GB 9706.8-1995
Replaced
JB/T 20190-2018
Active
Industry standards-Mechanical
JB/T 20190-2018 Inner sealed infusion bag/bottle Blow-Fill-Seal(BFS)integrated machine
JB/T 20190-2018 Inner sealed infusion bag/bottle Blow-Fill-Seal(BFS)integrated machine
Basic Information
Standard Code:
JB/T 20190-2018
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Pharmaceutical processing machinery and equipment
ICS Name:
Medical equipment
Publish Date:
2018-07-04
Implement Date:
2019-01-01
Pages:
13 pages
Scope
This standard specifies the terms and definitions, abbreviations, markings, requirements, test methods, inspection rules, labels, user manuals, packaging, transportation, and storage of integrated machines for the blowing, filling, and sealing (BFS) of inner-sealed infusion bags (bottles). This standard applies to integrated machines for the blowing, filling, and sealing (BFS) of inner-sealed infusion bags (bottles) (hereinafter referred to as "integrated machines").
Development Information
Referenced Standards
GB 5226.1-2008 Electrical safety of machinery—Electrical equipment of machines—Part 1:General requirements
GB/T 16292-2010 Test method for airborne particles in clean room (zone) of the pharmaceutical industry
JB/T 20188-2017 Method of type symbolization for pharmaceutical machinery product
YBB 00012002-2015
YY/T 0114-2008 Polyethylene material for manufacture of infusion,transfusion and injection equipments for medical use
YY/T 0242-2007 Polypropylene material for manufacture of infusion,transfusion and injection equipments for medical use
《药品生产质量管理规范》(2010年修订)中华人民共和国卫生部
中华人民共和国药典(2015年版)
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 6388-1986 Transport package shipping mark
GB/T 9969-2008 General principles for preparation of instructions for use of industrial products
GB 9969.1-1998 General principles for preparation of instructions for use of industrial products
GB/T 10111-1988 Methods for random sampling by utilizing dices of random number
GB/T 10111-2008 Generation of random numbers and procedures applied to sampling inspection for product quality
GB/T 13306-1991 Plates
GB/T 13306-2011 Plates
GB/T 13384-1992 General specifications for packagings of mechanical and electrical products
GB/T 13384-2008 General specifications for packing of mechanical and electrical product
GB/T 16769-1997 Metal-cutting machine tools—Measurement method of sound pressure level
GB/T 16769-2008 Metal-cutting machine tools—Measurement method of sound pressure level
YBB 00022002-2015 PP Infusion Bottles
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
GB 11235-1997
Replaced
GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced