A safety data sheet (SDS), material safety data sheet (MSDS), or product safety data sheet (PSDS) is a document that lists information relating to occupational safety and health for the use of various substances and products. SDSs are a widely used system for cataloguing information on chemicals, chemical compounds,chemical mixtures. SDS information may include instructions for the safe use and potential hazards associated with a particular material or product, along with spill-handling procedures. The older MSDS formats could vary from source to source within a country depending on national requirements; however, the newer SDS format is internationally standardized.
The European Committee for Standardization is a public standards organization whose mission is to foster the economy of the European Single Market and the wider European continent in global trading, the welfare of European citizens and the environment by providing an efficient infrastructure to interested parties for the development, maintenance and distribution of coherent sets of standards and specifications.
The presence of the logo on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark.
Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world. Processes and certifications known as type approval in English are often called homologation, or some cognate expression, in other European languages.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, 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. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
Toy safety is the practice of ensuring that toys, especially those made for children, are safe, usually through the application of set safety standards. In many countries, commercial toys must be able to pass safety tests in order to be sold. In the U.S., some toys must meet national standards, while other toys may not have to meet a defined safety standard. In countries where standards exist, they exist in order to prevent accidents, but there have still been some high-profile product recalls after such problems have occurred. The danger is often not due to faulty design; usage and chance both play a role in injury and death incidents as well.
European Organisation for Technical Assessment (EOTA) is a European non-profit association. Its primary purpose is to draft the European Technical Assessment (ETA) documents. Once ratified, these become EU standards. Manufacturers and vendors of products that display the CE mark warrant that their products meet these standards.
The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices — is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. 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.
The CLP Regulation is a European Union regulation from 2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS). It is expected to facilitate global trade and the harmonised communication of hazard information of chemicals and to promote regulatory efficiency. It complements the 2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation and replaces an older system contained in the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC).
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
British Approvals Service for Cables is an independent accredited certification body headquartered in Milton Keynes, United Kingdom. Here, the organization's dedicated testing laboratory also operates which is believed to be the largest of its type in Europe. BASEC was established in 1971 and principally provides product certification services for all types of cable and wire, ancillary products and management systems within the cable industry. The organization maintains operations throughout the world including Africa, Middle East, America, Asia and Europe.
PD 5500 is a specification for unfired pressure vessels. It specifies requirements for the design, manufacture, inspection and testing of unfired pressure vessels made from carbon, ferritic alloy, and austenitic steels. It also includes material supplements containing requirements for vessels made from aluminium, copper, nickel, titanium and duplex. PD 5500 is the UK’s national pressure vessels code, although the code is used outside the UK. A new edition of PD5500 is published every three years. An amendment is usually published every year in September.
Regulation No. 305/2011 of the European Parliament and of the Council of the European Union is a regulation of 9 March 2011 which lays down harmonised conditions for the marketing of construction products and replaces Construction Products Directive (89/106/EEC). This EU regulation is designed to simplify and clarify the existing framework for the placing on the market of construction products. It replaced the earlier (1989) Construction Products Directive (89/106/EEC).
The Low Voltage Directive (LVD) 2006/95/EC is one of the oldest Single Market Directives adopted by the European Union before the "New" or "Global" Approach. The Directive provides common broad objectives for safety regulations, so that electrical equipment approved by any EU member country will be acceptable for use in all other EU countries. The Low Voltage Directive does not supply any specific technical standards that must be met, instead relying on IEC technical standards to guide designers to produce safe products. Products that conform to the general principles of the Low Voltage Directive and the relevant particular safety standards are marked with the CE marking to indicate compliance and acceptance throughout the EU. Conformance is asserted by the manufacturer based on its conformity assessment.
Market surveillance for products ensures that products on the market conform to applicable laws and regulations. This helps to foster trust among consumers buying products or financial services and protects consumers and professionals from harm from non-compliant products. It also helps companies that comply to stay in business and avoid losing market share to rogue traders.
The Recreational Craft Directive, Directive 2013/53/EU, originally Directive 94/25/EC on recreational craft amended by Directive 2003/44/EC, is a European Union directive which sets out minimum technical, safety and environmental standards for boats, personal watercraft, marine engines and components in Europe. It covers boats between 2.5 and 24m, personal watercraft, engines and a number of components built since 1998. It ensures their suitability for sale and use in Europe.
The Machinery Directive, Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 is a European Union directive concerning machinery and certain parts of machinery. Its main intent is to ensure a common safety level in machinery placed on the market or put in service in all member states and to ensure freedom of movement within the European Union by stating that "member states shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with [the] Directive".
EN 16034 refers to a set of European standards which specify the technical performance characteristics for fire resisting and/or smoke control products, or better known in common language as fire/smoke doors or fire/smoke proof doors. Compliance with this standard requires to fulfill the requirements of the Construction Product Regulation for construction products, which are placed on the EU market with the intention to become permanent parts of a construction.
The Radio Equipment Directive established a regulatory framework for placing radio equipment on the market in the EU. All radio equipment within the scope of this directive that are placed on the EU market must have been compliant with the directive from 13 June 2017. The delay of the publication and approval of the details of this directive has led to difficulties for companies attempting to comply with the directive.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.
