GB/T 31063-2014 (English Version) PDF

Standard No.: GB/T 31063-2014
Language: Chinese, Available in English version
Release Date: 2014
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 31063-2014

Scope: This standard specifies the chemical requirements and test methods for the extractables from high-pressure water for medicinal bottle stoppers made of butyl rubber. The performance requirements specified in this standard are the minimum requirements for extractables from butyl rubber pharmaceutical bottle stoppers (hereinafter referred to as stoppers) in high-pressure water. This standard does not specify the compatibility research steps of the bottle stopper and the predetermined drug. This standard applies to butyl rubber pharmaceutical bottle stoppers.

GB/T 31063-2014 Referenced Document

ISO 8362-2 Injection containers and accessories*， 2024-03-01 Update
ISO 8362-5 Injection containers and accessories - Part 5: Freeze drying closures for injection vials*， 2016-02-01 Update
ISO 8536-2 Infusion equipment for medical use — Part 2: Closures for infusion bottles*， 2023-01-31 Update
ISO 8536-6 Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles — Amendment 1

2014 GB/T 31063-2014 Extracables in aqueous autoclavates for pharmaceutical closures of butyl rubber