METAL BACK

ISO and ASTM (USA standard) compliance documentary checks

Material sampling and analysis by approved lab

Chemical composition check

Chemical composition check

Mechanical traction and stretch at break resistance check

Mechanical traction and stretch at break resistance check

Grain size test

Grain size check

First part setting dimensional test

Full dimensional and three-dimension machine geometry test, 2 micron accuracy

1 part out of 10 in process check by production operator using a micrometer, calliper, gauge

Digital control machine programmes

Random daily check by quality control with its own measuring instruments (possible detection of calibration error in production's control instrument)

100 daN load block resistance check

Weld parameter inspection and recording (intensity, tension, flow, argon)

1 out of 10 part sampling (all parts redone if random check shows 1 out of tolerance result.

Weld quality check by destructive part test and metallurgic analysis.

Visual inspection according to standards

Pressure, tie and abrasion load quality parameter inspection

Regular used load screening

Powder batch check according to ISO standard

Thickness inspection

Pressure, plasma speed, temperature inspection

Heavy metal %

Crystalline phase % control on deposit

Crystalline phase %

Porosity check

Tear resistance

Unit visual inspection

Coating peak-to-valley

Part bacterial contamination check

Cleaning water inspection

Chemical contamination check (for Na, nitrates)

Rinsing water ultra violet treatment efficiency check

Initial contamination inspection according to pharmacopoeia

Parameter irradiation dose check.

Part sterilisation check

Blister pack stripping

Blister pack sealing check

Shell and tyveck thickness inspection

Production quantity check at each step in order to identify possible mixes

Unit weighing inspection (for size error)

HMWPE INSERT

High molecular weight polyethylene (higher than 4.5 million g / mole) stearate free in accordance with ISO and ASTM standard

ISO and ASTM (USA standard) compliance documentary checks

Material sampling and analysis by approved lab

Chemical composition check

Chemical composition check

Mechanical traction and stretch at break resistance check

Mechanical traction and stretch at break resistance check

Grains size check

Grain size check

Oxidation check by approved laboratory

Dryer stabilising in argon including temperature, argon pressure, time parameter recording

Dimensional first part setting check

Total dimensional and geometry checks on three-dimensional checks, 2 micron measuring accuracy

1 part out of 10 in process check by production operator with a micrometer, calliper, gauge.

Digital control machine programme

Random daily check by quality control with its own measuring instruments (possible detection of calibration error in production's control instrument)

Friction surface peak to valley

Part bacterial contamination

Regular cleaning water check

Chemical pollution check (for Na, nitrates, carbon hydride)

Rinsing water ultraviolet treatment efficiency check

Initial contamination inspection according to pharmacopoeia

Process validated according to ISO standard

Part sterilisation check

Blister pack stripping

Blister pack sealing check

Shell and tyveck thickness inspection

Ethylene oxide rate check

Produced quantity checked at each step for possible mixes

Unit weighing inspection (for size error)

ALUMINIUM OXIDE / UWMWPE SANDWICH INSERT

UHMWPE

High molecular weight polyethylene (higher than 4.5 million g per mole) without stearates, in accordance with ISO and ASTM standards.

ISO and ASTM (USA standard) compliance check

Material sampling and analysis by approved laboratory

Chemical composition check

Chemical composition check

Mechanical traction and break elongation resistance check

Mechanical traction and break elongation resistance check

Grain size check

Grain size check

Load elongation check on standardised test tube.

Irradiation dose check applied on degassed fabricated materials under high pressure

ALUMINIUM
OXIDE

Grain size density check according to ISO and ASTM

Unit resistance to water pressure
Dimensional on three-dimensional machine
Peak to valley of friction surfaces

Oxidation check by approved laboratory

Dryer stabilising in argon including temperature, argon pressure, time parameter recording

Dimensional setting check on first part.

Total dimensional and geometry checks on three-dimensional checks, 2 micron measuring accuracy

1 part out of 10 in process check by production operator with a micrometer , calliper, gauge.

Digital control machine programmes.

Random daily check by quality control with its own measuring instruments (possible detection of calibration error in production's control instrument)

ALUMINIUM OXIDE INSERT ASSEMBLING IN ENVELOPPE.

Load rotation check of inset in PE envelope

Production oxidation, time, argon pressure, temperature parameter check

Part bacterial pollution check

Regular cleaning water check

Chemical contamination check (for Na, nitrates)

Rinsing water ultraviolet treatment efficiency check

Initial contamination check according to pharmacopoeia

Process validated according to ISO

Part sterilisation check

Irradiation parameter check

Blister pack stripping

Blister pack sealing check

Shell and tyveck thickness inspection

Production quantity check at each step in order to identify possible mixes

Unit weighing inspection (for size error)

SCREW

TA6V ELI

ISO and ASTM (USA standard) compliance documentary checks

Material sampling and analysis by approved lab

Contrôle composition chimique

Chemical composition check

Mechanical traction and stretch at break resistance check

Mechanical traction and stretch at break resistance check

Grain size check

Grain size check

Dimensional setting check on first part.

Total dimensional and geometry checks on three-dimensional checks, 2 micron measuring accuracy

1 part out of 10 in process check by production operator with a micrometer , calliper, gauge.

Digital control machine programmes

Net check according to ISO standard.

Random daily check by quality control with its own measuring instruments (possible detection of calibration error in production's control instrument)

Visual inspection according to standardised sets

Abrasive filler quality, time and pressure parameter check

Regular load screening (removal of out of spec. Material)

Part bacterial pollution check

Regular cleaning water check

Chemical contamination check (for Na, nitrates, carbon hydrides)

Rinsing water ultraviolet treatment efficiency check

Produced quantity check at each step for possible mixes

Unit weighing inspection (for size error)