{"$schema":"nativecad-dfm-pack/1","id":"medical","title":"Medical devices — biocompatibility, sterilization, cleanability, labware","sector":"medical","version":"2026-09-03","summary":"Biocompatibility contact categories and USP Class VI materials, sterilization compatibility (autoclave/EtO/gamma/H2O2), cleanability geometry, IEC 60601-1 mechanical tests, ISO 80369-7 Luer fittings, tubing, and ANSI/SLAS microplate, tube-rack, cuvette, slide and syringe labware dimensions.","aliases":["medical device","lab","laboratory","microplate","well plate","sbs","tube rack","luer","syringe","autoclave","sterilisation","sterilization","biocompatible","pipette","cuvette","petri","lab fixture","diagnostic device"],"crossSector":false,"size":"standard","sources":[{"id":"iso-10993-1","title":"ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process","url":"https://www.iso.org/standard/68936.html","accessed":"2026-09-03"},{"id":"usp-class-vi","title":"USP <88> Biological Reactivity Tests, In Vivo — Class VI plastics","accessed":"2026-09-03"},{"id":"iso-13485","title":"ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes","url":"https://www.iso.org/standard/59752.html","accessed":"2026-09-03"},{"id":"iec-60601-1","title":"IEC 60601-1:2005+AMD1+AMD2 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance","url":"https://webstore.iec.ch/publication/2606","accessed":"2026-09-03"},{"id":"iso-80369-7","title":"ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications (Luer)","url":"https://www.iso.org/standard/79831.html","accessed":"2026-09-03"},{"id":"ansi-slas-1","title":"ANSI/SLAS 1-2004 (R2012) Microplates — Footprint Dimensions","url":"https://www.slas.org/education/ansi-slas-microplate-standards/","accessed":"2026-09-03"},{"id":"ansi-slas-2","title":"ANSI/SLAS 2-2004 (R2012) Microplates — Height Dimensions","url":"https://www.slas.org/education/ansi-slas-microplate-standards/","accessed":"2026-09-03"},{"id":"ansi-slas-4","title":"ANSI/SLAS 4-2004 (R2012) Microplates — Well Positions","url":"https://www.slas.org/education/ansi-slas-microplate-standards/","accessed":"2026-09-03"},{"id":"iso-7886-1","title":"ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use","url":"https://www.iso.org/standard/64837.html","accessed":"2026-09-03"},{"id":"iso-11135","title":"ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for development, validation and routine control","url":"https://www.iso.org/standard/56137.html","accessed":"2026-09-03"},{"id":"iso-11137-2","title":"ISO 11137-2:2013 Sterilization of health-care products — Radiation — Part 2: Establishing the sterilization dose","url":"https://www.iso.org/standard/62058.html","accessed":"2026-09-03"},{"id":"iso-17665-1","title":"ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for development, validation and routine control","url":"https://www.iso.org/standard/46707.html","accessed":"2026-09-03"},{"id":"ensinger-medical","title":"Ensinger — Medical Grade Plastics Design Guide","url":"https://www.ensingerplastics.com/en/shapes/medical-plastics","accessed":"2026-09-03"},{"id":"solvay-medical","title":"Solvay Specialty Polymers — Healthcare & Medical Materials Guide","url":"https://www.solvay.com/en/brands/healthcare-polymers","accessed":"2026-09-03"}],"entries":[{"id":"biocompat-contact-duration","kind":"rule","tier":1,"title":"ISO 10993-1 body-contact duration categories","summary":"Classify device contact by duration before picking materials: limited contact < 24 h, prolonged contact 24 h to 30 days, permanent contact > 30 days — each step up adds required biocompatibility endpoints.","applies":["biocompatibility","medical device"],"value":{"table":[{"category":"limited","max_h":24},{"category":"prolonged","min_h":24,"max_d":30},{"category":"permanent","min_d":30}],"unit":"h","note":"limited <24h; prolonged 24h-30d; permanent >30d"},"basis":"ISO 10993-1 Table A.1 contact-duration categories drive which biological endpoints (cytotoxicity, sensitization, irritation, systemic toxicity, etc.) a device must be evaluated against","sources":["iso-10993-1"],"tags":["biocompatibility","iso10993","contact-duration"]},{"id":"usp-class-vi-materials","kind":"material","tier":1,"title":"USP Class VI plastics for patient-contact parts","summary":"USP Class VI / ISO 10993 grades commonly specified for patient or drug contact: PC, PSU/PPSU, PEEK, POM-C, silicone, 316L stainless, Ti-6Al-4V and PP — 8 material families cover most rigid, flexible and metal medical parts.","applies":["biocompatibility","material","medical device"],"value":{"options":["PC","PSU/PPSU","PEEK","POM-C","silicone","316L","Ti-6Al-4V","PP"]},"basis":"USP <88> Class VI in-vivo reactivity plus ISO 10993 testing is the baseline grade qualification most medical-device resin and metal suppliers publish against","sources":["usp-class-vi","iso-10993-1"],"tags":["material","usp-class-vi","biocompatibility"]},{"id":"autoclave-steam-sterilization","kind":"process","tier":1,"title":"Steam autoclave sterilization compatibility","summary":"A steam-autoclavable device must survive 121C for 15-20 min (gravity cycle) or 134C for 3-20 min (pre-vacuum cycle); PSU/PPSU, PEEK, PP and 316L tolerate repeated cycles, ABS and POM do not.","applies":["sterilization","autoclave","reusable device"],"value":{"min":121,"max":134,"unit":"C","note":"121C 15-20min gravity; 134C down to 3min pre-vacuum"},"basis":"ISO 17665-1 moist-heat sterilization cycle parameters and published resin heat-deflection temperatures set which polymers survive repeated autoclaving","sources":["iso-17665-1","ensinger-medical"],"tags":["sterilization","autoclave","steam"]},{"id":"eto-sterilization-compatibility","kind":"process","tier":1,"title":"Ethylene oxide (EtO) sterilization compatibility","summary":"EtO sterilizes most plastics (PC, ABS, PVC, PP, PA) at 37-63C without heat damage, but a sealed cavity needs a vent path >=1 mm or a porous membrane so residual gas can aerate out over the 8-12 h cycle.","applies":["sterilization","eto","single-use device"],"value":{"min":37,"max":63,"unit":"C"},"basis":"ISO 11135 EtO cycle runs at low temperature so it suits heat-sensitive plastics broadly, but trapped gas in an unvented cavity fails residual-limit testing","sources":["iso-11135"],"tags":["sterilization","eto","venting"]},{"id":"gamma-sterilization-compatibility","kind":"process","tier":1,"title":"Gamma irradiation sterilization compatibility","summary":"Gamma sterilization uses a validated dose of 25-50 kGy; PC and stabilised PP hold up, but unstabilised POM and PTFE degrade (chain scission, discolouration, embrittlement) at these doses and should not be gamma-sterilized.","applies":["sterilization","gamma","single-use device"],"value":{"value":"25-50 kGy","unit":"text"},"basis":"ISO 11137-2 dose-setting methods target a validated sterility assurance level; radiation-stable grades (gamma-stabilised PP, PC) are formulated specifically to survive this dose band","sources":["iso-11137-2","ensinger-medical"],"tags":["sterilization","gamma","radiation"]},{"id":"cleanability-internal-radius","kind":"rule","tier":1,"title":"Minimum internal radius for cleanable wetted surfaces","summary":"Radius every internal corner on a wetted or reprocessed surface to at least 3 mm; a sharper corner traps residue and biofilm that a brush or cleaning fluid cannot reach.","applies":["cleanability","wetted surface","reusable device"],"value":{"min":3,"unit":"mm"},"basis":"Cleaning-validation guidance for reusable devices treats any internal radius under a few mm as a residue trap that fails a worst-case soil challenge","sources":["iso-13485"],"tags":["cleanability","radius","reusable"]},{"id":"cleanability-no-crevice","kind":"rule","tier":1,"title":"No blind pockets or crevices on wetted geometry","summary":"A wetted or reprocessed part must have no blind pocket or crevice; where two surfaces must meet, hold the gap to >=1 mm (cleaning fluid can flow through) or 0 mm (a true seal with no gap at all) — nothing in between.","applies":["cleanability","wetted surface","reusable device"],"value":{"value":1,"unit":"mm","note":"gap >=1mm (flushable) or 0mm (sealed); no partial gap"},"basis":"A gap narrower than 1 mm traps fluid by capillary action but is too tight for a brush or jet to clear, so cleaning validation treats anything between 0 and 1 mm as a failure mode","sources":["iso-13485"],"tags":["cleanability","crevice","gap"]},{"id":"cleanability-surface-roughness","kind":"tolerance","tier":1,"title":"Surface roughness for wetted stainless vs. housing surfaces","summary":"Hold wetted 316L stainless surfaces to Ra <= 0.8 um so residue and bacteria can't lodge in the finish; a non-wetted housing surface only needs Ra <= 1.6 um.","applies":["cleanability","surface finish","316l","housing"],"value":{"max":1.6,"unit":"um","note":"wetted stainless Ra<=0.8um; housings Ra<=1.6um"},"basis":"Ra 0.8 um is the common pharmaceutical/medical wetted-surface polish floor; a dry housing surface has no cleaning-validation driver so it can stay at a coarser machining/moulding finish","sources":["iso-13485","ensinger-medical"],"tags":["surface-finish","ra","cleanability"]},{"id":"cleanability-drain-angle","kind":"rule","tier":2,"title":"Minimum drain angle on cleanable trays and troughs","summary":"Slope any surface meant to drain cleaning fluid or condensate at least 3 deg toward a low point; a flatter floor leaves standing liquid that reintroduces bioburden after the cycle.","applies":["cleanability","tray","reusable device"],"value":{"min":3,"unit":"deg"},"basis":"A 3 deg minimum slope is the common cleanroom/pharma equipment-drainage floor that reliably sheets liquid off a flat pan rather than pooling it","sources":["iso-13485"],"tags":["drain","cleanability","angle"]},{"id":"enclosure-ip-rating-60601","kind":"rule","tier":1,"title":"Minimum ingress protection for a medical electrical enclosure","summary":"IEC 60601-1 treats an ordinary medical electrical enclosure as needing at least IP21 (protected against solid objects >=12.5 mm and vertically dripping water); a device meant for wipe-down or splash exposure should target IP22 or higher.","applies":["ip rating","enclosure","medical device"],"value":{"options":["IP21","IP22","IP54"]},"basis":"IP21 is the IEC 60601-1 baseline ingress class for a general medical electrical enclosure with no explicit liquid-exposure claim","sources":["iec-60601-1"],"tags":["ip-rating","enclosure","60601"]},{"id":"enclosure-push-force-60601","kind":"test","tier":2,"title":"Enclosure push-force test (IEC 60601-1)","summary":"IEC 60601-1 pushes a rigid test finger against an enclosure at 250 N; a wall, boss or vent grille under it must not deflect enough to touch an internal hazardous part or crack.","applies":["mechanical strength","enclosure","medical device"],"value":{"value":250,"unit":"N"},"basis":"IEC 60601-1 clause 15's push-test load simulates a person leaning on the enclosure in normal use","sources":["iec-60601-1"],"tags":["test","push-force","mechanical"]},{"id":"handheld-drop-test-60601","kind":"test","tier":2,"title":"Handheld device drop test","summary":"Drop a handheld medical device 1 m onto a hard surface in the orientations most likely in normal use; the shell must keep enclosure integrity (no crack exposing hazardous parts) and IP rating after the drop.","applies":["drop test","handheld","medical device"],"value":{"value":1000,"unit":"mm","note":"1 m drop height"},"basis":"IEC 60601-1's drop-test provision for portable/handheld equipment uses a 1 m fall onto a hard floor as the normal-use worst case","sources":["iec-60601-1"],"tags":["test","drop","handheld"]},{"id":"ball-impact-test-60601","kind":"test","tier":2,"title":"Spring-hammer / ball impact test (IEC 60601-1)","summary":"IEC 60601-1's impact test drops a 0.5 kg steel ball from 1.3 m onto the enclosure; the wall must not crack or deform enough to expose an internal hazardous part.","applies":["impact test","enclosure","medical device"],"value":{"value":0.5,"unit":"kg","note":"ball dropped from 1300mm (1.3m)"},"basis":"IEC 60601-1 clause 15.3.4's ball-impact provision simulates an accidental knock against the enclosure in normal use","sources":["iec-60601-1"],"tags":["test","impact","mechanical"]},{"id":"sharp-edge-radius-60601","kind":"rule","tier":2,"title":"Minimum edge radius to avoid a sharp edge (IEC 60601-1)","summary":"Round every accessible edge on a medical device to at least 0.5 mm radius; IEC 60601-1's sharp-edge test fails any edge that can cut the standard test finger below this radius.","applies":["sharp edge","enclosure","medical device"],"value":{"min":0.5,"unit":"mm"},"basis":"IEC 60601-1 clause 23's sharp-edge requirement is checked by an edge-radius gauge; 0.5 mm is the common practical floor moulders and machinists design to","sources":["iec-60601-1"],"tags":["sharp-edge","radius","safety"]},{"id":"luer-male-taper","kind":"dimension","tier":1,"title":"ISO 80369-7 male Luer taper","summary":"A male Luer tip runs a 6% taper, outer diameter growing from 4.0 mm at the tip to 4.3 mm over a 7.5 mm engagement length, so it self-seals by friction against the matching female taper.","applies":["luer","syringe","tubing connector"],"value":{"min":4,"max":4.3,"unit":"mm","note":"over 7.5mm length; 6% taper"},"basis":"ISO 80369-7 defines the 6% Luer taper geometry so male and female fittings from different manufacturers seal and disconnect predictably","sources":["iso-80369-7"],"tags":["luer","taper","connector"]},{"id":"microplate-sbs-footprint","kind":"dimension","tier":1,"title":"SBS/ANSI SLAS microplate footprint","summary":"An SBS-format microplate footprint is 127.76 x 85.48 mm, +/-0.5 mm, so it registers on any standard plate reader, washer or liquid handler built to the ANSI/SLAS envelope.","applies":["microplate","well plate","sbs","lab automation"],"value":{"table":[{"axis":"x","value":127.76},{"axis":"y","value":85.48}],"unit":"mm","note":"tolerance +/-0.5mm"},"basis":"ANSI/SLAS 1-2004 Footprint Dimensions is the interoperability standard every microplate handler, reader and robotic gripper is built against","sources":["ansi-slas-1"],"tags":["microplate","sbs","footprint"],"check":{"process":"injection_molding","rule":"min_wall_thickness"}},{"id":"microplate-corner-radius","kind":"dimension","tier":2,"title":"SBS microplate outer corner radius","summary":"An SBS microplate's outer corner radius is 3.18 mm (1/8 in), the value nest and carrier fixtures across the industry design their locating pockets to.","applies":["microplate","well plate","sbs"],"value":{"value":3.18,"unit":"mm"},"basis":"ANSI/SLAS 1-2004 specifies the 3.18 mm corner radius as part of the footprint envelope so nests and grippers clear consistently","sources":["ansi-slas-1"],"tags":["microplate","corner-radius","sbs"]},{"id":"microplate-96-well-pitch","kind":"dimension","tier":1,"title":"96-well microplate grid pitch and A1 offset","summary":"A 96-well SBS microplate uses a 9.0 mm well-to-well pitch on both axes, with well A1 centred at 14.38 mm from the left edge and 11.24 mm from the top edge of the footprint.","applies":["microplate","96-well","well plate"],"value":{"value":9,"unit":"mm","note":"A1 center at x=14.38mm, y=11.24mm"},"basis":"ANSI/SLAS 4-2004 Well Positions fixes the 9 mm pitch and A1 datum so pipetting heads and readers index every well correctly","sources":["ansi-slas-4"],"tags":["microplate","96-well","pitch"]},{"id":"microplate-height-family","kind":"dimension","tier":1,"title":"Microplate overall height by format","summary":"A standard SBS microplate stands 14.35 mm tall, a low-profile plate 10.4 mm, and a deep-well plate up to 44 mm — the height a stacker, lid or robotic gripper must clear.","applies":["microplate","well plate","deep well","low profile"],"value":{"table":[{"format":"standard","height":14.35},{"format":"low-profile","height":10.4},{"format":"deep-well","height":44}],"unit":"mm"},"basis":"ANSI/SLAS 2-2004 Height Dimensions plus common deep-well plate practice sets the three heights lab automation decks are designed to stack and grip","sources":["ansi-slas-2"],"tags":["microplate","height","deep-well"]},{"id":"tube-rack-microtube-bore","kind":"dimension","tier":1,"title":"Tube rack bore for 1.5/2.0 mL microtubes","summary":"A rack pocket for a 1.5-2.0 mL conical microtube bores 10.8-11.0 mm diameter, tight enough to hold the tube upright without a lid interference, loose enough to drop and pull the tube by hand.","applies":["tube rack","microtube","laboratory"],"value":{"min":10.8,"max":11,"unit":"mm"},"basis":"Common 1.5/2.0 mL conical microcentrifuge tube cap-flange outer diameter plus a light hand-insertion clearance","sources":["ensinger-medical"],"tags":["tube-rack","microtube","bore"]},{"id":"tube-rack-hole-spacing","kind":"dimension","tier":2,"title":"Tube rack hole-to-hole spacing family","summary":"Lab tube racks index holes on 16 mm, 20 mm or 32 mm centres depending on tube size — 16 mm for microtubes in dense grids, 20 mm for spaced microtube racks, 32 mm for 15/50 mL centrifuge tube racks.","applies":["tube rack","laboratory","microtube","centrifuge tube"],"value":{"options":[16,20,32],"unit":"mm"},"basis":"Common commercial tube-rack pitch families balancing tube density against wall thickness between adjacent bores","sources":["ensinger-medical"],"tags":["tube-rack","spacing","pitch"]},{"id":"material-pc-medical","kind":"material","tier":1,"title":"Polycarbonate (PC) for medical housings and windows","summary":"Medical-grade PC (~1.2 g/cm3) autoclaves and gamma-sterilizes well, is USP Class VI gradeable, and is the default clear or opaque housing resin for reusable diagnostic and monitoring device shells.","applies":["housing","window","material","reusable device"],"value":{"value":1.2,"unit":"g/cm3"},"basis":"Medical PC grade datasheet density; PC's clarity, impact strength and steam/gamma tolerance make it the default reusable-enclosure resin","sources":["ensinger-medical","usp-class-vi"],"tags":["material","pc","housing"]},{"id":"material-peek-medical","kind":"material","tier":2,"title":"PEEK for implant-adjacent and repeat-autoclave parts","summary":"PEEK (~1.3 g/cm3) survives thousands of 134C autoclave cycles without degrading and is USP Class VI/ISO 10993 gradeable, making it the material of choice for surgical instrument components and permanent-contact parts.","applies":["surgical instrument","material","permanent contact","reusable device"],"value":{"value":1.3,"unit":"g/cm3"},"basis":"Medical PEEK grade datasheet density and published repeat-autoclave/chemical-resistance performance versus PSU/PPSU and PC","sources":["solvay-medical","usp-class-vi"],"tags":["material","peek","autoclave"]},{"id":"h2o2-plasma-sterilization","kind":"process","tier":2,"title":"Hydrogen peroxide (H2O2) gas plasma sterilization","summary":"H2O2 gas plasma sterilizes heat- and moisture-sensitive devices at 45-55C in a roughly 30-75 min cycle with no water condensation, but it cannot penetrate a long narrow lumen (typically <1 mm bore over >125 mm length) or cellulose-based materials.","applies":["sterilization","h2o2","plasma"],"value":{"min":45,"max":55,"unit":"C"},"basis":"Low-temperature plasma sterilization avoids the thermal load of steam and the aeration time of EtO, at the cost of lumen-penetration and material-compatibility limits vendors publish per cycle","sources":["ensinger-medical"],"tags":["sterilization","h2o2","plasma"]},{"id":"tube-rack-large-tube-bore","kind":"dimension","tier":2,"title":"Tube rack bore for 15 mL and 50 mL centrifuge tubes","summary":"A 15 mL conical tube rack pocket bores 17 mm diameter; a 50 mL conical tube pocket bores 29-30 mm — both sized to the tube's moulded body OD plus a light drop-in clearance.","applies":["tube rack","centrifuge tube","laboratory"],"value":{"table":[{"tube":"15mL","diameter":17},{"tube":"50mL","diameter":29.5}],"unit":"mm"},"basis":"Common 15 mL and 50 mL polypropylene conical centrifuge tube body OD plus drop-in assembly clearance","sources":["ensinger-medical"],"tags":["tube-rack","centrifuge-tube","bore"]},{"id":"microplate-384-well-pitch","kind":"dimension","tier":2,"title":"384-well microplate grid pitch","summary":"A 384-well SBS microplate halves the 96-well pitch to 4.5 mm on both axes within the same SBS footprint, quadrupling well density for high-throughput screening.","applies":["microplate","384-well","well plate"],"value":{"value":4.5,"unit":"mm"},"basis":"ANSI/SLAS 4-2004 fixes the 384-well pitch at exactly half the 96-well 9 mm pitch so both formats share the same footprint and edge datums","sources":["ansi-slas-4"],"tags":["microplate","384-well","pitch"]},{"id":"luer-lock-thread","kind":"fastener","tier":2,"title":"Luer-lock collar thread engagement","summary":"A Luer-lock collar threads onto the mating fitting with a 5.2 mm major diameter, coarse-pitch thread giving at least one full turn of engagement before the taper seats, so the connection resists axial pull-off under line pressure.","applies":["luer","luer lock","syringe","tubing connector"],"value":{"value":5.2,"unit":"mm"},"basis":"ISO 80369-7 specifies the Luer-lock collar thread envelope so a locking male and female pair from different manufacturers engage and resist disconnection under pressure","sources":["iso-80369-7"],"tags":["luer","luer-lock","thread"]},{"id":"tubing-silicone-medical","kind":"dimension","tier":2,"title":"Silicone peristaltic/pump tubing sizes","summary":"Common medical silicone tubing runs 1/8 in x 1/4 in (ID x OD) for pump and peristaltic lines and 1/16 in ID for fine dosing lines; size a barb OD roughly 10% over the tubing's nominal ID for a friction-tight push-fit.","applies":["tubing","silicone","fluidics"],"value":{"options":["1/8x1/4in","1/16in ID"],"unit":"in"},"basis":"Common platinum-cured silicone pump-tubing catalogue sizes; the +10% barb-over-ID rule is standard push-fit practice to seal without a clamp","sources":["ensinger-medical"],"tags":["tubing","silicone","barb"]},{"id":"tubing-pvc-medical-grade","kind":"material","tier":2,"title":"Medical-grade PVC tubing","summary":"Medical-grade PVC (~1.3 g/cm3, DEHP-free grades increasingly specified) is the default flexible tubing material for IV sets and disposable fluid paths, chosen for kink resistance and low cost over silicone's better biocompatibility and thermal range.","applies":["tubing","pvc","fluidics","single-use device"],"value":{"value":1.3,"unit":"g/cm3"},"basis":"Medical PVC compound datasheet density; PVC dominates disposable IV/fluid-path tubing on cost and kink resistance where full silicone-grade biocompatibility isn't required","sources":["ensinger-medical"],"tags":["material","pvc","tubing"]},{"id":"cuvette-standard-dimensions","kind":"dimension","tier":2,"title":"Standard 1 cm cuvette envelope","summary":"A standard laboratory cuvette is a 12.5 mm square cross-section tube sized to a 1 cm (10 mm) optical path, the dimension every spectrophotometer cuvette holder is machined to accept.","applies":["cuvette","spectrophotometer","laboratory"],"value":{"value":12.5,"unit":"mm"},"basis":"12.5 mm external square section with a 10 mm internal optical path is the near-universal spectrophotometer cuvette holder standard","sources":["ensinger-medical"],"tags":["cuvette","optical","dimension"]},{"id":"microscope-slide-dimensions","kind":"dimension","tier":2,"title":"Standard microscope slide envelope","summary":"A standard glass or plastic microscope slide is 75 x 25 x 1 mm, the footprint every slide holder, stage clip and slide-scanner cassette is built to.","applies":["slide","microscope","laboratory"],"value":{"table":[{"axis":"length","value":75},{"axis":"width","value":25},{"axis":"thickness","value":1}],"unit":"mm"},"basis":"75 x 25 x 1 mm is the long-standing ISO/ANSI-aligned glass microscope slide size that stage clips and slide trays are machined to","sources":["ensinger-medical"],"tags":["slide","microscope","dimension"]},{"id":"petri-dish-diameters","kind":"dimension","tier":2,"title":"Common petri dish diameter family","summary":"Petri dishes come in a 35/60/90/100 mm diameter family; a plate carrier or incubator rack needs a distinct pocket diameter per size rather than one universal bore.","applies":["petri dish","laboratory","cell culture"],"value":{"options":[35,60,90,100],"unit":"mm"},"basis":"Common commercial polystyrene petri dish diameter family used across cell culture and microbiology labware","sources":["ensinger-medical"],"tags":["petri","dish","diameter"]},{"id":"pipette-tip-cone-angle","kind":"feature","tier":2,"title":"Pipette tip cone geometry","summary":"A pipette tip cone tapers roughly 2-4 deg included half-angle from the shank to a fine orifice tip, sized in a family from ~10 uL to 1000 uL, and must seal onto the pipette shaft by friction alone with no separate gasket.","applies":["pipette tip","laboratory","consumable"],"value":{"min":2,"max":4,"unit":"deg"},"basis":"A shallow, consistent cone taper is what lets a moulded tip friction-seal reliably onto a wide range of pipette shaft diameters across brands","sources":["ensinger-medical"],"tags":["pipette","tip","cone"]},{"id":"syringe-barrel-od-family","kind":"dimension","tier":2,"title":"Syringe barrel OD by nominal volume","summary":"Syringe barrel outer diameter scales with nominal volume across the common 1/3/5/10/20/60 mL family, so a syringe pump clamp or holder must be sized (or made adjustable) per volume rather than assuming one universal barrel OD.","applies":["syringe","barrel","fluidics"],"value":{"options":["1mL","3mL","5mL","10mL","20mL","60mL"],"unit":"text"},"basis":"ISO 7886-1 sterile hypodermic syringe series defines the common nominal-volume family whose barrel OD a syringe pump or clamp must accommodate","sources":["iso-7886-1"],"tags":["syringe","barrel","dimension"]},{"id":"lab-fixture-noncontact-materials","kind":"material","tier":2,"title":"3D-printed materials for non-patient-contact lab fixtures","summary":"For a non-patient-contact lab jig or fixture, PETG (~1.27 g/cm3) and PA/nylon (~1.01-1.15 g/cm3) print robust, chemical-resistant tooling; reserve PC or PEEK for any surface that will actually touch a patient, drug or reagent under the biocompatibility rule.","applies":["lab fixture","jig","3d printing","non-contact"],"value":{"table":[{"material":"petg","density":1.27},{"material":"pa12","density":1.05}],"unit":"g/cm3"},"basis":"PETG and PA12 are common FDM/SLS tooling-grade materials selected for chemical resistance and print robustness where biocompatibility is not required","sources":["ensinger-medical"],"tags":["material","lab-fixture","3d-printing"],"see":["consumer/material-pla-petg-fdm"]},{"id":"handheld-grip-diameter","kind":"dimension","tier":2,"title":"Handheld device grip diameter","summary":"Size a handheld device's grip section 30-45 mm diameter for a comfortable one-hand hold across a 5th-to-95th-percentile adult hand, tapering toward the low end for a gloved-hand use case.","applies":["handheld device","ergonomics","grip"],"value":{"min":30,"max":45,"unit":"mm"},"basis":"Common handheld-instrument grip-diameter ergonomics band balancing a secure power grip against finger-length reach to any buttons","sources":["ensinger-medical"],"tags":["ergonomics","grip","handheld"]},{"id":"handheld-button-force","kind":"dimension","tier":2,"title":"Handheld device button actuation force","summary":"Size a handheld medical device's control button for 1-3 N actuation force, low enough for a gloved or reduced-dexterity user to press deliberately, high enough to resist accidental activation in a pocket or bag.","applies":["button","handheld device","ergonomics"],"value":{"min":1,"max":3,"unit":"N"},"basis":"Common tactile-dome/silicone-pad actuation-force band for a handheld medical control that must be both glove-operable and resistant to accidental actuation","sources":["ensinger-medical"],"tags":["button","force","handheld"]},{"id":"handheld-ip-rating-family","kind":"rule","tier":2,"title":"Handheld device IP rating family","summary":"A handheld diagnostic device typically targets IP22 (drip-proof, tilted) at minimum and up to IP54 (dust-protected, splash-proof) for a device used near fluids or in the field, driving seam, button and vent gasket design.","applies":["ip rating","handheld device","seal"],"value":{"options":["IP22","IP54"]},"basis":"IP22-IP54 spans the common ingress-protection range specified for portable diagnostic and point-of-care devices depending on fluid-exposure risk","sources":["iec-60601-1"],"tags":["ip-rating","handheld","seal"]},{"id":"udi-label-recess","kind":"dimension","tier":2,"title":"UDI / label recess on a device housing","summary":"Recess a Unique Device Identifier (UDI) or rating label 0.1-0.2 mm below the surrounding housing surface so the label sits flush and its edge can't be caught and peeled, while staying legible through a cleaning-agent wipe cycle.","applies":["udi","label","housing"],"value":{"min":0.1,"max":0.2,"unit":"mm"},"basis":"A shallow flush recess sized to common label-stock thickness keeps a regulatory UDI label attached and legible through repeated cleaning","sources":["iso-13485"],"tags":["udi","label","recess"],"see":["consumer/label-recess"]},{"id":"drug-contact-material-selection","kind":"rule","tier":2,"title":"Drug-contact material selection","summary":"Any surface in direct contact with a drug product or biologic needs extractables/leachables data in addition to ISO 10993 biocompatibility — PP, PC, PSU/PPSU and silicone are the common low-extractable choices; avoid PVC without a validated plasticiser-migration study.","applies":["drug contact","material","fluidics"],"value":{"options":["PP","PC","PSU/PPSU","silicone"]},"basis":"Drug-contact qualification adds an extractables/leachables burden on top of ISO 10993 that most PVC formulations fail without a dedicated migration study, due to plasticiser leaching","sources":["iso-10993-1","usp-class-vi"],"tags":["drug-contact","material","extractables"]},{"id":"test-cleaning-cycle-reusable","kind":"test","tier":2,"title":"Cleaning-cycle durability test (IPA / dilute bleach)","summary":"Cycle a reusable device through 100-500 manual cleaning cycles with 70% IPA and 10% bleach solution; passing means no crack, no colour change and no dimensional drift beyond this pack's tolerance entries at snaps, bosses and seams.","applies":["cleaning","reusable device","test"],"value":{"min":100,"max":500,"unit":"cycles"},"basis":"Reprocessing validation for a reusable device targets its labelled service-life cycle count under the actual disinfectants the hospital protocol specifies","sources":["iso-13485"],"tags":["test","cleaning","cycle"]},{"id":"test-autoclave-cycle-life","kind":"test","tier":2,"title":"Autoclave cycle-life test","summary":"Cycle a reusable autoclavable part through 100 full 121-134C steam cycles; passing means no warp, crack or seal degradation, and any dimensional drift stays within the part's mating tolerance.","applies":["autoclave","reusable device","test"],"value":{"value":100,"unit":"cycles"},"basis":"100 cycles is a common reusable-instrument service-life validation target against ISO 17665-1 moist-heat sterilization parameters","sources":["iso-17665-1"],"tags":["test","autoclave","cycle"]},{"id":"test-ingress-handheld","kind":"test","tier":2,"title":"Ingress protection test (IP22) for a handheld device","summary":"IP22 testing drips water vertically onto the enclosure tilted up to 15 deg and probes openings with a 12.5 mm finger; passing means no water reaches a hazardous or moisture-sensitive internal part.","applies":["ingress","ip22","handheld device","test"],"value":{"value":22,"unit":"count","note":"IP2X solids + IPX2 water (tilted 15deg) test"},"basis":"IEC 60601-1 references the IEC 60529 IP test methods; IP22 is the common handheld-device minimum for incidental drip exposure","sources":["iec-60601-1"],"tags":["test","ingress","ip-rating"]},{"id":"material-pom-c-medical","kind":"material","tier":2,"title":"POM-C (acetal copolymer) for medical mechanisms","summary":"POM-C (~1.41 g/cm3) is USP Class VI gradeable and used for low-friction mechanisms (valves, gears, latches) in diagnostic devices, but is not EtO- or gamma-preferred and should be limited to steam or H2O2 plasma cycles.","applies":["mechanism","valve","material"],"value":{"value":1.41,"unit":"g/cm3"},"basis":"Medical POM-C grade datasheet density; POM's low friction and dimensional stability suit precision mechanisms, but its formaldehyde off-gassing under radiation limits sterilization method choice","sources":["ensinger-medical","usp-class-vi"],"tags":["material","pom-c","mechanism"]},{"id":"material-316l-medical","kind":"material","tier":2,"title":"316L stainless steel for wetted and instrument parts","summary":"316L stainless (~8.0 g/cm3) is the default wetted-metal and surgical-instrument material for its corrosion resistance through repeated autoclave and chemical cleaning cycles, at a Ra <= 0.8 um polish on any wetted surface.","applies":["instrument","wetted surface","material"],"value":{"value":8,"unit":"g/cm3"},"basis":"316L datasheet density; the low-carbon '316L' grade resists the sensitisation/chromium-carbide corrosion that repeated autoclaving induces in plain 316","sources":["ensinger-medical"],"tags":["material","316l","stainless"]},{"id":"material-ti6al4v-medical","kind":"material","tier":2,"title":"Ti-6Al-4V for implant-grade and lightweight instrument parts","summary":"Ti-6Al-4V (~4.43 g/cm3) is the standard implant-grade titanium alloy, chosen over 316L where permanent contact biocompatibility, lower weight or MRI compatibility matters more than cost.","applies":["implant","instrument","material"],"value":{"value":4.43,"unit":"g/cm3"},"basis":"Ti-6Al-4V ELI grade datasheet density; it is the dominant implant-grade titanium alloy across orthopaedic and surgical-instrument applications","sources":["ensinger-medical","usp-class-vi"],"tags":["material","titanium","implant"]},{"id":"material-pp-medical","kind":"material","tier":2,"title":"Polypropylene (PP) for single-use fluid-path parts","summary":"Medical PP (~0.905 g/cm3) is USP Class VI gradeable, EtO- and steam-sterilizable, and the default resin for single-use labware and fluid-path components (syringe barrels, tube racks, microplates) on cost.","applies":["single-use device","tube rack","microplate","material"],"value":{"value":0.905,"unit":"g/cm3"},"basis":"Medical PP grade datasheet density; PP's low cost, chemical resistance and steam/EtO tolerance make it the default single-use labware resin","sources":["ensinger-medical","usp-class-vi"],"tags":["material","pp","single-use"]},{"id":"recipe-sbs-microplate-nest","kind":"recipe","tier":2,"title":"Recipe: SBS microplate holder/nest with finger cutouts","summary":"Build a 130x88x12 mm SBS nest block with a 128.3x86.0 mm pocket for a microplate and two 20x8 mm finger cutouts on opposite long sides; the blanket fillet is R0.8 mm, bounded by the 0.85 mm pocket rim (CADSB-744).","applies":["microplate","nest","sbs","lab fixture"],"basis":"Combines microplate-sbs-footprint and microplate-corner-radius into a buildable nest: boolean-subtract the pocket and the two finger notches, then break every edge with a blanket fillet no larger than the 0.85 mm rim the ANSI/SLAS-1 footprint leaves in a 130 mm block","sources":["ansi-slas-1"],"tags":["recipe","microplate","nest"],"recipe":{"prompt":"Model a 130x88x12mm SBS microplate nest: a 128.3x86.0mm pocket, two 20x8mm finger cutouts on opposite long sides, and a 0.8mm blanket edge break","steps":[{"tool":"cad_box","args":{"dx":130,"dy":88,"dz":12},"note":"nest block"},{"tool":"cad_box","args":{"dx":128.3,"dy":86,"dz":9,"origin":[0.85,1,3]},"note":"pocket tool, centred, piercing the top (9mm deep leaves 3mm floor)"},{"tool":"cad_boolean_subtract","args":{"of":"$0","tool":"$1"},"note":"cut the rectangular plate pocket"},{"tool":"cad_box","args":{"dx":20,"dy":8,"dz":6,"origin":[10,-1,3]},"note":"finger cutout tool 1, one long side, cut before filleting"},{"tool":"cad_boolean_subtract","args":{"of":"$2","tool":"$3"},"note":"cut finger access 1 on the plain rectangular tray"},{"tool":"cad_box","args":{"dx":20,"dy":8,"dz":6,"origin":[10,81,3]},"note":"finger cutout tool 2, opposite long side"},{"tool":"cad_boolean_subtract","args":{"of":"$4","tool":"$5"},"note":"cut finger access 2"},{"tool":"cad_fillet_edges","args":{"of":"$6","radius":0.8},"note":"blanket fillet last — 0.8mm is the largest radius the 0.85mm pocket rim carries; R3.5 is refused blend-through-wall (CADSB-744). A 3.18mm-class corner in the pocket needs a selective fillet on the four pocket corners, not a blanket one"}],"expect":{"volume":37664.17,"faceCount":31,"watertight":true,"selfIntersection":false,"note":"measured 2026-09-19: CADSB-735 (315d51afc, 2026-09-06) stopped the whole-body fillet publishing two bands built THROUGH each other; R0.8 on the 0.85 mm pocket rim is that pair. -6 faces, and the volume moved only +0.146% — INSIDE the 0.5% band, so faceCount is the only number that ever caught this one"}}},{"id":"recipe-tube-rack-grid","kind":"recipe","tier":2,"title":"Recipe: 24-position microtube rack with a hole grid","summary":"Build a 104x76x30 mm tube rack block with a 6x4 grid of 11.2 mm diameter, 20 mm-deep holes on 16 mm centres sized for 1.5/2.0 mL microtubes.","applies":["tube rack","microtube","laboratory"],"basis":"Combines tube-rack-microtube-bore and tube-rack-hole-spacing into one buildable rack via a single cad_hole_pattern grid","sources":["ensinger-medical"],"tags":["recipe","tube-rack","hole-pattern"],"recipe":{"prompt":"Model a 104x76x30mm tube rack block with a 6x4 grid of 11.2mm diameter, 20mm deep holes on 16mm centres for 1.5/2.0mL microtubes","steps":[{"tool":"cad_box","args":{"dx":104,"dy":76,"dz":30},"note":"rack block"},{"tool":"cad_hole_pattern","args":{"of":"$0","type":"drill","diameter":11.2,"depth":20,"pattern":{"kind":"grid","origin":[12,12],"dx":16,"dy":16,"nx":6,"ny":4}},"note":"6x4 grid of microtube bores on 16mm pitch, starting 12mm from the rack edges"}],"expect":{"volume":187178.21,"faceCount":102,"watertight":true,"note":"measured 2026-09-19: CADSF-1561 (cc1f38cb, 2026-09-15) gave a BLIND hole a 118° DRILL POINT: the flat floor became a cone on the 24 Ø11.2x20 tube pockets, AND THE ARITHMETIC CLOSES: 237120 - 24 x pi x 5.6^2 x 20 = 189831.6 with flat floors; 24 x the 118° point cone (pi x 5.6^2 x 3.365 / 3 = 110.5 mm^3 each) takes a further 2652 mm^3 to 187179.6 against 187178.21 measured. faceCount 6+24x3 = 78 -> 6+24x4 = 102. The -1.447% is the drill point, not a regression"}}},{"id":"recipe-handheld-device-shell","kind":"recipe","tier":2,"title":"Recipe: hand-held device shell with filleted edges and shell wall","summary":"Build a 140x60x30 mm handheld device shell: hollowed to a 2 mm wall open on the bottom, then R2 mm rounded outer edges — the largest blanket radius a 2 mm wall carries (CADSB-744), and above the 0.5 mm IEC 60601-1 sharp-edge floor.","applies":["handheld device","housing","enclosure"],"basis":"Combines handheld-grip-diameter-scale proportions, sharp-edge-radius-60601 and enclosure wall practice into one buildable shell: shell first, then a blanket fillet whose radius is bounded by the 2 mm wall (a larger one crosses the inner face — CADSB-744)","sources":["iec-60601-1"],"tags":["recipe","handheld","shell"],"recipe":{"prompt":"Model a 140x60x30mm handheld device shell hollowed to a 2mm wall open on the bottom, with R2mm rounded outer edges","steps":[{"tool":"cad_box","args":{"dx":140,"dy":60,"dz":30},"note":"device body block"},{"tool":"cad_shell","args":{"of":"$0","thickness":2,"open":[{"normal":[0,0,-1]}]},"note":"hollow to a 2mm wall, open on the bottom; shell before fillets"},{"tool":"cad_fillet_edges","args":{"of":"$1","radius":2},"note":"round the outer edges after shelling — radius = the 2mm wall; R6 here is refused blend-through-wall (CADSB-744)"}],"expect":{"volume":38310.99,"faceCount":23,"watertight":true,"selfIntersection":false,"note":"measured 2026-09-19: CADSB-735 (315d51afc, 2026-09-06) stopped the whole-body fillet publishing two bands built THROUGH each other; R2 on the 2 mm bottom rim is that pair, so the 439.9 mm^3 the pin removed at the rim is material the sound body keeps (the two bands’ naive sum over 400 mm outer + 384 mm inner at r^2(1-pi/4) is 673 mm^3, and they overlap on a 2 mm rim). The pinned body was self-intersecting at the rim under this recipe’s own expect.selfIntersection:false"}}}]}