GB/T 2639-2008Infusion glass bottles (English PDF)

Foreword

This revised standard adopts ISO 8536-1:2006 "medical infusion apparatus - Part 1. Infusion glass bottles" (in English).

This standard redrafted in accordance with ISO 8536-1.

This standard and ISO 8536-1:2006 is the difference.

--- Remove the ISO 8536-1:2006 preamble and reference standards;

--- Increase the directory with the preface;

--- Increasing the requirements and test methods for the thermal stability of the product;

--- Bottle-shaped product based upon the requirements of the provisions.

This standard replaces GB 2639-1990 "glass infusion bottle." the difference between standard and GB 2639-1990.

--- Cancel the product level requirements;

--- Size only given tolerances, 4.2.2.2 ~ 4.2.2.4 cited GB/T 21299-2007 "glass container tolerance";

--- Type II glass bottle from the water level in line with GB/T 12416.2 in grade 2 or 3 to comply with the requirements of GB/T 12416.2 in Tier 2;

--- Increasing the temperature difference between the thermal shock resistance requirements I type of bottle;

--- Stress requirements to 40nm/mm;

--- Increasing the thickness of the bottom, the bottom of the same thickness and the same bottle than the thickness than required;

--- Canceled a standard Appendix A, Standard Test Method for nominal capacity according to GB/T 20858 regulations were measured.

The standard proposed by China National Light Industry Council.

This standard by the National Standardization Technical Committee household glass (SAC/TC377) centralized.

This standard was drafted. Donghua University, the National Optical glass enamels Quality Supervision and Inspection Center.

1 Scope

This standard specifies the infusion bottle glass product classification, technical requirements, test methods, inspection rules, packaging, labeling, transportation and storage.

This standard applies to the injection of liquid containing a glass infusion bottle.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan (GB/T 2828.1-2003, ISO 2859-1:1999, IDT) GB/T 4546 Glass containers - Internal pressure resistance - Test methods (GB/T 4546-1998, neq ISO 7458. 1989) GB/T 4547 Glass containers - Thermal shock resistance and thermal shock endurance - Test methods (GB/T 4547-2007, ISO 7459:2004, IDT) GB/T 4548 glass container surface water erosion performance test methods and classification (GB/T 4548-1995, eqv ISO 4802-1.

1988)

GB/T 8452 Bolipingguan vertical axis deviation test methods Within the GB/T 12415 pharmaceutical glass container stress testing methods GB/T 12416.2 glass particles at 121 °C water resistance test method and classification (GB/T 12416.2-1990, eqv ISO 720. 1985) Capacity Test Method GB/T 20858 Glass containers with gravimetric method (GB/T 20858-2007, ISO 8106:2004, IDT)

3 Product Categories

3.1 Products by type of glass is divided into type I and II, and should be marked on the bottom of the bottle.

Note. I type glass bottles borosilicate glass. Type II glass bottle of soda lime glass, the inner surface of the bottle should be treated. Type II only for disposable bottles Use of glass infusion bottles.

3.2 product is divided into two by the bottle type A, B.

4 Requirements