Product Overview
This is a high-standard medical-grade injection mold fully compliant with ISO13485 medical quality management system. Adopting premium S136 stainless steel, advanced hot runner system, and manufactured in a strict 10,000-class cleanroom, this mold is exclusively designed for producing biocompatible, sterile, and high-precision medical device plastic components.
Different from ordinary industrial molds, this medical mold implements full-process contamination control, biocompatibility verification, and standardized medical production validation. It supports mass production of implant accessories, dental parts, surgical tools, diagnostic consumables, and sterile medical packaging parts with zero pollution, high stability, and long service life — fully meeting global medical device regulatory requirements.
Product Specification Table
| Item | Specification |
| Product Type | Medical Device Precision Injection Mold |
| Certification Standard | ISO13485 Medical Device QMS Certified |
| Mold Core & Cavity Steel | High-purity S136 Stainless Steel |
| Production Environment | 10,000-Class (ISO 7) Cleanroom |
| Runner System | Precision Hot Runner System |
| Applicable Materials | Biocompatible medical-grade plastics (PP, PC, PETG, ABS Medical) |
| Processing Standard | Dust-free, sterile, no secondary pollution |
| Application | Dental implants, surgical parts, medical packaging, diagnostic devices |
| Core Advantage | Biocompatible, sterile, high precision, regulatory compliant |
Core Technical Advantages
1. ISO13485 Full Medical Compliance
This mold is developed and manufactured under strict ISO13485:2016 medical quality system. Every production step including raw material inspection, CNC machining, assembly, trial testing and delivery follows medical device traceability standards. It supports IQ/OQ/PQ process validation, batch record tracking, and quality documentation output, helping customers pass medical audits and global market certification smoothly.
2. Premium S136 Stainless Steel for Medical Use
Adopting professional medical-grade S136 stainless steel for core and cavity, the mold features ultra-high corrosion resistance, rust resistance and polishability. It perfectly adapts to frequent medical sterilization environments such as Gamma irradiation and EtO sterilization. No metal precipitation, no oxidation pollution, fully guaranteeing the biocompatibility and safety of finished medical parts.
3. Advanced Hot Runner System
Equipped with a precision hot runner system, the mold realizes balanced melt filling, no cold runner waste, and stable temperature control. It effectively eliminates common medical part defects such as flow lines, shrinkage, bubbles and residual material. The closed hot runner structure avoids dust and particle contamination, ensuring ultra-clean molding for high-standard medical components.
4. 10,000-Class Cleanroom Dust-Free Production
All mold trial, sample production and mass production processes are completed in a 10,000-class dust-free cleanroom. Strict control of air cleanliness, temperature and humidity eliminates dust, bacteria and particulate impurities. Zero pollution during molding ensures the finished medical products reach sterile grade, meeting the requirements of implantable and invasive medical devices.
5. Strict Biocompatibility & Safety Control
The whole mold structure and manufacturing materials are non-toxic, harmless and biocompatible. No harmful chemical precipitation occurs during high-temperature injection. All molded parts comply with medical biocompatibility standards, suitable for long-term contact with human tissues and body fluids, ensuring patient safety and clinical applicability.
Mold Performance Comparison
| Item | ISO13485 Medical S136 Mold | Ordinary Industrial Mold |
| Certification | ISO13485 Medical Certified | Only ISO9001 general certification |
| Mold Steel | S136 medical stainless steel, anti-corrosion | P20/45# steel, easy rust & precipitate |
| Production Environment | 10,000-class cleanroom, dust-free sterile | Ordinary factory, dust & impurity risk |
| Runner System | Hot runner, clean & balanced filling | Cold runner, material waste & contamination risk |
| Biocompatibility | Medical-grade safe, human-body friendly | Not suitable for medical contact parts |
| Sterilization Resistance | Adaptable to Gamma/EtO sterilization | Failed after repeated sterilization |
![ISO13485 Certification Biocompatible Materials molding]( "ISO13485 Certification Biocompatible Materials molding")
Wide Application
This professional medical injection mold is widely used for manufacturing dental implant packaging parts, surgical instrument housings, medical disposable consumables, diagnostic device shells, laboratory sterile containers and human-contact medical components. It is the preferred mold solution for high-end medical device manufacturers pursuing safety, stability and regulatory compliance.
Quality & Compliance Guarantee
We implement full-process ISO13485 standardized management, from DFM analysis, precision machining, cleanroom assembly, mold trial to final delivery. All molds pass strict dimensional inspection, surface purity testing and biocompatibility verification. We provide complete certification documents, test reports and process traceability records to support customers’ global medical registration and market access.
FAQ
Q1: What makes this mold different from ordinary plastic molds?
This is a professional medical-grade sterile mold with ISO13485 certification, S136 anti-corrosion steel, hot runner system and 10,000-class cleanroom production. It focuses on biocompatibility, zero pollution and sterilization resistance, which ordinary industrial molds cannot achieve.
Q2: Can molded parts support medical sterilization?
Yes. The S136 steel mold and biocompatible molding process allow finished parts to withstand Gamma irradiation and EtO sterilization without deformation, precipitation or discoloration, maintaining permanent sterile performance.
Q3: Why adopt 10,000-class cleanroom production?
Medical parts contacting human body or requiring sterile packaging must avoid dust and bacterial contamination. The 10,000-class cleanroom strictly controls air particles and microorganisms, ensuring products meet medical sterile safety standards.
Q4: What medical materials can this mold process?
It supports all mainstream biocompatible medical resins, including medical-grade PP, PC, PETG, ABS, PA and other sterile plastic materials, covering most medical device molding demands.
Q5: Can you provide full certification documents?
Absolutely. We can provide ISO13485 certificate, steel material report, cleanroom production record, mold inspection report and biocompatibility test data to support customer product registration and audit.
Q6: What is the service life of this medical mold?
With high-purity S136 stainless steel and precise hot runner design, the mold features strong wear and corrosion resistance. Under standard cleanroom maintenance, its service life can reach 800,000–1,200,000 shots with stable medical-level output.
