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 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 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