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GBZ2640-2021: Injection vials made of moulded glass
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| GB/Z 2640-2021 | English | 389 |
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Injection vials made of moulded glass
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GB/Z 2640-2021
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Basic data | Standard ID | GB/Z 2640-2021 (GB/Z2640-2021) | | Description (Translated English) | Injection vials made of moulded glass | | Sector / Industry | National Standard | | Classification of Chinese Standard | N64 | | Word Count Estimation | 18,155 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GBZ2640-2021: Injection vials made of moulded glass---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.
GB /Z 2640-2021
Injection vials made of moulded glass
ICS 81.040.01
CCSN64
National Standardization Guiding Technical Documents of the People's Republic of China
Replace GB/T 2640-1990
Molded injection bottle
(ISO 8362-4.2011,Injectioncontainersandaccessories-
Released on 2021-10-11
2022-05-01 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces GB/T 2640-1990 "Molded Antibiotic Glass Bottles". Compared with GB/T 2640-1990, except for structural adjustment and compilation
In addition to the editorial changes, the main technical changes are as follows.
---Change the scope of application of this document (see Chapter 1, Chapter 1 of the.1990 edition);
---The normative references have been changed (see Chapter 2, Chapter 2 of the.1990 edition);
---Added terms and definitions (see Chapter 3);
---C type bottle has been added (see Chapter 4);
---Deleted the grade of the product (see 3.2 in the.1990 edition);
--- Changed the technical requirements for sutures, stones, and bubbles (see 5.1.4, 5.1.5, 5.1.6, 5.2.3, 5.2.4, and 5.2.5 of the.1990 edition);
---Increase the linear thermal expansion coefficient, lead, cadmium, arsenic, antimony leaching amount, 121℃ granular water resistance and borosilicate glass molded injection bottle three
Diboron oxide content, 98°C granular method water resistance, acid resistance, and alkali resistance requirements (see 5.2);
--- Changed the internal stress requirements (see 5.2, 5.1.4 of the.1990 edition);
---Change the limit deviation of the specification size (see 5.3, 4.1 in the.1990 edition);
---Deleted the size classification and appearance quality classification (7.1.2 of the.1990 edition);
---Added physical and chemical performance test methods (see 6.2);
---The factory inspection rules are changed (see 7.2.2, 7.1.2 of the.1990 edition);
--- Type inspection has been added (see 7.4);
---Added the lightweight index measurement method (see Appendix D).
This document uses the redrafting method to modify and adopt ISO 8362-4.2011 "Injection Containers and Accessories Part 4.Molded Injection Bottles".
Compared with ISO 8362-4.2011, this document has many adjustments in structure. Appendix A shows the difference between this document and ISO 8362-4.2011.
The chapter number comparison list.
Compared with ISO 8362-4.2011, this document has technical differences. Appendix B gives a list of corresponding technical differences and their reasons.
The following editorial changes have been made to this document.
---Revised the standard name to "Molded Injection Bottle";
---Informative Appendix C has been added.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents.
This document was proposed by the China National Light Industry Council.
This document is under the jurisdiction of the National Glass Instrument Standardization Technical Committee (SAC/TC178).
This document was drafted by. Shandong Pharmaceutical Glass Co., Ltd., Beijing Pharmaceutical Packaging Material Inspection Institute.
The main drafters of this document. Song Yijuan, Yuan Chunmei, Yuan Hengxin, Liang Ye, Wang Xingjun.
The previous releases of this document and the documents it replaced are as follows.
---First published in 1981 as GB/T 2640-1981 "Molded Antibiotic Glass Bottles";
---The first revision in.1990 was GB/T 2640-1990 "Molded Antibiotic Glass Bottles";
---This is the second revision.
Molded injection bottle
1 Scope
This document specifies the terms and definitions, product classification, technical requirements, test methods, inspection rules and signs, packaging,
Transportation and storage.
This document applies to molded injection bottles for injections.
2 Normative references
The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations
Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
This document.
GB/T 191 Packaging, Storage and Transportation Graphic Mark (GB/T 191-2008, ISO 780.1997, MOD)
GB/T 2828.1 Sampling Inspection Procedures by Attributes Part 1.Batch Inspection Sampling Plan Retrieved by Acceptance Quality Limit (AQL)
(GB/T 2828.1-2012, ISO 2859-1.1999, IDT)
GB/T 4546 Test method for internal pressure resistance of glass containers (GB/T 4546-2008, ISO 7458.2004, IDT)
GB/T 4548 The test method and classification of the water erosion resistance of the inner surface of glass containers (GB/T 4548-1995, eqvISO 4802-1.
1988)
GB/T 6579 Laboratory glass instrument thermal shock and thermal shock strength test method (GB/T 6579-2007, ISO 718.
1990, IDT)
GB/T 6580 Test method and classification of corrosion resistance of glass with boiling mixed alkali aqueous solution (GB/T 6580-1997, eqvISO
695.1991)
GB/T 6581 Flame emission or atomic absorption spectrometric method for determination of resistance to hydrochloric acid attack on glass at 100℃ (GB/T 6581-
2007, ISO 1776.1985, MOD)
GB/T 6582 Particle test method and classification of water resistance of glass at 98℃ (GB/T 6582-1997, eqvISO 719.1985)
GB/T 8452 Vertical axis deviation test method for glass bottles and cans (GB/T 8452-2008, ISO 9008.1991, MOD)
GB/T 12416.2 Test method and classification of water resistance of glass particles at 121℃
GB/T 15726 Test method for internal stress of glass instruments
GB/T 15728 Weight test method and classification of resistance to boiling hydrochloric acid for glass
GB/T 16920 Determination of the average linear thermal expansion coefficient of glass (GB/T 16920-2015, ISO 7991.1987, NEQ)
GB/T 28194 Determination of double-line normal thermal expansion coefficient of glass
GB/T 28209 Chemical analysis method for borosilicate glass
GB 31604.24 National Food Safety Standard Determination of Cadmium Migration in Food Contact Materials and Products
GB 31604.34 National Food Safety Standard Determination of Lead in Food Contact Materials and Products and Determination of Migration Amount
GB/T 35595 Method for determination of arsenic and antimony elution from glass containers
3 Terms and definitions
The following terms and definitions apply to this document.
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