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

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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.