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

Standard No.

BS ISO 18385:2016

Release Date

2016

Published By

British Standards Institution (BSI)

Latest

BS ISO 18385:2016

BS ISO 18385:2016 Referenced Document

• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
• ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne*， 2023-12-23 Update
• ISO 11137 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Technical Corrigendum 1
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes*， 2016-03-01 Update
• ISO 14644 Cleanrooms and associated controlled environments — Part 9: Assessment of surface cleanliness for particle concentration*， 2022-05-09 Update
• ISO 14644-1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
• ISO 14644-2 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
• ISO 14644-4 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up*， 2022-11-28 Update
• ISO 14644-5 Cleanrooms and associated controlled environments - Part 5: Operations
• ISO 14644-7 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
• ISO 14644-8 Cleanrooms and associated controlled environments — Part 8: Assessment of air cleanliness by chemical concentration (ACC)*， 2022-06-21 Update
• ISO 14698 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data; Technical Corrigendum 1
• ISO 14937 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
• ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
• ISO 15189 Medical laboratories — Particular requirements for quality and competence*， 2023-12-23 Update
• ISO 17665 Sterilization of health care products*， 2023-11-01 Update
• ISO 31000 Risk management - Guidelines*， 2018-02-01 Update
• ISO 3696 Water for analytical laboratory use; Specification and test methods
• ISO 9001 Quality management systems*， 2024-01-01 Update
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories*， 2017-11-29 Update
• ISO/IEC 31010 Risk management - Risk assessment techniques

BS ISO 18385:2016 history

• 2016 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