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JB/T 20104-2007

Chinese Standard: 'JB/T 20104-2007'
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Detail Information of JB/T 20104-2007; JB/T20104-2007
Description (Translated English): Hardness tester
Sector / Industry: Mechanical & Machinery Industry Standard (Recommended)
Classification of Chinese Standard: C95
Classification of International Standard: 11.120.30
Word Count Estimation: 11,116
Date of Issue: 2007-11-14
Date of Implementation: 2008-05-01
Quoted Standard: GB/T 191; GB 5226.1-2002; GB/T 6388; GB/T 13306; GB/T 13384; GB/T 14710; YY/T 0216
Drafting Organization: Tianjin Science and Technology Co., Ltd. big day
Administrative Organization: Pharmaceutical Equipment Industry Standardization Technical Committee
Regulation (derived from): NDRC Notice No. 77 of 2007
Summary: This standard specifies the tablet hardness tester terms and definitions, marking, requirements, test methods, inspection rules and signs, packaging, transport and storage. This standard applies to pharmaceutical tablet hardness measuring motor-driven digital display instrument (hereinafter referred to as hardness tester).

JB/T 20104-2007
ICS 11.120.30
C 95
Filing ID. 22188-2007
JB
Pharmaceutical Machinery Industry Standard
of the People’s Republic of China
Hardness tester
片剂硬度仪
ISSUED ON. NOVEMBER 14, 2007
IMPLEMENTED ON. MAY 1, 2008
Issued by. National Development and Reform Committee
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Marks ... 5
5 Requirements ... 5
6 Test methods ... 7
7 Inspection rules ... 9
8 Signs, packaging, transportation and storage ... 11
Foreword
This Standard is formulated according to "Good manufacture practice of drugs",
and standardization working directive requirements of GB/T 1.1-2000 and
GB/T 1.2-2002.
This Standard is formulated according to the relevant specifications of GB
5226.1-2002 "Safety of machinery - Electrical equipment of machines - Part 1.
General requirements" and GB/T 14710 "The environmental requirements and
test methods for medical electrical equipment", so as to ensure the
performance quality and safety of products.
This Standard was proposed by China Pharmaceutical Equipment Industry
Association.
This Standard shall be administrated by Pharmaceutical Equipment Industry
Standardization Technical Committee.
Main drafting organization of this Standard. Tianjin Tianda Tianfa Technology
Co., Ltd..
Main drafters of this Standard. Gao Yucheng, Su Lin, Wang Zhaowu, Luo
Shijin, and Ye Hongyu.
Hardness tester
1 Scope
This Standard specifies the terms and definitions, marks, requirements, test
methods, inspection rules and signs, packaging, transportation and storage of
hardness tester.
This Standard applies to the motor-driven digital display instruments used to
measure the hardness of pharmaceutical tablets (hereinafter referred to as
hardness tester).
2 Normative references
The provisions in following documents become the provisions of this Standard
through reference in this Standard. For dated references, the subsequent
amendments (excluding corrections) or revisions do not apply to this Standard,
however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 5226.1-2002 Safety of machinery - Electrical equipment of machines -
Part 1. General requirements
GB/T 6388 Transport package shipping mark
GB/T 13306 Plates
GB/T 13384 General specifications for packing of mechanical and electrical
product
GB/T 14710 The environmental requirements and test methods for medical
electrical equipment
YY/T 0216 Editorial nominating method for the model designation of
pharmaceutical machinery
8 Signs, packaging, transportation and storage
8.1 Signs
8.1.1 The plates shall comply with the specifications of GB/T 13306. The
contents of plates are as follows.
a) Name of manufacturer;
b) Product name and model;
c) Trademark;
d) Production serial number and date;
e) Power supply voltage and maximum power;
f) Implemented standard ID.
8.1.2 Pictorial signs of packaging, storage and transportation shall comply with
the specifications of GB/T 191. There shall be signs such as "Fragile",
"Keep-up", "Keep dry", "No rolling".
8.1.3 Signs of transportation and shipping shall comply with the specifications
of GB/T 6388.
8.2 Packaging
8.2.1 The packaging of products shall comply with the specifications of GB/T
13384.
8.2.2 The following documents shall be within the package of tester.
a) Product certificate;
b) Product instructions;
Related standard:   JB/T 20105-2007  JB/T 20178-2017
   
 
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