ISO 14155 2nd Edition, dated 2/2011 and titled “Clinical investigation of medical devices for human subjects — Good clinical practice,” has just been amended by a new Technical Corrigendum. This Corrigendum is a correction sheet making two pen-and-ink changes to the standard. You’ll need it in order to confirm that your copy is current and correct.
There are corrections for two paragraphs in the standard. First is Page 12, Paragraph 4.7.4, where a list is not numbered correctly. The second is Page 21, Paragraph 7.3, and involves replacing one word with another.
The corrigendum itself is numbered ISO 14155:2011/Cor.1:2011(E). If you have not already purchased the ISO 14155 2011 Edition, you should get the corrigendum included with your purchase. If you already have a copy of the ISO standard, feel free to contact Document Center Inc. to get a copy.
All ISO standards are available on our website, www.document-center.com. Or phone us at 650-591-7600, fax us at 650-591-7617, or email us at info@document-center.com. We’re available to assist you with all your standards questions and purchases.