医疗器械（迟发型超敏）检测

GB/T 16886.10-2005 医疗器械生物学评价 第10部分;刺激与迟发型超敏反应试验

GB/T 16886的本部分描述了医疗器械及其组成材料潜在刺激和迟发型超敏反应的评价步骤。 GB/T 16886的本部分包括： a)试验前的考虑； b)试验步骤，以及 c)结果解释的关键因素。 附录A给出了与上述试验有关的特定材料制备说明

Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity

TIS 2395.10-2008 医疗器械生物学评价.第10部分:刺激和迟发型超敏反应的试验

Biological evaluation of medical devices.part 10: tests for irritation and delayed-type hypersensitivity

SANS 10993-10:2004 医疗器械的生物学评价.第10部分:刺激及迟发型超敏反应试验

Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation

Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity

LST EN ISO 10993-10:2013 医疗器械生物学评价. 第10部分: 刺激与迟发型超敏反应试验(ISO 10993-10-2010)

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

TCVN 7391-10-2007 医疗器械生物学评价.第10部分:刺激与迟发型过敏症试验

Biological evaluation of medical devices.Part 10: Tests for irritation and delayed-type hypersensitivity

SN/T 2247-2009 化学品 迟发型超敏反应试验方法

Delayed type hypersensitivity test method for chemicals

ANSI/AAMI BE78-2002 & A1-2006 医疗装置的生物学评估.第10部分:刺激和迟延型超敏性试验.

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

IS 12572 Pt.7-1988 医疗器械生物危害评估指南 第7部分致敏试验方法：评估医疗器械产生迟发性接触性皮炎的可能性

1.1 This standard ( Part 7 ) prescribes methods of test designed to provide information on the potential to induce delayed contact dermatitis (Type

T/ZMDS 20002-2017 医疗器械软件开发中敏捷方法应用指南

提供了采用敏捷方式开发医疗器械软件时符合国际标准与监管机构要求的建议

Guidance on the use of AGILE practices in the development of medical device

GOST ISO 10993-10-2011 医疗器械.医疗器械的生物学评价.第10部分.刺激与持续型过敏症试验

Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity

CNS 14393-10-2005 医疗器材生物性评估－第10部：刺激性及延迟型过敏性测试

本标准规定医疗器材及其组成材料潜在产生刺激及延迟过敏反应之评估程序，包括：(a) 测试前之考虑(b) 详细之试验步骤(c) 诠释结果之主要参数

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

CNS 14393.10-2005 医疗器材生物性评估－第１０部：刺激性及延迟型过敏性测试

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

ANSI/AAMI BE78-2002/A1-2006 医疗装置的生物学评估.第10部分:刺激和迟延型超敏性试验.修改件1

Changes clauses 4(d), 6.4.4.3.5, 6.4.5.3(e), 7.5.4.3.1, and Annex B

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1

EN ISO 10993-10:1995 医用设备的生物学评定.第10部分:刺激和迟发型超敏反应的试验

Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization (ISO 10993-10 : 1995)

EN ISO 10993-10:2009 医用设备的生物学评定.第10部分:刺激和迟发型超敏反应的试验

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

GB/T 16886.10-2005 医疗器械生物学评价 第10部分;刺激与迟发型超敏反应试验

GB/T 16886的本部分描述了医疗器械及其组成材料潜在刺激和迟发型超敏反应的评价步骤。 GB/T 16886的本部分包括： a)试验前的考虑； b)试验步骤，以及 c)结果解释的关键因素。 附录A给出了与上述试验有关的特定材料制备说明

Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity

TIS 2395.10-2008 医疗器械生物学评价.第10部分:刺激和迟发型超敏反应的试验

Biological evaluation of medical devices.part 10: tests for irritation and delayed-type hypersensitivity

SANS 10993-10:2004 医疗器械的生物学评价.第10部分:刺激及迟发型超敏反应试验

Describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation

Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity

LST EN ISO 10993-10:2013 医疗器械生物学评价. 第10部分: 刺激与迟发型超敏反应试验(ISO 10993-10-2010)

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

TCVN 7391-10-2007 医疗器械生物学评价.第10部分:刺激与迟发型过敏症试验

Biological evaluation of medical devices.Part 10: Tests for irritation and delayed-type hypersensitivity

SN/T 2247-2009 化学品 迟发型超敏反应试验方法

Delayed type hypersensitivity test method for chemicals

ANSI/AAMI BE78-2002 & A1-2006 医疗装置的生物学评估.第10部分:刺激和迟延型超敏性试验.

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

IS 12572 Pt.7-1988 医疗器械生物危害评估指南 第7部分致敏试验方法：评估医疗器械产生迟发性接触性皮炎的可能性

1.1 This standard ( Part 7 ) prescribes methods of test designed to provide information on the potential to induce delayed contact dermatitis (Type

T/ZMDS 20002-2017 医疗器械软件开发中敏捷方法应用指南

提供了采用敏捷方式开发医疗器械软件时符合国际标准与监管机构要求的建议

Guidance on the use of AGILE practices in the development of medical device

GOST ISO 10993-10-2011 医疗器械.医疗器械的生物学评价.第10部分.刺激与持续型过敏症试验

Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity

CNS 14393-10-2005 医疗器材生物性评估－第10部：刺激性及延迟型过敏性测试

本标准规定医疗器材及其组成材料潜在产生刺激及延迟过敏反应之评估程序，包括：(a) 测试前之考虑(b) 详细之试验步骤(c) 诠释结果之主要参数

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

CNS 14393.10-2005 医疗器材生物性评估－第１０部：刺激性及延迟型过敏性测试

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

ANSI/AAMI BE78-2002/A1-2006 医疗装置的生物学评估.第10部分:刺激和迟延型超敏性试验.修改件1

Changes clauses 4(d), 6.4.4.3.5, 6.4.5.3(e), 7.5.4.3.1, and Annex B

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1

EN ISO 10993-10:1995 医用设备的生物学评定.第10部分:刺激和迟发型超敏反应的试验

Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization (ISO 10993-10 : 1995)

EN ISO 10993-10:2009 医用设备的生物学评定.第10部分:刺激和迟发型超敏反应的试验

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity