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Chinese RoHS labels, a lower case "e" within a circle with arrows, can also imply compliance. The WEEE directive logo. RoHS 2 attempts to address this issue by requiring the aforementioned CE mark whose use is policed by the Trading Standards enforcement agency. [32] It states that the only permitted indication of RoHS compliance is the CE mark ...
The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010. [citation needed] The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), [2] effective on 26 May 2021. [3]
The European Chemical Agency (ECHA) has published the REACH Authorisation List, [28] in an effort to tighten the use of Substances of Very High Concern (SVHCs). The list is an official recommendation from the ECHA to the European Commission. The list is also regularly updated and expanded.
Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products which, under Articles 9 and 10 of the Treaty, must be admitted for free movement, as regards laws, regulations or administrative provisions prohibiting the use of the said products and prescribing the use of national products or making such use subject ...
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Medical staff, of course, are sporting the limited-edition Figs x Team USA Medical Team scrubs. Coming in solid “Winning Red,” “Optic White,” “Winning Blue,” and “Team USA Blue ...
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]