{"$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":"core","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-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"}],"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":"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":"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-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":"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"]}]}