Tip for Developing A Stainless Steel Container Vessel Flask for Medical Equipment

This article provides all the essential information you need about?the SUS316 stainless steel container vessel flask for medical equipment. This will help you make informed choices that align with your needs.

As a leading?manufacturer of stainless steel containers and vessels, Watersy receives inquiries every week about developing vacuum-insulated vessels for the medical and pharmaceutical industry. We specialize in manufacturing medical-grade parts for medical device applications. And we are committed to delivering high-quality containers that meet rigorous standards, empowering you to provide the best healthcare possible.

SUS316 Stainless Steel: A Medical Grade Material

What is SUS316 stainless steel? SUS316 stainless steel is the best material among stainless steels. It has a density of 8.03 g/cm3 and shares similar physical properties with SUS304 stainless steel. In terms of composition, SUS316 stainless steel must contain 16% to 18% chromium and 10% to 14% nickel. For this reason, it is also referred to as 18/10 stainless steel.

What Certification Is Required for SUS316 Stainless Steel Vessels for Medical Equipment?

Since medical-grade stainless steel is particularly applied to medical devices, it must comply with rigorous standards to ensure the safety of medical procedures.

1. SAE Credential:

First,?when it comes to materials, we need to select the appropriate steel to ensure purity.?According to the?SAE?(Society of Automotive Engineers), there is a series of stainless steels ranging?from SAE 100 – 600. In order to be?approved by ANSI?(American National Standards Institute)?and?NSF?(National Science Foundation),?the composition of?SUS316 medical-grade stainless steel needs to comply with SAE 300 Series.

To be more specific, the chemical composition of 316 medical-grade stainless steel?includes the following elements:

• Iron (Fe): Balance (the majority of the alloy)
• Chromium (Cr): 16.0% ~0%
• Nickel (Ni): 10.0% ~0%
• Molybdenum (Mo): 2.0% ~0%
• Carbon (C): ≤ 0.03% (for medical applications)
• Manganese (Mn): ≤ 2.0%
• Silicon (Si): ≤ 1.0%
• Phosphorus (P): ≤ 0.045%
• Sulfur (S): ≤ 0.03%

SUS316 stainless steel is widely recognized for its stability and exceptional corrosion resistance. In fact, this material is essential for medical equipment and devices, ensuring safety with no harm to the human body.

Besides, as medical-grade stainless steel is required for contact with the body, it needs strict control over the leaching of metal ions. Therefore, the carbon content must be no more than 0.03%.

2. ISO 9001:2015 Certification

Second, ISO 9001:2015 is an international standard that specifies requirements for a quality management system. It emphasizes a systematic approach to managing an organization’s processes and improving quality, leading to increased efficiency and customer satisfaction. It applies to any organization, regardless of size or industry. Certification to this standard demonstrates a commitment to quality management practices.

As a matter of fact, as a professional wholesale manufacturer of SUS316 stainless steel containers for medical equipment, KingSatr’s products strictly meet all global standards.

Why Use SUS316 Stainless Steel for Medical Equipment?

1. Exceptional Corrosion Resistance

• Due to the extra 2% molybdenum, SUS316 stainless steel vessels have stronger corrosion resistance. This property allows them to resist corrosive media like chlorides. Additionally, SUS316 containers can withstand exposure to body fluids, drugs, and cleaning agents.

2. Easy to Clean

• 316 stainless steel flasks have a smooth and even surface. This makes it easy to clean and disinfect, which helps maintain the hygiene and safety of medical equipment.

3. Durability and Stability

• 316 stainless steel vessels for medical equipment have high hardness and high strength. So they are extremely tough and durable, allowing them to last longer, which is very cost-effective in the long run.
• Besides, this property greatly enhances their stability and safety.

4. High-Temperature Resistance

• Some processes of sterilization require a high-temperature condition. 316 stainless steel medical containers can withstand temperatures of 1200–1300°C without losing their structural integrity.

5. Biocompatibility

• 316 stainless steel is biocompatible. It means this material is safe for contact with the human body, which is essential during medical procedures without causing any adverse reactions.

6. Non-magnetic

• Containers made from medical-grade stainless steel are non-magnetic, minimizing magnetic interference. This means this equipment is safe to use in a magnetic resonance environment.

7. Antibacterial properties

• Medical-grade stainless steel containers have a smooth surface and antibacterial characteristics. This feature enables them to effectively resist bacterial growth, and reduce the risk of cross-contamination.

How to Develop Medical-Grade Stainless Steel Containers / Vessels

Manufacturing SUS316 stainless steel container vessel flask for medical equipment involves several key steps:

1. Material Selection

• Begin by sourcing high-quality SUS316 stainless steel which needs to comply with SAE 300 Series.

2. Design

• Create detailed designs of the medical containers, including dimensions, shapes, and features such as lids and seals. Use CAD software for 3D modeling to visualize the design and facilitate modifications.

3. Prototyping

• Develop prototypes using techniques like CNC machining or 3D printing.

4. Testing and Quality Control

• Conduct rigorous testing, including:Corrosion Resistance Tests: Ensure it meets medical standards for exposure to fluids and cleaning agents.Mechanical Testing: Assess strength, toughness, and failure points.Biocompatibility Testing: Verify that the material is safe for contact with human tissues.
• Implement quality control measures throughout the manufacturing process.

5. Regulatory Compliance

• Ensure that all SUS316 stainless steel containers for medical equipment comply with SAE, and ISO 9001: 2015 standards.

6. Manufacturing

• Choose appropriate manufacturing methods (e.g., stamping, welding, or forming) to produce medical vessels at scale.
• Ensure proper handling and processing of the stainless steel to maintain material integrity.

7. Sterilization and Packaging

• Develop a sterilization process suitable for the containers, considering methods like autoclaving or ethylene oxide.