BS ISO 15198:2004

Cross References:
ISO 3534-1
ISO 5725-1
ISO 13485:2003
VIM
ISO 9000:2000
ISO 9001
ISO 10005
ISO 15194
ISO/IEC Guide 51
EN 375
EN 591
EN 1041
MIL-STD 1629A:1980
NCCLS EP18:2002
NCCLS C24:1999




Keywords: Medical equipment; Clinical laboratory equipment; Clinical investigation instruments; Medical instruments; Quality control; Verification

Product Code(s): 30112772,30112772

This product references:ISO 3534-1:1993 - Statistics - Vocabulary and symbols - Part 1: Probability and general statistical terms
ISO 9001:2000 - Quality management systems -- Requirements
ISO 15194:2002 - In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Description of reference materials
ISO 5725-1:1994 - Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
This product same asISO 15198:2004 - Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer