{"@context":"https://schema.org","@type":"Article","id":"medical","industry":"醫療器材","industryEn":"Medical Devices","url":"https://cnc-factory-hub.replit.app/case/medical","clientType":"竹南醫療器材製造商（匿名）","part":"骨科固定件","material":"Ti-6Al-4V ELI Grade 23","challengeSummary":"醫療植入物需生物相容性最高等級（ELI），公差嚴格，每批需附完整精密量測報告，符合 ISO 13485 法規。","tolerance":"±0.005 mm","surfaceRoughness":"Ra 0.4 μm","quantifiedOutcomes":{"cooperationYears":"三年","defectRate":"0%","compliance":"ISO 13485 醫療器材法規","inspection":"完整精密量測報告"},"relatedMaterials":["鈦合金 Ti-6Al-4V"],"relatedServices":["cnc-turning","cnc-milling"],"slug":"medical","industryZh":"醫療器材","headlineZh":"醫療級鈦合金骨科固定件加工案例 — Ti-6Al-4V ELI 生物相容性精密零件","headlineEn":"Medical-Grade Titanium Orthopedic Implant Machining — Ti-6Al-4V ELI Biocompatible Precision Parts","clientDesc":"竹南醫療器材製造商（匿名），持有 FDA 510(k) 許可，專注於骨科固定板與脊椎手術輔助器械的設計與製造。","challengeZh":"客戶委託建成精密工業加工骨科固定板，材質為 Ti-6Al-4V ELI Grade 23（醫療植入物級鈦合金），此材質硬度高、切削性差（切削性指數僅為鋁合金的 1/5），加工後表面需達 Ra 0.4 μm，且每件零件必須附完整精密量測報告，以符合 ISO 13485 醫療器材法規要求。批量小（10 件 / 批）、但品質規格極嚴苛，不允許任何尺寸超差件出貨。","challengeEn":"The client required orthopedic bone plates in Ti-6Al-4V ELI Grade 23 — a difficult-to-machine medical-grade titanium alloy with machinability just 1/5 of aluminum. Parts demanded Ra 0.4 μm finish, full precision measurement reports per piece, and zero tolerance for out-of-spec shipments under ISO 13485 medical device regulations.","solution":[{"title":"鈦合金專用切削策略","desc":"採用低切削速度（Vc = 40–60 m/min）、大進給量策略，搭配 TiAlN 塗層硬質合金刀具，避免鈦合金加工常見的工件熱累積與刀具黏著問題。切削液選用全合成水溶性切削液，切削區溫度控制在 300°C 以下，確保零件材質不受熱影響。"},{"title":"高精度車銑複合加工","desc":"骨科固定板採用車銑複合加工中心一次裝夾完成外徑車削（公差 ±0.005 mm）與側面銑削特徵（公差 ±0.008 mm），降低因重新裝夾引入的定位誤差，確保各平面間的垂直度在 0.005 mm 以內。"},{"title":"表面品質處理","desc":"加工後以機械拋光將表面粗糙度從加工面 Ra 1.6 μm 提升至 Ra 0.4 μm，符合醫療植入物表面要求。所有接觸面以電解拋光去除毛邊，鈦合金自然氧化層保留，確保生物相容性。"},{"title":"ISO 13485 品質文件","desc":"每件零件逐一精密量測，量測項目含 18 個關鍵尺寸（含孔徑、位置度、平面度），出具完整量測報告隨貨附上，材料附鈦合金 ELI Grade 23 認證書，合作三年批次不良率 0%。"}],"metrics":[{"value":"0%","label":"批次不良率","sublabel":"三年合作紀錄"},{"value":"Ra 0.4μm","label":"表面粗糙度","sublabel":"符合醫療植入物規範"},{"value":"18項","label":"精密量測特徵","sublabel":"每件附完整量測報告"},{"value":"±0.005mm","label":"加工公差","sublabel":"符合 ISO 13485 規範"}],"datePublished":"2026-07-24","relatedServiceLinks":[{"label":"CNC 車床加工服務","href":"/#services"},{"label":"鈦合金 / 特殊材質加工","href":"/#services"},{"label":"立即詢價","href":"/#contact"}],"_links":{"self":{"href":"/api/v1/case-studies/medical"},"collection":{"href":"/api/v1/case-studies"},"corporate":{"href":"/api/v1/corporate-summary"}}}