• There are no items in your cart

BS ISO 18385:2016

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-29-2016

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.

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

Committee
FSM/1
DevelopmentNote
Supersedes 14/30289934 DC. (02/2016)
DocumentType
Standard
Pages
30
PublisherName
British Standards Institution
Status
Current
Supersedes

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

View more information
US$222.80
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.