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Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination.
The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories.
It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies).
These are outside of the scope of this document.
Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination.
These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated DNA.
International, national or regional regulations or requirements can also apply to specific topics covered in this document.
| SDO | BSI: British Standards Institution |
| Document Number | CEN/TS 17626 |
| Publication Date | May 10, 2021 |
| Language | en - English |
| Page Count | 42 |
| Revision Level | |
| Supercedes | |
| Committee | CH/212 |
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Version 1 - 2026-06-22
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This section applies to everyone who accesses or uses the Nimonik Online Store, whether or not a purchase is made. In this section, “you” means any such user.
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Acceptable Use. You shall not use the Nimonik Online Store in any unlawful manner; attempt to gain unauthorized access to, interfere with, or disrupt the Nimonik Online Store or its underlying systems; introduce any malware or other harmful code; or use any robot, spider, scraper, or other automated means to access, harvest, index, or copy the Nimonik Online Store or its catalogue, except for standard search-engine indexing. You shall not resell, or provide commercial access to, the Nimonik Online Store. You shall not circumvent, disable, or interfere with any security, access control, or digital rights management (DRM) or other technical protection measure applied to the Nimonik Online Store or any Product.
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Website Availability. The Nimonik Online Store is provided on an “as is” and “as available” basis. Nimonik does not warrant that it will be uninterrupted, error-free, or secure, and may modify, suspend, or discontinue all or part of it at any time without notice. The disclaimers and limitations of liability in Part A, Section 7 apply equally to your access to and use of the Nimonik Online Store.
This Part D applies to Parts A, B, and C and to all access to and use of the Nimonik Online Store and the Products.
Governing Law and Dispute Resolution. These Terms are governed exclusively by the laws of the State of California, United States, without reference to its conflict of laws principles and to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods. The parties consent to the exclusive jurisdiction of the state and federal courts located in California, United States. In any action to enforce these Terms, the prevailing party shall be entitled to recover its reasonable attorneys’ fees and costs.
Changes to these Terms. Nimonik may amend or update these Terms at any time by posting the revised Terms in the Nimonik Online Store. The version of these Terms in effect at the time an order is placed governs that order, and the version in effect at the time the Nimonik Online Store is used governs that use. Continued use of the Nimonik Online Store or any Product following any change constitutes acceptance of the revised Terms.
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