国家标准题录

GB/T 14728.1-2024

双臂操作助行器 要求和试验方法 第1部分：框式助行器

Assistive products for walking manipulated by both arms—Requirements and test methods—Part 1： Walking frames

实施日期

2025-10-01

ICS 分类

11.180

GB/T 20405.2-2024

失禁者用尿液吸收剂 聚丙烯酸酯高吸水性粉末 第2部分：测定丙烯酸酯单体残余量的试验方法

Urine-absorbing aids for incontinence—Polyacrylate superabsorbent powders—Part 2:Test method for determination of the amount of residual acrylate monomers

实施日期

2025-01-01

ICS 分类

11.180.20

GB/T 44469-2024

牙科旋转器械 技工室研磨器械

Dental rotary instruments—Laboratory abrasive instruments

实施日期

2025-10-01

ICS 分类

11.060.20

GB/T 44467-2024

分子体外诊断检验 唾液检验前过程的规范 提取人类DNA

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for saliva—Isolated human DNA

实施日期

2025-04-01

ICS 分类

11.100.10

GB/T 18281.7-2024

医疗保健产品灭菌 生物指示物 第7部分：选择、使用和结果判断指南

Sterilization of health care products—Biological indicators—Part 7:Guidance for the selection, use and interpretation of results

实施日期

2025-10-01

ICS 分类

11.080.01

GB/T 42080.3-2024

分子体外诊断检验 冷冻组织检验前过程的规范 第3部分：分离DNA

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 3: Isolated DNA

实施日期

2025-04-01

ICS 分类

11.100.10

GB/T 44613-2024

牛羊副流感病毒3型诊断技术

Diagnostic techniques for bovine and caprine parainfluenza virus type 3

实施日期

2025-04-01

ICS 分类

11.220

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 44668-2024

0岁～6岁视障儿童早期干预机构服务规范

Service specification of early intervention institutions for children of ages 0～6 with visual impairment

实施日期

2025-01-01

ICS 分类

11.180

GB/T 44665-2024

上下肢运动功能评估与训练设备通用要求

General requirements for upper and lower limb motor function rehabilitation equipment with assessment and training

实施日期

2025-01-01

ICS 分类

11.180

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 44666-2024

指矫形器

Finger orthoses

实施日期

2025-01-01

ICS 分类

11.180

GB/T 44704-2024

无障碍洗浴机

Accessible bath machines

实施日期

2025-01-01

ICS 分类

11.180.99

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