T/GDPCIA 007-2023 Additive manufacturing generic specification for 3D printing equipment used in the production of medical devices

Scope

Scope: This document specifies the technical requirements for 3D printing equipment used in the production of medical devices, describes the corresponding test methods, and stipulates the inspection rules and requirements for marking, labeling, packaging, transportation, and storage. This document applies to additive manufacturing (3D printing) equipment that uses metal materials, polymer materials, ceramic materials, or composite materials as printing consumables, and produces first-class medical devices, among others, using single-step or multi-step processes such as material extrusion, powder bed fusion, or melt deposition & sintering (AMSS). Main technical content: 4. Requirements 4.1 Overview 4.2 Appearance and structure 4.3 Power adaptability 4.4 Electrical safety 4.5 Electromagnetic compatibility 4.5.1 Radio interference 4.5.2 Harmonic current 4.5.3 Immunity 4.6 Mechanical safety 4.7 Main performance 4.7.1 Build size 4.7.2 Positioning accuracy 4.7.3 Minimum layer thickness 4.7.4 Forming speed 4.7.5 Printing accuracy 4.7.6 Formed part performance 4.8 Noise 4.9 Reliability 5. Test methods 5.1 Test conditions 5.2 Appearance and structure 5.3 Power adaptability 5.4 Electrical safety 5.5 Electromagnetic compatibility 5.5.1 Radio interference 5.5.2 Harmonic current 5.5.3 Immunity 5.6 Mechanical safety 5.7 Main performance 5.7.1 Build size 5.7.2 Positioning accuracy 5.7.3 Minimum layer thickness 5.7.4 Forming speed 5.7.5 Printing accuracy 5.7.6 Formed part performance 5.8 Noise 5.9 Reliability 6. Quality assessment procedures 6.1 Inspection classification 6.2 Type-approval inspection 6.3 Batch inspection 7. Marking, packaging, transportation, and storage 7.1 Marking and packaging 7.2 Transportation and storage

Development Information

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