Řízení procesů

Oblast zaměření: Řízení procesů
Komise : IEC/SC 65B (Measurement and control devices)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 21.08.2018
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This technical specification applies in the field of metrology to the statement and testing of technical data in datasheets and instruction manuals for thermographic cameras that are used to measure the temperature of surfaces. This includes, unless otherwise stated, both two-dimensional and one-dimensional (line cameras or line scanners) temperature measuring instruments, and that independently of the scanning principle (fixed multi-element detector or scanning camera system).

The directive describes standard test methods to determine relevant metrological data of thermographic cameras. It is not compulsory for manufacturers and sellers of thermographic cameras to include all technical data given in this document in the data sheets for a specific type of the products. Only the relevant data should be stated and should comply with this specification.

Oblast zaměření: Řízení procesů
Komise : IEC/SC 62A (Common aspects of electrical equipment used in medical practice)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 12.09.2018
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This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic (IVD) medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this document are applicable to all stages of the life-cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as for example those related to biocompatibility, data and systems security, electricity, moving parts, radiation, usability, and other risks.

This document does not apply to decisions on the use of a medical device in the context of any particular clinical procedure. This document does also not apply to business risk management.

This document does not specify acceptable risk levels, but requires manufacturers to establish objective criteria for risk acceptability.

This document does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

NOTE   Guidance on the application of this document can be found in ISO/TR 24971 [9].