BS EN ISO 11135:2014 pdf free.STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES. A sterile medical device is one that is free of viable microorganisms. Medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see for example ISO...
BS EN ISO 19011:2011 free download
BS EN ISO 19011:2011 free download.Guidelines for auditing management systems. Since the first edition of this International Standard was published in 2002, a number of new management system standards have been published. As a result, there is now a need to consider a broader scope of management system auditing, as well as providing guidance that is more generic. In 2006,...
BS EN ISO 14001:2004 free download
BS EN ISO 14001:2004 free download.Environmental management systems — Requirements with guidance for use. Organizations of all kinds are increasingly concerned with achieving and demonstrating sound environmental performance by controlling the impacts of their activities, products and services on the environment, consistent with their environmental policy and objectives. They do so in the context of increasingly stringent legislation, the development...
BS EN ISO 15614-7:2007 pdf free download
BS EN ISO 15614-7:2007 pdf free download.Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 7: Overlay welding. This part of ISO 15614 is part of a series of standards. Details of this series are given in ISO 15607:2003, Annex A. Previous procedure qualifications to former national standards or specifications should be taken into...
BS EN ISO 10434:2004 download free
BS EN ISO 10434:2004 download free.Bolted bonnet steel gate valves for the petroleum, petrochemical and allied industries. The purpose of this International Standard is to establish the basic requirements and practices for flanged and butt-welding end steel gate valves of bolted bonnet construction that parallel those given in American Petroleum Institute API Standard 600, eleventh edition, 2001 (ISO 10434:1998). It...
BS EN ISO 7010:2012 pdf free
BS EN ISO 7010:2012 pdf free.Graphical symbols — Safety colours and safety signs — Registered safety signs. There is a need to standardize a system of giving safety information that relies as little as possible on the use of words to achieve understanding. Continued growth in international trade, travel and mobility of labour requires a common method of communicating safety...
BS EN ISO 15883-2:2009 pdf
BS EN ISO 15883-2:2009 pdf.Washer-Disinfectors - Part2:Requirements And Tests For Washer-Disinfectors Employing Thermal Disinfection For Surgical Instruments, Anaesthetic Equipment, Bowls, Dishes, Receivers, Utensils, Glassware, Etc. ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment,...
BS EN ISO 14155:2011 pdf
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:...