GB/T 14233.1医用输液、输血、注射器具检验方法 第1部分:化学分析方法
GB/T 14233.2医用输液、输血、注射器具检验方法 第2部分:生物学试验方法
GB/T 16886.1医疗器械生物学评价 第1部分:风险管理过程中的评价与试验
GB/T 35021 增材制造 工艺分类及原材料
GB/T 35351 增材制造 术语
GB/T 36984外科植入物用多孔金属材料X射线CT检测方法
YY 0118 关节置换植入物 髋关节假体
YY/T 0343 外科金属植入物液体渗透检验
YY/T 0640 无源外科植入物 通用要求
YY/T 0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求
YY/T 0809.1 外科植入物 部分和全髋关节假体 第1部分分类和尺寸标注
YY/T 0920 无源外科植入物 关节置换植入物 髋关节置换植入物的专用要求
GB 18278系列标准
GB 18279 系列标准
GB 18280 系列标准
WS310.2-2016《医院消毒供应中心第2部分:清洗消毒及灭菌技术操作规范》
ISO 7206 -12 Implants for surgery -- Partial and total hip joint prostheses -- Part 12: Deformation test method for acetabular shells
ASTM1820-13 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
ASTM F2052 Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment
ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 17296-2:2015 Additive manufacturing -- General principles -- Part 2: Overview of process categories and feedstock
ISO 17296-3:2014 Additive manufacturing -- General principles -- Part 3: Main characteristics and corresponding test methods
ISO 17296-4:2014 Additive manufacturing -- General principles -- Part 4: Overview of data processing
ISO19227:2018 Implants for surgery -- Cleanliness of orthopedic implants -- General requirements
ASTM F3122-14 Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via additive manufacturing process
ISO/ASTM 52921:2013 Standard terminology for additive manufacturing -- Coordinate systems and test methodologies
ISO/ASTM52915:2016 Specification for additive manufacturing file format (AMF) Version 1.2
ISO/ASTM 52901:2017 Additive manufacturing -- General principles -- Requirements for purchased AM parts
ISO/ASTM 52900:2015 Additive manufacturing -- General principles – Terminology
ISO/ASTM 52910:2018 Additive manufacturing -- Design -- Requirements, guidelines and recommendations
ASTM F2924-12 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
ASTM F3001-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
ASTM F3091/F3091M-14 Standard Specification for Powder Bed Fusion of Plastic Materials
ASTM F3049-14 Standard Guide for Characterizing Properties of Metal Powders Used for Additive Manufacturing Processes
FDA-2016-D-1210 Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff