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Guidelines established by the United
States Pharmacopeia (USP), which were initially used to
determine the suitability of plastics for use in medical
devices, were and still are, used by adhesive
manufacturers for the same purpose. Adhesives are tested
for effect on cells (cytotoxicity), effect on blood
constituents (hemolysis), effect following implantation,
and overall effect (muscles and system). Exposure
temperatures, solvents used for extraction and test
duration are factors which can vary by supplier. Although
several classes of biocompatibility exist, adhesive
suppliers test to USP Class VI, indicating that the
material/device may come in contact with bodily fluids.
The results of Class VI testing are typically provided to
adhesive users on an as-requested basis in the form of
certificates of compliance.
In the past 10 years, several nations came
together to develop a more widely accepted standard for
biocompatibility testing: ISO-10993. The International
Standardization Organization (ISO) standard typically
involves additional tests, extract solutions, extract
temperatures and test durations as compared to Class VI
compliance testing. The ISO-10993 standard is recognized
by a wide variety of North American, European and Asian
countries.
Loctite® brand adhesives feature a
complete line of medical adhesives that comply to
ISO-10993 certification.
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Loctite® Medical Adhesives:
Whether your medical device assembly
requires an adhesive that is biocompatible and
sterilizable – or one that meets a host of other
performance characteristics – Henkel offers an unmatched
line of Medical Adhesives under Loctite® brand.
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Loctite® adhesives have been specified by
medical device manufacturers all over the world for over
two decades. The Loctite® brand features the world’s most
diversified and comprehensive line of adhesives,
dispensing equipment, and curing systems available.
Offering over forty products for medical device assemblies
requiring biocompatibility testing and hundreds of other
products for applications not requiring such evaluation.
Loctite® Medical Adhesives can provide design advantages,
improve overall product performance, speed assembly time,
and increase production efficiency and quality.
Following case histories further confirm
the benefits offered by Loctite® engineering adhesives
over conventional assembly methods.
Case History 1: Catheter Manufacturing
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A thermal dilution catheter manufacturer
requested Henkel for assistance in bonding a latex balloon
to a rigid, multi-lumen PVC tube. The catheter is inserted
into a major vein near the heart to take blood samples,
administer fluids, and monitor blood pressure and body
temperature. The transducer must endure temperatures
ranging from freezing to 110°F, while the balloon must
withstand pressures up to 110 lbs. After bonding, the
balloon is inflated fifty times to check bond durability.
Loctite® 4014™ cyanoacrylate was selected
on the balloon bond, for its low viscosity, thermal
resistance and controlled setting time. This allowed time
to assemble and place the balloon precisely. The customer
reports that the adhesive works so well that “the balloon
ruptures before the adhesive fails.” |
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Case History 2: Blood Collection
Devices
Devices
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A leading manufacturer of blood collection
and processing systems used solvents such as methylene
chloride for bonding various device components and
subassemblies. OSHA and the EPA were encouraging
industries to move away from using solvents, and this
device manufacturer particularly wanted to eliminate their
use of methylene chloride. Since the devices were made of
glass-like plastics, their engineers required clear bonds
with no stress cracking or crazing.
The collection reservoir, a disposable
device used to clean and return blood to patients during
various surgical procedures, consists of a clear,
polycarbonate lid assembly joined to a polycarbonate
bucket. Environmental concerns and issues associated with
solvent bonding were eliminated with a new tongue and
groove design and with Loctite® 3211™ – a safer, faster
and more consistent bonding choice. Loctite® 3211™ light
curing adhesive provided the aesthetic bondline the
manufacturer wanted. It also provided the structural
strength that the collection reservoir manufacturer needed
to maintain a competitive edge in the marketplace. |
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For more details on Loctite® medical
adhesive solutions please contact:
Pradhyumna Ingle
Marketing Manager
Henkel Loctite India Private Limited
1, Airport Service Road, Domlur Layout
Bangalore – 560 071, INDIA
E-mail: marketing@loctite.co.in
Phone: +91-80-25357771
Fax: +91-80-25357770
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