Medical and Micro Manufacturing Terms and Definitions

Term Definition
510(k) The U.S. Food and Drug Administration (FDA) has two regulatory pathways that allow the sale and marketing of medical devices; 510(k) and Premarket Approval process. The 510(k) process is the most common. A new medical device that can be demonstrated to be substantially equivalent to a previously legally marketed device can be cleared by the FDA for marketing as long as the general and special controls are met.
ASQ certified quality technician Demonstrates that an individual has the knowledge to assure quality of products and services by the American Society for Quality.
Battenfeld Microsystem 50 Fully servo-electric plastic injection molding machine specifically designed for micromolding.
Cardiology The branch of medicine dealing with disorders of the heart and blood vessels.
Class I Medical Device Class I Medical Devices have the least amount of of regulatory control. Class I devices present minimal harm to the user. Examples of Class I devices include elastic bandages, examination gloves and hand-held surgical instruments.
Class II Medical Device Class II Medical Devices are devices where general controls are not sufficient to assure safety and effectiveness. Class II devices typically require pre-market notification by submission and FDA review of a 510(k) clearance to market submission. Examples of Class II devices include catheter guide wires, catheter introducers and pacemaker leads.
Clean Room A clean room is an environment that has a controlled level of contamination specified by the number of particles per cubic meter at a specified particle size and are classified according to the number and size of particles permitted per volume of air.
Colonoscopy The endoscopic examination of the large colon and the distal part of the small bowel.
Device Classification There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by risk the medical device presents to the patient and the level of regulatory control the FDA needs to legally market the device. As the classification increases, the risk to the patient and FDA regulatory control increase.
Distal Catheter component situated farthest from the point of attachment or origin. The distal end is usually flexible to allow passage of the catheter tip through the blood vessel without causing trauma.
Endoscopy The examination of the inside the body for medical reasons using an instrument called an endoscope. Endoscopy can also refer to using a borescope.
French Catheter Scale Is commonly used to measure the size (diameter) of a catheter.  The abbreviation for the French scale is Fr.  1 Fr = .33 mm.  The diameter of the catheter in millimeters can be determined by dividing the French size by 3.  For example, if the French size is 6, the diameter is 2 mm.
Gastrology/ Gastroenterology The branch of medicine dealing with the study of the digestive system (stomach) and its diseases.
Gastroscopy The examination of the inside of the gullet, stomach and duodenum.
Gynecology The branch of medicine dealing with the health of the female reproductive system.
HEPA filter High efficiency particulate air filter.
Insufflation Blowing air or gas into the body cavity for minimally invasive surgery.
ISO/TS 16949 Common automotive quality system requirements based on the ISO 9001:200 and specific requirements for the automotive sector.
Laparoscopy The examination of the abdominal organs or the female pelvic organs.
Laparoscopic surgery Minimally invasive surgery performed in the abdomen.
Micromolding Components that have a volumetric size of 1 cm3 or less. Other commonly used phrases are micro injection molding, miniature plastic molding, nano molding, plastic micromolding and precision micromolding.
Minimally invasive surgery A type of surgery performed through small ports rather than large incisions, often resulting in shorter recovery times, less trauma to the patient, fewer complications and reduced hospital costs.
MIS Abbreviation for minimally invasive surgery.
Morcellator A surgical instrument used for division and removal of large masses of tissue during laparoscopic surgery. Used in gynecologic surgery.
Oncology The branch of medicine dealing that studies tumors and seeks to understand their development, diagnosis, treatment and prevention.
Premarket approval (PMA) FDA permission to medical device manufacturers to sell their devices to the medical profession.
Proximal Catheter component situated nearest to the point of attachment or origin. The proximal end is usually stiff to allow pushing and maneuvering of the catheter through the blood vessel.
Sidmoidoscopy The endoscopic examination of the large intestine.
Urology The branch of medicine that focuses on the urinary tracts of males and females, and on the reproductive system of males.

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Mikrotech, LLC
9900 58th Place
Kenosha, WI

Tel 262.577.0232