New whitepaper - Generating clinical evaluation reports: A guide to effectively analysing medical device safety and performance. Written by Dr Hassan Achakri, PhD, Director, International Clinical Affairs, Zimmer GmbH, Peter Fennema, Director, AMR Advanced Medical Research and Dr Itoro Udofia, PhD, Orthopaedic & Dental Team Leader, BSI. Use this new whitepaper for guidance on how to satisfy important regulatory requirements e.g. the concept of equivalence and post-market clinical follow-up (PMCF). - download now

New book - Implementing an ISO 13485 Quality Management System for Medical Devices - obtain the appropriate background information and all the practically-based guidance you need to confidently tackle an implementation of ISO 13485 - buy now

Medical Device Standards — quality management systems, risk management and terminology

Medical Devices

According to the European Medical Device Directive (93/42/EEC), a medical device is,

"any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease 
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap 
  • Investigation, replacement or modification of the anatomy or of a physiological process
  • Control of conception.

. . . and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means . . ."

Read more about medical devices and MD Directives

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Medical Devices standards for quality, risk management and terminology

Guide to European Medical Device Trials and BS EN ISO 14155
Guide to European Medical Device Trials and BS EN ISO 14155

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

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

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

BS ISO 15223-2:2010
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation

BS EN ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives. Application of risk management

BS EN ISO 14971:2012
Medical devices. Application of risk management to medical devices

BS EN ISO 13485:2012
Medical devices. Quality management systems. Requirements for regulatory purposes

BS EN ISO 11737-1:2006
Sterilization of medical devices. Microbiological methods. Determination of a population of microorganisms on products


Contains a PDF of the full text of BS EN 980 and the symbol graphics for  labelling medical devices. Eliminates the need to re-draw

standard cover

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


standard cover

BS EN 15424:2007
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices 

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

BS EN 55011:2009 front cover

BS EN 55011:2009+Amendment 1:2010
Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics. Limits and methods of measurement

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

See more standards and publications for healthcare

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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.





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


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

  • Establishing compliance with the In Vitro Diagnostic Medical Devices Directive (98/97/EC)
  • Implementing: BS EN 13845
  • Clinical Requirements for Regulatory Compliance
  • Establishing compliance with the Medical Device Directive 93/42/EEC (MDD)
  • FDA - The Quality System Regulation (QSR, 21 CFR Part 820)
  • Introduction to: ISO 13485
  • Medical Device Design (and Development) Control
  • Process Validation
  • Risk Management ISO 14971

    Medical Devices - Auditing Training Courses

  • Internal Auditor: ISO 13485

    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 and register today!

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