Name: EN 12306:1997
Brand: CEN

Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination

Published date

22-10-1997

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General considerations
5 Quality control procedures
Annex A (informative) Bibliography

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 microorganisms.

Committee	CEN/TC 233
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
NBN EN 12306 : 1998	Identical
UNE-EN 12306:1998	Identical
SN EN 12306 : 1998	Identical
DIN EN 12306:1998-02	Identical
NS EN 12306 : 1ED 1998	Identical
I.S. EN 12306:1998	Identical
NF EN 12306 : 1997	Identical
NEN EN 12306 : 1997	Identical
BS EN 12306:1998	Identical
PN EN 12306 : 2000	Identical
UNI EN 12306 : 1999	Identical

ISO 9004-1:1994	Quality management and quality system elements Part 1: Guidelines
EN ISO 9002:1994/AC:1997	QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
EN ISO 9003:1994/AC:1997	QUALITY SYSTEMS - SPECIFICATION FOR FINAL INSPECTION AND TEST
ISO 9002:1994	Quality systems — Model for quality assurance in production, installation and servicing
EN ISO 9000-1 : 1994	QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - PART 1: GUIDELINES FOR SELECTION AND USE (ISO 9000-1:1994)
EN 1619:1996	Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
EN 375 : 2001	INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
EN ISO 9001:2015	Quality management systems - Requirements (ISO 9001:2015)
EN ISO 9004-1 : 1994	QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS
ISO 9001:2015	Quality management systems — Requirements
ISO 9003:1994	Quality systems Model for quality assurance in final inspection and test
ISO 9000-1:1994	Quality management and quality assurance standards — Part 1: Guidelines for selection and use
ISO 3534-1:2006	Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability