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YY/T 0639-2019: In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
Status: Valid YY/T 0639: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0639-2019 | English | 319 |
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In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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YY/T 0639-2019
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| YY/T 0639-2008 | English | 639 |
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In Vitro Diagnostic Medical Devices. Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
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YY/T 0639-2008
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PDF similar to YY/T 0639-2019
Basic data | Standard ID | YY/T 0639-2019 (YY/T0639-2019) | | Description (Translated English) | In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 16,185 | | Date of Issue | 2019 | | Date of Implementation | 2020-08-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies requirements for information provided by manufacturers for reagents used for biological staining. This standard applies to manufacturers, suppliers and retailers of dyes, stains, chromogenic reagents and other stains for histology and cytology (microbiology, hematology, histochemistry). These reagents are used for routine staining in medical laboratories, as well as in all areas of biological staining for microbiological research. The requirements for information provided by the manufacturer, as specified in this standard, are a prerequisite for obtaining referable and reproducible results. This standard replaces YY/T 0639-2008 "In Vitro Diagnostic Medical Device Manufacturers Information for In Vitro Diagnostic Reagents for Biological Staining". | YY/T 0639-2019: In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
---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.
(In vitro diagnostic medical device Information provided by the manufacturer for in vitro diagnostic reagents for biological staining)
ICS 11.040.55
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0639-2008
In vitro diagnostic medical device manufacturer is biological
Information from in vitro diagnostic reagents for scientific staining
(ISO 19001..2013, IDT)
Published on July 24,.2019
2020-08-01 implementation
Published by the State Drug Administration
Contents
Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Manufacturer's request for information 3
4.1 General requirements 3
4.2 Additional requirements for special reagents 4
Appendix A (informative) Examples of information provided by manufacturers' (biostaining) reagents6
References 11
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 EN375 and EN376 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).
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the Standardization Technical Committee for In vitro Diagnostic Systems (SAC/TC136).
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Du Haiou, Yang Zhong, Dai Leiying.
The previous versions of the standards replaced by this standard are.
--- YY/T 0639-2008.
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.
In vitro diagnostic medical device manufacturer is biological
Information from in vitro diagnostic reagents for scientific staining
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 article
Pieces. 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.
3.1
Antibody
Specific immunoglobulins produced by B-lymphocytes stimulated by immunogenic substances and capable of binding to immunogenic substances.
Note. The molecule of immunogenic substance contains one or more parts with unique chemical composition, namely epitope.
3.2
Blockingreagent
Reagents used to reduce the inherent background of the sample before staining.
3.3
Chromogenicreagent
Reagent that reacts with specific chemical groups existing or induced in cells and tissues to produce colored complexes in situ.
Example. Diazonium salt, Schiff reagent.
3.4
Dye
Colored organic compounds can color a substance when dissolved in a suitable solvent.
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