14/30289934 DC : 0

Superseded

BS ISO 18385 - MINIMIZING THE RISK OF DNA CONTAMINATION IN PRODUCTS USED TO COLLECT AND ANALYSE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES

Available format(s)

Hardcopy , PDF

Superseded date

29-02-2016

Language(s)

English

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Definitions and abbreviations
4 Types of products
5 Quality systems
6 Contamination prevention in manufacturing
7 Quality assurance and monitoring of manufacturing
environments
8 Post-production treatment of products
9 Product packaging, labelling and documentation
Annex A (normative) - Compliance testing
Annex B (informative) - Methods currently used for
postproduction treatment and its effects on DNA
Bibliography

BS ISO 18385.

Committee	FSM/1
DocumentType	Draft
Pages	22
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS ISO 18385:2016

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 14644-6:2007	Cleanrooms and associated controlled environments Part 6: Vocabulary
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 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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