Injection needle and ISO10993
10/11/2025
Injection needles are among the most widely used medical devices worldwide, essential in hospitals, clinics, and even at home. Whether for administering vaccines, delivering medications, or drawing blood, their design must guarantee both safety and precision. Behind their simple appearance lies advanced engineering, and adhesives and sealants play a crucial role in ensuring their performance and reliability.
What Are Injection Needles Used For ?
Injection needles are designed to pierce the skin and deliver or extract fluids in a controlled and sterile manner. Common uses include :
- Drug delivery (insulin, vaccines, antibiotics, pain management).
- Blood collection for laboratory analysis.
- Intravenous therapy, where fluids or medications are administered directly into the bloodstream.
- Specialized treatments, such as chemotherapy or biologics.
Given their direct contact with the human body, every component of an injection needle must meet the highest standards of biocompatibility, sterility, and mechanical reliability.
The Role of Adhesives & Sealants in Injection Needles
While needles may look like simple metal tubes, their assembly requires high-performance adhesives and sealants. These materials serve multiple functions :
- Needle-to-Hub Bonding
- The metal cannula (needle) must be securely attached to the plastic hub.
- Adhesives ensure a strong, leak-free connection that resists pressure during injections.
- Sealing and Leak Prevention
- Sealants prevent fluids from leaking at the junctions between components.
- This is critical for both safety and dosage accuracy.
- Precision Alignment
- Adhesives keep the needle aligned correctly within the hub, ensuring smooth insertion and accurate drug delivery.
- Durability and Sterilization Resistance
- Medical adhesives must withstand sterilization processes (e.g., gamma radiation, autoclaving, or ethylene oxide).
- They must also resist chemicals and maintain stability over the product’s shelf life.
The most common adhesives used for injection needles include UV-curable acrylates, epoxies, and cyanoacrylates : all formulated for medical-grade biocompatibility.
ISO 10993 & Security
When adhesives and sealants are used in medical devices like injection needles, they must be proven safe for contact with the human body. This is where ISO 10993 comes in.
- ISO 10993 is the international standard that evaluates the biocompatibility of medical devices.
- It sets out a series of tests to ensure that materials do not cause toxic, allergic, or harmful reactions when in contact with tissues, blood, or bodily fluids.
- Tests cover areas such as cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility.
For adhesives in injection needles, ISO 10993 compliance is essential. It provides :
- Patient safety : confirming the adhesive won’t leach harmful substances into the bloodstream.
- Regulatory approval : compliance is often required by authorities such as the FDA (U.S.) or EMA (Europe).
- Manufacturer confidence : ensuring consistency and global acceptance of their devices.
Although often invisible, adhesives and sealants are critical components in injection needle manufacturing. They guarantee secure bonding, leak-proof assembly, and long-term stability, while also withstanding sterilization and clinical use. But just as important as their performance is their safety : and this is assured through compliance with ISO 10993.
By meeting these rigorous standards, manufacturers ensure that injection needles remain safe, reliable, and effective tools in modern medicine, helping protect millions of patients every day.
Features
ThreeBond 2202C
One component epoxy resin
- Can be cured at low temperature (80°C)
- Heat curing resin
- Bonding, potting, sealing of electronic components, fixing connectors
- Can be used on various medical components such as needles or endoscopes
- ISO 10993 compliant product
Viscosity
31 Pa.s
Colour
White
Hardness
D98
