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GB/T 36118-2018Filter elementsof pleated polytetrafluoroethylene microfiltration membrane for gas sterilizing (English PDF)

气体除菌用聚四氟乙烯微滤膜折叠式过滤芯

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

March 15, 2018

Implementation date

October 1, 2018

Scope

GB/T 36118-2018 is the English-translated version of 气体除菌用聚四氟乙烯微滤膜折叠式过滤芯.

GB/T 36118-2018 covers pleated filter cartridges made of polytetrafluoroethylene (PTFE) microfiltration membrane that are used to sterilize gases.

It sets out their classification and the requirements for appearance, bacterial retention, leakage, integrity, resistance, the number of steam sterilization cycles withstood, hot air resistance and oxidant resistance, each with its own test method.

It also gives the inspection rules, with batching, exit-factory and type inspection, and the rules for marking, packaging, transport and storage. Informative annexes relate bubble point pressure, diffusion flow and water intrusion to bacterial challenge levels and give an example of the hot air resistance test.

The standard applies to gas-sterilizing pleated PTFE filter cartridges and can also be used for other gas-sterilizing filters built with pleated PTFE microfiltration membrane. It was issued on 15 March 2018 and has applied since 1 October 2018.

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Document preview — GB/T 36118-2018

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

Preface
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and Definitions
3.2 Abbreviations
4 Category
5 Request
5.1 Appearance
5.2 Bacterial Retention
5.3 Leakage
5.4 Integrity
5.5 Resistance
5.6 steam sterilization times
5.7 Hot Air Resistance
5.8 Oxidant Resistance
6 Test method
6.1 appearance
6.2 Bacterial Retention
6.3 Leakage
6.4 Integrity
6.5 Resistance
6.6 steam sterilization times
6.7 Hot Air Resistance
6.8 Oxidant Resistance
7 Inspection Rules
7.1 Batch Rules
7.2 Inspection Classification
7.3 Factory Inspection
7.4 Type Inspection
8 Identification, Packaging, Transport and Storage
8.1 Logo
8.2 Packaging
8.3 Transportation and Storage
Appendix A (informative annex) Bubble point pressure and bacterial challenge level
Appendix B (informative annex) Diffusion flow and bacterial challenge levels
Appendix C (informative annex) Water intrusion and bacterial challenge levels
Appendix D (Informative) Test Example of Hot Air Resistance Test
Reference

Foreword

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

1 Scope

This standard stipulates the classification, requirements, test methods, and inspection rules for PTFE microfiltration membrane folded filter cartridges (hereinafter referred to as "filter cartridges"). Then, identification, packaging, transportation and storage.

This standard applies to gas sterilizing folded PTFE micro filter cartridge filter cartridge, also applicable to gas sterilization with folded PTFE Allen microfiltration membrane filter.

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 version (including all amendments) applies to this document.

GB/T 191 packaging, storage and transportation logo

GB/T 6165-2008 HEPA filter performance test method efficiency and resistance

GB/T 7141-2008 Thermal aging test method for plastics

YY/T 0918-2014 Liquid filtration membrane, liquid filter, bacterial retention test method

YY/T 1551.1-2017 Air filter for infusion and blood transfusion apparatus - Part 1. Aerosol bacterial retention test method

Pharmacopoeia of the People's Republic of China (2015 edition)

3 Terms, definitions and abbreviations

3.1 Terms and Definitions

The following terms and definitions apply to this document.

3.1.1 Folded filter element

A flat-plate microfiltration membrane is a filter element formed in a folded form.

3.1.2 Cartridge filter

A cylindrical filter element consisting of a filter membrane and other structural materials and that is used in conjunction with the housing through an interface. [GB/T 34244-2017, definition 3.1.2]

3.1.3 Capsule filter

A capsule filter element consisting of a filter membrane and other structural materials with a plastic housing on the outside. [GB/T 34244-2017, definition 3.1.3]

3.1.4 Log reduction value

Under the specified conditions, the common logarithm of the ratio of the number of microorganisms before filtration to the filtered liquid or gas to the number of filtered microorganisms.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

GB/T 42525-2023Technical specification for microfiltration membrane sterilizing system

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