JB/T 20175-2017
Aseptic isolators (English Version)

Standard No.
JB/T 20175-2017
Language
Chinese, Available in English version
Release Date
2017
Published By
Professional Standard - Machinery
Latest
JB/T 20175-2017
Scope
This standard specifies the terms and definitions, classification and labeling, requirements, test methods, inspection rules, markings, instructions for use, packaging, transportation and storage of sterile isolators. This standard applies to sterile isolators (hereinafter referred to as "isolators") used in aseptic production and sterility inspection.

JB/T 20175-2017 Referenced Document

  • EJ/T 1096-1999 Containment enclosures: Classification according to leak tightness and associated checking method
  • GB/T 10111 Generation of random numbers and procedures applied to sampling inspection for product quality
  • GB/T 13306 Plates
  • GB/T 13384 General specifications for packing of mechanical and electrical product
  • GB/T 13554-2008 High efficiency particulate air filter
  • GB/T 16292-2010 Test method for airborne particles in clean room(zone) of the pharmaceutical industry
  • GB/T 16293-2010 Test method for airborne microbe in clean room(zone) of the pharmaceutical industry
  • GB/T 16294-2010 Test method for setting microbe in clean room(zone) of the pharmaceutical industry
  • GB/T 16769 Metal-cutting machine tools.Measurement method of sound pressure level
  • GB/T 191 Packaging.Pictorial marking for handling of goods
  • GB/T 24342-2009 Electrical equipment of industrial machines.Continuity of the protective bonding circuit test specifications
  • GB/T 25915.7-2010 Cleanrooms and associated controlled environments.Part 7:Separative devices (clean air hoods,gloveboxes,isolators and minienvironments)
  • GB/T 6388 Transport package shipping mark
  • GB/T 9969 General principles for preparation of instructions for use of industrial products
  • GBZ 2.1 "Occupational Exposure Limits of Hazardous Factors in the Workplace Part 1: Chemical Hazardous Factors" (GBZ 2.1-2019) No. 1 Amendment*2022-11-08 Update
  • GBZ/T 160.32-2004 Methods for determination of oxides in the air of workplace
  • YY/T 0216-1995 Editorial nominating method for the model designation of pharmaceutical machinery

JB/T 20175-2017 history

Aseptic isolators



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