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immediate downloadReleased: 2004-07-23
BS ISO 15198:2004
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
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| Standard number: | BS ISO 15198:2004 |
| Pages: | 18 |
| Released: | 2004-07-23 |
| ISBN: | 0 580 44155 5 |
| Status: | Standard |
DESCRIPTION
BS ISO 15198:2004
This standard BS ISO 15198:2004 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer is classified in these ICS categories:
- 11.100.10 In vitro diagnostic test systems
This International Standard 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. This International Standard applies to all in vitro diagnostic medical devices.