INTERNATIONAL SEED TESTING ASSOCIATION 
                              ASSOCIATION INTERNATIONALE D’ESSAIS DE SEMENCES 
                              INTERNATIONALE VEREINIGUNG FÜR SAATGUTPRÜFUNG 
                                                                             Secretariat, Zürichstrasse 50, P.O. Box 308, 8303 Bassersdorf, CH-Switzerland -  
                                                   Phone: +41-44-838 60 00 - Fax: +41-44-838 60 01 - Email: ista.office@ista.ch - http://www.seedtest.org
                         
                         
                         
                         
                         
                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                                                                         
                                           ISTA Method Validation  
                                                         for Seed Testing 
                                                                                         
                                                                                         
                         
                         
                         
                                       Note: Any electronic or hard copies of this document are uncontrolled copies.  
                                                                       Confirm validity before use. 
                                                                                         
                                                                                         
                        Approved by ECOM: 30.11.2006                            Version: 1.0    
                        ISTA Method Validation for Seed Testing-V1.0           Status: FINAL                                                    26/01/2007 
                            ISTA Method Validation for Seed Testing                                                                                                page 2 of 70 
                             
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                         Acknowledgments 
                                                                                                         
                                        The ISTA Method Validation Working Group is grateful to 
                                                                   the ISTA Seed Health Committee 
                                                           for permission to use their Handbook of 
                                         Method Validation as the framework for this publication 
                                                          ISTA Method Validation for Seed Testing 
                                                                                                         
                                                                                                         
                             
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                                                                                                         
                            Approved by ECOM: 30.11.2006                                     Version: 1.0       
                            ISTA Method Validation for Seed Testing-V1.0                    Status: FINAL                                                               26/01/2007 
                            ISTA Method Validation for Seed Testing                                                                                                page 3 of 70 
                             
                                                                                                         
                                                                                                         
                                                                                  CONTENTS 
                             
                            1.                SCOPE  
                             1.1 Introduction                                                                                                                                  
                             1.2 What is Method Validation?                                                                                                                    
                                              1.3            Why is Method Validation Necessary?                                                                               
                                              1.4 Professional Responsibilities                                                                                                
                                              1.5            How Should Methods be Validated?                                                                                  
                                              1.6            Method Validation in ISTA 
                              
                            2.                OBJECTIVES OF THE ISTA METHOD VALIDATION PROGRAMME                                                                               
                                              2.1            Develop a Validated Test Method for a New Species                                                                 
                                              2.2            Compare Different Methods to Choose a Test Method to Validate                                                     
                                              2.3            Improve a Validated Test Method(s)                                                                                
                                              2.4            Compare the Present Validated Test Method with a New Method(s)  
                 
                            3.                COLLABORATIVELY VALIDATED METHODS                                                                                                
                                              3.1 Scope                                                                                                                        
                                              3.2 Purpose                                                                                                                      
                                              3.3            Parties Involved in Collaborative Method Validation and Their 
                                                             Responsibilities  
                                              3.4 Procedure                                                                                                                    
                                              3.5 Related Procedures                                                                                                           
                       
                            4.                PERFORMANCE VALIDATED METHODS                                                                                                    
             4.1 Scope                                                                                                                                                         
                               4.2  Purpose 
                                              4.3            Parties Involved in Performance Validation and Their Responsibilities 
                                              4.4            Procedure – Test Kit Methods                                                                                      
                                              4.5            Procedure – Non-Test Kit Methods                                                                                  
                               4.6  Related Procedures 
                             
                             
                            Approved by ECOM: 30.11.2006                                     Version: 1.0       
                            ISTA Method Validation for Seed Testing-V1.0                    Status: FINAL                                                               26/01/2007 
                            ISTA Method Validation for Seed Testing                                                                                                page 4 of 70 
                             
                             
                            5.                MODIFICATIONS TO ISTA RULES                                                                                                      
                                              5.1            Method Modification Categories                                                                                    
                                              5.2            Validation Requirements for Method Modifications                                                                  
                                              5.3            Examples of Editorial Changes that Correct or Clarify Language                                                    
                             
                            6.                VALIDATION OF METHODS FOR TESTING FOR THE PRESENCE OF 
                                              SPECIFIED TRAITS                                                                                                                 
                               6.1  Introduction                                                                                                                               
                                              6.2            Previously Validated Methods                                                                                      
                                              6.3            Inter-Laboratory Validation for a New or Modified Method                                                          
                                              6.4            Single Laboratory Validation for a New or Modified Method 
                              
                             
                            APPENDICES 
                             
                            Appendix 1:                      Statistical Aspects of Method Validation                                                                          
                             
                            Appendix 2:                      General Procedures for Method Validation                                                                          
                             
                            Appendix 3:                      Instructions to Authors: Preparation of Test Method Descriptions                                                  
                             
                            Appendix 4:                      Test Method Validation Application Form                                                                           
                             
                            Appendix 5:                      Instructions for Reviewers: Draft Test Plan                                                                       
                             
                            Appendix 6:                      Instructions to Authors: Preparation of Validation Reports for New Test 
                                                             Methods or Revisions to Existing Test Methods                                                                     
                             
                            Appendix 7:                      Instructions for Reviewers: the Validation Report                                                                 
                             
                            Appendix 8:                      Performance Validated Test Method Submission Requirements for 
                                                             Other Than Test Kits                                                                                              
     
     
     
                            GLOSSARY 
     
     
     
     
     
     
     
     
     
                            Approved by ECOM: 30.11.2006                                     Version: 1.0       
                            ISTA Method Validation for Seed Testing-V1.0                    Status: FINAL                                                               26/01/2007