BAS EN 540:2002
Clinical investigation of medical devices for humans subjects
General Information
Status: Withdrawn
No. of pages: 18
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 22.03.2002
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices;
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
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Abstract
This European Standard pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment before being placed on the market. This European Standard does not apply to in vitro diagnostic devices.
Lifecycle
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Original document and degree of correspondence
- EN 540:1993, identical