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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 [citation needed] The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), [2] effective on 26 May 2021.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.
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 ...
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]
China RoHS (Restriction of Hazardous Substances), officially known as Administrative Measure on the Control of Pollution Caused by Electronic Information Products [1] is a Chinese government regulation to control certain materials, including lead.
IEC 61070 Compliance test procedures for steady-state availability; IEC 61071 Capacitors for power electronics; IEC 61073 Fibre optic interconnecting devices and passive components – Mechanical splices and fusion splice protectors for optical fibres and cables; IEC 61076 Connectors for electronic equipment – Product requirements
The list of SVHCs is primarily a public list of substances for which the European Chemicals Agency is considering imposing a requirement for authorisation for some or all uses. However, there are some direct consequences of including a substance on the list of SVHCs.