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JB/T 20104-2007Tablet hardness testers (English PDF)

片剂硬度仪

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Issued by

MIIT

Level / Type

Industry · Recommended

Issue date

November 14, 2007

Implementation date

May 1, 2008

Scope

JB/T 20104-2007 is the English-translated version of 片剂硬度仪.

JB/T 20104-2007 is the Chinese standard "Tablet hardness testers". Its scope clause reads: 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). Its clauses include signs, packaging, transportation and storage.

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Document preview — JB/T 20104-2007

National Standard of the People's Republic of China

Issued by: Ministry of Industry and Information Technology of the People's Republic of China

Contents

  • Foreword3
  • 1 Scope4
  • 2 Normative references4
  • 3 Terms and definitions5
  • 4 Marks5
  • 5 Requirements5
  • 6 Test methods7
  • 7 Inspection rules9
  • 8 Signs, packaging, transportation and storage11

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;

c) Packing list;

d) Other documents (such as supporting documents to the instrument).

8.3 Transportation

Transportation is according to the specifications of order contract. The hardness testers shall be firmly fixed on the transport means during transportation. Tumbling is forbidden.

8.4 Storage

After packaged, hardness tester shall be stored in dry, ventilated, no-corrosive-gas indoor place.

______________________ […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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