GB/T 34244-2017Technical code for liquid sterilizing-grade filter elements (English PDF)
液体除菌用过滤芯技术要求
This is a limited preview
Buy now to download the full PDF (24 pages)
Need quotation for your management?
Get a formal quotation for GB/T 34244-2017 in 30 minutes.
Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
September 7, 2017
Implementation date
April 1, 2018
Scope
GB/T 34244-2017 is the English-translated version of 液体除菌用过滤芯技术要求.
GB/T 34244-2017 is the Chinese standard "Technical code for liquid sterilizing-grade filter elements". Its scope clause reads: This standard specifies the technical requirements, test methods, inspection rules, labeling, packaging, Transport and storage.
This standard applies to the filter aperture is not greater than 0.22µm liquid sterilization grade cartridge filter and capsule filter. Its clauses include terms and definitions, abbreviations.
Found what you need?
Document preview — GB/T 34244-2017
National Standard of the People's Republic of China
- ICS
- 71.120
- Classification
- J 77
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions, Abbreviations
- 3.1 Terms and definitions
- 3.2 Abbreviations
- 4 Requirements
- 4.1 Appearance
- 4.2 Biosafety
- 4.3 Extractable mass
- 4.4 bacterial retention capacity
- 4.5 Integrity
- 4.6 flux
- 4.7 steam sterilization times
- 4.8 maximum operating pressure
- 4.9 cleanliness
- 4.10 Endotoxin release
- 5 test methods
- 5.1 Appearance
- 5.2 Biosafety
- 5.3 Extractable quality
- 5.4 bacteria retention capacity
- 5.5 Integrity
- 5.6 flux
- 5.7 steam sterilization
- 5.8 Maximum operating pressure
- 5.9 cleanliness
- 5.10 Endotoxin release
- 6 Inspection rules
- 6.1 test classification
- 6.2 factory inspection
- 6.3 type test
- 7 Identification, Packaging, Transport and Storage
- 7.1 logo
- 7.2 Packaging
- 7.3 Transport and storage
- Appendix B (informative) flux test results calculation
- References
1 Scope
This standard specifies the technical requirements, test methods, inspection rules, labeling, packaging,
Transport and storage.
This standard applies to the filter aperture is not greater than 0.22µm liquid sterilization grade cartridge filter and capsule filter.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 14233.2-2005 Medical infusion, transfusion, injection apparatus test methods Part 2. Biological test methods
GB/T 16886.12-2005 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples
GB/T 20878 stainless steel and heat-resistant steel grades and chemical composition
YY/T 0918 liquid filtration membrane, liquid filter bacterial retention test method
The People's Republic of China Pharmacopoeia.2015 edition
3 Terms and Definitions, Abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this document.
3.1.1 Pore poresize
Filter pore size characterized by specific microbial retention.
3.1.2 Cartridge filter
A cylindrical filter element consisting of a filter and other structural materials that mates with the housing through an interface.
3.1.3 Capsule filter
Capsule filter element made of filter membrane and other structural materials and externally with a plastic housing.
3.1.4 Extractables
Under extreme conditions (such as organic solvents, extreme high temperatures, ionic strength, pH, contact time, etc.), the extract from the filter all the material
Contact surface extraction of chemical components.
3.1.5 Logreductionvalue
Under specified conditions, the filtered liquid was filtered before the number of microorganisms and the number of microorganisms after filtration than the common logarithm.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download GB/T 34244-2017
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 10003-2026 — Biaxially oriented polypropylene (BOPP) film
GB/T 10004-2026 — Plastic/Plastic laminated films and pouches for packaging
GB/T 10007-2026 — Rigid cellular plastics - Determination of shear properties
Secure payment via Stripe
Payments accepted
GB/T 34244-2017
$415.00