Search results
Results from the WOW.Com Content Network
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation. A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations.
Lux meter for measuring illuminance, i.e. incident luminous flux per unit area; Luminance meter for measuring luminance, i.e. luminous flux per unit area and unit solid angle; Light meter, an instrument used to set photographic exposures. It can be either a lux meter (incident-light meter) or a luminance meter (reflected-light meter), and is ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Control charts are graphical plots used in production control to determine whether quality and manufacturing processes are being controlled under stable conditions. (ISO 7870-1) [1] The hourly status is arranged on the graph, and the occurrence of abnormalities is judged based on the presence of data that differs from the conventional trend or deviates from the control limit line.
Function block: Each function on an FFBD should be separate and be represented by single box (solid line). Each function needs to stand for definite, finite, discrete action to be accomplished by system elements. Function numbering: Each level should have a consistent number scheme and provide information concerning function origin. These ...
The X-bar chart is always used in conjunction with a variation chart such as the ¯ and R chart or ¯ and s chart. The R-chart shows sample ranges (difference between the largest and the smallest values in the sample), while the s-chart shows the samples' standard deviation. The R-chart was preferred in times when calculations were performed ...