BS ISO 18385:2016
Current
The latest, up-to-date edition.
Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements
Hardcopy , PDF
English
29-02-2016
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Foreword
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
4 Types of products
5 Quality management systems
6 Human DNA contamination risk management
7 Environmental human DNA monitoring
8 Requirements for products subject to post-production
treatment
9 Requirements for products not subject to post-production
treatment
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
Provides 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.
| Committee |
FSM/1
|
| DevelopmentNote |
Supersedes 14/30289934 DC. (02/2016)
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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 Figure1. Figure1 Overview of the processes covered by this International Standard
| Standards | Relationship |
| ISO 18385:2016 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 14644-8:2013 | Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC) |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14644-2:2015 | Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 31000:2009 | Risk management Principles and guidelines |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| AAMI TIR17 : 2008 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
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