现行

JIS L 1918-2011

Testing for skin primary irritation on textile products -- in vitro human skin model method
纺织品皮肤原发性刺激试验体外人体皮肤模型法

2011-01-01

现行

KS P ISO 10993-10

의료기기의 생물학적 평가 — 제10부: 자극성과 피부 감작성 시험
医疗器械的生物学评估 - 第10部分:刺激和皮肤致敏试验

2018-08-22

现行

GB/T 16886.10-2017

医疗器械生物学评价　第10部分：刺激与皮肤致敏试验
Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization

2017-12-29

现行

AAMI/ISO 10993-10-2010/(R)2014

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
医疗器械的生物学评价.第10部分:刺激性和皮肤致敏性试验

2010-09-04

现行

SN/T 3948-2014

化学品 体外皮肤刺激：重组人表皮试验
Chemical - In vitro skin irritation - Reconstructed human epidermis test method

2014-04-09

现行

SN/T 4577-2016

化妆品皮肤刺激性检测 重建人体表皮模型体外测试方法
Skin irritation test for cosmetics-Reconstructed human epidermal model in vitro alternative method

2016-08-23

现行

BS EN ISO 10993-23-2021

Biological evaluation of medical devices-Tests for irritation
医疗器械的生物学评价

2021-04-09

现行

UNE-EN ISO 10993-10-2011

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
医疗器械的生物学评价.第10部分:刺激性和皮肤致敏性试验（ISO 10993-10-2010）

2011-02-23

现行

KS P ISO 10993-23

의료기기의 생물학적 평가 제 제23부부: 자극 시험
医疗器械的生物学评价.第23部分:刺激性试验

2022-12-28

现行

ISO 10993-23-2021

Biological evaluation of medical devices — Part 23: Tests for irritation
医疗器械生物学评价第23部分:刺激性试验

2021-01-20

现行

GOST R 51352-2013

Медицинские изделия для диагностики ин витро. Методы испытаний
体外诊断医疗器械 测试方法

现行

ISO/TS 11796-2023

Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
医疗器械的生物学评价——实验室间研究的要求 以证明经验证的体外方法对评估医疗器械皮肤致敏的适用性

2023-07-27

现行

BS EN ISO 10993-5-2009

Biological evaluation of medical devices-Tests for in vitro cytotoxicity
医疗器械的生物学评价

2009-07-31

现行

BS EN 13532-2002

General requirements for in vitro diagnostic medical devices for self-testing
自检测用体外诊断医疗器械的一般要求

2002-05-08

现行

YY/T 1454-2016

自我检测用体外诊断医疗器械基本要求
General requirements for in vitro diagnostic medical devices for self-testing

2016-01-26

现行

UNE-EN 13532-2002

General requirements for in vitro diagnostic medical devices for self-testing.
自我检测用体外诊断医疗设备的一般要求

2002-10-29

现行

GOST R EN 13532-2010

Общие требования к медицинским изделиям для диагностики in vitro для самотестирования
体外诊断医疗器械的一般要求进行自检

现行

BS EN ISO 18113-4-2011

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for self-testing
体外诊断医疗设备 制造商提供的信息（标签）

2012-01-31

现行

BS EN ISO 18113-5-2011

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for self-testing
体外诊断医疗设备 制造商提供的信息（标签）

2012-01-31

现行

AAMI/ISO 10993-5-2009/(R)2014

Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
医疗器械的生物学评价.第5部分:体外细胞毒性试验

2009-06-23