This document specifies the general regulations for the prevention and control of human-derived contamination of DNA testing products, product types, quality management system, risk management of human-derived DNA contamination, monitoring of human-derived DNA contamination in the environment, and products requiring post-production treatment requirements, requirements for products that do not require post-production processing, product packaging, labeling and supporting documents. This document applies to the production of consumables and reagents that can be used without cleaning. This document does not cover product technical specifications (such as product design).
GB/T 41844-2022 history
2022GB/T 41844-2022 Specifications for prevention and control of human DNA contamination in DNA testing products
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