Healthcare and medical devices standards

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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.

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Key standards for healthcare and medical devices

BS EN ISO 14155:2011
Clinical investigation of medical devices for human subjects. Good clinical practice

BS EN 15986:2011
Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

BS EN 80001-1:2011
Application of risk management for IT-networks incorporating medical devices. Roles, responsibilities and activities

PAS 5748:2011
Specification for the planning, application and measurement of cleanliness services in hospitals
This PAS is free for NHS staff in England.
Read more, download or buy PAS 5748

PAS 2015:2010 Framework for health services resiliencePAS 2015
Framework for health services resilience
Read more and buy PAS 2015

 

Providing rehabilitation services. Code of practicePAS 150
Providing rehabilitation services. Code of practice
Read more and buy PAS 150


BS EN ISO 14971:2009
Medical devices. Application of risk management to medical devices

BS EN ISO 10993-1:2009
Biological evaluation of medical devices. Evaluation and testing

BS EN 980:2008
Symbols for use in the labelling of medical devices

Graphical symbols for use in the labelling of medical devices CD-ROM

 

 

BS EN 285:2006+A2:2009
Sterilization. Steam sterilizers. Large sterilizers

BS EN ISO 13485:2003
Medical devices. Quality management systems. Requirements for regulatory purposes

BS EN 1041:2008
Information supplied by the manufacturer of medical devices

BS EN 60601-1:2006
Medical electrical equipment. General requirements for basic safety and essential performance

Europe Releases Draft EU Medical Device Regulation on Electronic Instructions for Use
The European Commission has published and released the draft Regulation on Electronic Instructions for Use as notified to the World Trade Organization (WTO).
Current expectation is that the EU Regulatory Committee on Medical Devices will deliberate and consider the draft Regulation at a meeting on September 20, 2011.
View the draft regulation 


Re-issue of MEDDEV 2.4/1 Classification of Medical Devices guidance document now available

End to EU notifications in sight for IVD manufacturers as Eudamed becomes mandatory

BSI PRESS RELEASE: Improving the quality of life for people with dementia

Arterial stent standard: BS EN 14299:2004 will cease to give MDD Presumption of Conformity as of 21 March 2010


View a presentation about the Amendment to the Medical Devices Directive, on SlideShare.View a presentation about the Amendment to the Medical Devices Directive, on SlideShare.

 

 

 

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View the case study on YouTube and see how one MCS Medical uses ISO 13485 to enhance its business.

 

Free downloads on best practice, terminology and definitions

Nanotechnology

Visit the nanotechnology website for nanotechnology standards, news and the latest developments. 10 free downloads are available at www.bsigroup.com/nano



Regenerative Medicine

Get the terminology for regenerative medicine

Free download for regenerative medicine PAS 84


Need medical devices training?

BSI offers a range of courses. You can choose whether you would like to attend one of our scheduled public courses or have it delivered on your premises as an in-company solution.

See the range of courses for medical devices
 


Medical Devices - Awareness Training Courses

 


Medical Devices - Auditing Training Courses


Comment on drafts of new medical devices standards

Have your say on new standards for medical devices and healthcare. Use the new BSI Draft Review system. You can now comment online on any new national Drafts for Public Comment (DPCs). Go to http://drafts.bsigroup.com and register today!

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