This standard was last reviewed and confirmed in 2008. Therefore this version remains current.
Abstract Preview
ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.
General information
-
Status : PublishedPublication date : 2004-07
-
Edition : 1Number of pages : 10
-
- ICS :
-
In vitro diagnostic test systems
Buy this standard
| Format | Language | |
|---|---|---|
| Paper |
- CHF58
Life cycle
-
Now
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.