1 .Scope This part of ISO 10993 provides guidance on - ⦁ general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use ⦁ two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test ⦁ considers only those degradation products generated by a chemical alteration of the finished polymeric device 2. Normative references ISO 3696:1987, Water for analytical laboratory use — Specification and test methods. ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing. ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products …show more content…
4.1.10 Determination of the mass balance after removal from test solution sample shall be rinsed with adequate quantities of analytical grade water sample and the debris eventually obtained from the separation apparatus shall be dried to a constant mass after that the mass balance shall be determined. 4.1.11 Final material characterization The material shall be determined using the same methods as used in the initial material characterization. 4.2 Accelerated degradation test 4.2.1 Temperature temperature greater than 37 °C and below the melting or softening range of the polymer 4.2.2 Test periods intended use is longer than 30 days - test periods of 2 and 60 days shall be used. intended use is less than 30 days - test periods of 2 and 7 days shall be used. Additional test periods may be chosen depending on the polymer under investigation or the intended use of the device 4.3 Real-time degradation test 4.3.1 Temperature Carry at the test temp 37 °C ± 1 °C. 4.3.2 Test period intended use is longer than 30 days- test periods of 1 month, 3 months, 6 months and 12
Next, about 10 mL of both solutions, Red 40 and Blue 1, were added to a small beaker. The concentration of the stock solution were recorded, 52.1 ppm for Red 40 and 16.6 ppm for Blue 1. Then, using the volumetric pipette, 5 mL of each solution was transferred into a 10 mL volumetric flask, labelled either R1 or B1. Deionized water was added into the flask using a pipette until the solution level reached a line which indicated 10 mL. A cap for the flask was inserted and the flask was invented a few times to completely mix the solution. Then, the volumetric pipette was rinsed with fresh deionized water and
The test can be performed at various pressures depending on the application in which the connector is going to be used. For example, in undersea application the pressure will be high on the connectors. [26] 7.4.2 Insulation Resistance Testing
To begin with, is the experimental process used to determine the identity of the rock. In doing so one will need to discover the density of the rock. By measuring the rock sample with grams per milliliter is a way used to figure out the density. In starting one will need to measure the mass of the rock using grams. Then using a set milliliter amount of a liquid substance, such as water, one will place the rock sample inside.
DOI: 12/13/2012. This is a case of a 63-year-old male security officer who sustained a work-related injury to the right knee when he missed a step and fell down the stairs. As per Omni, the patient had a right knee meniscus tear. The patient had right knee replacement on 11/19/14.
Characteristic Property- Test 2- Density Materials: Triple Beam balance, distilled water, graduated cylinder, unknown 6 Procedure: first we found the mass of the empty graduated cylinder and then its mass with the now distilled unknown. After subtracting the mass of the graduated cylinder, we were able to find the volume. For every 1mL=1cm³ so there we had the volume found with the graduated cylinder. We divided the mass by the volume in order to get the density Data: We found that the density of our unknown was 0.76 g/cm3.
The anion tests followed the cation tests. To test for the presence of the chloride (Cl-) anion, a small scoop of the unknown compound was mixed with 1 mL of water in a test tube to create a solution. Then, 1 mL of 6 M nitric acid (HNO3) and 1 mL of silver nitrate (Ag(NO3)2) solution were added to the test tube to see if a white precipitate formed. To test for the presence of the sulfate (SO42-) anion, a small scoop of the unknown compound was mixed with 1 mL of water in a test tube to create a solution. Then, 1 mL of 6 M hydrochloric acid (HCl) and 1 mL of barium chloride (BaCl2) solution were added to the test tube to see if a white precipitate formed.
On January 31, 2000, Dr. Harold Shipman was convicted of murdering 15 of his patients, as well as, forging a will of 1 of them. The evidence against him was that he had killed them by administering lethal doses of either morphine or diamorphine, more commonly known as heroin. Shipman had been convicted for fraudulently obtaining drugs in order to support an addiction when he was 29. As a result of his past addiction, the police considered that he had obtained heroin illicitly for his killings just as he had obtained the drugs 1975 to feed his addiction. Another way that Shipman may have obtained the drugs is that, he would issue prescriptions for patients, those who required the drug and those who did not, retaining some or all
I. Purpose: To experimentally determine the mass and the mole content of a measured sample. II. Materials: The materials used in this experiment a 50-mL beaker, 12 samples, a balance and paper towels. III.
( this is an analysis that is done by a Toxicologist).
15) After each cuvette was tested, place the distilled water sample (Cuvette zero) to reset the spectrometer and to ensure that the scale is calibrated and repeat for each cuvette test. Data/Results: Tube Number Concentration Of CoCL2 (Mg/ML) CoCL2 Stock (ML) Distilled Water (ML) Spectrometry Reading at
1. 150 ml of boiled water was poured into each of the three beakers labeled A, B, C. 2. Five tea bags were soaked for the time given by the manufacturer (two minutes) , in beaker A (Control). The teabags were immediately removed after the time elapsed. 3.
Also, although this likely served no contribution in disheveling the results, using a stirrer of the same material to ensure the separate testing of each substance will be as uniform as
Purpose/Introduction The process of recrystallization is an important method of purifying a solid organic substance using a hot solution as a solvent. This method will allow the separation of impurities. We will analyze Benzoic Acid as it is dissolved and recrystallized in water and in a solvent of Methanol and water. Reaction/Summary
Next, a basic stock solution was used to prepare various concentrations ranging from 1.0 x 10-8M to 1.0 x 10-1M by serial dilution. The tissue was washed by overflow with reservoir’s solution for 5 seconds to obtain baseline before adding 0.1ml, 0.3ml and 0.5ml for each concentration respectively into the tissue bath. The tissue’s peak response for each final bath concentration(FBC) was measured and recorded. Rmax and EC50 of histamine were recorded.