GB/T 4506-1984
Abolished
GB/T 35511-2017
Active
National standards
GB/T 35511-2017 Biological requirements and test methods for closures of butyl rubber
GB/T 35511-2017 Biological requirements and test methods for closures of butyl rubber
Basic Information
Standard Code:
GB/T 35511-2017
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Rubber products for medical and food industry use
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2017-12-29
Implement Date:
2018-07-01
Pages:
9 pages
Scope
This standard specifies the biological performance requirements and test methods for butyl rubber bottle stoppers.
This standard applies to pharmaceutical bottle stoppers (hereinafter referred to as "bottle stoppers") made primarily from butyl rubber as the main material.
Development Information
Referenced Standards
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
Adopt standards
ISO 8871-4:2006
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced