ISO 14971
Encyclopedia
ISO 14971 is an ISO standard, of which the latest revision was published in 2007, that represents the requirements for a risk management system for medical device
s.
This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality standards such as ISO 13485
.
This standard adopted by CEN
as EN ISO 14971:2009 is harmonized with respect to the European Medical Devices Directive
93/42/EEC.
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
s.
This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality standards such as ISO 13485
ISO 13485
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices...
.
This standard adopted by CEN
CEN
CEN may refer to:*Cen, or sen, is the currency of the fictional nation of Amestris of the anime/manga "Fullmetal Alchemist"As a three-letter acronym:* Cambridge Evening News, former name for the Cambridge News...
as EN ISO 14971:2009 is harmonized with respect to the European Medical Devices Directive
Medical Devices Directive
The Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union...
93/42/EEC.
See also
- List of ISO standards
- ISO 13485ISO 13485ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices...
- Medical technologyMedical technologyMedical Technology encompasses a wide range of healthcare products and is used to diagnose, monitor or treat diseases or medical conditions affecting humans. Such technologies are intended to improve the quality of healthcare delivered through earlier diagnosis, less invasive treatment options and...
- Medical deviceMedical deviceA medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
- Medical Devices DirectiveMedical Devices DirectiveThe Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union...
- Clinical EngineeringClinical engineeringClinical engineering is a specialty within Biomedical engineering responsible primarily for applying and implementing medical technology to optimize healthcare delivery...
- System suitability test
- ISO 690ISO 690ISO 690 is an ISO standard for bibliographic referencing in documents of all sorts. It includes electronic documents, and specifies the elements to be included in references to published documents, and the order in which the elements of the reference should be stated...