FINAL 06 - Medical Devices Flashcards
Refers to any instrument used for diagnosis and prevention of disease
Medical device
Defined as medical devices requiring calibration, maintenance, repair, user training, and decommissioning, activities usually managed by clinical engineers
Medical equipment
Includes medical imaging machines which are used to aid in diagnosis (Types of medical equipment)
Diagnostic equipment
Includes infusion pumps, medical lasers, and LASIK surgical machines (Types of medical equipment)
Treatment equipment
Is used to maintain a patient’s bodily function; includes medical ventilators and incubators (Types of medical equipment)
Life support equipment
Allow medical staff to measure a patient’s medical state; includes ECG and EEG (Types of medical equipment)
Medical monitors
Automates or helps analyze blood, urine, genes, and dissolved gases in the blood (Types of medical equipment)
Medical laboratory equipment
Includes physical therapy machines like continuous passive range of motion (CPM) machines (Types of medical equipment)
Therapeutic equipment
May be used in the periphery of the operating room or at point sources including near the surgical site for the removal of surgical plume (Types of medical equipment)
Air purifying equipment
FDA circular which includes the guidelines covering the issuance of an authorization for a medical device
FDA 001-2020
Meaning of CDRRHR
Center for Device Regulation, Radiation Health, and Research
Meaning of CMDR
Certificate of Medical Device Registration
Meaning of CMDN
Certificate of Medical Device Notification
Meaning of CMDL
Certificate of Medical Device Listing
The ISO standards for medical devices are covered by ICS __________ and ICS __________
ICS 11.100.20, ICS 11.040.01
The quality and risk management regarding the topic for regulatory purposes is convened by ISO __________ and ISO __________
ISO 13485, ISO 14971
ISO __________ is applicable to all providers and manufacturers of medical devices, components, contract services, and distributors of medical devices
ISO 13485:2016
ISO __________ sets precedence because it signifies that a company engages in the creation of new products
ISO 9001:2008
Standard guide for design and evaluation of primary flexible packaging for medical products (Relevant standards for medical device packaging)
ASTM
Standard guide for biocompatibility evaluation of medical device packaging materials (Relevant standards for medical device packaging)
ASTM F2475-11
Packaging materials and systems for medical devices to be sterilized, general requirements, and test methods (Relevant standards for medical device packaging)
EN 868
Is a part of quality management system, including verification and validation
Package testing
EN ISO __________ defines symbols that can be used to convey important information on packaging and labeling
EN ISO 15223-1
Medical device cleanliness has come under greater scrutiny since 2000, when __________ recalled several thousand metal hip implants that contained a manufacturing residue
Sulzer Orthopedics
Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis (Standards for permanent implants)
ASTM F2459
Standard practice for reporting and assessment of residues on single use implants (Standards for permanent implants)
ASTM F2847
Standard guide for validating cleaning processes used during the manufacture of medical devices (Standards for permanent implants)
ASTM F3172
