If you want to introduce your medical device to the U.S. market, you will need to obtain clearance from the FDA. This clearance is obtained via a 510(k) submission. A 510K premarket submission is made to demonstrate to the FDA that the device to be marketed is at least as safe and as effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Nearly all devices must go through the 510(k) process. Most Class III devices obtain market approval via the PMA process, which is significantly more strenuous than the 510(k).
A statistical method of sampling in which product is tested for acceptance or rejection (standard).
A substance compounded into a resin to enhance or improve certain characteristics.
The process of joining two or more plastic parts by means of an adhesive.
The process of, or the results of, exposure of plastics to natural or artificial environmental conditions for a prolonged period of time.
Cell therapies which use a donor cell that is expanded and used to treat several patients.
A private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States.
The process of relieving internal stresses of molded plastic articles by heating to a predetermined temperature, maintaining this temperature for a prearranged length of time, and slowly cooling the articles
Antimicrobial is the characteristic of a chemical which, when used to treat a material or component, prevents the growth of mold, mildew, and bacteria.
Refers to an operation performed in a sterile environment or the action of using appropriate precautions designed to prevent contamination through introduction of bacteria.
The process of joining parts by several methods.
A chamber for sterilizing with saturated steam filters or equipment by using constant high temperature and pressure.
Cell therapies which use a patient’s own cells as starting material.
A backward surge of pressure from downstream to upstream of the component. Measured in PSI, it represents the resistance offered by a valve.
Biocompatibility is the material’s lack of interaction with living tissue or a living system by not being toxic, injurious, or physiologically reactive. A material that is biocompatible does not cause an immune response in a host.
Evidence of one color overlapping or altering another color. The spreading of pigment beyond the intended boundaries.
Method of fabrication in which a warm plastic hollow tube is placed between the two halves of a mold cavity and forced to assume the shape of that mold cavity by use of internal pressure. This process forms hollow articles such as bottles, tanks, etc.
A fatal neurodegenerative disease in cattle that may be passed on to humans by consumption of infected meat.
“The fundamental unit of life. The living tissue of every organism is composed of these fundamental living units. Unicellular organisms, such as yeast or a bacterium, perform all life functions within the one cell. In a higher organism, a multicellular organism, entire populations of cells may be designated a particular task.” (per ISPE)
Also known as mad cow disease, BSE/TSE is produced from animal, plant, human or microbial sources and affects cattle. A manufacturer of materials can state if a material does not contain any raw materials produced from or substances derived or animal origin.
Showing evidence of excessive heating during processing or use of a plastic, as evidenced by blistering, discoloration, distortion or destruction of the surface.
Brown marks or streaks.
The inside-out differential pressure that causes outward pressure on the structure of the housing which can cause rupture.
Proposition 65 regulates substances officially listed by California as having a 1 in 100,000 chance of causing cancer over a 70-year period or birth defects or other reproductive harm in two ways. The first statutory requirement of Proposition 65 prohibits businesses from knowingly discharging listed substances into drinking water sources, or onto land where the substances can pass into drinking water sources. The second prohibits businesses from knowingly exposing individuals to listed substances without providing a clear and reasonable warning.
A depression, or a set of matching depressions, in a plastics-forming mold which forms the outer surfaces of the molded articles.
A CE marking, which translates to European Conformity or “Conformite Europeene,” is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. "CE" originated as an abbreviation of Conformité Européenne, meaning European Conformity, but is not defined as such in the relevant legislation.
Also called cellular therapy or cryotherapy, this is a therapy in which cellular material is injected into a patient. Typically, this means intact living cells.
An important document that certifies that goods in a particular export shipment are wholly obtained, produced, manufactured or processed in a particular country.
The chronological documentation, or paper trail, that records the sequence of custody, control, transfer, analysis and disposition of a material. In autologous CGT, this usually refers to the patient’s own cells.
A symmetrical sloping surface at an edge or corner. A cut away (a right-angled edge or corner) to make a symmetrical sloping edge. A beveled edge connecting two surfaces.
The FDA’s classification system divides medical devices into three classes:
• Class I: devices posing the lowest risk to patients or users
• Class II: devices that could harm patients or users if used improperly or if they malfunction
• Class III: devices that could severely injure or kill patients or users if used improperly or if they malfunction
Typically, Class I devices do not require FDA pre-market clearance or approval for sale in the U.S. But Class I device manufacturers must still register their products with the agency. Most Class II devices, however, must go through the FDA 510(k) process, while nearly all high-risk Class III devices go through a more rigorous premarket approval (PMA) process.
A Certificate of Compliance is a document provided by a competent authority that certifies the supplied goods or services meet the required specifications.
A plastic compound which contains a high percentage of pigment to be blended with a base resin until the correct final color is achieved.
A method of molding in which the molding material, generally preheated, is placed in an open heated mold cavity and closed with a top force. Pressure is then applied to force the material into contact with all mold areas.
Fulfillment of a requirement.
Areas of discoloration from foreign matter or foreign material embedded in the surface of a part.
Also called corrective action / preventive action, or simply corrective action, CAPA is an improvement to an organization’s process that is made to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice and numerous ISO business standards.
Stress induced splitting or fissures causing separation of material.
Minimum pressure upstream at which a valve will operate and open.
A defect in plastic articles characterized by distinct surface cracks or minute frost-like internal cracks, resulting from stresses within the article that exceed the tensile strength of the plastic.
These serve as the benchmarks that most quality by design implementation revolve around. They include chemical, physical, biological and microbiological characteristics, or properties that can be consistently measured and quantified.
The process of changing the properties of a polymer into a more stable and usable condition. This is accomplished by the use of heat, radiation, or reaction with chemical additives.
The time periods at defined conditions to which a reacting thermosetting material is processed to reach a desired property level.
A firm specializing in the molding of items or components to the specifications of another firm that handles the sale of distribution of the item, or to incorporate the custom molded components in one of its own products.
Refers to cell damage caused by materials, either by direct contact or by leachable substances (extracts).
This method required that the test article first pass through a size exclusion membrane capable of retaining microorganisms before the membrane is transferred to the test medium.
Any change from the designated color of the material or component.
A slight taper in a mold wall designed to facilitate removal of the molded object from the mold.
Durometer is a measurement of the hardness of a material. Hardness may be defined as a material's resistance to permanent indentation. Developed by Albert F. Shore in the 1920's, the term durometer is often used to refer to the measurement as well as the instrument itself. It is typically used to measure the hardness in polymers, elastomers and rubbers. There are several scales of durometer. The two most common scales are shore A and shore D scales. The A scale is for softer plastics, while the D scale is for harder ones. Rockwell R hardness is generally chosen for 'harder' plastics such as nylon and polypropylene. Often, durometer is confused with the flexibility of a material. Flexibility is a subjective characteristic, impacted not only by durometer but also by the bend radius (which is a function of wall thickness and material properties). In other words, a softer durometer does not always equate with higher flexibility.
Areas of visible contamination within the body of a component from foreign matter during the molding or manufacturing process.
A toxic heat stable lipopolysaccharide present in the outer membrane of Gram- negative bacteria that is released from the cell upon cell lysis.
Estimated time of arrival.
Ethylene oxide is a toxic compound used in gaseous form as a sterilizing agent, usually as a 10% mixture with carbon dioxide or 12% mixture with Freon (referred to as 12-88. Sterilization using EtO leaves residual chemicals such as ethylene chlorohydrin and ethylene glycol. Residual EtO can be difficult to remove completely from a device. At an elevated temperature of 1500 º F and high relative humidity, it facilitatespermeation into the material being sterilized.
E&L studies are utilized to test a material, package or component’s plastic compounds that may be inadvertently released and absorbed in the product. Common products that receive E&L studies are plastics and polymers, elastomers, adhesives, rubbers, latex, tubing and filters.
Chemical species that can be released from a product contact surface which include extraction solvent, temperature, contact time, surfactants, ahesives, etc.
The process of forming continuous shapes by forcing a molten plastic material through a die. This is the process used to make tubing.
(Noun) A specialized piece of equipment for carrying out filtration, consisting of the filter medium and suitable holder for constraining and supporting the filter in the fluid path. (Verb) Passing a fluid that contains particles through a filter medium wherein particles are removed from the fluid.
The channel through which the molten resin flows from the runner into the cavity.
Also known as radiation sterilization, gamma sterilization uses radiation emitted from radioactive materials such as cobalt 60 or cesium 137. If proper dosage of nuclear radiation can be documented, sterility testing is not required.
GMPs are the Food and Drug Administration’s regulations governing the manufacturing of drugs. GMP, sometimes referred to as CGMP, is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
A membrane or other material which is water accepting or wetting.
A membrane or other material which repels and cannot be wetted by aqueous and other high surface tension fluids. When pre-wetted with low surface tension fluid such as alcohol, the filter will then wet with water.
Instructions for use
The method of forming objects from granular or powdered plastics, most often of the thermoplastic type, in which the material is fed from a hopper to a heated chamber where it is softened, after which a ram or screw forces the material into a mold. Pressure is maintained until the mass has hardened sufficiently for removal from the mold.
Insert molding is the process of molding plastic around pre-formed metal inserts. This process is compatible with both thermoplastic and thermoset materials.
Taking place outside of a living organism in an experimental artificial environment e.g. cells in tissue culture or experiments carried out in test tubes.
Performed or taking place within the living organism.
Inspection Quality Record
Biological evaluation of medical devices or material components. A 20-part test that evaluates the effects of the medical device or material component on the body (biocompatibility).
This international standard concerns the conical fittings (a 6% taper) with regard to the designs of a luer. It consists of two separate standards:
594-1 (the taper on the male luer stem and the inside stem of the female luers)
594-2 (deals with lock fittings).
A series of standards developed by the International Organization for Standardization to improve patient safety and reduce the risk of small-bore misconnections used in liquid and gas healthcare applications. Small-bore connectors convey liquids or gases in a patient-care setting. Such connectors are used in enteral, respiratory, urinary, blood pressure, neuraxial and intravenous systems. Medications or other fluids can be delivered through the wrong route, causing patient injuries and death.
The standards include:
• 80369-1 – General Requirements and Overview
• 80369-2 – Respiratory
• 80369-3 – Enteral Feeding
• 80369-4 – Urinary and Urethral
• 80369-5 – Blood Pressure
• 80369-6 – Neuraxial
• 80369-7 – Intravascular
The United States and the Republic of Korea signed the United States-Korea Free Trade Agreement (KORUS FTA) on June 30, 2007. On December 3, 2010, the United States and Korea concluded new agreements, reflected in letters signed on February 10, 2011, that provide new market access and level the playing field for U.S. auto manufacturers and workers. Congress approved the agreement on October 12, 2011, and Korea’s National Assembly approved it on November 22, 2011. The United States and Korea completed their review of the measures both sides had taken to implement the FTA and exchanged diplomatic notes on February 21, 2012 agreeing to bring the agreement into force on March 15, 2012.
Chemical species that migrate from a product contact surface into an associated drug product under normal conditions of use or during accelerated drug product stability studies.
Any fat and fat-like materials that are insoluble in water but are soluble in common organic solvents.
The process that involves an integrated system for proportioning, mixing and dispensing two component liquid resin formulations and directly injecting the resultant mix into a mold which is clamped under pressure.
A substance used to reduce friction between surfaces in mutual contact. Internal lubricants, without affecting the fusion properties of a compound, promote resin flow. External lubricants promote release from metals, which aids in the smooth flow of melt-over die surfaces.
Documentation prepared by the manufacturer regarding the toxicity or hazards associated with the contact with specific substances.
The principal set of regulations covering medical devices in Europe. It applies to all medical devices and accessories, with the exception of devices for in-vitro diagnostics and active implantable medical devices, both of which have their own separate directives.
A directive that leads to CE marking for medical devices and applies to all general medical devices. CE marking is a legal requirement for medical devices sold in Europe.
Material through which fluid passes in the process of filtration and retains particles. Also, nutrients containing solutions in which cells or microorganisms are grown. For example, in a typical drip coffee maker, the medium is the paper filter.
An instrument, apparatus, implant, etc., which achieves its principal purpose through physical action, within or on the body and which is not dependent on being metabolized for the achievement of its principal intended purpose. The primary differentiation between a device and a drug are the words "chemical action" and "metabolized."
Media through which a liquid is passed; usually associated with an extremely fine or tight type of filtration. Highly engineered, thin polymeric film containing a narrow distribution of pores. Used as the separation mechanism in R/O, Electro dialysis (ED), Ultrafiltration (UF), Nanofiltration (NF) and Microfiltration (MF).
One one-millionth (0.000001) (1/1,000,000) of one meter, or 0.00003937 inch. Bacteria are typically less than one micron in length. The smallest object visible to the naked eye is approximately 40 microns across. Human hairs are between 60 and 80 microns in diameter.
The smallest size of particles a filter can remove.
One thousandth of an inch. 1 mil = 0.001 in. = 0.025 mm. Commonly used to describe the thickness of a membrane or film.
A hollow form or matrix into which a plastic material is placed and which imparts to the material its final shape as a finished article.
To impart shape to a plastic mass by means of a confining cavity or matrix.
A series of steel plates which contain mold components, including cavities, cores, runner system, cooling system, ejection system, etc.
In injection molding, a lubricant used to coat the surface of the mold to enhance ejection of the molded article or prevent it from sticking to the tool.
Minimum order quantity
Material Safety Data Sheet: A safety data sheet (SDS), material safety data sheet (MSDS), or product safety data sheet (PSDS) is an important component of product stewardship, occupational safety and health, and spill-handling procedures.
The public health services of England, Scotland and Wales and commonly used to refer to those of Northern Ireland.
A report issued when a product, process or procedure does not comply with set standards.
Non-fulfillment of a requirement.
A process in which a mold cavity is first partially filled with one plastic, and then a second shot is injected to encapsulate the first shot.
Loose mobile matter or embedded matter that is unintentionally present in/on the single-use component/assembly and potentially may contact or may end up in the process/product fluid.
1. Particle (see above), or
2. Particulate matter in injections and parenteral infusions consist of mobile un- dissolved particles other than gas bubbles unintentionally present in the solutions.
A document issued by a manufacturer to inform customers about a change to a mass-produced product or its manufacturing process.
A non-invasive pump functioning by alternate pinching and release of tubing which drives the fluid forward in a pulsing action. The major advantage is that the peristaltic pump does not contact the fluid being filtered, and only the inner wall of the tubing contacts the fluid.
Chemical plasticizers used to soften plastics that would otherwise be brittle and crack when bent. The most important use of phthalates is in plastics, especially PVC, where they act as plasticizers. Plasticizer acronyms that end in a “P” are phthalates; common phthalates are DBP (dibutyl phthalate), DNOP (di-n-octyl phthalate), DiNP (diisononyl phthalate), DEP (diethyl phthalate), BBzP (benzyl butyl phthalate), DEHP (di 2-ethylhexl phthalate), DiDP (diisodecyl phthalate), DnHP (di-n-hexyl phthalate), DMP (dimethyl phthalate), and DnOP (di-n-octylphthalate).
An imperfection or a small crater in the surface of the plastic.
Crater-like imperfections on the surface of the part.
A substance or material incorporated in a material (usually a plastic or an elastomer) to increase its flexibility, workability or extensibility.
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class II and Class III medical devices. These devices support or sustain human life or are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA.
A preliminary mold built upon which the final mold will be based.
Pounds per square inch.
Pounds per square inch absolute.
Pounds per square inch differential.
Pounds per square inch gauge.
Produced under conditions involving intense heat.
Sterilization using gamma radiation emitted from radioactive materials such as cobalt 60 or cesium 137. If proper dosage of nuclear radiation can be documented, sterility testing is not required.
REACH is a regulation of the European Union adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. In principle, REACH applies to all chemical substances, not only those used in industrial processes but also in our day-to-day lives. For example, in cleaning products, paints, as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU. REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users. If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones. Companies established outside the EU are not bound by the obligations of REACH, even if they export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as pre-registration or registration, lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.
Waste material such as sprues, runners, excess parison material and reject parts from injection molding, blow molding and extrusion, which has been reclaimed by shredding or granulating. Regrind is usually mixed with virgin compound at a predetermined percentage for remolding.
A material sprayed on the mold which facilitates easy removal of the molded product.
A substance, usually a chemical contaminant, left over after a process or test procedure.
Any polymer that is a basic material for plastics.
Also known as Directive 2002/95/EC, RoHS originated in the European Union and restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU marketed after July 1, 2006 must pass RoHS compliance. RoHS impacts the entire electronics industry and many electrical products as well. The substances banned under RoHS are lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (CrVI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and four different phthalates (DEHP, BBP, BBP, DIBP). RoHS compliance is important because the restricted materials are hazardous to the environment and pollute landfills, and are dangerous in terms of occupational exposure during manufacturing and recycling.
Also known as a safety data sheet (SDS), material safety data sheet (MSDS) or product safety data sheet (PSDS), an SDS is an important component of product stewardship, occupational safety and health, and spill-handling procedures.
The appearance of melted edges as a result of failure to completely fill the mold or cavities of the mold with raw material.
The dimensional allowance which must be made in molds to compensate for shrinkage of the plastic compound on cooling.
Shrinkage occurs when there is contraction upon cooling of all or areas of the part. Shrinkage occurs less in disorientated material and more across chains of molecules than along their lengths. Lower pack areas have lower areas of orientation and shrinkage.
“Consist of fluid path components to replace reusable stainless steel components. The most typical systems are made up of bag chambers, connectors, tubing and filter capsules.” (per BPSA).
A nonwoven fabric formed by producing, laying and self-bonding a web of filament material in one continuous set of processing steps. Usually made of polyester or polyolefins.
Free from microorganisms
There are three types of stress cracking: 1. Thermal stress cracking, which is caused by prolonged exposure of the part to elevated temperatures or sunlight. 2. Physical stress cracking, which occurs between crystalline and amorphous portions of the part when the part is under an internally or externally induced strain. 3. Chemical stress cracking, which occurs when a liquid or gas permeates the part’s surface. All of these types of stress cracking have the same end result: the splitting or fracturing of a molded product.
A document that summarizes the performance and other technical characteristics of a material or compound.
Resistance to breaking. The amount of force required to break a membrane by stretching.
The process of forming a thermoplastic sheet into a three-dimensional shape by clamping the sheet in a frame, heating it until it’s tender, soft and flowable. Differential pressure is then applied to make the sheet conform to the shape of a mold or die positioned below the frame.
The family of polymers that resemble elastomers in that they can be repeatedly stretched without distortion of the unstressed part shape, but are true thermoplastics and thus do not require curing.
Material that will repeatedly soften when heated and harden when cooled.
A polymer that doesn't melt when heated. Thermoset polymers "set" into a given shape when first made and afterwards do not flow or melt, but rather decompose upon heating. They are often highly cross-linked polymers, with properties similar to those of network covalent solids (i.e., hard and strong).
An allowable amount of variation of a specified size, especially in the dimensions of a part or tube. Offers a minimum and maximum or percentage regarding the specified size.
In injection molding, the term sometimes used to describe the mold.
Also known as prion diseases, TSEs are progressive, invariably fatal conditions that affect the brain and nervous system of many animals, including humans. A manufacturer of materials can state if a material does not contain any raw materials produced from or substances derived or animal origin.
The United States Pharmacopeia (USP) is a non-government organization that establishes the standards to safeguard the quality of medicines and other health care technologies. USP Class VI types of products go through a series of biological tests. The USP Class VI compounds must be made from ingredients with clear histories of biocompatibility that meet tight requirements for leachates. Although USP Class VI testing is widely used and accepted in the medical products industry, some view it as the minimum requirement a raw material must meet to be considered for use in health care applications.
USP Class VI typically requires the following tests:
1) Acute Systemic Toxicity
2) Intracutaneous Toxicity
3) Implantation Test
Demonstration that a process or product does what it is supposed to do by challenging the system and providing complete documentation.
A type of consumption tax that is placed on a product whenever value is added at a stage of production and at final sale. VAT is most often used in the European Union.
Any plastic compound or resin that has not been subjected to use or processing other than that required for its original manufacture.