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ISO 81060-3:2022 This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output…

IEC 60721-2-6:2022 deals with environmental conditions appearing in nature related to earthquake vibrations and shocks. Its object is to define some fundamental properties and quantities for characterization of earthquakes as background material for the severities to which products are liable to be exposed during storage and use. The accelerations given are for ground surface conditions only.…

IEC TS 62607-6-18:2022(E) establishes a standardized method to determine the chemical key control characteristic functional groups for functionalized graphene-based material and graphene oxide by thermogravimetry analysis (TGA) coupled with Fourier transform infrared spectroscopy (FTIR), referred to as TGA-FTIR. The content of functional groups is derived by changes in mass of the…

This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also…

This document specifies requirements and gives guidance to suppliers and users of ancillary materials (AMs) to improve the consistency and quality of AMs of biological (human and animal) and chemical origin used in the production of cellular therapeutic products and gene therapy products for human use. This document is applicable to materials that are used for cell processing and that come into…

IEC TS 63134:2020+AMD1:2022 identifies AAL scenarios and use cases based on real-world applications and requirements. The use cases provide a practical context for considerations of interoperability and standards based on user experience. Use cases provide a context for utilizing existing standards and identifying further standardization work. User requirements have also been identified. This…

1 Scope 1.1 Purpose This Standard specifies general requirements related to the safety of human CTOs 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 CTOs. 1.2 Areas of application This Standard applies to…

1 Scope 1.1 Purpose This Standard addresses issues related to the safety of human perfusable organs used for transplantation. It includes quality system requirements and aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to, or affected by, the transplantation of perfusable organs. 1.2 Areas of application This Standard applies to…

1 Scope 1.1 Purpose This Standard addresses issues related to the safety of human allogeneic and autologous cells of lymphohematopoietic origin used for transplantation and includes quality system requirements. This Standard includes aspects of safety for potential and actual donors and recipients, personnel, and others who might be exposed to or affected by the transplant of…

1 Scope 1.1 Applicability This Standard applies to newly produced compressed natural gas vehicle (NGV) fuelling connection devices, hereinafter referred to as “devices”, constructed entirely of new, unused parts and materials. NGV fuelling connection devices consist of the following components, as applicable: a) receptacle and protective cap (mounted on vehicle) (see Clause 4.4); b) nozzle…