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GB/T 2637-2016: Ampoules
Status: Valid GB/T 2637: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 2637-2016 | English | 199 |
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3 days [Need to translate]
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Ampoules
| Valid |
GB/T 2637-2016
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| GB 2637-1995 | English | 599 |
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3 days [Need to translate]
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Ampoule
| Obsolete |
GB 2637-1995
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| GB 2637-1990 | English | RFQ |
ASK
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3 days [Need to translate]
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Ampoule
| Obsolete |
GB 2637-1990
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PDF similar to GB/T 2637-2016
Basic data | Standard ID | GB/T 2637-2016 (GB/T2637-2016) | | Description (Translated English) | Ampoules | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | N64 | | Classification of International Standard | 81.040.01 | | Word Count Estimation | 10,185 | | Date of Issue | 2016-02-24 | | Date of Implementation | 2016-09-01 | | Older Standard (superseded by this standard) | GB 2637-1995 | | Regulation (derived from) | National Standard Announcement No | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | GB/T 2637-2016: Ampoules---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.
Ampoule
ICS 81.040.01
N64
National Standards of People's Republic of China
Replacing GB 2637-1995
ampoule
[ISO 9187-1.2010, Injection equipment for medical use-
Published on.2016-02-24
2016-09-01 Implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Administration released
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).
This standard is drafted by. Chengdu Plain Pharmaceutical Packaging Co., Ltd., Beijing Pharmaceutical Packaging Materials Inspection Institute.
The main drafters of this standard. Ping Yuyan, Guo Rong, Fan Junying, Yuan Chunmei, Liang Ye.
The previous versions of the standards replaced by this standard are.
--- GB/T 2637-1981, GB/T 2637-1990, GB 2637-1995.
ampoule
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
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