国家标准题录

GB/T 44671-2024

精液基础检验 要求和试验方法

Basic semen examination—Specification and test methods

实施日期

2025-04-01

ICS 分类

11.100.01

GB/T 44586.1-2024

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

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

实施日期

2025-04-01

ICS 分类

11.100.10

GB/T 44672-2024

体外诊断医疗器械 建立校准品和人体样品赋值计量溯源性的国际一致化方案的要求

In vitro diagnostic medical devices—Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

实施日期

2025-04-01

ICS 分类

11.100.10

GB/T 40984-2021

Quality assessment requirements for severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） IgM antibody detection kit

实施日期

—

ICS 分类

11.100.10

GB/T 40966-2021

Quality assessment requirements for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection kit

实施日期

—

ICS 分类

11.100.10

GB/T 40999-2021

Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2（SARS-CoV-2） total antibody detection kit

实施日期

—

ICS 分类

11.100.10

GB/T 40983-2021

Quality assessment requirements for severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） IgG antibody detection kit

实施日期

—

ICS 分类

11.100.10

GB/T 40982-2021

Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) nucleic acid detection kit

实施日期

—

ICS 分类

11.100.10

GB/Z 44363-2024

致热性 医疗器械热原试验的原理和方法

Pyrogenicity—Principles and methods for pyrogen testing of medical devices

实施日期

—

ICS 分类

11.100.20

GB/T 16886.10-2024

医疗器械生物学评价 第10部分：皮肤致敏试验

Biological evaluation of medical devices—Part 10:Tests for skin sensitization

实施日期

2025-09-01

ICS 分类

11.100.20

GB/T 44353.2-2024

动物源医疗器械 第2部分：来源、收集与处置的控制

Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing, collection and handling

实施日期

2025-09-01

ICS 分类

11.100.20

GB/T 44353.1-2024

动物源医疗器械 第1部分：风险管理应用

Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management

实施日期

2025-09-01

ICS 分类

11.100.20

GB/T 42216.4-2024

分子体外诊断检验 福尔马林固定及石蜡包埋组织检验前过程的规范 第4部分：原位检测技术

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 4: In situ detection technique

实施日期

2025-03-01

ICS 分类

11.100.10

GB/Z 43280-2023

医学实验室 测量不确定度评定指南

Medical laboratories—Practical guidance for the estimation of measurement uncertainty

实施日期

—

ICS 分类

11.100

GB/T 43450-2023

化学品 急性眼刺激体外细胞试验 TRPV1活性检测法

Chemicals—In vitro cellular assay for acute eye irritation—TRPV1 activity detection method

实施日期

2024-06-01

ICS 分类

13.300;11.100

GB/T 16886.12-2023

医疗器械生物学评价 第12部分：样品制备与参照材料

Biological evaluation of medical devices—Part 12: Sample preparation and reference materials

实施日期

2024-12-01

ICS 分类

11.100.20

GB/T 16886.23-2023

医疗器械生物学评价 第23部分：刺激试验

Biological evaluation of medical devices—Part 23: Tests for irritation

实施日期

2024-12-01

ICS 分类

11.100.20

GB/T 43278-2023

医学实验室 风险管理在医学实验室的应用

Medical laboratories—Application of risk management to medical laboratories

实施日期

2024-06-01

ICS 分类

11.100.01

GB/T 43279.3-2023

分子体外诊断检验 静脉全血检验前过程的规范 第3部分：分离血浆循环游离DNA

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 3: Isolated circulating cell free DNA from plasma

实施日期

2024-06-01

ICS 分类

11.100.10

GB/T 43279.2-2023

分子体外诊断检验 静脉全血检验前过程的规范 第2部分：分离基因组DNA

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 2:Isolated genomic DNA

实施日期

2024-06-01

ICS 分类

11.100.10