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English: This psychrometric chart represents the acceptable combination of air temperature and humidity values, according to the PMV/PPD method in the ASHRAE 55-2010 Standard. The comfort zone in blue represents the 90% of acceptability, which means the conditions between -0.5 and +0.5 PMV, or PPD < 10%.
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Montevideo units are a method of measuring uterine performance during labor. They were created in 1949 by two physicians, Roberto Caldeyro-Barcia and Hermogenes Alvarez, from Montevideo, Uruguay. They are exactly equal to 1 mmHg within 10 minutes.
to measure concentration of glucose in blood: Haemodialysis machine: to remove toxic materials from the blood that are generally removed by the kidneys; used in case of kidney failure [3] Hypodermic needle / Syringe: for injections and aspiration of blood or fluid from the body Infection control equipment
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 anesthetic machine with integrated systems for monitoring of several vital parameters, including blood pressure and heart rate. Monitoring of vital parameters can include several of the ones mentioned above, and most commonly include at least blood pressure and heart rate, and preferably also pulse oximetry and respiratory rate.
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.
Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products.