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《法医用生物材料的收集 存储和.pdf

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1、BSI Standards PublicationBS ISO 18385:2016Minimizing the risk of humanDNA contamination in productsused to collect, store andanalyze biological materialfor forensic purposes RequirementsBS ISO 18385:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18385:201

2、6. The UK participation in its preparation was entrusted to TechnicalCommittee FSM/1, Forensic Science Processes.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract.

3、Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 84301 3 ICS 11.100.99 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authori

4、ty of the Standards Policy and Strategy Committee on 29 February 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 18385:2016 ISO 2016Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic pur

5、poses RequirementsRduire au maximum le risque de contamination de lADN dans les produits utiliss pour recueillir et analyser du matriel biologique en criminalistique ExigencesINTERNATIONAL STANDARDISO18385First edition2016-02-01Reference numberISO 18385:2016(E)BS ISO 18385:2016ISO 18385:2016(E)ii IS

6、O 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on t

7、he internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09

8、47copyrightiso.orgwww.iso.orgBS ISO 18385:2016ISO 18385:2016(E)Foreword ivIntroduction v1 Scope . 12 Terms and definitions . 23 Abbreviated terms 54 Types of products 54.1 General . 54.2 Products that come into direct contact with biological stains or material potentially containing human DNA . 54.3

9、 Chemicals, reagents, solvents, and some disposables involved in the analysis of human DNA 64.4 Protective barrier products that are used during the collection and analysis of biological material . 65 Quality management systems . 65.1 General . 65.2 Documents and records 65.3 Authorization . 75.4 Su

10、bcontracting of work and purchase of components . 75.5 Control of nonconforming product . 75.6 Corrective and preventive action 85.7 Staff contamination detection provision 86 Human DNA contamination risk management . 86.1 General . 86.2 Risk assessment . 86.3 Risk mitigation . 106.4 Risk control me

11、asures . 106.4.1 Equipment 106.4.2 Personnel . 106.4.3 Cleaning and maintenance . 107 Environmental human DNA monitoring .118 Requirements for products subject to post-production treatment 119 Requirements for products not subject to post-production treatment .129.1 Product testing . 129.2 Batch rec

12、ords . 1210 Product packaging, labelling, and documentation 12Annex A (normative) Compliance testing .13Annex B (informative) Guidance on the effectiveness of post-production treatments currently used in the manufacture of products 15Annex C (informative) Relevant markers for DNA profiling .17Biblio

13、graphy .18 ISO 2016 All rights reserved iiiContents PageBS ISO 18385:2016ISO 18385:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out

14、 through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO col

15、laborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different appro

16、val criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the su

17、bject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any tra

18、de name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Te

19、chnical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 272, Forensic sciences.iv ISO 2016 All rights reservedBS ISO 18385:2016ISO 18385:2016(E)IntroductionThis International Standard was produced with the aim t

20、o create global standards for manufacturers of forensic products used in human DNA analysis. Inadvertent contamination by manufacturers of consumables and reagents, when combined with the improved sensitivity of DNA testing methods, increasingly interferes with forensic analysis. ISO 2016 All rights

21、 reserved vBS ISO 18385:2016BS ISO 18385:2016Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes RequirementsWARNING This International Standard calls for the use of procedures that may be a health hazard or cause in

22、jury if adequate precautions are not taken.1 ScopeThis 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 analys

23、is.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

24、, 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 microbiolo

25、gical 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.INTERNATIONAL STAND

26、ARD ISO 18385:2016(E) ISO 2016 All rights reserved 1BS ISO 18385:2016ISO 18385:2016(E)5.4Subcontracting of work andpurchase of components5.6Corrective andpreventative actionFailFailPass Clause 8Requirements forproducts subject topost-productiontreatmentClause 10 Product packaging, labellingand docum

27、entation Clause 9Requirements forproducts not subjectto post-productiontreatmentClause 6 Human DNAcontaminationrisk management6.2Risk assessment:Acceptable6.2Risk assessment:Conditionally acceptable6.2Risk assessment:UnacceptableConsider for furtherrisk reductionManufacturingA.3Validation ofpost-pro

28、ductiontreatmentsClause 7 Environmentalhuman DNAmonitoringPassPost-production treatment6.3Risk mitigation5.5Control of nonconformingproductyes noFigure 1 Overview of the processes covered by this International Standard2 Terms and definitionsFor the purposes of this document, the following terms and

29、definitions apply.2.1alleleone of a number of alternatives at a specific location on an individuals DNA2.2amplificationprocess of copying segments of the DNA sequence exponentiallyNote 1 to entry: This is also called Polymerase Chain Reaction (PCR).2.3amplification negative controlsample with no DNA

30、 material used to verify that the amplification (2.2) is free of contamination (2.7)2.4amplification positive controlsample with known DNA material used to verify that the amplification (2.2) works2.5analytical thresholdrelative fluorescence unit value at which a laboratory has determined to call a

31、peak an allele (2.1)2 ISO 2016 All rights reservedBS ISO 18385:2016ISO 18385:2016(E)2.6batch release testtest performed by or on behalf of the manufacturer (2.15) on a batch of components, which has to be satisfactorily completed before the batch can be releasedSOURCE: ISO/TS 21003-7:2008, 3.1.92.7c

32、ontaminationintroduction of detectable nuclear DNA or human cellular material during the manufacturing or assembly processes that would compromise the forensic human DNA analysis2.8contamination detection limitvalue at or above which human DNA is deemed to be detected and below which the compound is

33、 deemed to be not detected2.9DNA reduction factorratio of the DNA quantity of an untreated cell-spiked sample to the DNA quantity of an identical cell-spiked sample that has undergone appropriate post-production treatment2.10eluatesolution resulting from the DNA extraction process2.11extraction nega

34、tive controlsample with no cellular or DNA material used to verify that the DNA extraction is free of contamination (2.7)2.12extraction positive controlsample with known cellular or DNA material used to verify that a DNA extraction works2.13ISO 18385 forensic DNA gradelabel given to products that ha

35、ve been produced in accordance with this International Standard2.14kitset of consumables and/or chemicals (or reagents), and instructions for use, packaged together and intended for use as specified by the manufacturer (2.15)2.15manufacturerorganization that produces and/or packages the product2.16m

36、anufacturing environmentarea, room, or space identified for the production and/or packaging of products used to collect and analyze biological materials2.17out-of-specificationtest results that do not comply with the product specification2.18person reference samplebiological material taken from a kn

37、own source with the purpose of creating a DNA profile for comparison ISO 2016 All rights reserved 3BS ISO 18385:2016ISO 18385:2016(E)2.19post-production treatmentcontamination (2.7) reduction treatment conducted after primary packaging (2.20) to ensure that any human DNA contaminants above the conta

38、mination detection limit (2.8) are physically destroyed or not accessible to DNA amplification (2.2)2.20primary packagingpackaging designed to come into direct contact with the productSOURCE: ISO 21067:2007, 2.2.22.21primary transport containerproduct designed to transport the sampleEXAMPLE Envelope

39、s, evidence bags, specimen jars, swab boxes, and collection devices with integrated transport mechanisms.2.22productconsumables and reagents which do not require cleaning for continued use and are used to collect, store, and analyze biological material for forensic purposes, but not used in post-amp

40、lification analysis2.23productionprocess or method for the manufacture of products2.24sampleportion of biological material or collected item, on which the test or analysis is carried out2.25validationconfirmation, through the provision of objective evidence, that the requirements for a specific inte

41、nded use or application have been fulfilledNote 1 to entry: The term “validated” is used to designate the corresponding status.Note 2 to entry: The use conditions for validation can be real or simulated.SOURCE: ISO 9000:2015, 3.8.132.26verificationconfirmation, through the provision of objective evi

42、dence, that specified requirements have been fulfilledNote 1 to entry: The term “verified” is used to designate the corresponding status.Note 2 to entry: Confirmation can comprise activities such as performing alternative calculations, comparing a new design specification with a similar proven desig

43、n specification, undertaking tests and demonstrations, and reviewing documents prior to issue.SOURCE: ISO 9000:2015, 3.8.124 ISO 2016 All rights reservedBS ISO 18385:2016ISO 18385:2016(E)3 Abbreviated termsbp Base pairDNA Deoxyribonucleic acidEO Ethylene oxideHEPA High efficiency particulate airPCR

44、Polymerase chain reactionQA Quality assuranceqPCR Quantitative PCRSTR Short tandem repeat4 Types of products4.1 GeneralFor the purposes of this International Standard, the products used in the collection, storage, and analysis of biological material for forensic DNA purposes are as outlined below. T

45、hese products include, but are not limited to, the examples listed in 4.2, 4.3, and 4.4.4.2 Products that come into direct contact with biological stains or material potentially containing human DNAThese products are considered to be high risk because the contaminating biological material or DNA is

46、likely to be transferred. As a result, they should undergo post-production treatment provided it does not damage the product.These products include, but are not limited to, the following examples:a) gloves;b) paper substrates onto which samples are deposited from persons;c) plate seals/covers/strips

47、;d) plates;e) primary transport container;f) sampling kits;g) spin baskets;h) swabs;i) tapes for sample recovery;j) tips;k) tubes. ISO 2016 All rights reserved 5BS ISO 18385:2016ISO 18385:2016(E)4.3 Chemicals, reagents, solvents, and some disposables involved in the analysis of human DNAThese produc

48、ts are considered high risk because contaminating biological material or DNA is likely to generate a profile. If post-production treatment is not possible and batch release testing is unlikely to detect contamination due to the heterogeneous nature of the material, the stringency of anti-contaminati

49、on measures adopted during manufacture shall be considered during the risk assessment as outlined in Clauses 6 and 7.These products include, but are not limited to, the following examples:a) DNA extraction kits;b) DNA microconcentrators;c) PCR amplification kits;d) other chemicals and reagents used to identify, recover, and analyze biological material.4.4 Protective barrier products that are used during the collection and analysis of biological materialThese products are not specifically designed to come in contact with bio