EN 12306:1997
Current
The latest, up-to-date edition.
Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination
22-10-1997
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 |
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