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

Standard Number:  GB/T 16886.1-2011
Title:  Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Language:  Simplified Chinese
Replacing Standard:  GB/T 16886.1-2001

Publication Date:  2011/6/16
Execute Date:  2011/12/1
Status:  Current
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Medical equipment>>Medical equipment in general
Publisher:  Chinese Standards(GB)
Price:28.80  
Number of Pages:25P.;A4  

Description:This section describes the GB/T 16886:
- medical equipment risk management framework to guide the basic principles of biological evaluation of medical devices;
- according to the equipment contact with human nature and the time of the general classification;
- all data associated with the sources of evaluation;
- based on risk analysis of the recognition of defects of the available data set;
- medical equipment biology security analysis of the recognition of other data sets required;
- medical apparatus and instruments, biology The whole evaluation.
This section does not include not direct or indirect contact with the patient of experimental materials and devices don't include any mechanical failure caused by biological hazards. Is given in the preamble of GB/T 16886 included in other parts of the specific test.  
Cross References:AAMI ISO 10993-2 Ed. 2 Biological Evaluation Of Medical Devices - Part 2: Animal Welfare Requirements;ISO/DIS 10993-3 Biological Evaluation Of Medical Devices - Part 3: Tests For Genotoxicity, Carcinogenicity And Reproductive Toxicity;ISO/AWI 10993-4 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood;ISO/FDIS 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;ISO/CD 10993-6 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation;ISO/NP 10993-7 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals;ISO/FDIS 10993-9 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products;AAMI ISO 10993-10 Ed. 1 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Sensitization;ISO/DIS 10993-11 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity;AAMI ISO 10993-12 Ed. 3 Biological Evaluation Of Medical Devices - Part 12: Sample Preparation And Reference Materials;AAMI ISO 10993-13 Ed. 1 Biological Evaluation Of Medical Devices - Part 13: Identification And Quantification Of Degradation Products From Polymeric Devices;ISO/FDIS 10993-14 Biological Evaluation Of Medical Devices - Part 14: Identification And Quantification Of Degradation Products From Ceramics;ISO/CD 10993-15 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys;ISO/DIS 10993-16 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables;ISO/DIS 10993-17 Biological Evaluation Of Medical Devices - Part 17: Establishment Of Allowable Limits For Leachable Substances Using Health-based Risk Assessment;ISO/DIS 10993-18 Biological Evaluation Of Medical Devices - Part 18: Chemical Characterization Of Materials;ISO/NP TS 10993-19 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials;AAMI ISO 10993-2 Ed. 2 Biological Evaluation Of Medical Devices - Part 2: Animal Welfare Requirements0;ISO 14971  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  741KB
Tile in English:  Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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