YY/T 1725-2020 Active Industry standards-Medicine

YY/T 1725-2020 Multiplex nucleic acid detection kit for infection of microorganisms

Publish Date: 2020-06-30 Implement Date: 2021-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1725-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2020-06-30

Implement Date: 2021-12-01

Pages: 10 pages

Scope

This standard specifies the terms and definitions, requirements, test methods, labels and user manuals, packaging, transportation, and storage for multi-nuclear acid detection kits for bacterial and fungal infections (hereinafter referred to as "kits").
This standard applies to the quality control of kits that can detect three or more bacteria and fungi (hereinafter referred to as "pathogens", excluding mycoplasma and chlamydia) in a single test of human samples (including blood, cerebrospinal fluid, and feces) or their cultures. It is suitable for kits with detection principles such as isothermal amplification by polymerase chain reaction and second-generation sequencing.
This standard does not apply to kits that can detect one or two pathogens in a single test. It does not apply to kits that can detect different genes of one or two pathogens in a single test. It does not apply to kits that can detect different types (genotypes or serotypes) of one or two pathogens in a single test.