Skip to main content

RoHS Directive and Exemptions

BayBiotech.NET
RoHS (Restriction of the Use of Certain Hazardous Substances) directive bans placing the new electrical and electronic equipments on the EU market containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants. These are the regulations under EU Directive 2002/95. The RoHS Directive and the UK RoHS regulations came into force on 1 July 2006. Since then, there have been amendments about exemptions regarding the levels of abovementioned articles in certain products. In order to get the latest on the exemptions as well as to understand the directive before manufacturing your product for the European market, follow the link: http://www.rohs.gov.uk/Default.aspx.

Comments

Post a Comment

Popular posts from this blog

ISO Management Standards for Medical Devices

Two main ISO standards that have a direct application to Medical Device Industry are ISO 9001 and ISO 13485. While ISO 9001 is for evolving a Quality Management System for an organization, ISO 13485 has a direct application to Medical Device Industry. Although, ISO standards for a company are not a legal requirement, but provide a validation and ease of global marketing of the product.
1 comment
Read more

A Facility Inspection Checklist

BayBiotech.NET Whether you are a Quality Assurance/ Compliance personnel planning to make a visit for a facility inspection, this checklist will help you prepare an inspection report based on the information that might be required to collect about the facility during the inspection. This checklist may help you evolve different forms for the inspection in order to accumulate complete information about the facility: 1.General information (a) name of establishment inspected (b) date of inspection (c) name(s) of the inspector(s) (d) date of last inspection. 2.Type of inspection Comprehensive, concise, follow-up, special, investigative, announced, and unannounced. 3.Licensing (a) licensing of premises (b) person with supervisory role in establishments (c) adherence to licensing provisions. 4. Activities undertaken on premises manufacturing, wholesale, importation, export, retail, hospital, pharmacy, clinic, nursing and maternity homes. 5. Adequacy and suitability of pre...
1 comment
Read more

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of...
1 comment
Read more