ISO 13179-1 Surgical Implants - Coatings on Metallic Surgical Implants - Part 1: Plasma Sprayed Coatings Derived from Titanium or Titanium-6 Aluminium-4 Vanadium Alloy Powders

The standard "ISO 13179-1 Surgical implants - Coatings on metallic surgical implants - Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminium-4 vanadium alloy powders" developed by the International Organization for Standardization (ISO) describes the general requirements for plasma-sprayed titanium coatings on metallic surgical implants. This standard is applicable to atmospheric plasma spraying and vacuum plasma spraying. However, it does not apply to coatings made from materials other than titanium or titanium-6 aluminium-4 vanadium alloys or coatings performed by a technology other than plasma spraying.

Plasma spraying is a thermal spraying method that produces coatings using a plasma jet. Vacuum plasma spraying is a process in which plasma spraying is performed in a controlled inert environment at pressures below atmospheric pressure. Atmospheric plasma spraying is a process in which plasma spraying is performed at atmospheric pressure.

The powder used in plasma spraying must comply with the standard “ASTM F1580-18 Standard specification for titanium and titanium-6 aluminum-4 vanadium alloy powders for coatings of surgical implants”.

A risk assessment should be performed to identify and evaluate impurities generated during the plasma spraying process. For vacuum plasma spray coatings and atmospheric plasma spray coatings, the composition limits of the elements listed in the table given in the standard should not exceed the specified mass fraction. The chemical composition is determined using the sampling procedure and the chemical analysis procedure.

For the purposes of this standard, the following terms and definitions apply:

• Delta ring and ball express the increase in the softening point of a bitumen/filler aggregate mixture in a composition of 37,5 parts by volume filler aggregate and 62,5 parts by volume bitumen, compared to the softening point of the bitumen used in this mixture.
• Constant mass refers to the mass determined by successive weighings made at least 1 hour apart and not differing by more than 0,1 percent. In many cases, constant mass can be achieved after a test piece has been dried in a specific oven at 110 degrees plus/minus 5 degrees for a predetermined period of time. Testing laboratories can determine the time required to reach constant mass for specific types and sizes of samples based on the drying capacity of the oven used.
• Laboratory sample refers to the reduced sample derived from the bulk sample for laboratory testing.
• Test piece refers to the sample used as a whole in a single test.
• The softening point refers to the temperature at which the material reaches a certain consistency between solid and liquid behavior under standard test conditions.

This test method is carried out using bitumen and filler aggregate particles smaller than 0,125 mm. Double discs of bitumen and bitumen/filler aggregate mixture are cast into brass rings. The rings are heated at a controlled rate in a water bath while supporting a steel ball and the temperature at which the discs soften sufficiently to allow the steel ball to fall to a distance of 25,0 plus/minus 0,4 mm is determined. Average temperatures are calculated for rings containing bitumen and rings containing bitumen/filler aggregate mixture. The difference between the two average temperatures is recorded.

Unless otherwise stated, all equipment used in these tests must comply with the general requirements of the standard “EN 932-5 Tests on general properties of aggregates - Part 5: Common equipment and calibration”. The main equipment used in these tests includes:

• Scales with accuracy up to 0,1 g.
• Drying oven that can be adjusted to maintain temperatures of 110 degrees plus/minus 5 degrees and 150 degrees plus/minus 5 degrees.
• Heat resistant mixer.
• 12591/70 class asphalt bitumen specified in EN 100 standard.
• Heatable containers.
• Heat-resistant evaporator dish with a round base, with a capacity of approximately 140 ml.
• Square shouldered brass rings specified to EN 1427 standard.
• Bottle warmer suitable for use with evaporator.
• Desiccant and drying agent.
• Glass or metal sheet, approximately 150 mm x 150 mm in size, coated with release agent.
• Cork ring for weighing the evaporator dish.
• 0,125 mm size test sieve.

Among the numerous testing, measurement, analysis and evaluation studies that our organization has provided for businesses in various sectors, our organization also provides testing services defined in the standard “ISO 13179-1 Surgical implants - Coatings on metallic surgical implants - Part 1: Plasma sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders” with its trained and expert staff and advanced technological equipment.