Healthcare providers are used to dealing with all types of medical issues every single day. Whether it’s a common cold or a life-threatening injury, each condition requires careful examination by specialists, and the utilization of the appropriate tools during treatment.
If you are involved in the healthcare manufacturing field, you likely hear the term “medical grade” somewhat often. But what is this term all about? To give you a better understanding, this medical grade metal supplier in Phoenix, Arizona is going to discuss some of the key things you should know below.
Defining “Medical Grade”
The term “medical grade” can have different implications depending on how you analyze it based on compatibility or risk management. In addition, there is no straightforward and formal definition for understanding what medical grade refers to.
However, materials can be certified as “medical grade” through a range of tests and standards. Final products must also be manufactured according to the set standards and be utilized in a suitable manner.
Looking specifically at surgeries, the operation requires the use of medical grade instruments that are specifically designed for that operation. Then there are the medical grade implants, such as replacement joints, trauma plates, and the fasteners needed to keep them in place.
In addition to meeting mechanical and chemical properties, the biocompatibility of the material is a major factor that makes it suitable for medical use — i.e., the material can be used in the human body without causing any harmful reaction.
Titanium and certain grades of stainless steel, for example, are two popular medical-grade metals that have the right mechanical properties, are, resilient and are biocompatible. These do not react with the human body in specific applications, which makes these metals an absolute game changer for the industry. However, before they can be used in the human body, your medical grade metal supplier in Phoenix, Arizona must ensure that numerous tests have been performed on the raw materials to determine their efficacy and safety.
Their broad range of applications includes hearing, dental, and medical implants, catheters, syringes, needles, artificial joints, sutures, bone plates, stents, medical devices, like pacemakers and much more.
Earning the Medical Grade Designation
Because the human body easily rejects foreign elements, it is crucial to produce materials that can be safely used for medical purposes. There are several governing bodies that formulate standards and specifications to approve materials as “medical grade” and determine their functionality and duration of contact. Some of the benchmarks you should be aware of include (but aren’t limited to) the following:
- ISO 13485 is the certification standard for the manufacture of high-quality medical materials. It ensures that your chosen medical grade metal supplier in Phoenix, Arizona meets and exceeds the quality requirements for designing and producing medical devices.
- Developed by top metallurgical and technical experts, the ASTM international standardsfor specific grades of materials must also be met when producing sterile and structurally durable devices and instruments.
- The metal must be resistant to extreme temperatures, chemicals, acids, and contaminants.
- The materials must also be tested for degradation, toxicity, skin sensitivity, and other factors.
When you partner with a knowledgeable medical grade metal supplier in Phoenix, Arizona, the metal you order will be customized explicitly in terms of its chemical and mechanical composition, corrosion resistance, strength, and other factors to ensure safe use in the medical sector. Every finished component can then be manufactured to the highest standard and with utmost precision, quality, and reliability.
Looking for a Medical Grade Metal Supplier in Phoenix, Arizona?
Manufacturers in the healthcare sector work to save lives. They need to be confident in the quality of the products and equipment they produce. That is why only authentic, medical-grade materials should be used during the manufacturing process.
Are you looking for a certified medical grade metal supplier in Phoenix, Arizona that can help you source the highest quality raw materials for your manufacturing needs? If so, look no further than the experts at Banner Industries. Contact us today at (800) 950-3562 to discuss your project.