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GB/T 36138-2018Flat-plate microfiltration membrane of polytetrafluoroethylene for sterilizing (English PDF)

除菌用聚四氟乙烯平板式微滤膜

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

May 14, 2018

Implementation date

December 1, 2018

Scope

GB/T 36138-2018 is the English-translated version of 除菌用聚四氟乙烯平板式微滤膜.

GB/T 36138-2018 deals with hydrophobic polytetrafluoroethylene (PTFE) flat microfiltration membranes used to sterilize gases or liquids, with an average thickness of 20 µm to 90 µm and a pore diameter not above 0.22 µm.

It sets the classification of the membranes and requirements for appearance, width and relative thickness deviation, tensile strain, heat shrinkage, air permeability, bacterial retention capacity and bubble point pressure.

The matching test methods, sampling and conditioning are given, followed by inspection rules with factory and type tests, and the marking, packing, transport and storage of the filter membranes.

An informative annex relates bubble point pressure to the bacterial challenge level. Membrane makers and filter manufacturers use it to qualify their products. It was issued on 14 May 2018 and has applied since 1 December 2018.

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Document preview — GB/T 36138-2018

National Standard of the People's Republic of China

ICS
71.120; 23.100.60
Classification
J 77

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms, definitions and abbreviations
  • 3.1 Terms and Definitions
  • 3.2 Abbreviations
  • 4 Category
  • 5 Requirements
  • 5.1 Appearance
  • 5.2 Width deviation
  • 5.3 Relative thickness deviation
  • 5.4 tensile strain
  • 5.5 heat shrinkage rate
  • 5.6 Air permeability
  • 5.7 Bacterial retention capacity
  • 5.8 Bubble point pressure
  • 6 Test method
  • 6.1 Sampling General Requirements
  • 6.2 Condition adjustment environment and test environment
  • 6.3 Appearance
  • 6.4 Width deviation
  • 6.5 Relative thickness deviation
  • 6.6 Tensile strain
  • 6.7 Thermal shrinkage rate
  • 6.8 Air permeability
  • 6.9 Bacterial retention capacity
  • 6.10 Bubble point pressure
  • 7 Inspection rules
  • 7.1 Group Batch Rule
  • 7.2 Inspection Category
  • 7.3 Factory inspection
  • 7.4 Type test
  • 8 Identification, packaging, transportation and storage
  • 8.1 Mark
  • 8.2 Packing
  • 8.3 Transportation
  • 8.4 Storage
  • Appendix A (informative) Correlation between bubble point pressure and bacterial challenge level
  • Appendix B (informative) Test data record table
  • Reference

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the classification, requirements, test methods and inspection rules for hydrophobic polytetrafluoroethylene flat microfiltration membranes (hereinafter referred to as "filter membranes"). Then, label, package, transport and store.

This standard is applicable to hydrophobic polytetrafluoroethylene flat microfiltration membrane for gas or liquid sterilization with an average thickness of 20µm~90µm and a pore diameter of not more than 0.22µm.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 191 packaging storage and transportation icon

GB/T 1040.1-2006 Determination of tensile properties of plastics - Part 1. General

Determination of tensile properties of plastics - Part 3. Test conditions for films and sheets

Standard environment for GB/T 2918 plastic sample conditioning and testing

GB/T 5453 Determination of the permeability of textile fabrics

GB/T 6672-2001 Plastic film and sheet thickness measurement - Mechanical measurement

GB/T 6673-2001 Determination of length and width of plastic films and sheets

GB/T 10003-2008 general purpose biaxially oriented polypropylene (BOPP) film

YY/T 0918-2014 Test method for bacterial retention of liquid filtration membrane and liquid filter

Air filters for infusion and blood transfusion devices - Part 1. Methods

Air filters for infusion and blood transfusions - Part 3. Integrity test method

3 Terms, definitions and abbreviations

3.1 Terms and definitions

The following terms and definitions apply to this document.

3.1.1 PTFE flat membrane

A flat sheet or film made of a polytetrafluoroethylene dispersion resin, which has a microporous shape by biaxial stretching or other methods. Flat membrane.

3.1.2 Lateral direction

The width direction of the film roll.

3.1.3 Longitudinal direction

The direction in which the film roll is unfolded.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

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