GB/T 16886.1-2011 English Version, GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (English Version)

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Position: Chinese Standard in English/GB/T 16886.1-2011

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (English Version)
Standard No.:	GB/T 16886.1-2011	Status:	superseded remind me the status change Email:
Language:	English	File Format:	PDF
Word Count:	10000 words	Price(USD):	120.0 remind me the price change Email:
Implemented on:	2011-12-1	Delivery:	via email in 1 business day

Standard No.:	GB/T 16886.1-2011
English Name:	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Chinese Name:	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
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:	2011-6-16
Implemented on:	2011-12-1
Status:	superseded
Superseded by:	GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
Superseded on:	2023-5-1
Superseding:	GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1:Evaluation and testing
Language:	English
File Format:	PDF
Word Count:	10000 words
Price(USD):	120.0
Delivery:	via email in 1 business day

GB/T 16886.1-2011 is referred in:

* GB/T 22752-2008 Technical aids for persons with disabilities - Grab - rails
* GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
* GB/T 22752-2008 Technical aids for persons with disabilities - Grab - rails
* GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
* GB/T 22752-2008 Technical aids for persons with disabilities - Grab - rails
* YY/T 0821-2010 Dispensing syringe for single use
* GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY/T 0148-2006 Medical adhesive bandages-General requirements
* YY/T 0148-2006 Medical adhesive bandages-General requirements
* YY/T 0908-2013 Single-use filter for syringe
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY/T 0031-2008 Silicone tubes and elastomeric parts for infusion and transfusion
* YY/T 0964-2014 Implants for surgery―Bioglass and glass ceramic biomaterials
* GB 15811-2016 Sterile hypodermic needles for single use
*YY 0053-2016 Hemodialysis and relavant therapics -Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
*YY 1282-2016 Intravenous catheter for single use
*GB 23719-2009 Ophthalmic optics and instruments - Optical devices for enhancing low vision
*YY 0465-2009 Disposable membrane plasmaseparator
*GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
*GB 18671-2009 Intravenous needles for single use
*YY/T 0450.3-2016 Accessory devices for sterile single-use intravascular catheters- Part 3：Inflation devices for balloon of balloon dilatation catheters
*YY 0785-2010 Clinical thermometers—Performance of electrical thermometers for continuous measurement
*YY/T 0148-2006/XG1-2020 Medical adhesive bandages-General requirements
*YY 0649-2016 Electrical potential therapy equipment
*YY 0861-2011 Ophthalmic optics—Ophthalmic viscosurgical devices
*YY/T 1794-2021 General technical requirements for dental collagen membrane
*GB 19335-2003 Blood flow products for single use—General specification
*YY/T 1287.3-2016 Intracranial external drainage system- Part 3:Intracranial external drainage catheter
*YY 0450.1-2020 Accessory devices for sterile single-use intravascular catheters- Part 1: Introducers
*YY/T 1615-2018 Surgical implants. Anodizing oxide layers on titanium and titanium alloys. General requirements
*YY/T 1553-2017 Cardiovascular implants-Cardiac occluder
*YY/T 1587-2018 Medical endoscopes—Video endoscopes
*GB 8369.2-2020 Transfusion sets for single use—Part 2: With pressure infusion apparatus use
*YY/T 1754.1-2020 Preclinical animal study of medical devices—Part 1:General considerations
*YY 0613-2007 Blood components separation sets for single use centrifuge bag type
*YY/T 1739-2020 Cardiopulmonary bypass systems—Centrifugal pump-head
*GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization
*YY/T 1472.1-2016 Thoracic minimally invasive instruments—Part 1:Dual pivot surgical clamps
*YY/T 1266-2015 Evaluation of materials of medical device subject to hydrogen peroxide sterilization

Standard

GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (English Version)
Standard No.	GB/T 16886.1-2011
Status	superseded
Language	English
File Format	PDF
Word Count	10000 words
Price(USD)	120.0
Implemented on	2011-12-1
Delivery	via email in 1 business day

Detail of GB/T 16886.1-2011

Standard No.

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Chinese Classification

Professional Classification

ICS Classification

Issued by

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Implemented on

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Abolished on

Superseding

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Keywords

Introduction of GB/T 16886.1-2011

GB/T16886的本部分描述了:
———医疗器械风险管理框架内指导医疗器械生物学评价的基本原则;
———按器械与人体接触性质和时间的一般分类;
———所有来源的相关数据的评价;
———建立在风险分析基础之上的可用数据组中缺陷的识别;
———医疗器械生物学安全分析所需其他数据组的识别;
———医疗器械生物学安全性的评定。
本部分不包括不直接或不间接与患者身体接触的材料和器械的试验,也不包括任何机械故障引起的生物学危害。前言中给出了GB/T16886的其他部分所包括的具体试验。

Contents of GB/T 16886.1-2011

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