Tell your friends about this article!

Friend's email address:
	For example, username@domain.com
Your email address:
	For example, username@domain.com
Subject:
Message:	I thought you might be interested in this page http://www.standards.co.nz/touchstone/Issue+14/Health/Clinical+investigations+of+medical+devices+new+Standard.htm at http://www.standards.co.nz/touchstone/

This message has been sent to you from Touchstone, Standards New Zealand's free electronic magazine. Standards New Zealand is the country's leading Standards body, developing and promoting Standards for the benefit of all New Zealanders.

When the message is sent, you'll automatically be copied on the message. The text immediately above will be added to the message automatically, identifying the message as coming from Touchstone.

Thanks

Your email has been sent

Issue 14 – Mar 10

RSS Feed Print page Email to a friend

Keyword

VIEW PAST ISSUES

Back to Home page

Back to Standards website

Clinical investigations of medical devices – new Standard

A new Standard for Clinical investigation of medical devices for human subjects – General requirements BS EN ISO 14155-1:2009 defines the procedures for the conduct and performance of clinical investigations of medical devices, where their clinical performance and safety is being assessed in people. The Standard is intended to protect people and to ensure the scientific conduct of the clinical investigation.

BS EN ISO 14155-1:2009 specifies:

requirements for the organisation, conduct, monitoring, data collection, and documentation of the clinical investigation
requirements that establish the performance of the device under conditions intended to mimic normal clinical use, thereby revealing adverse events in normal use and allowing the assessment of acceptable risks.

Reproduced with permission from the British Standards Institute 'Health and medical devices newsletter', January 2010.

→ Buy BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects. General requirements