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

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

Status : Current, Under review   Published : February 2016

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What is this standard about?

BS ISO 18385:2016 is the world’s first international standard on forensic science and outlines the requirements for the manufacture of kits and consumables for DNA analysis by the global forensic science community.

Who is this standard for?

  • Police forces and forensic science laboratories
  • Manufacturers for the forensic DNA community

Why should you use this standard? 

ISO 18385:2016 is being recognized internationally as setting the standard for the forensic DNA community.

The standard is important because:

  • In forensic DNA analysis contamination is inevitable and the quality of consumables used in the recovery and processing of DNA material has been recognized as a route for the introduction of contamination
  • It helps to avoid incidents such as the “The Phantom of Heilbronn” or “Woman without a Face” 
  • End users will be able to purchase consumables with confidence from manufacturers meeting the standard and satisfy the requirements of their own accreditation to ISO 17025 and manufacturers will understand what is required of them to service this market



Standard NumberBS ISO 18385:2016
TitleMinimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements
StatusCurrent, Under review
Publication Date29 February 2016
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO 14644, ISO 14644-5, ISO 14937, ISO 15189, ISO 17665, ISO 14644-2, ISO 3696, ISO 11137, ISO/IEC 17025, ISO 14644-4, ISO 14698, ISO 14644-1, ISO 10993, ISO 13485, AAMI TIR 17:2008, AAMI TIR 52, ISO 9001, ISO/IEC 31010, ISO 14644-7, ISO 14971, ISO 14644-8, ISO 11135, ISO 11137-2, ISO 31000:2018, ISO 10993-7
International RelationshipsISO 18385:2016
Draft Superseded By14/30289934 DC
DescriptorsGloves, Products, Containers, Protective clothing, Accreditation, Quality assurance, Contamination, Risk assessment, Packaging, Deoxyribonucleic acid, Masks (protective clothing), Amplification
ICS07.140
Title in FrenchRéduire au maximum le risque de contamination de l’ADN dans les produits utilisés pour recueillir et analyser du matériel biologique en criminalistique. Exigences
CommitteeFSM/1
ISBN978 0 580 84301 3
PublisherBSI
FormatA4
DeliveryYes
Pages30
File Size1.053 MB
Price£186.00


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