
Essential information for healthcare practitioners, users of healthcare information and medical device manufacturers.
The healthcare sector is highly regulated with standards, rules and legislation. To help manufacturers sift through the minefield of regulations, BSI British Standards can help with best practice guidelines, standards, supporting documentation and seminars.
BSI British Standards brings together industry and Government stakeholders to produce standards that maximise the safe and effective provision of healthcare throughout the UK. This is achieved by developing standards in support of legislation for medical device products, and providing guidance on the risk and quality management within the manufacturing process. Standards are also developed to describe best practise in healthcare service provision, and to support emerging industries such as eHealth, nanotechnology and regenerative medicine.
BSI British Standards publishes a wide range of standards applicable to the healthcare and medical sectors, including anaesthetic and respiratory equipment, cleanrooms, dental equipment, fume cupboards, imaging equipment, implants for surgery, prosthetics and orthotics, legal admissibility and records management, neurosurgical implants, optics, prosthetics, quality control, risk and terminology and much more!
Included in this collection are standards on the evaluation, validation and sterilization of medical devices and their use in the healthcare sector as well as a whole section on health informatics.
BS EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
BS EN 60601-1-2 is an international standard for use by manufacturers of medical electrical equipment, test houses, and hospitals that connect equipment up to form medical electrical systems.
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We offer a wide range of Medical Devices courses, held either in-house at your organization, or at BSI in London. For full course details and to download a programme visit the Training & Conferences area of the website.
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BSI Professional Services provides tailored solutions for individual clients in all areas surrounding standardization. Outsource your standards management and development to us and your organization will reap the benefits.
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