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Issued by
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Level / Type
National · Recommended
Issue date
February 24, 2016
Implementation date
September 1, 2016
Scope
GB/T 2637-2016 (Ampoules) is available as an English-translated PDF.
GB/T 2637-2016 — This standard specifies the dimensions, product markings, technical requirements, test methods, inspection rules and signs, packaging, transportation and Storage.
This standard applies to disposable color rings and point nicks foldable glass ampoules.
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Document preview — GB/T 2637-2016
National Standard of the People's Republic of China
- ICS
- 81.040.01
- Classification
- N 64
- Replacing
- GB 2637-1995
Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Specifications and Product Markings
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 2637-1995 "Amphoe." the main differences between this standard and GB/T 2637-1995 are as follows.
--- Specifications have been modified;
--- Change the breaking force value;
--- Increased flatness requirements and inspection methods after fracture;
--- Increased requirements and test methods for water resistance of granular methods;
--- Increased type inspection requirements;
--- Increased requirements for arsenic, antimony, lead and cadmium elution and test methods;
--- Increased inspection level and acceptance quality limit.
This standard uses the redrafted law reference ISO 9187-1:2010 "Medical injection equipment - Part 1. Ampoules for injections" and ISO 9187-2:2010 "Medical Injection Equipment Part 2. Puncture Ampoules" preparation, and ISO 9187-1:2010 and ISO 9187-2.
The consistency of 2010 is not equivalent.
This standard is proposed by China Light Industry Federation.
This standard is under the jurisdiction of the National Glass Instrument Standardization Technical Committee (SAC/TC178).
1 Scope
This standard specifies the dimensions, product markings, technical requirements, test methods, inspection rules and signs, packaging, transportation and Storage.
This standard applies to disposable color rings and point nicks foldable glass ampoules.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 191 packaging, storage and transportation logo GB/T 2828.1 Count Sampling Inspection Procedures Part 1. Batch Inspection Sampling Plans Retrieved by Acceptance Quality Limit (AQL) GB/T 4548 Test method and classification of water-resistant erosion performance of inner surface of glass containers GB/T 6543 single corrugated cartons and double corrugated cartons for transport and packaging GB/T 12414 medical glass tube GB/T 12415 medical glass container internal stress test method Test method and classification of GB/T 12416.2 glass particles at 121°C water resistance GB/T 21170 Determination of lead and cadmium elution from glass containers GB/T 35595 Determination of arsenic and antimony dissolution in glass containers
3 Specifications and Product Markings
Specifications shall comply with the provisions of Figure 1, Figure 2 and Table 1.
Note. See Table 1 for the remaining dimensions.
Figure 1 color ring easy to fold
Note. See Table 1 for the remaining dimensions.
Figure 2 Dot Scratches
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 2828.1Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- GB/T 4548Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Determination by titration and classification
- GB/T 6543Single and double corrugated boxes for transport packages
- GB/T 12415Pharmaceutical glass containers glassware stress examination methods
- GB/T 12416.2Glass. Hydrolytic resistance of glass grains at 121 Celsius. Test method and classification
GB/T 12414 · GB/T 21170
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Related Standards
GB/T 12415-2015 — Pharmaceutical glass containers glassware stress examination methods
GB/T 12416.2-1990 — Glass. Hydrolytic resistance of glass grains at 121 Celsius. Test method and classification
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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GB/T 2637-2016
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