標準號：BS EN 12306-1998
中文標準名稱：生物技術.農業,植物和動物傳染病控制和環境污染用的隨身攜帶診斷儀的質量控制指南
英文標準名稱：Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination
標準類型：B91
發布日期：1998/3/15 12:00:00
實施日期：1998/3/15 12:00:00
中國標準分類號：B91
國際標準分類號：07.080;07.100.99
適用范圍：This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to micro-organisms. This standard does not apply to diagnostic kits used either in the food industry or for human health monitoring, or control of non-biological contaminants. This European Standard does not concern single kit components such as reagents (i.e. monoclonal or polyclonal antibodies) or materials (i.e. ELISA plate). This standard does not concern any specific diagnostic method (such as ELISA, Dot blot, DNA probe). This European Standard does not aim to establish a system of quality assurance but it is recommended that quality control procedures are in accordance with a system of quality assurance such as EN ISO 9000 series.