Glossary

Angles of Rotation: One or multiple angles of a point geometry as measured from the axis of the tubing. Has a direct correlation to sharpness, penetration, bevel and lancet length.

Anneal: A heating and cooling treatment of metal or glass used to alleviate internal stresses and make less brittle. This helps the manufacture of components that are bent, flared or swaged to prevent cracking or splitting.

Annealing Point: Temperature at which the internal strains in glass are reduced to an acceptable limit.

Anti-core Heel: A blasting operation to dull the bevel heel in order to reduce coring.

AQL (Acceptable Quality Levels): A statistical method of sampling in which product is tested for acceptance or rejection (standard).

ASTM A967: Chemical passivation standard by the American Society for Testing and Materials.

Austenitic Stainless Steel: Stainless steel principally made up of austenite, made stable by alloying with nickel.

Back Bevel: A cannula with the two secondary grinds located on opposing sides of the primary grinds.

Bevel Length: The complete distance of a bevel, usually measured from the tip of the needle to the most proximal area of grinding behind the heel, is also referred to as the primary bevel length. Side bevel length is measured between (1) the juncture of side bevel and the outside surface of tubing and (2) the tip of the needle, also known as the secondary level length.

Bevel: The angled surface formed on a cannula when a needle is ground. A typical lancet point has three bevels. After a primary grind is made, the primary bevel is subsequently partially ground away to form two side bevels. Styles include: “A” bevel, “B” bevel, “C” bevel, Trocar, Tuohy, Bias, Chiba, Crawford, Bent/Deflected Tip, Hustead®, Huber tip, etc.

Bioburden: The number of microorganisms on a product usually measured as incubated aerobic, anaerobic and fungi spores.

Biopsy: Surgical removal of live cells from a patient for further examination. Different types of cannulae are employed. For fluid biopsies, a small gauge cannula is used to draw fluid from a suspect area. For core biopsies, a larger gauge with a specifically designed cutting tip is used to remove a tissue sample.

Blank: Tubing that has been cut to length and will later be ground to cannulae.

Blunt: A cutoff provided in a bulk clean state that is considered its finished form and used as is. Typically, it has a square cut (90 degrees) end.

Borosilicate Glass: Borosilicate is a glass type (USP Type 1) with main components of boron oxide and silica. This type of glass has high resistance to thermal shock, making it highly practical for use in the laboratory and for cookware. Borosilicate glass is also highly impermeable, allowing it to be used as a storage container for volatile compounds.

Bulk Clean: Parts are free from pyrogens, ready to be sterilized and need no further cleaning.

Burrs: Thin metal pieces that attach to ground and cut areas of cannula and have the potential of breaking free.

Cannula: A small pointed hollow tube with a ground point. Note: When the hub is added, it becomes a needle. The proper plural of cannula is cannulae.

Cannulas: An incorrect term. Cannulae is a Latin-based term and is the plural form of cannula.

Certificate of Compliance: Documentation that accompanies a shipment, upon customer request, to certify that parts are manufactured to specification.

cGMP: Current Good Manufacturing Practice (cGMP) is a term used by the FDA (Food and Drug Administration) for the control and management of manufacturing and quality control practices of pharmaceutical and medical device products. These practices are meant to minimize the possibility of manufacturing problems adversely affecting the final product and reaching the patient. (Also see 21CFR820.)

Chamfer: A large radius on the butt end of a tube with distinct angles. Chamfers are often used to help guide cannulae into automatic assembly equipment.

Chemical Polish: Method of applying chemicals to the outside of a cannula, melting the surface and resulting in a shiny finish.

Coefficient of Expansion: Measure of the average linear expansion for temperature changes between 0° and 300°C as it pertains to glass.

Contract Manufacturer: A producer of parts for other end users or original equipment manufacturers (OEM).

Cord: An inclusion, possessing optical and physical properties, differing from those of the surrounding glass.

Coring: When a plug of tissue or other medium is cut as the needle passes through a surface. Cannulae with this characteristic are generally viewed as undesirable. Certain manufacturing processes are designed to minimize coring.

Cpk: A statistical measure of control for manufacturing. Cpk measures how closely the measurements are centered to the nominal and how far from the specification limits.

Cutoff: Tubing that has been cut to length and has no ground bevel.

Density: Weight in grams per one cubic centimeter of glass.

Distal End: The end of the needle furthest from the hub.

Double Point: A cannula with points ground on both ends.

Echogenic Cannula: Cannula with surface treatments that increase ultrasonic reflectivity in ultrasound procedures.

Echogenic Tip: An area often found at or near the bevel tip that allows for good reflection while using ultrasonic equipment.

Electro-polish: A process that smooths and brightens metals by removing microscopic layers of material to produce a uniform, brilliant surface.

Epidural: Regional anesthesia technique where drugs are introduced into the epidural space to block the transmission of sensation and pain.

Etching: Definition #1: A process that uses a caustic material to create an impression on the surface. ISPG can use this process to mark cannula.

Etching: Definition #2: A process used to microscopically break down the edges of a point to enhance their cutting (penetration) characteristic.

FDA Registered: Manufacturers of medical devices are required to register with the United States Food and Drug Administration to sell their products in the United States.

Feather: A thin portion of metal on cannula remaining after grinding. They are later removed with further processing. Feathers are unacceptable attributes in a final product.

First In First Out (FIFO): Inventory received first is used first.

Flare: The spreading of a tube to a larger diameter. A flare is typically applies to the proximal (butt) end.

Flash: Excess material present on plastic, usually occurring at the mold parting lines and gate. This is an unacceptable attribute.

Free length: The distance between the tip of the cannulae and the hub; i.e., the distance the cannula is exposed or not covered by the hub.

Gauge: O.D. of needle or cannula, expressed as a Stubs Iron Wire Gauge Number. The number increases as the tube diameter gets smaller.

GG-N-196: U.S. government specification for hypodermic needles from 1947. This specification is obsolete but is still referenced.

Grit blast: A blast on the butt end usually to roughen the O.D. of the cannulae. Is often used to improve the surface of the cannula for bonding.

Hardness: A measure of the yield strength of metals. ISPG measures hardness with the Vickers Diamond Pyramid Number. With the Vickers test, a material’s ability to resist deformation from a standard source (a diamond) is observed and measured on a scale. The scale yields a unit of hardness called a Vickers Diamond Pyramid Number (HV). Other methods to measure hardness include: Rockwell, Knoop, and Brinell.

Heel of bevel: The proximal rounded inner edge of the point.

Holes: Holes can be produced by laser, EDM and drilling. Holes allow the hypo tube to retain more rigidity and resistance to breakage than ground notches.

Hook: A hook is a deflection of 0.002” or more. A deflection of the point (point damage), greater than 0.002”, will adversely affect penetration.

Hub: A fitting attached to cannulae to make a needle.

Huber Point: A point that is bent in a particular manner to reduce coring.

Hypodermic: Beneath the skin.

I.D.: The inside diameter of tubing.

Insert molding: Method of inserting cannula during a plastic injection process.

Installation Qualification (IQ): Documented verification that aspects of equipment installation adhere to proper codes and approved design intentions.

Intra-arterial: Within or into an artery.

Intra-dermal: Within or into the skin.

Intra-muscular: Within or into the substance of a muscle. “A” style tip per GG-N-196 is commonly used.

Intra-vascular: Within or into a vein. “B” style tip per GG-N-196 is commonly used.

ISO 13485: An international quality standard that harmonizes medical device regulatory requirements for Quality Management Systems.

ISO/TR 14969:2004: Guidance on the application of ISO 13485.

ISO 9001:2000 Certified: A company’s quality management system that has been audited by a third party and certified to meet the requirements of the ISO 9001 international quality standard.

ISO 9626: International standard for stainless steel needle tubing for the manufacture of medical devices.

Just in Time: An inventory management methodology where customer demand dictates manufacturing. Materials and components are delivered from the supplier as needed by the manufacturing process.

Laminar Flow Booth: A tabletop enclosure used to create a controlled environment.

Lancet point: A three-grind needle point formed from a primary grind and two secondary grinds. Lancet points are also referred to as “A” bevel, “B” bevel and “C” bevel, depending on the length. Other common terms for Lancet are side grinds or diamond points.

Laser Marking: The use of a laser beam to permanently mark the surface of a material without the use of solvents or inks.

Lean Manufacturing: A process improvement methodology focused on eliminating waste.

LOR Technique: Loss of Resistance is the regional anesthetic technique to identify the epidural space.

Lot Traceability: Written procedures that provide a means to document and identify products in all stages from receipt of raw materials to production and distribution. Proper traceability includes both backwards and forwards information and facilitates any necessary corrective action.

Lot: ISPG defines this term as a specific quantity controlled production.

Luer: Taper on end of hub or syringe (male or female) to connect a needle to a syringe or other Luer fitting. Hubs can be Luer Slip or Luer Lock and conform to standard ISO 594-2.

Luer slip: A syringe tip that conforms to Luer taper dimensions and which holds the needle by friction.

Luer taper: This taper is standardized by ISO 594-1 and ISO 594-2; ISO 595-1 and ISO 595-2.

Lumen: The hole through the (cannula) tube.

Magnetic Permeability: A characteristic of material that is a proportion of magnetic induction produced in a material divided by the strength of the field. This characteristic can be controlled in stainless steel cannula and is measured in "µ".

Malleable: A material that is bendable without breaking or cracking. Stainless steel tubing can be drawn to less than full hard conditions to increase malleability.

Micron: A unit of length: one one-thousandth part of one millimeter.

Mirror finish: Hypodermic tubing that has characteristics of brighter and smoother O.D. and I.D. surfaces than standard drawn tubing.

Needle assembly: A cannula plus a hub (also may include packaging and/or protective material or internal components such as filters, etc.).

Needle: A cannula with a hub attached.

Nominal: A value that represents the center of a tolerance range.

Notch: Ground holes in the cannula, usually added for another fluid, air or gas pathway.

O.D.: Outside diameter of tubing.

Obturator: A solid rod having a handle, used to block the lumen of a needle (stylet).

Occlude: To block or close off (i.e., an occluded lumen, a blocked cannula).

OEM: Original Equipment Manufacturer.

Operational Qualification (OQ): Documented verification that equipment-related systems perform properly throughout their operating ranges.

Original Design Manufacturer (ODM): A company that designs a product to be branded by another firm for sale.

Overall Length (OAL): The full length of the cannula from the distal end to the proximal end. This includes the portion of the cannula covered by the hub, referred to as the OAL.

Particulate Matter: Any foreign substance or contaminate. These particles can be characterized according to their morphological and optical properties and evaluated under high magnification.

Passivate: Treatment of metal with acid to prevent corrosion. See ASTM A967.

PDMS Coating: Polydimethylsiloxane application to the O.D., providing electrical insulation for low voltage applications.

Pencil Point: A hollow tube with a closed tip for piercing without creating a coring plug. Pencil point tips have different angles and sharpness and may or may not include a notch.

Penetration Tests: Testing procedure used to measure the sharpness or penetration characteristics of cannula when passed through a standard membrane. ISPG measures sharpness in grams.

Performance Qualification (PQ): Documented verification that the process system performs as intended in all ranges.

Plug drawn: Tubing drawn over a plug rather than a mandrel. The plug drawn process typically produces a smoother I.D. surface than mandrel/rod drawing.

Primary Grind: The first grind performed during the grinding process.

Production Quantity: The quantity required for a production run, without lot charge.

Proximal End: The end of the cannula closest to the hub.

PTFE Coating: Polytetrafluoroethylene application to the O.D., providing electrical insulation for low voltage applications.

Punch biopsy: Cannula with a cutting chamfer at the proximal end designed to cut a plug of tissue.

Pyrogen: A fever producing substance. Cleanliness in all phases of handling is essential to avoid pyrogenic product.

Qualification Lot: A small initial quantity produced for the purpose of testing a design and manufacturing process.

Radius: A broken or rounded edge typically on the proximal end of the cannula.

Refractive Index: Measurement of the ratio between the velocities of light in air to velocity in glass.

Resistance to Breakage: The characteristic of the tubing that describes its ability not to break when bent a given distance for a particular number of times. Limits are set in ISO 9626 and GG-N-196.

Seed: A small gaseous inclusion in glass.

Six Sigma: A quality improvement methodology that employs a set of statistical analysis tools to reduce defects. Six Sigma’s focus on providing business process improvement measurable in dollar savings has made it a popular methodology.

Softening Point: Temperature at which glass will deform under its own weight.

Spinal Anesthesia: Regional anesthesia technique where drugs are injected directly into the cerebrospinal fluid to block sensation and pain from being transmitted through the spinal cord.

Sterile: Free from viable micro-organisms.

Stiffness Testing: A method of testing the strength of tubing. The hypodermic tubing is placed in a specified span and a force is applied perpendicular to the axis of the tubing. A maximum amount of deflection is allowed per ISO 9626.

Stone: Crystalline contamination in glass.

Stylet: A solid rod with a handle. The tip is ground to fit the bevel of the needle through which it is run. A stylet, when introduced with the needle, helps prevent coring.

Strain Point: Temperature where the internal stresses in glass are reduced to their lowest values.

Subcutaneous: Under the skin. “C” style tip per GG-N-196.

Surface Roughness Analysis: A way of determining the surface roughness of O.D. and I.D. of tubing. Typically, roughness analysis is done using a roughness average per microinch (Ra µ).

Swaging: Process for tapering rod or tube by reducing its diameter by several methods: forging, squeezing or hammering. Also spelled “swedging”.

Tattoo Test: A method to confirm cleanliness of the O.D. surface of a cannula or cutoff by inserting it through a medium and measuring any residue against a controlled sample.

Temper: A process that, through heating and cooling of a material, allows a manufacturer to harden steel or glass.

Tempered Glass: Glass rapidly cooled in a controlled manner from near the softening point in order to improve its mechanical and thermal endurance.

Temperature Limit: Temperature range at which no breakage should occur. At maximum temperature, glass is likely to fail if not in good condition.

Thermal Endurance: Glassware’s capability to withstand thermal shock.

Tip damage: Damage to cannula points caused by improper handling.

Tolerance: An allowable degree of variation from a nominal value.

Tooling: Equipment purposely built for the production of specialty products. Tooling is an upfront cost that is sometimes required for production of specialty product.

Trocar: A three-sided, sharp point usually on a solid wire fitted with a cannula; inserted into a body cavity.

Validation (IQ, PQ, OQ): Establishment of evidence that gives an acceptable level of assurance that a process will consistently produce product according to specification and quality characteristics. Three stages of the validation process: Installation Qualification Validation (IQ Validation: equipment and systems have been installed in accordance with specifications and that the facility meets applicable requirements), Operation Qualification Validation (OQ Validation: standard operating procedure review and testing), Process Qualification Validation (PQ Validation: documentation that facilities and approved operating procedures work in concert to produce consistent product).

Wall: Thickness of the tube wall. Wall thickness can be calculated as O.D. minus I.D. then divided by 2.

Wall Types: Tubing wall is described with an ISO wall naming system: RW = regular wall, TW = thin wall, XTW = extra thin wall, UTW = ultra thin wall, XXTW = extra extra thin wall, HW = heavy wall, SP = special wall (custom combination of O.D. and I.D.).

Work Hardening: Increased hardness accompanying plastic deformation of metal below re-crystallization temperature range. Metal that increases strength as it is stretched or formed.

21CFR820: United States Code of Federal Regulations for Food and Drugs.