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GB/T 33419-2016 English PDF

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US$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 33419-2016: Test method of biological indicator for ethylene oxide sterilization processes
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 33419-2016	279	Add to Cart	3 days	Test method of biological indicator for ethylene oxide sterilization processes	Valid

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Basic data

Standard ID: GB/T 33419-2016 (GB/T33419-2016)
Description (Translated English): Test method of biological indicator for ethylene oxide sterilization processes
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C50
Classification of International Standard: 11.080
Word Count Estimation: 14,138
Date of Issue: 2016-12-30
Date of Implementation: 2017-07-01
Regulation (derived from): National Standard Notice No.27 of 2016
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China

GB/T 33419-2016: Test method of biological indicator for ethylene oxide sterilization processes

---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.
Test method of biological indicator for ethylene oxide sterilization processes ICS 11.080 C50 National Standards of People's Republic of China Ethylene oxide sterilization - Biological test method 2016-12-30 release 2017-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Management Committee released Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 technical requirements 2 5 test method 3 Appendix A (Normative Appendix) Resistance Tester Requirements and Resistance Tests 4 Appendix B (Normative Appendix) Method for counting viable culture 5 Appendix C (Normative Appendix) Survival Curve Method for Determining D Values 6 Appendix D (normative) Partial negative analysis for the determination of D values Appendix E (normative) Verification of D value 10

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and centralized by the Health and Family Planning Commission of the People's Republic of China. The drafting of this standard. Jiangsu Provincial Center for Disease Control and Prevention, China Center for Disease Control and Prevention, Environmental and Health Related Products Safety, National Health and Family Planning Commission Health and Family Planning Supervision Center, Xuzhou City Center for Disease Control and Prevention. Standard drafters. Xu Yan, Sun Jun, Wu Xiaosong, Chen Yueying, Zhang Runbo, Duan Yabo, Shi Shaoyi, Wang Hongmin, Huang Jingxiong, Tan Zhi, Zhang Jian, Wang Ling, Sun Wei, Zhang Wei, Chu Hongliang, Chang Guiqiu. Ethylene oxide sterilization - Biological test method

1 Scope

This standard specifies the terms and definitions of ethylene oxide sterilization biological indicators, technical requirements and test methods. This standard applies to the detection of ethylene oxide sterilization biological indicators.

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. Health care products - Sterilization - Biological indicators - Part 1. General rules GB 18281.1 GB 18281.2 Sterilization products for health care products - Part 2. Biological indicators for sterilization of ethylene oxide GB/T 24628 Sterilization products for medical and health products - Test equipment for biological and chemical indicators Disinfection technical specifications (2002 edition) Ministry of Health

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Biological indicator biologicalindicator; BI The specific sterilization procedures under the specified conditions have a certain resistance, and installed in the inner packaging available in the bacteria carrier. Contains bacteria tablets And self-contained biological indicators. 3.2 Carrier carrier Test the support of microbes. 3.3 Indicating microbial testorganism Microorganisms for the preparation of vector carriers. 3.4 Viable count viabletestorganismcount The amount of viable bacteria contained in the sample such as bacterial suspension, bacteria carrier and the like was determined under the prescribed culture conditions. By calculating the growth of a single bacteria And the number of viable bacteria in the suspension of the unit volume or the bacteria on the carrier. 3.5 D value Dvalue In the set conditions, kill the number of microorganisms up to 90% of the time required. Note. The unit is min (min). 3.6 Survival curve survivorcurve Under the set conditions, the survival of microbes and the changes in exposure to sterilization media curve. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 33419-2016_English be delivered?

Answer: Upon your order, we will start to translate GB/T 33419-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 33419-2016_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 33419-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.