This Standard specifies provisions for the manufacture of products used in forensic DNA collection and analysis. Products covered by the scope of this Standard include consumables used for evidence collection (including those used in DNA kits), such as swabs, containers and packaging, and also products used in the analysis of DNA samples, such as tubes and other plastic ware, disposable laboratory coats, gloves, masks and other consumables.
Table of contents
Header
About this publication
Preface
1 Scope
2 Referenced and related documents
2.1 Referenced documents
2.2 Related documents
3 Definitions and abbreviations
3.1 Definitions
3.2 Abbreviations
4 Types of products
4.1 General
4.2 Products that come into direct contact with biological stains or material potentially containing human DNA
4.3 Chemicals, reagents and solvents and some disposables involved in the analysis of human DNA
4.4 Products used in areas where human DNA is collected or analysed
4.5 Products used in the collection of human DNA
5 Quality systems
5.1 General
5.2 Documentation
5.3 Authorization
5.4 Subcontracting of work and purchase of components
6 Environment provisions
6.1 General
6.2 Manufacturing environments
6.2.1 Equipment
6.2.2 Personnel
6.2.3 Maintenance
6.3 Sensitive environments
6.4 Critical environments
7 Quality assurance and monitoring of sensitive and critical environments
7.1 General
7.1.1 Quality assurance plan
7.1.2 Tests
7.1.3 Focus
7.2 Pass/fail parameters
8 Post-manufacture treatment of products
8.1 General
8.2 Where post-manufacture treatment is undertaken
8.3 Where post-manufacture treatment is not undertaken
9 Monitoring of contamination minimization measures
9.1 General
9.2 Where post-manufacture treatment is undertaken
9.3 Where no post-manufacture treatment is undertaken
