Specification builder · Tier B
Profile projector (optical comparator) with digital readout, for dimensional and angle measurement of small medical-device parts
A profile projector shines light past a part and throws a magnified shadow (or surface image) onto a large screen, where lengths, angles, radii and profiles are measured with a moving XY stage and digital readout. Drug and device testing labs, needle/syringe/IV set makers and pharma plants use it to check needle bevels, cannula tips, luer tapers and threads, small moulded parts and tablet punches without touching them. An edge detector and 2D data processor make results less operator-dependent; a video option adds stored images.
What this equipment will do
- Part types: hypodermic needles, IV cannulas and catheter tips, luer connectors and small moulded device parts.
- Part types: tablet punches and other cylindrical parts held between centres or in V-blocks (tip profile and wear). (with the optional module)
- Lengths and X-Y distances with the measuring stage and digital readout (accuracy about (5 + L/25) um, checked with a certified glass scale).
- Angles with the rotating screen, read to 1 minute of arc (0.01 degree).
- Needle tubing outside diameter (ISO 9626).
- Needle point and bevel: primary and secondary bevel angles and bevel length viewed in profile (ISO 7864). (with the optional module)
- Luer 6% taper and luer lock thread profiles checked against overlay charts or on a centre holder with helix tilt (ISO 80369-7). (with the optional module)
- Higher magnification (20x and 50x, or up to 100x) for very fine needle tips and small features. (with the optional module)
- Radii, circles, intersections and part alignment calculated by a 2D data processor, with tolerance pass/fail and stored programs. (with the optional module)
- Automatic edge detection, so results depend less on the operator. (with the optional module)
- Saved images with measurement overlay and video edge measurement (ISO 10360-7). (with the optional module)
- Comparison of the measured outline with the 2D CAD drawing (DXF), with deviation report. (with the optional module)
Not covered: 3D form, flatness and surface roughness need a coordinate measuring machine or surface roughness tester; the projector measures 2D outlines only.; Needle sharpness and penetration force need the needle penetration tester.; Needle tubing stiffness and breakage (ISO 9626 Annexes B and C) need the flexural (bend) testing machine with ISO 9626 fixtures.; Luer connector leakage, separation and stress cracking (ISO 80369-20) need the luer connector test system.
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Standards this specification draws on
- IEC 61010-1 Basic electrical safety standard for measurement and laboratory equipment, covering the mains-powered lamps, readout and encoders.
- IEC 61326-1 EMC requirements for laboratory and measurement equipment, so the readout and encoders are not disturbed by or disturbing other equipment.
- ISO 7864:2016 Sterile hypodermic needles; the projector is used to check needle point, bevel and length features of samples against this standard and the maker's design.
- ISO 9626:2016 Stainless steel needle tubing; outside diameter and wall dimensions of needle tubing are checked optically.
- ISO 80369-7:2021 Defines the dimensions of luer (6% taper) connectors and luer lock threads that the projector is used to verify.
- ISO 1101:2017 Geometrical tolerancing rules (form, orientation, profile) used to read device drawings and report profile and angle results.
- ISO 14253-1:2017 Decision rules for proving conformity or non-conformity when measurement uncertainty is taken into account, important for legal DTL decisions.
- ISO 10360-7:2011 Acceptance and reverification tests for coordinate measuring systems with imaging probing, applicable to the video measuring option.
- JIS B 7184:1999 Japanese industrial standard for profile projectors, widely used by makers to state magnification and stage accuracy and the test methods to check them.
- ISO/IEC 17025:2017 Accreditation standard for testing and calibration labs; needs calibrated equipment with SI-traceable certificates and stated uncertainty.
- 21 CFR Part 11 US FDA rule on electronic records and signatures; relevant only when projector software stores results used for batch release.
Common mistakes in tenders for this equipment
- Copying one maker's exact figures (a 306 mm or 315 mm screen, a 300 x 170 mm stage, a 0.08% magnification accuracy) so only one brand can comply; write 'not less than' minimums instead.
- Using proprietary names for edge sensors, data processors or software in the specification instead of describing the function and accuracy needed.
- Asking for display resolution (0.5 or 1 um) as if it were accuracy; ask for the XY accuracy formula and verify it at installation with a certified glass scale.
- Buying the projector with only the 10x lens and no needle holders, centre holders or overlay charts, so needles and luer parts cannot actually be measured.
- No ISO/IEC 17025 accredited calibration in the bid and no fixed-price calibration after warranty, so DTL results cannot be defended.
- Installing it in a hot, dusty room without air conditioning or a stable bench; temperature changes and vibration spoil micron-level measurements.
- Asking for DRAP medical-device registration or ISO 13485 for a laboratory test instrument, which only confuses bidders and reduces competition.