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JB/T 20135-2011Automatic ampoule injection impurity detecting machine (English PDF)

安瓿注射液异物自动检查机

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Issued by

MIIT

Level / Type

Industry · Recommended

Issue date

May 18, 2011

Implementation date

August 1, 2011

Scope

JB/T 20135-2011 is the English-translated version of 安瓿注射液异物自动检查机.

Ampoule inspection equipment is the subject of JB/T 20135-2011, a recommended Chinese machinery industry standard for automatic machines that check injection solutions in ampoules for foreign matter.

It sets the marking, the requirements, the test methods and the inspection rules for these machines, and it covers the signs, the instruction brochure, the packaging, the transport and the storage.

The machines in scope detect visible foreign particles in filled ampoules from a stated size upwards. The standard was issued by the Ministry of Industry and Information Technology and is classified C92 in China and 11.120.30 internationally.

Its normative references include GB/T 191, GB 2637, GB 5226.1-2008, GB/T 6388, GB/T 9969, GB/T 10111, GB/T 13306, GB/T 13384, GB/T 16769 and YY/T 0216-1995.

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Document preview — JB/T 20135-2011

National Standard of the People's Republic of China

ICS: 11.120.30

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

Foreword
Scope
Normative references
About this standard
Classification and status

1 Foreword

JB/T 20135-2011 was issued by MIIT on 18 May 2011 and has been in force since 1 August 2011.

2 Scope

Ampoule inspection equipment is the subject of JB/T 20135-2011, a recommended Chinese machinery industry standard for automatic machines that check injection solutions in ampoules for foreign matter. It sets the marking, the requirements, the test methods and the inspection rules for these machines, and it covers the signs, the instruction brochure, the packaging, the transport and the storage. The machines in scope detect visible foreign particles in filled ampoules from a stated size upwards. The standard was issued by the Ministry of Industry and Information Technology and is classified C92 in China and 11.120.30 internationally. Its normative references include GB/T 191, GB 2637, GB 5226.1-2008, GB/T 6388, GB/T 9969, GB/T 10111, GB/T 13306, GB/T 13384, GB/T 16769 and YY/T 0216-1995.

3 Normative references

JB/T 20135-2011 cites the following standards, which apply in full or in part through the references made to them in its clauses.

GB/T 191

GB 2637

GB 5226.1-2008

GB/T 6388

GB/T 9969

GB/T 10111

GB/T 13306

GB/T 13384

GB/T 16769

YY/T 0216-1995 — Method for compiling model designations of pharmaceutical machinery products

4 About this standard

Issued by: MIIT

English translation: about 15 pages

5 Classification and status

International classification (ICS): 11.120.30

Prefix JB/T: recommended standard.

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

Referenced standards

Normative references

GB 2637 · GB 5226.1-2008

Similar standards

JB/T 20153-2013|GB/T 33468-2016|JB/T 20151-2013|JB/T 20150-2012|YY 0259.1-1997|YY 0259.2-1997

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