YY/T 1479-2016 English PDF

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YY/T 1479-2016: Sterility test method for membrane filters
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1479-2016	179	Add to Cart	3 days	Sterility test method for membrane filters	Valid

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Basic data

Standard ID: YY/T 1479-2016 (YY/T1479-2016)
Description (Translated English): Sterility test method for membrane filters
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Word Count Estimation: 9,982
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration

YY/T 1479-2016: Sterility test method for membrane filters

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Sterility test method for membrane filters ICS 11.080.99 C47 People's Republic of China Pharmaceutical Industry Standard Sterile Test Method for Film Filtration 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Test conditions 1 5 Test method for sterility 2

6 culture and observation

7 judgment 4 Appendix A (informative) Preparation of media and detection of medium 5

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200) centralized. The standard drafting unit. Hangzhou Tailin Biotechnology Equipment Co., Ltd., the State Food and Drug Administration Guangzhou Medical Equipment Quality Supervision Supervisory center. The main drafters of this standard. Zhao Zhenbo, Huang Xiulian, Gao Kaifei, Xia Xinqun, Miao Xiaolin. Sterile Test Method for Film Filtration

1 Scope

This standard specifies sterile film filtration as used in the production, testing or other treatment of medical products and as a final product Aseptic test method. NOTE. Filtration of the membrane is not applicable to the twisted or partially oversized membrane filter.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T.19973.2-2005 Sterilization methods for medical devices - Part 2. Sterility test for confirmation of sterilization (ISO 11737-2..1995, IDT) YY/T 0567.1-2013 Sterile processing of health care products - Part 1. General requirements (ISO 13408-1..2008 IDT) Pharmacopoeia of the People's Republic of China

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Membrane filter membranefilter For the use of liquid impurities, sterilization, microbial limit inspection or sterility inspection and other purposes of the diaphragm, and other pre-installed filter or filter can be installed Of the filter device. 3.2 Sterility test sterilitytest Under the given culture conditions, the test used to determine whether there is a viable microorganism on the product unit.

4 test conditions

4.1 water Unless otherwise stated, the water involved should comply with the relevant provisions of the Purified Water in the Pharmacopoeia of the People's Republic of China. 4.2 medium The preparation of the culture medium and the examination of the culture medium are given in Appendix A. 4.3 conditions for aseptic testing of film filters The conditions for aseptic testing should include the following. a) test in a controlled environment; For example. in the B-class clean area A-level unidirectional air area, aseptic isolation system; YY/T 0567.1-2013 ......

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