GB/T 16886.2-2011 English Version, GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements (English Version)

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GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements (English Version)
Standard No.:	GB/T 16886.2-2011	Status:	valid remind me the status change Email:
Language:	English	File Format:	PDF
Word Count:	7000 words	Price(USD):	140.0 remind me the price change Email:
Implemented on:	2012-5-1	Delivery:	via email in 1~3 business day

Standard No.:	GB/T 16886.2-2011
English Name:	Biological evaluation of medical devices—Part 2:Animal welfare requirements
Chinese Name:	医疗器械生物学评价第2部分：动物福利要求
Chinese Classification:	C30 Medical apparatus and devices in general
Professional Classification:	GB National Standard
ICS Classification:	11.040.01 11.040.01 Medical equipment in general 11.040.01
Issued by:	AQSIQ;SAC
Issued on:	2011-12-30
Implemented on:	2012-5-1
Status:	valid
Superseding:	GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2:Animal welfare requirements
Language:	English
File Format:	PDF
Word Count:	7000 words
Price(USD):	140.0
Delivery:	via email in 1~3 business day

GB/T 16886.2-2011 is referred in:

*GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
*YY 0861-2011 Ophthalmic optics—Ophthalmic viscosurgical devices
*YY/T 1754.1-2020 Preclinical animal study of medical devices—Part 1:General considerations
*YY/T 1754.2-2020 Preclinical animal study of medical devices—Part 2:Model of skin defect in induced diabetic rats
*GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
*GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

Standard

GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements (English Version)
Standard No.	GB/T 16886.2-2011
Status	valid
Language	English
File Format	PDF
Word Count	7000 words
Price(USD)	140.0
Implemented on	2012-5-1
Delivery	via email in 1~3 business day

Detail of GB/T 16886.2-2011

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Introduction of GB/T 16886.2-2011

GB/T16886的本部分适用于委托、设计和进行试验或评价动物试验数据,以对医疗器械用材料或器械生物相容性进行评价的过程。本部分规定了最基本的要求,以通过所制定的相应规定来确保评价医疗器械材料生物相容性动物试验所用动物的福利,并形成文件。
本部分还给出了建议和指南,以利于进一步减少动物总体数量、优化试验方法以减轻或消除动物的疼痛或痛苦,以及采用其他不需要动物试验的科学有效的方法来替代动物试验。
本部分适用于除人类外的活体脊椎动物试验,该类试验用于确定材料或医疗器械的生物相容性。
本部分不适用于在无脊椎动物以及其他分化程度较低的动物体上进行的试验,也不适用于在实施人道方式处死的脊椎动物分离组织和器官上进行的试验(除了动物种属、来源、健康状况、饲养与管理规定方面)。

Contents of GB/T 16886.2-2011

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Keywords:
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