GB/T 44586.1-2024

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In vitro diagnostic medical devices—Multiplex molecular testing for nucleic acids—Part 1:Terminology and general requirements for nucleic acid quality evaluation

体外诊断医疗器械多重核酸分子检测第1部分：核酸质量评价术语和通用要求

Standard Type

GBT

ICS

11.100.10

CCS

C30

Status

现行

Issue Date

2024-09-29

Implementation

2025-04-01

Responsible Dept

国家药监局

Drafting Unit

N/A

🔗 Related Standards / 同类标准

GB/Z 30154-2013 Medical laboratories―Guidance on laboratory implementation of GB/T 22576-2008 GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials GB/Z 43281-2023 Guidance for supervisors and operators of point-of-care testing(POCT) devices GB/Z 43280-2023 Medical laboratories—Practical guidance for the estimation of measurement uncertainty GB/Z 44363-2024 Pyrogenicity—Principles and methods for pyrogen testing of medical devices GB/Z 136-2026 Medical laboratories—Reagents for staining biological specimen—Guidance for users GB/Z 157-2026 In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials