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Codes of making and using for quality control serum of HIV antibody
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Basic data
| Standard ID | SN/T 3951-2014 (SN/T3951-2014) |
| Description (Translated English) | Codes of making and using for quality control serum of HIV antibody |
| Sector / Industry | Commodity Inspection Standard (Recommended) |
| Classification of Chinese Standard | C27 |
| Classification of International Standard | 11.120 |
| Word Count Estimation | 10,133 |
| Date of Issue | 4/9/2014 |
| Date of Implementation | 11/1/2014 |
| Quoted Standard | GB 19489; JJG 1006 |
| Regulation (derived from) | State inspection certification (2014) 210 |
| Issuing agency(ies) | General Administration of Customs |
| Summary | This standard specifies the HIV antibody quality control preparation, use and storage methods serum. This standard applies to the inspection and quarantine authorities for preparing and using HIV antibody quality control serum. |
Similar standards
GB/T 41907|SN/T 2632|
SN/T 3951-2014: Codes of making and using for quality control serum of HIV antibody
---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.
Codes of making and using for quality control serum of HIV antibody
People's Republic of China Entry-Exit Inspection and Quarantine Standards
HIV antibody quality control procedures for preparing and using serum
Issued on. 2014-04-09
2014-11-01 implementation
People's Republic of China
The State Administration of Quality Supervision, Inspection and Quarantine released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard was drafted. People's Republic of China Guangdong Entry Inspection and Quarantine Bureau, People's Republic of China Beijing Entry-Exit Inspection and
Quarantine Bureau.
The main drafters of this standard. Lvjie Yi, Dai Jun, Wang Shuxiang, Ding Guoyun and Interrelationship Lu Lin, Hezhen Yi, red.
HIV antibody quality control procedures for preparing and using serum
1 Scope
This standard specifies the HIV antibody quality control preparation, use and storage methods serum.
This standard applies to the inspection and quarantine authorities for preparing and using HIV antibody quality control serum.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 19489 General requirements for laboratory biosafety
JJG1006 a standard substance
Disinfection technical specifications (formerly People's Republic of China Ministry of Health)
National AIDS testing specification (Chinese Center for Disease Control and Prevention)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Control serum qualitycontrolserum
Samples for quality control purposes.
3.2
Uniformity homogeneity
With one or more properties of the material associated with the same structure or composition of the state. By measuring from different packing units (such as.
Sample bottles, bags, etc.) or from the same packaging unit, the specific size measurements fall within the specified range of uncertainty can be considered standard
The amount of the material properties of the specified uniform.
3.3
Room bottle uniformity between-bottlehomogeneity
Characteristics of standard material between the bottle and the bottle variation.
Note. The term "inter-bottle uniformity" applicable to other types of packaging (such as vials) and other physical shape and test pieces.
3.4
Stability of stability
Under certain time and storage conditions, the magnitude of the standard material properties to maintain capacity within the predetermined range.
3.5
Open bottle stability bottle-unsealedstability
Stability under specific storage conditions after opening the standard properties of substances. (bottles, packages and other such) packaging unit.
3.6
Long-term stability of the long-termstability
In the standard reference material producers to stability properties of matter under storage conditions.
...