JB/T 20010-2017_English: PDF (JB/T20010-2017)
| Standard ID | USD | BUY PDF | Lead-Days | Standard Title (Description) | Status |
| JB/T 20010-2017 | 209 |
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3 days
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Pharmaceutical universal mixer
| Valid |
| JB 20010-2004 | 479 |
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3 days
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[JB/T 20010-2004] Three dimensional motions mixer
| Obsolete |
| Standard ID | JB/T 20010-2017 (JB/T20010-2017) | | Description (Translated English) | Pharmaceutical universal mixer | | Sector / Industry | Mechanical & Machinery Industry Standard (Recommended) | | Classification of Chinese Standard | C92 | | Classification of International Standard | 11.120.30 | | Word Count Estimation | 9,91 | | Date of Issue | 2017-11-07 | | Date of Implementation | 2018-04-01 | | Older Standard (superseded by this standard) | JB/T 20010-2004 | | Quoted Standard | GB/T 191; GB 5226.1-2008; GB/T 6388; GB/T 9969; GB/T 10111; GB/T 12309; GB/T 13306; GB/T 13384; GB/T 16769; GB/T 24342-2009; JB/T 20188-2017 | | Regulation (derived from) | Ministry of Industry and Information Technology Bulletin 2017 No. 48 | | Issuing agency(ies) | Ministry of Industry and Information Technology of the People Republic of China | | Summary | This standard specifies the marking, requirements, test methods, inspection rules, signs, packaging, instructions for use, transportation and storage of medicinal universal mixers. |
JB/T 20010-2017
(Medicinal universal mixer)
ICS 11.120.30
C92
Record number. 60770-2018
People's Republic of China pharmaceutical machinery industry standard
Replace JB 20010-2004
Medicinal universal mixer
Released on.2017-11-07
2018-04-01 implementation
Ministry of Industry and Information Technology of the People's Republic of China
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009 "Standardization Work Guide Part 1. Standard Structure and Compilation".
Revision of JB 20010-2004 "3D Mixer".
This standard replaces JB 20010-2004 "3D Mixer".
Compared with JB 20010-2004, this standard changes the following main technical contents except for editorial changes.
--- Remove the cleanliness after cleaning, see Appendix B (see 6.4 of.2004 edition);
--- Revised the cleanliness after cleaning to a chemical residue content of not more than 10μm/g (see 4.2.2;.2004 version 5.4);
--- Revise the method for testing the roughness of the barrel inside and outside for the roughness meter and the roughness sample comparison method (see 5.2.3;.2004)
Version 6.3);
--- Mixing uniformity M should be not less than 99%. Amended as. the content uniformity of the mixer should comply with the Pharmacopoeia of the People's Republic of China
(2015 edition) Four [General] "Content uniformity inspection method" (see 4.3.9);
--- Increased mixing time should be able to be set and displayed (see 4.3.3);
--- Increased the safety of the mixer machine (see 4.3.7).
This standard was proposed by the Pharmaceutical Equipment Industry Association.
This standard is under the jurisdiction of the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356).
This standard was drafted. Zhejiang Xiaolun Pharmaceutical Machinery Co., Ltd.
The main drafters of this standard. Wang Yuan, Yang Jun, Luo Wei.
The previous versions of the standards replaced by this standard are.
---JB 20010-2004.
Medicinal universal mixer
1 Scope
This standard specifies the marking, requirements, test methods, inspection rules, signs, packaging, instructions for use, transportation of medicinal universal mixers.
And storage.
This standard applies to medicinal universal mixers (hereinafter referred to as mixers).
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 edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB 5226.1-2008 Mechanical electrical safety machinery and electrical equipment - Part 1. General technical conditions
GB/T 6388 transport packaging receipt and delivery mark
GB/T 9969 General guidelines for the use of industrial products
GB/T 10111 Generation of Random Numbers and Its Application in Product Quality Sampling Inspection
GB/T 12309 industrial corn starch
GB/T 13306 signage
General technical conditions for GB/T 13384 mechanical and electrical product packaging
GB/T 16769 metal cutting machine noise noise level measurement method
GB/T 24342-2009 Industrial machinery electrical equipment protective earthing circuit continuity test specification
JB/T 20188-2017 Pharmaceutical machinery product model preparation method
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 mark
3.1 Model preparation
Prepared according to the provisions of JB/T 20188-2017.
Category code. pharmaceutical machinery and equipment
Function code. mixing machine
Feature code. universal
Specification code. Mixed barrel nominal volume (L)
3.2 Tag example
Example. ZHW1000. A medicinal universal mixer with a nominal volume of 1000L.
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