YY/T 0639-2019In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (English PDF)

Foreword

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

This standard uses the translation method equivalent to ISO 19001.:2013 "In vitro diagnostic medical device manufacturers for in vitro diagnosis of biological staining Information provided by Broken Reagents.

This standard replaces YY/T 0639-2008 "In vitro diagnostic medical device manufacturers for in vitro diagnostic reagents for biological staining information".

Compared with YY/T 0639-2008, the main technical changes of this standard are as follows.

--- Modified the description of the scope (see Chapter 1);

--- Modified the content of normative references, replacing EN 375 and EN 376 with GB/T 29791.1 and GB/T 29791.2 (see chapter 2);

--- Revised terms and definitions, all of which were described in accordance with GB/T 29791.1 and GB/T 29791.2 (see Chapter 3);

--- Added "Warnings and Cautions" (see 4.1.2);

--- Added "Information format provided by the manufacturer" (see 4.1.3);

--- Added a footnote "10% neutral buffered formalin (NBF) is usually used in China, pH 7.2 ~ 7.4" (see A.2.4.1);

--- Delete the "immunohistochemical demonstration of estrogen receptors" (see A.4 of the 2008 edition);

--- Delete the "T-lymphocyte flow cytometry demonstration" (see A.5 of the 2008 edition).

Introduction

This standard is related to GB/T 29791.1 and GB/T 29791.2 and should be used in conjunction with both.

The reagents required for biological staining and the two staining procedures provided by the manufacturer in Appendix A are specific examples in accordance with Europe The opinions adopted are based on; the European side gives a scientific and reasonable explanation for the manufacturer's request for information. This information can help Manufacturers, suppliers, and retailers of toners, stains, luminescent reagents, and other reagents for biological staining comply with specific product information.

1 Scope

This standard specifies requirements for information provided by manufacturers for reagents for biological staining.

This standard applies to dyes, stains, chromogenic reagents, and other histological and cytological staining (microbiology, hematology, tissue Producers, suppliers, and retailers. These reagents are used for routine staining in medical laboratories, and for biological staining in microbiological research Color in all areas. The requirements for manufacturers to provide information specified in this standard are prerequisites for obtaining reference and reproducible results.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.

GB/T 19001 Quality Management System Requirements

GB/T 29791.1-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1. Terms, definitions and General requirements (ISO 18113-1.:2009, IDT)

GB/T 29791.2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostics for professional use Breaking reagent (ISO 18113-2.:2009, IDT)

YY/T 0287 Medical device quality management system for regulatory requirements

ISO 80000-1, Quantitiesandunits-Part 1. General

ISO 80000-9, Quantitiesandunits-Part 9. Physicalchemistryandmolecularphysics

3 Terms and definitions

The following terms and definitions apply to this document.