Precision
Est. 1950
P L A ST I C B A L L C O M PA N Y
Choosing a Partner in
the Medical Device Field
Trends and Requirements for
Medical Grade Precision Balls
The Growth of Medical Grade Balls
Medical technology is a comprehensive field where innovation and precision are vital tools in sustaining
patient health. The development of medical equipment and devices—such as MRI machines, prosthetic limbs,
and synthetic organs—has significantly improved healthcare throughout the world. Today, several medical
technologies are supported by medical grade precision ball bearings.
As the name implies, medical grade balls are specifically made for healthcare applications. Common applications
include: medical instrumentation, biological testing, surgical implantation, and personal protection equipment.
The use of medical grade balls is constantly growing; medical device designers and manufacturers are discovering
that plastic ball bearings provide a number of advantages over metal bearings. As such, plastic bearings have
been deployed in everything from diagnosis to rehabilitation equipment.
Materials of Medical Grade Balls
Depending on the specific application, medical grade bearings can be composed entirely of plastic or a
combination of plastic and metal material—each material has its unique advantages and drawbacks.
Plastic Ball Bearings
In the medical industry, plastic balls are commonly used in fluid handling applications that include intravenous
check valves, infusion systems, organ assist pumps, and many other critical care systems. Specific types of
plastics are ideal for flow control due to low friction and high resistance to abrasion and various chemicals
and temperatures. In addition to their chemical-resistant qualities, the plastic used may also be inert, further
enhancing its benefits in biomedical research—plastic balls are used to a great extent in systems that test the
effectiveness of different antibodies.
Plastics are also used in blood separators; non-lubricated, sterilized plastic bearings are disposable, yet highly
essential components that contain fluid collection tubes and storage reservoirs.
In MRI machines, the use of plastic ball bearings is a critical factor in system design; this is due to the fact that
plastic bearings won’t disrupt the magnetic imaging.
Any type of metal interferes with the powerful
magnetic field employed by MRI machines, resulting
in serious, possibly fatal consequences for patients.
Plastic ball bearings are lightweight products that
are especially resilient in harsh environments. For
medical applications, Torlon, polypropylene, and
acetal plastic ball bearings are exceptional options
thanks to their hygienic properties and multiple
chemical resistances.
Precision
Est. 1950
P L A ST I C B A L L C O M PA N Y
10129 West Pacific Ave. • Franklin Park, Illinois 60131
www.precisionplasticball.com • P: 847.678.2255 • [email protected]
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Metal Ball Bearings
Metal has been used in medical devices for quite some time. Innovations in
manufacturing processes—such as heat treating, annealing, and forging—
help to enhance the strength and durability of metal materials for diverse
medical applications.
Metal ball bearings are integral components of many high-speed medical
devices, such as dental and surgical drills and other handpieces. Some
medical drills have turbines that need to run at nearly 500,000 RPM; to
achieve such high speeds, medical drills must be fitted with miniature metal
bearings capable of handling substantial loads.
The use of metal is preferable in this instance, as metals are better suited to move heavy loads through the
application with ease. Moreover, metal bearing raceways have exacting patterns, roundness, and harmonic
amplitudes that enable medical devices to reach higher speeds.
Stainless steel is a popular material in metal bearings. There are three main types commonly used: 316 stainless
(austenitic) and 420 & 440 stainless (martensitic). These are referred to as “surgical steels” due to their ability to
withstand the harshest biomedical applications.
Dental and surgical devices must undergo constant sterilization after each use; the corrosion-resistant properties
of stainless steel ball bearings help maintain the integrity of the instruments
Though resistant to corrosion, stainless steel is prone to many types of wear: adhesive, when metal surfaces come
into direct contact causing damage; abrasive, when a harder material creates grooves in softer surfaces;
and thermal, when high temperatures cause erosion.
Industry Standards
To support healthcare applications, ball bearings must be of the highest purity and
quality. Sterilization has an essential need in healthcare, as it stems the growth
and spread of diseases and prevents infections from occurring during surgical
procedures.
The medical industry has increasingly stringent hygienic requirements; as such,
medical grade balls are manufactured in accordance with diverse industry
standards.
The two foremost medical standards are: Code of Federal Regulations (CFR) Title 21, Part 820 enforced by the
Food and Drug Administration (FDA) in America and ISO 13485:2003 which is required by the European Union.
FDA CFR Title 21, Part 820 – This set of standards pertains to quality systems regulations; more specifically, the
design, production, packaging and labeling, storage, installation, and maintenance of any devices to be used on
humans.
ISO 13485:2003 – This standard specifies the requirements necessary for a manufacturing company’s quality
management system, which must consistently provide quality devices and related services to healthcare
customers.
Precision
Est. 1950
P L A ST I C B A L L C O M PA N Y
10129 West Pacific Ave. • Franklin Park, Illinois 60131
www.precisionplasticball.com • P: 847.678.2255 • [email protected]
Connect With Us!
There are other standards set in place, such as ISO 7153-1:1991 for stainless steel surgical instruments. This
standard—extended to include dental instrumentation—has a survey of steel materials that are available for use
in surgical procedures. The ISO standards 5832-1 and 5832-9 give specifications for wrought stainless steel and
high nitrogen stainless steel to be used in medical implantation.
Plastic ball bearings are lightweight products that are especially resilient in harsh environments. For medical
applications, Torlon, polypropylene, and acetal plastic ball bearings are exceptional options thanks to their
hygienic properties and multiple chemical resistances.
Choose Quality Manufacturers
To meet the needs of healthcare providers, you must choose a company that abides by industry regulations and
can deliver results. Precision Plastic Ball Co. is a leading manufacturer of high-quality ball bearings that are ideal
for various medical applications. We have the capabilities to create ball bearings using FDA-approved materials
and colorants.
All of our medical grade balls are manufactured in separate control areas
to ensure the best quality bearing possible. These control areas allow
our team to focus on factors that affect finished bearings—including
temperature and humidity. We still recommend sterilizing the balls upon
receipt to maintain a 100% sterile product.
By choosing a quality manufacturer like Precision Plastic Ball Co.,
customers can be assured to receive products that exceed the most
stringent industry regulations and qualifications. In addition to our
manufacturing services, Precision can also advise customers on choosing
ball bearings that suit their needs and their budget; we can also provide
samples for testing purposes.
Precision Plastic Ball Co. has the capabilities to make ball bearings of any size or material to complement a wide
range of medical devices. Contact us to find out how Precision can support your healthcare applications.
Precision
Est. 1950
P L A ST I C B A L L C O M PA N Y
10129 West Pacific Ave. • Franklin Park, Illinois 60131
www.precisionplasticball.com • P: 847.678.2255 • [email protected]
Connect With Us!
References:
http://www.precisionplasticball.com/medical-and-laboratory-industries/
https://www.aimseducation.edu/blog/the-impact-of-technology-on-healthcare/
http://www.healthcarebusinesstech.com/medical-technology/
http://oilslickpad.com/products/slick-ball/
http://www.tantalumbeads.com/
http://www.azom.com/article.aspx?ArticleID=6641
http://www.industrialspec.com/medicalflowcontrol-luercheckvalves.html
http://www.salemball.com/plastic.htm
http://www.itiball.com/plastic_balls.php
http://www.precisionballs.com/Producing_Medically_Oriented_Ball%20Products.php
http://www.precisionballs.com/
http://www.precisionplasticball.com/medical-and-laboratory-industries/
http://www.dentalbearings.net/dental-bearings/
http://www.nickelinstitute.org/~/Media/Files/TechnicalLiterature/ReviewofWearandGallingCharacteristicsofStainlessSteel_9006_.
pdf#page=
Precision
Est. 1950
P L A ST I C B A L L C O M PA N Y
10129 West Pacific Ave. • Franklin Park, Illinois 60131
www.precisionplasticball.com • P: 847.678.2255 • [email protected]
Connect With Us!