ISO 18385:2016
Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements
ISO 18385:2016 specifies requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis.
The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, and other consumables.
ISO 18385:2016 applies to the production of consumables and reagents which do not require cleaning for continued use. This International Standard does not cover technical product specifications (i.e. product design).
ISO 18385:2016 excludes microbiological testing.
ISO 18385:2016 specifies a requirement for manufacturers to minimize the risk of occurrence of detectable human nuclear DNA contamination in products used by the global forensic community.
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Foreword
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
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, solvents, and some disposables involved in the analysis of human DNA
4.4 Protective barrier products that are used during the collection and analysis of biological material
5 Quality management systems
5.1 General
5.2 Documents and records
5.3 Authorization
5.4 Subcontracting of work and purchase of components
5.5 Control of nonconforming product
5.6 Corrective and preventive action
5.7 Staff contamination detection provision
6 Human DNA contamination risk management
6.1 General
6.2 Risk assessment
6.3 Risk mitigation
6.4 Risk control measures
6.4.1 Equipment
6.4.2 Personnel
6.4.3 Cleaning and maintenance
7 Environmental human DNA monitoring
8 Requirements for products subject to post-production treatment
9 Requirements for products not subject to post-production treatment
9.1 Product testing
9.2 Batch records
10 Product packaging, labelling, and documentation
Annex A (normative) Compliance testing
Annex B (informative) Guidance on the effectiveness of post-production treatments currently used in the manufacture of products
Annex C (informative) Relevant markers for DNA profiling
Bibliography
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BS ISO 18385:2016
Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
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, solvents, and some disposables involved in the analysis of human DNA
4.4 Protective barrier products that are used during the collection and analysis of biological material
5 Quality management systems
5.1 General
5.2 Documents and records
5.3 Authorization
5.4 Subcontracting of work and purchase of components
5.5 Control of nonconforming product
5.6 Corrective and preventive action
5.7 Staff contamination detection provision
6 Human DNA contamination risk management
6.1 General
6.2 Risk assessment
6.3 Risk mitigation
6.4 Risk control measures
6.4.1 Equipment
6.4.2 Personnel
6.4.3 Cleaning and maintenance
7 Environmental human DNA monitoring
8 Requirements for products subject to post-production treatment
9 Requirements for products not subject to post-production treatment
9.1 Product testing
9.2 Batch records
10 Product packaging, labelling, and documentation
Annex A (normative) Compliance testing
Annex B (informative) Guidance on the effectiveness of post-production treatments currently used in the manufacture of products
Annex C (informative) Relevant markers for DNA profiling
Bibliography