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General requirements of performance evaluation of in vitro diagnostic medical devices
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Basic data
| Standard ID | YY/T 1441-2016 (YY/T1441-2016) |
| Description (Translated English) | General requirements of performance evaluation of in vitro diagnostic medical devices |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C30 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 8,844 |
| Date of Issue | 2016-01-26 |
| Date of Implementation | 2017-01-01 |
| Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 |
| Issuing agency(ies) | State Food and Drug Administration |
YY/T 1441-2016: General requirements of performance evaluation of in vitro diagnostic medical devices
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
General requirements of performance evaluation of in vitro diagnostic medical devices
ICS 11.100
C30
People's Republic of China Pharmaceutical Industry Standard
General requirements for in vitro diagnostic medical device performance evaluation
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
The drafting of this standard. Beijing Medical Device Testing Institute, Beijing Medical Device Technology Review Center, Beijing Tongren Hospital, Chinese food
Drug Testing Institute Medical Device Testing Institute, Roche Diagnostic Products (Shanghai) Co., Ltd.
The main drafters of this standard. Zhao Yang, Zhang Hong, Liu Xiangyi, Yu Ting, Tao Yuan, Qu Yuanyuan.
General requirements for in vitro diagnostic medical device performance evaluation
1 Scope
This standard applies to the performance evaluation of in vitro diagnostic medical devices (hereinafter referred to as IVDMD), including self-examination in vitro diagnostic medical
Equipment, performance evaluation.
This standard specifies the responsibilities and general requirements of the manufacturer for research planning, implementation, evaluation and documentation in performance evaluation studies.
This standard does not apply to a specific IVDMD or a specific use of the assessment program.
Note. For the selection of specific assessment programs, see the relevant references.
Taking into account the nature and use of IVDMD For manufacturers of operation quality systems, this standard follows the GB/T 19001 "Quality Management Body
And "YY/T 0287-2003" requirements for regulatory requirements for medical device quality management systems "and" design confirmation "and
"Design changes" section.
In particular, this standard applies to IVDMD to.
- produce evidence of the IVDMD performance evaluation results issued by the manufacturer to the competent authority;
- obtaining adequate performance assessment data through appropriate research or from existing literature;
Meet the requirements of the quality system for design validation.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 19001-2008 Quality management system requirements
Medical Device Quality Management System for Regulatory Requirements YY/T 0287-2003
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Performance Assessment Research Leader co-ordinatorofaperformanceevaluationstudy
Responsible personnel appointed by the manufacturer for the entire IVDMD performance evaluation study.
3.2
Exit dropout
Sample or subject, has been selected as a performance assessment study object, but not as planned.
3.3
Evaluation plan
A description of the performance evaluation study plan.
3.4
Evaluation report
A description of the findings of a performance assessment study.
...
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