YY/T 1441-2016 (English Version) PDF

Scope: This standard applies to the performance evaluation of in vitro diagnostic medical devices (hereinafter referred to as IVD MD), including self-testing of in vitro diagnostic medical devices. This standard specifies the manufacturer's responsibilities and general requirements for study planning, conduct, evaluation, and documentation during performance evaluation studies. This standard does not apply to evaluation protocols for a specific IVD MD or for a specific use. Considering the nature and purpose of IVD MD, this standard follows the requirements of GB/T 19001 "Quality Management System Requirements" and YY/T 0287-2003 "Medical Device Quality Management System for Regulations" for manufacturers operating quality systems. The “Design Validation” and “Design Changes” sections described above. In particular, this standard applies to IVD MD to: 　——present evidence to the competent authority of the IVD MD performance evaluation results published by the manufacturer; 　——obtain sufficient performance evaluation data through appropriate studies or from existing literature; satisfy Quality system requirements for design validation.

YY/T 1441-2016 Referenced Document

GB/T 19001-2008 Quality management systems.Requirements
YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes

2016 YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices