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BS ISO 18385:2016

BS ISO 18385:2016

$142.49

Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements

Published By Publication Date Number of Pages
BSI 2016 30
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This International Standard 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.

This International Standard 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).

This International Standard excludes microbiological testing.

This International Standard 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.

An overview of the International Standard is provided in Figure 1.

Figure 1 Overview of the processes covered by this International Standard

PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 1 Scope
10 2 Terms and definitions
13 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
14 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
15 5.3 Authorization
5.4 Subcontracting of work and purchase of components
5.5 Control of nonconforming product
16 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
18 6.3 Risk mitigation
6.4 Risk control measures
6.4.1 Equipment
6.4.2 Personnel
6.4.3 Cleaning and maintenance
19 7 Environmental human DNA monitoring
8 Requirements for products subject to post-production treatment
20 9 Requirements for products not subject to post-production treatment
9.1 Product testing
9.2 Batch records
10 Product packaging, labelling, and documentation
21 Annex A (normative) Compliance testing
23 Annex B (informative) Guidance on the effectiveness of post-production treatments currently used in the manufacture of products
25 Annex C (informative) Relevant markers for DNA profiling
26 Bibliography

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BS ISO 18385:2016
$142.49