GB/T 16886.1-2011 in English

SUPERSEDED

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Issued on:2011-06-16
Implemented on:2011-12-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $120.00
$117.00

Standard No:	GB/T 16886.1-2011
Document status:	SUPERSEDED
Superseded by:	GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
Superseded on:	2023-05-01
Title in English:	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Title in Chinese:	医疗器械生物学评价第1部分：风险管理过程中的评价与试验
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2011-06-16
Implemented on:	2011-12-01
Superseding:	GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
ICS Classification:	11.040.01-Medical equipment in general
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	GB-National Standard
Related Keywords:	medical device risk management medical devices biological evaluation risk management process scopethis part sources evaluation
Related Topics:	biology gbt 16886.1 2011 Medical Device Biology Medical Device Biology biological evaluation biological evaluation Chemical Evaluation of Medical Devices Evaluate Physics Biological Evaluation Program Biological Evaluation of Medical Devices Biological Evaluation of Medical Devices gb/t16886.1 gb16886.1 Biology Triple Evaluation Medical Device Evaluation GB/T 16886.1 Test data evaluation biological standard Test data evaluation Medical Device Evaluation gb/16886.1 Toxicity Risk Assessment Test data evaluation Frontiers in Biomedical Engineering Process monitoring and evaluation GB 16886.1 GB T16886.1 GB/T 16886.1 GB/T 16886.1-2001 GB/T 16886.1-2011 GB/T 16886.1-2022 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Risk Management Process Validation and evaluation of nitrogen generator for liquid quality Texture evaluation

《GB/T 16886.1-2011医疗器械生物学评价第1部分：风险管理过程中的评价与试验》由TC248（全国医疗器械生物学评价标准化技术委员会）归口，主管部门为国家药品监督管理局。

Scope

This part of GB/T 16886 describes: - the basic principles guiding the biological evaluation of medical devices within the framework of medical device risk management; - a general classification according to the nature and duration of contact between the device and the human body; - a summary of relevant data from all sources Evaluation; - identification of deficiencies in available data sets based on risk analysis; - identification of other data sets required for biological safety analysis of medical devices; - assessment of biological safety of medical devices. This section does not include experiments on materials and devices that are not in direct or indirect contact with the patient's body, nor does it include any biological hazards caused by mechanical failure. Specific tests included in other parts of GB/T 16886 are given in the preface.

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