brown colour in solution is not more intense than the brown colour obtained by
repeating the operation using mixture 5 ml of s lead standard solution (10 ppm pb) & 5
ml of water.
D. Radio-opaque Substance Identification:
Cut approximately 2 gm form the radio-opaque portion of sample & mix with 10 ml
concentrated sulphuric acid. Prepare standard solution with above procedure by
replacing 2 gm of sample to 1 gm of barium sulphate.
Barium: Solution of barium salt yield a white ppt with 2N sulphuric acid; this ppt
insoluble in hydrochloric acid & nitric acid.
Sulphate: Solution of sulphate yield a white ppt with 10 % of barium chloride; this ppt
insoluble in hydrochloric acid & nitric acid.
