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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 >
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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, 2016
- 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 [Go to Page]