BS EN ISO 10993-10:2013 pdf.Biological Evaluation Of Medical Devices - Part10:Tests For Irritation And Skin Sensitization. This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and...
BS EN ISO 9606-1:2013 pdf
BS EN ISO 9606-1:2013 pdf.Qualification testing of welders - Fusion welding - Part1:Steels. The ability of a welder to follow verbal or written instructions and verification of a person’s skills are important factors in ensuring the quality of the welded product. The testing of a welder’s skill in accordance with this International Standard depends on the welding techniques and conditions...
BS EN ISO 4414:2010 download free
This third edition cancels and replaces the second edition (ISO 44 14:1998), which has been technically revised, specifically with regards to the following: a) integration of ISO 4414:1998 and EN 983:1996; b) integration of safety requirements to comply with the European Machinery Directive 2006/42/EC; c) updating of safety requirements, taking into account International Standards on machine safety. This International Standard...
BS EN ISO 4126-2:2003 pdf free
BS EN ISO 4126-2:2003 pdf free.Safety devices for protection against excessive pressure - Part2: Bursting disc safety devices. A bursting disc safety device is a non-reclosing pressure relief device used to protect pressure equipment such as pressure vessels, piping, gas cylinders or other enclosures from excessive pressure and/or excessive vacuum. A bursting disc safety device typically comprises an assembly of...
BS EN ISO 15223-1:2016 pdf free
BS EN ISO 15223-1:2016 pdf free.Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part1:General requirements. This document addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to...
BS EN ISO 6789:2003 pdf
BS EN ISO 6789:2003 pdf.Assembly tools for screws and nuts - Hand torque tools - Requirements and test methods for design conformance testing, quality conformance testing and recalibration procedure. The revision of the previous edition of ISO 6789 became necessary, because the requirements of ISO 9001, concerning the procedure of the control of test devices, as well as the introduction...
BS EN ISO 13857:2008 free download
BS EN ISO 13857:2008 free download.Safety of machinery — Safety distances to prevent hazard zones being reached by upper and lower limbs. This document is a type B standard as stated in ISO 12100-1. The provisions of this document can be supplemented or modified by a type C standard. For machines which are covered by the scope of a type...
BS EN ISO 23640:2013 pdf free
BS EN ISO 23640:2013 pdf free.In Vitro Diagnostic Medical Devices - Evaluation Of Stability Of In Vitro Diagnostic Reagents. One important aspect of the development and manufacture of in vitro diagnostic (IVD) medical device reagents is initially designing the stability of a product, then determining and verifying the expiry date of the product that is placed on the market. To...
BS EN ISO 14971:2009 pdf free
BS EN ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a...
BS EN ISO 19001:2013 free
BS EN ISO 19001:2013 free.In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology. This International Standard relates to ISO 181 13-1 and ISO 18113-2, which can be used in conjunction with it. The use of reagents required for staining in biology as well as the specific examples of information...