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ISO 16142:2016, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended. This part of ISO 16142 identifies and describes the six general essential principles of…

ISO/TR 79:2015 summarizes the state of the art of the production and certification or characterization of qualitative property reference materials (RMs). The need for guidance documents for the production of RMs certified for qualitative properties was recognized by many experts. At the same time, the available information was found to be too immature to develop an internationally accepted…

1.4 CSA N286 recognizes that a facility might not have the internal capability or capacity to address all of its facility life cycle activity needs. Where a supplier is needed to fill a gap, the supplier is required to adhere to the CSA N286 requirements, but only in relation to the specific life cycle activities the supplier will be providing. Suppliers might not be required to address all…

Scope This part of ISO/IEC 13066 defines the responsibilities of different information technology (IT) and assistive technology (AT) functional units in supporting interoperability. It recognizes that AT can be provided both as functional units that are installed or otherwise connected to a system or can be utilized by being provided as a service which is accessed via communications connections.…

CISPR 16-4-2:2011+A1:2014 is a basic EMC publication. It specifies the method of applying Measurement Instrumentation Uncertainty (MIU) when determining compliance with CISPR disturbance limits. The material is also relevant to any EMC test when interpretation of the results and conclusions reached will be impacted by the uncertainty of the measurement instrumentation used during testing. This…

ISO 16049-2:2013 provides general utilization guidelines and calculation methods adequate to guarantee the effectiveness and ultimate load strength of tie-down/lashing arrangements performed to restrain cargo on board civil transport aircraft during flight: a) cargo loaded and tied down onto airworthiness approved air cargo pallets, themselves restrained into aircraft lower deck or main…

Scope 1.1 This Standard establishes requirements and recommendations for the geological storage of carbon dioxide. The purpose of these requirements is to promote environmentally safe and long-term containment of carbon dioxide in a way that minimizes risks to the environment and human health. is primarily applicable to saline aquifers and depleted hydrocarbon reservoirs and does not preclude…

IEC/TR 62258-4:2012 has been developed to facilitate the production, supply and use of semiconductor die products, including: - wafers; - singulated bare die; - die and wafers with attached connection structures; - minimally or partially encapsulated die and wafers. This technical report contains a questionnaire, based on the requirements of other parts of IEC 62258, which may be used in…

1.1 Scope This standard specifies uniform methods for testing and evaluating the performance of fittings for use with compressed hydrogen gas and hydrogen rich gas mixtures. It does not address special requirements for liquid and slush hydrogen. This standard applies to hydrogen systems applications to meet current market needs. In this standard, the term “fittings” includes fittings,…

1 SCOPE 1.1 This Standard sets forth minimum requirements for the material properties and performance of liners used for secondary containment under and around the area of tanks that are installed aboveground for the storage of flammable liquids and combustible liquids. 1.2 Liners used for secondary containment are intended for permanent installation to contain spills or leakage of product…