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JLY Precision Technology

Чек-лист DFM ЧПУ + требования к авиации/медицине (издание 2026)

Практический чек-лист DFM (Design for Manufacturing) для ЧПУ-деталей плюс требования авиационного AS9100 и медицинского ISO 13485 — написано инженерами.

14 min read
Aerospace-grade CNC machined components alongside medical implant parts on inspection bench

Хорошая проверка DFM может сократить 10–30% производственного предложения без изменения функциональности. Это руководство содержит тот же чек-лист, который инженеры JLYPT используют в каждом предложении.

Why DFM matters

Design for Manufacturing (DFM) is the practice of designing parts so they can be made faster, cheaper and more reliably without sacrificing function. The earlier in the design process you apply DFM, the more it pays back.

  • 10–30% cost savings on the production quote, no design changes needed beyond DFM optimisations.
  • 2–5× shorter lead times when the part doesn’t need special tooling, fixtures or hand operations.
  • Better first-pass yield — fewer scrapped parts, fewer revisions, fewer surprises at FAI.
  • Easier scaling — what works at 10 units works at 10,000.

The 20-point DFM checklist

Run through every item before sending a part to quote. Each one fixes a real cost or quality issue we see weekly:

  1. Internal corner radii ≥ 0.5 mm. Sharp internal corners need expensive small tools. Default to 1 mm where possible.
  2. Avoid deep narrow pockets. Pocket depth more than 4× tool diameter causes chatter and poor finish. Split into multiple operations or shallower pockets.
  3. Add tool-clearance to bottoms of pockets. Leave at least 0.5 mm flat clearance for the cutter to land on.
  4. Standard hole sizes for tapping. Use M3, M4, M5, M6, M8, M10 metric or #4-40, 1/4-20 imperial. Custom thread sizes need custom taps.
  5. Hole-to-edge distance ≥ 2× hole diameter. Closer distances cause edge break-out, especially on aluminium and plastics.
  6. No blind holes deeper than 4× diameter. Drill cycle becomes complex and chip evacuation fails. Add a relief or split the hole.
  7. Threaded hole depth = 1.5× thread diameter. Anything more is wasted; the engagement length doesn’t add strength.
  8. Wall thickness ≥ 0.8 mm in metals, 1.5 mm in plastics. Thinner walls deflect during cutting and warp on cool-down.
  9. Wall thickness consistency. Sudden changes in wall thickness cause warping. Taper transitions over a length of 3× thickness.
  10. Avoid undercuts where possible. Undercut tools are expensive and slow. If unavoidable, design for a standard T-slot cutter (e.g., 6 mm slot).
  11. Datum scheme: A-B-C. Pick the largest stable face as A. B and C perpendicular. Reference all GD&T from this scheme.
  12. One-sided machining when possible. Reduce setups by designing all critical features on one side or two opposing sides.
  13. Avoid sharp external corners. Add 0.2–0.5 mm chamfers to all external edges — improves handling, prevents burrs, looks more professional.
  14. Standard fastener clearance holes. M4 clearance = 4.5 mm (close), 5.0 mm (free). Don’t use 4.3 or 4.7 mm — they’re non-standard drills.
  15. Avoid mirror-finish surface specs unless required. Ra 0.8 µm is standard. Ra 0.4 µm requires extra polishing time.
  16. Specify a single overall material per part. Multi-material parts are an assembly, not a single CNC operation.
  17. Tolerance only what matters. 80% of dimensions can stay at ISO 2768-m default. Tighten only critical features.
  18. Provide a 3D STEP file. 2D drawings as the only source of truth lead to interpretation errors. Send STEP + PDF drawing.
  19. Mark up critical features clearly. Star or note the 3–5 features that absolutely must be in spec. Helps the shop prioritise inspection.
  20. Communicate the part’s purpose. One sentence — “this bracket holds a sensor in a vibration test rig” — helps the engineer suggest better DFM that you might never have considered.
Well-designed CNC aluminium parts with clear datums and proper fillet radii
Production aluminium parts that follow JLYPT’s standard DFM guidelines — fast to machine, cheap to inspect.

Aerospace requirements (AS9100 and friends)

When a part is destined for aerospace use, several layers of additional requirements kick in. They are not optional:

Quality system requirements

  • AS9100D (or revision) — the aerospace quality management system. The supplier must be certified.
  • AS9102 First Article Inspection — every dimension verified on the first part of a production run, with documented reports.
  • NADCAP accreditation for special processes (heat treat, surface finish, NDT, welding).
  • Production Part Approval Process (PPAP) — formal customer approval before serial production.

Material & traceability

  • Mill test reports (MTRs) for every batch of raw material.
  • Heat-lot traceability — each part traceable back to a specific batch of bar stock.
  • Certificates of conformance (CoC) with shipment.
  • DFARS / FAR 252 compliance for US defence work — material origin restrictions.
  • Specialty alloys — Ti-6Al-4V, Inconel 718, 17-4PH, often AMS-grade specifications.

JLYPT operates an ISO 9001 certified quality system with AS9100 capability for designated aerospace work. See our certifications page for current scopes and our aerospace manufacturing overview.

Medical device requirements (ISO 13485 and FDA)

Medical CNC work — surgical instruments, orthopaedic implants, drug-delivery components — operates under similar but distinctly different rules:

  • ISO 13485 — the medical device quality management standard. Equivalent role to AS9100 in aerospace.
  • FDA 21 CFR Part 820 — the US Quality System Regulation. Required for parts entering the US medical device supply chain.
  • EU MDR (Medical Device Regulation) — replaced MDD in 2021. Stricter clinical evidence and unique device identification (UDI) requirements.
  • Material biocompatibility — ISO 10993 testing for parts that contact patients. Common implant materials: Ti-6Al-4V ELI, CP-Ti Grade 4, 316L stainless, PEEK.
  • Lot traceability — every part traceable to material lot, machine, operator, inspection record.
  • Cleaning validation — for parts shipped clean or sterile, validated cleaning procedure with residue testing.
  • Environmental controls — controlled humidity and temperature in the machining cell prevent thermal expansion errors and contamination.
Precision-machined surgical instrument components in 316L stainless steel
Medical-grade 316L stainless surgical instruments — passivated, electropolished and lot-traced.

Documentation you must provide

For regulated work, the documentation package is part of the deliverable. Plan for this from day one:

DocumentStandard workAerospaceMedical
STEP file + 2D PDF drawing
Tolerance list / GD&T scheduleRecommended
Material specification (alloy + spec)Recommended
Surface finish specification
Critical feature listOptional
Acceptance criteriaOptional
Cleaning / packaging requirementsOptionalOptional
Lot identification schemeOptional
Special process requirements (heat, NDT)OptionalSometimes
Customer-specific quality clausesOptional

Common pitfalls

  • Specifying a tolerance you can’t inspect. “±0.005 mm true position over 200 mm” on a $10 part is impossible to verify economically.
  • Assuming the supplier knows your standards. If you need MIL-DTL-13924 black oxide rather than commercial black oxide, say so explicitly.
  • Forgetting the supply chain. If your customer requires DFARS-compliant materials, your supplier must source them — typically 20–40% premium and longer lead time.
  • Mixing up similar materials. Ti Grade 2 ≠ Ti Grade 5. 316L ≠ 316. CP Titanium ≠ Ti-6Al-4V. Specify the exact grade.
  • Treating documentation as optional. For aerospace and medical, the paperwork IS the deliverable. Without certs and traceability, the parts are unusable.
  • Late spec changes. Changing the alloy after machining starts, or the surface finish after kit-out, cascades into rework and lost time.

Cost implications of regulated work

These are realistic premiums vs the same part run as standard ISO 9001 work. Your mileage varies by program complexity.
Cost driverStandard partAerospace AS9100Medical ISO 13485
Quality system overhead0+10–15%+10–15%
Material certification0+5–10% (mat'l)+5–10% (mat'l)
First Article Inspection0–5%+5–10%+5–10%
Lot traceability0+3–5%+3–5%
Specialty NADCAP processes0+20–30% (when used)Not typical
Cleaning & sterile packaging00+10–20%
Special documentation0+5%+5%
Total typical premium+25–50%+25–50%

Часто задаваемые вопросы

Нужна ли сертификация AS9100 для каждой авиационной детали?
Нет. AS9100 требуется для критичных полётных работ и работ, требуемых заказчиком. Многие наземные опоры и неполётные детали поставляются по стандартному ISO 9001.
В чём разница между ISO 9001 и AS9100?
AS9100 — это ISO 9001 плюс требования, специфичные для авиации — управление конфигурацией, особые процессы, FAI, контроль поставщиков, управление рисками.
Может ли JLYPT выполнять медицинские работы, зарегистрированные FDA?
JLYPT работает по ISO 9001 со способностью выполнять медицинские работы класса ISO 13485. Регистрация FDA готовых медицинских устройств — ответственность производителя устройства.
Сколько занимает проверка DFM?
Для типичной модели CAD наши инженеры отвечают в течение 24 часов размеченным чертежом с возможностями ослабления допусков и упрощения геометрии.
Что такое NADCAP и нужен ли он мне?
NADCAP проводит аудит специальных процессов — термообработка, финишная обработка поверхности, NDT, сварка. Требуется крупными OEM (Boeing, Airbus) для этих процессов.
Могу ли я отправить черновик CAD до завершения проектирования?
Да — это на самом деле лучшее время. Мы предоставляем бесплатные проверки DFM для любого черновика CAD. Отправьте через контактную форму.
Какие документы я должен отправить с запросом расценок?
Минимум: 3D STEP-файл + 2D PDF-чертёж + спецификация материала. Полезно: список критических элементов, целевое количество, целевой срок, отрасль конечного использования.

Об авторе

JLYPT Engineering Team

Senior CNC Application Engineers

Our application engineering team brings 15+ years of combined experience producing precision components for aerospace, medical, robotics and industrial automation customers.

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