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Norms

Standards and Regulations

DIRECTIVE 93/42/EEC

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.
In 2016 the Medical Devices Directive is being repealed and replaced by a Medical Device Regulation (MDR).

GMP VALIDATION

GMP validation is an element of quality assurance program for a pharmaceutical/biotech product or process. To ensure that the products are absolutely fit for intended use, the company has to demonstrate in a documented form that the processes, methods, tests, activities and equipments they deploy are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions


CFR21-11

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.


EN 7396-1
EN 7396-1 specifies requirements for design, installation, function, performance, documentation, testing and commissioning of compressed medical gas and vacuum pipeline systems in health care facilities to ensure continuous delivery of the correct gas from the pipeline system. It includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas systems. It is applicable to pipeline systems for the following medical gases: oxygen, oxygen-enriched air, nitrous oxide, air for breathing, carbon dioxide, oxygen/nitrous oxide mixtures, air for driving surgical tools, nitrogen for driving surgical tools.


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