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IEC 61010-031:2015+A1:2018 specifies safety requirements for hand-held and hand-manipulated probe assemblies of the types described below, and their related accessories. These probe assemblies are for direct electrical connection between a part and electrical test and measurement equipment. They may be fixed to the equipment or be detachable accessories for the equipment. It has the status of a…

This document describes procedures to characterize quadrupole mass spectrometers (QMSs) with an ion source of electron impact ionization and which are designed for the measurement of atomic mass-to-charge ratios m/z < 300. This document is not applicable to QMSs with other ion sources, such as chemical ionization, photo-ionization or field ionization sources and for the measurements of higher…

1 Scope 1.1 General This Standard specifies the minimum requirements and best practices for the development, validation, and use of laboratory-developed tests in clinical and research laboratories for the screening, diagnosis, and management of clinical conditions. It does not provide specific details on how to achieve these requirements since they are provided in many other sources which are…

This clause of Part 1 is applicable, except as follows. 1.1.1 Equipment included in scope Replacement: • This part of IEC 61010 specifies safety requirements and related verification tests for any product performing the function of control equipment and/or their associated peripherals. In addition, these products have as their intended use the command and control of machines, automated…

1.1 This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including a) establishing a QMS for the MDRD, including i) key performance indicators; ii) policies and procedures; iii) documentation; iv) roles and responsibilities; v) management review; vi) planning, resources and operations…

ISO 12944-9:2018 specifies the performance requirements for protective paint systems for offshore and related structures (i.e. those exposed to the marine atmosphere, as well as those immersed in sea or brackish water). Such structures are exposed to environments of corrosivity category CX (offshore) and immersion category Im4 as defined in ISO 12944‑2. ISO 12944-9:2018 describes paint systems…

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors,…

ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors,…

ISO/TS 20658:2017 specifies requirements and good practice recommendations for the collection, transport, receipt and handling of samples intended for medical laboratory examinations. ISO/TS 20658:2017 is applicable to medical laboratories and other medical services involved in laboratory pre-examination processes that include the examination request, patient preparation and identification,…

1.1 This Standard specifies general requirements related to the safety of human cells, tissues, and organs used for transplantation, and includes quality system requirements. It includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplantation of cells, tissues, or organs. 1.2 This Standard applies to…