Rechercher

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…

1.1 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 lymphohematopoietic cells. The…

ISO/IEC 27050-3:2017 provides requirements and guidance on activities in electronic discovery, including, but not limited to, identification, preservation, collection, processing, review, analysis and production of electronically stored information (ESI). In addition, ISO/IEC 27050-3:2017 specifies relevant measures that span the lifecycle of the ESI from its initial creation through to final…

ISO 4254-7:2017, when used together with ISO 4254‑1, specifies the safety requirements and their verification for the design and construction of combine harvesters, forage harvesters, cotton harvesters and sugar cane harvesters. It describes methods for the elimination or reduction of hazards arising from the intended use of these machines by one person (the operator) in the course of normal…

ISO/IEC 27050-3:2017 provides requirements and guidance on activities in electronic discovery, including, but not limited to, identification, preservation, collection, processing, review, analysis and production of electronically stored information (ESI). In addition, ISO/IEC 27050-3:2017 specifies relevant measures that span the lifecycle of the ESI from its initial creation through to final…

ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout…

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e.…

ISO/TS 20443:2017 defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval…

ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616. Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal…

The information in ISO/TS 16829:2017 covers all kinds of ultrasonic testing on components or complete manufactured structures for either correctness of geometry, for material properties (quality or defects), and for fabrication methodology (e.g. weld testing). ISO/TS 16829:2017 enables the user, along with a customer specification, or a given test procedure or any standard or regulation to select…