Product
Product
Supplier
Search
Get Quote
730 people are quoting
Comprehensive Solution for Custom Injection Molds of Medical Oxygen Generators: Triple Guarantee of Precision, Compliance and Efficiency
I. Core Pain Points and Root Cause Analysis
Injection molding of medical oxygen generator components faces unique industry challenges. Enterprises often encounter issues like substandard precision, insufficient compliance and low mass production efficiency during mold customization. Specific pain points and root causes are as follows:
1.1 Pain Point 1: Equipment Malfunctions from Component Precision Deviations
Key components such as air channel assemblies and sealed cavities require micron-level dimensional tolerance control (e.g., ±0.02mm for air channel wall thickness). Insufficient mold cavity precision and excessive demolding deformation cause gas leakage and unstable oxygen concentration. One enterprise suffered 18% product defect rate due to mold clamping misalignment from excessive guide mechanism clearance.
Root Cause Analysis: Improper mold material selection, inadequate processing equipment precision (positioning error ＞ 0.005mm), unreasonable cooling system design leading to uneven shrinkage, and lack of professional MOLDFLOW simulation for defect prediction.
1.2 Pain Point 2: Failure to Pass Medical Certification Due to Non-Compliance
Medical oxygen generators are Class II medical devices. Their injection-molded components must comply with ISO 13485 and ISO 10993 standards. Mold issues like contaminant residues and excessive surface roughness (Ra ＞ 0.02μm) directly result in NMPA registration failure.
Root Cause Analysis: Non-medical-grade corrosion-resistant steel, sulfur-containing cleaning agent residues, inadequate surface polishing, and lack of full-process quality traceability to meet UDI management requirements.
1.3 Pain Point 3: Global Delivery Delays from Non-Uniform Mold Standards
Oxygen generator exporters must adapt to regional mold standards (HASCO for Europe, DME for North America). Misaligned standards during customization cause poor part interchangeability, inconvenient overseas maintenance and delivery delays.
Root Cause Analysis: Insufficient understanding of international standards, failure to integrate DME, HASCO, MISUMI and Modepao standards in design, and drawing format mismatches (e.g., customer STP requirements vs. factory DWG files).
1.4 Pain Point 4: Low Mass Production Efficiency and Cost Overruns
Volatile market demand, prolonged cooling cycles (＞ 30s), unreasonable demolding design, short mold lifespan (＜ 500,000 cycles) and repeated T1 tests (＞ 3 times) reduce capacity and raise costs.
Root Cause Analysis: Unoptimized cooling channels, improper hot work steel selection, unstable mold part quality, and lack of standardized testing and delivery processes.
II. Full-Process Solutions
To address these pain points, we developed an integrated solution: "standard adaptation - precise material selection - precision manufacturing - compliance control - efficient delivery", balancing precision, compliance and efficiency per medical norms.
2.1 Preliminary Planning: Standard Adaptation & Drawing Standardization
2.1.1 Multi-Standard Compatible Design
Precise alignment with target market standards ensures interchangeability and compliance:
• DME Standard: North American market, imperial dimensions. Core parts (ejector pins, guide pillars) meet U.S. medical wear requirements. MUD quick-change mold base enables fast production line switching.
• HASCO Standard: European market, metric dimensions (±0.002mm tolerance). Hot runner/cooling systems suit high-temperature precision molding, meeting CE certification.
• MISUMI Standard: Japanese/Southeast Asian markets, short standardized part lead times, ideal for small-batch high-precision molds with quick maintenance.
• Modepao Standard: Domestic market, cost-precision balance, suitable for mid-to-high-end oxygen generator mass production with high cost-performance.
2.1.2 Drawing & Software Adaptation
Supports full-format drawing import/export (STP, STEP, X_T, DWG, DXF) and mainstream software (NX, CAD, PROE, SOLIDWORKS). MOLDFLOW simulates filling, cooling and shrinkage to predict defects, optimizing runner/water channel layout (cavity pressure difference ≤ 5MPa, deformation ≤ 0.2mm).
2.2 Core: Precise Material Selection (Mold Steel + Injection Material)
Material selection follows "medical compliance, performance matching, cost optimization". Specific adaptations are shown below:
Table 1: Mold Steel Selection for Medical Oxygen Generators
|
Mold Steel Model |
Hardness (HRC) |
Core Performance |
Suitable Components |
Applicable Materials |
Lifespan (Cycles) |
|
S136 |
50-52 (quenched) |
Corrosion-resistant, mirror polish (Ra ≤ 0.01μm), medical-grade |
Air channels, sealed cavities |
PC, PMMA, PVC |
≥ 1,000,000 |
|
718H |
33-38 |
Pre-hardened, good polishability, no secondary heat treatment |
Housing, control panel |
ABS, PP, PS |
≥ 500,000 |
|
738H |
35-40 |
Upgraded 718H, higher strength/deformation resistance |
Large housing, frames |
ABS+GF, PA |
≥ 600,000 |
|
P20 |
28-36 |
Low-cost, easy-machining, balanced performance |
Decorative covers, secondary parts |
PE, PP |
≥ 300,000 |
|
8407 |
48-52 |
Hot work steel, high-temp/thermal fatigue resistance |
Heating module housings |
PEEK, LCP |
≥ 800,000 |
|
2316 |
48-50 |
Corrosion-resistant, excellent polishability for additive plastics |
Antibacterial housing, seals |
PP+antibacterial, PC |
≥ 900,000 |
|
2083 |
45-48 |
Stainless steel, rust-resistant, excellent machinability |
Oxygen-contacting components |
POM, PA |
≥ 850,000 |
|
420 (4Cr13) |
52-56 |
High-hardness, wear-resistant for reinforced plastics |
Brackets, fixing parts |
PA+GF, PC+GF |
≥ 700,000 |
|
SKD61 |
48-52 |
Good thermal fatigue, suitable for rapid molding |
Mass-produced housings |
PP, ABS |
≥ 800,000 |
|
CR12 Beryllium Copper |
35-40 |
High thermal conductivity for precision thin-walled parts |
Mini air channels, sensors |
PMMA, PC |
≥ 400,000 |
|
VINKING |
58-62 |
High wear/impact resistance for complex cavities |
Buckle structural parts |
PA, POM |
≥ 1,200,000 |
Table 2: Injection Material Selection & Compliance
|
Injection Material |
Core Performance |
Suitable Components |
Compliance Standards |
Processing Temp (℃) |
|
PP (Polypropylene) |
Chemically resistant, biocompatible, low-cost |
Housing, filter box |
ISO 10993-1, FDA 21 CFR 177.1520 |
160-220 |
|
PC (Polycarbonate) |
High-strength, transparent, impact-resistant |
Observation window, air channels |
ISO 13485, ISO 10993-5 |
220-300 |
|
ABS |
Rigid, easy-processed, paintable |
Control panel, frame |
ISO 13485 |
180-240 |
|
PEEK |
High-temp resistant, excellent biocompatibility |
Core air channels, medical seals |
ISO 10993-1, USP Class VI |
340-400 |
|
POM |
Dimensional stability, low friction |
Valves, gears |
ISO 10993-1 |
170-220 |
If you are interested in the product, contact 2bvideo.com for more information for more information
The information of 2bvideo.com limited shown above is provided by the user or collected on the network. Video 2B does not guarantee the authenticity,accuracy and legitimacy of 2bvideo.com limited information. Video 2B does not involve legal relationships and disputes between users arising from transactions other than secured transactions on this website. Disputes shall be settled by you through negotiation. If you are the person in charge or relevant employee of this enterprise, if you find that the enterprise information is incorrect or want to manage thiscompany, please contact us jacklee1558@gmail.com, after you claim the enterprise, you can obtain management permission, publish supplyand demand information, bring consulting orders, and remove page advertisements.
Main Product:
Plastic Mold,
Die Casting Mold,
overmoulding,
Automobile mold,
Outdoor sports mold ,
Precision part processing
