GB/T 19381-2015 (English Version) PDF

Standard No.: GB/T 19381-2015
Language: Chinese, Available in English version
Release Date: 2015
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 19381-2015
Replace: GB/T 19381-2003

Scope: This standard specifies the physical performance index requirements and test methods for butyl rubber medicinal stoppers used with pharmaceutical bottles when they are punctured by injection needles or infusion puncture devices. This standard applies to butyl rubber pharmaceutical bottle stoppers.

GB/T 19381-2015 Referenced Document

GB 15811 Sterile hypodermic needles for single use*， 2016-06-14 Update
ISO 8362-1 Injection containers and accessories - Part 1: Injection vials made of glass tubing*， 2018-07-31 Update
ISO 8362-3 Injection containers and accessories - Part 3: Aluminium caps for injection vials
ISO 8362-4 Injection containers and accessories - Part 4: Injection vials made of moulded glass
ISO 8362-6 Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials
ISO 8536-1 Infusion equipment for medical use - Part 1: Infusion glass bottles
ISO 8536-3 Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles — Amendment 1*， 2022-06-16 Update
ISO 8536-7 Infusion equipment for medical use - Part 7: Caps made of aluminium-plastics combinations for infusion bottles

2015 GB/T 19381-2015 Physical function requirements and testing for pharmaceutical closures of butyl rubber
2003 GB/T 19381-2003 General methods of test for medical closures of butyl rubber