GB/Z 136-2026Medical laboratories - Reagents for staining biological specimen - Guidance for users (English PDF)

Foreword

This document is a standard or guiding technical document.

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents". Drafting.

This document is modified to adopt ISO /T S17518.2015 "User Guide to Reagents for Staining Biomaterials in Medical Laboratories". Document type.

The technical specifications from ISO have been adjusted to my country's national standardization guidance technical documents.

The technical differences between this document and ISO /T S17518.2015, and the reasons therefor, are as follows.

---ISO 15189:2012 (see 4.1, 6.1, ISO /T S17518) has been replaced by the normatively referenced GB/T 22576.1-2026.

(4.1 and 6.1 of 2015), to maintain the document's advanced nature;

---The normative reference YY/T 0639 replaces ISO 19001 (see 4.1, 5.3.2, and 4.1 of ISO /T S17518.2015). 5.3.2), to facilitate domestic use;

---The term "medical device" (see section 3.21 of ISO /T S17518.2015) has been removed to avoid conflict with domestic regulations;

---The term "specimen" (see 3.22, 3.29 of ISO /T S17518.2015) has been changed to be applicable to anatomical pathology (AP);

---The term "sample" (see 3.29 of ISO /T S17518.2015) has been deleted; the term is described in note 3.22. The following editorial changes have been made to this document.

---The standard name has been changed to "User Guide to Reagents for Staining Biological Specimens in Medical Laboratories".

Introduction

This document is based on YY/T 0639 "Information provided by manufacturers of in vitro diagnostic medical devices for in vitro diagnostic reagents used in biological staining".

The document, titled "Information," describes the use of commercially available in vitro diagnostic reagents specifically designed for in vitro diagnostic testing in medical laboratories, and the procedures for conducting in vitro diagnostic experiments. The corresponding procedures for preparation.

This document describes the staining agents, solutions, and developers that laboratories need to obtain from suppliers and vendors when performing in vitro diagnostic biological staining.

Information on other reagents used for biological staining is also provided, along with guidance on their use. This information is intended for professional users in biological staining laboratories.

1 Scope

This document provides requirements and guidelines for the selection and quality assessment of biological staining reagents for in vitro diagnostics.

This document applies to medical laboratories using specialized biological staining reagents, especially in medical laboratory disciplines such as clinical cytology and hematology.

Requirements and evaluation of reagents used in pathology, microbiology and molecular biology.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.

GB/T 22576.1-2026 Requirements for the quality and competence of medical laboratories - Part 1: General requirements (ISO 15189. 2022, IDT)

YY/T 0639 Information provided by manufacturers of in vitro diagnostic medical devices for in vitro diagnostic reagents used in biological staining (YY/T 0639-2019,ISO 19001:2013,IDT)

3 Terms and Definitions

The following terms and definitions apply to this document.