Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
Sector / Industry
National Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
11.040.01
Word Count Estimation
27,260
Date of Issue
2011-06-16
Date of Implementation
2011-12-01
Older Standard (superseded by this standard)
GB/T 16886.1-2001
Quoted Standard
ISO 10993-2; ISO 10993-3; ISO 10993-4; ISO 10993-5; ISO 10993-6; ISO 10993-7; ISO 10993-9; ISO 10993-10; ISO 10993-11; ISO 10993-12; ISO 10993-13; ISO 10993-14; ISO 10993-15; ISO 10993-16; ISO 10993-17; ISO 10993-18-2005; ISO/TS 10993-19; ISO/TS 10993-20; ISO 14971
Adopted Standard
ISO 10993-1-2009, IDT
Regulation (derived from)
Announcement of Newly Approved National Standards No. 9 of 2011
Issuing agency(ies)
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary
This standard specifies: Medical Device Risk Management framework guiding biological evaluation of medical devices basic principles of human contact by equipment nature and timing of the general classification, all sources of relevant data evaluation, based on risk analysis based on the data available group identification of defects, biological safety of medical devices required for the analysis of other data set identification, medical assessment of biological safety.
