BS EN ISO 14155:2011 pdf.Clinical investigation of medical devices for human subjects - Good clinical practice. This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. The principles set forth in this International Standard also apply...
BS EN ISO 10993-18:2009 pdf free download
ISO 10993-1 provides a framework for a structured programme of assessment for the evaluation of biological safety. Clause 3 of ISO 10993-1:2003 states that in the selection of materials to be used for device manufacture the first consideration should be fitness for purpose. This should have regard to the characteristics and properties of the material, which include chemical, toxicological, physical,...
DIN EN ISO 10993-18:2009 pdf
DIN EN ISO 10993-18:2009 pdf.Biological Evaluation Of Medical Devices - Part 18: Chemical Characterization Of Materials (ISO 10993-18:2005); German Version EN ISO 10993-18:2009 1 Anwendungsbereich Dieses Dokument Iegt einen Rahmen für die Ermittlung biologischer Gelährdungen und für die Abschätzung und Beherrschung der von Bestandteilwerkstoffen ausgehenden biologischen Risiken unter Anwendung eines schrittweisen Ansatzes für die Charakterisierung eines Medizinprodukts durch Folgendes lest:...
BS EN ISO 1660:1996 pdf free
BS EN ISO 1660:1996 pdf free.Technical drawings - Dimensioning and tolerancing of profiles. 1 Scope and field of application This International Standard describes the dimensioning and the geometrical tolerancing of profiled outlines and of profiled surfaces. The methods described are related to the sub-clauses in Iso 1101 dealing with the “profile tolerance of any line” and “profile tolerance of any...
BS EN ISO 8317:2004 pdf free
BS EN ISO 8317:2004 pdf free.Child-Resistant Packaging - Requirements And Testing Procedures For Reclosable Packages. A significant number of suspected cases of ingestion by children of products used about the home is reported to the medical profession each year. Most are not serious and those that are associated with more serious side effects involve products known to be hazardous, e.g....
BS EN ISO 11290-1:2017 pdf
BS EN ISO 11290-1:2017 pdf free.Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp- Part1:Detection method. The main changes, listed in the foreword, introduced in this document compared to Iso 11290-1:1996 are considered as major (see ISO 17468). The technical changes were assessed and were considered to have no...
ISO 13503-1:2011 pdf free
ISO 13503-1:2011 pdf free.Petroleum and natural gas industries — Completion fluids and materials — Part 1: Measurement of viscous properties of completion fluids. For the purposes of this part of ISO 13503, completion fluids are defined as viscosified treating fluids used during the completion or workover of a petroleum- or natural-gas-producing well. The objective of this part of ISO 13503...
ASTM C567/C567M-11 pdf free
ASTM C567/C567M-11 pdf free.Standard Test Method for Determining Density of Structural Lightweight Concrete. This test method provides procedures to determine the oven-dry and equilibrium densities of structural lightweight concrete. 4. Summary of Test Method 4.1 This test method provides procedures for detennining the oven-dry and equilibrium densities of structural lightweight concrete, by calculation or measurement. The calculated ovendry density is...
BS EN ISO/IEC 17025:2017 pdf
BS EN ISO/IEC 17025:2017 pdf.General Requirements For The Competence Of Testing And Calibration Laboratories. This document has been developed with the objective of promoting confidence in the operation of laboratories. This document contains requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to this document will also operate...
BS EN ISO 19650-1:2018 free
BS EN ISO 19650-1:2018 free.Organization and digitization of information about buildings and civil engineering works, including building information modelling (BIM) - Information management using building information modelling - Part1:Concepts and principles. This document sets out the recommended concepts and principles for business processes across the built environment sector In support of the management and production of Information during the life...