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GB/T 33418-2016 English PDF

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US$159.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 33418-2016: Test method of chemical indicator for ethylene oxide sterilization processes
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 33418-2016	159	Add to Cart	3 days	Test method of chemical indicator for ethylene oxide sterilization processes	Valid

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Basic data

Standard ID: GB/T 33418-2016 (GB/T33418-2016)
Description (Translated English): Test method of chemical indicator for ethylene oxide sterilization processes
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C50
Word Count Estimation: 8,823
Date of Issue: 2016-12-30
Date of Implementation: 2017-07-01
Quoted Standard: GB/T 19633; ISO 11140-1-2005
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
Summary: This standard specifies the definition, classification, technical requirements and test methods for ethylene oxide sterilization chemical indicators. This standard applies to the inspection of ethylene oxide sterilization chemical indicators.

GB/T 33418-2016: Test method of chemical 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 chemical indicator for ethylene oxide sterilization processes ICS 11.080 C50 National Standards of People's Republic of China Test method for chemical indicators of ethylene oxide sterilization 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 III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Category 1 Technical requirements 2 6 Test Method 2 Appendix A (Normative Appendix) Process Indicator Additional Requirements 4 Appendix B (normative) Additional requirements for sterilization effect indicators in the package 5

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed by the National 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, Jiangsu Province Blood Center, National Health and Family Planning Commission Health and Family Planning Supervision Center, Shandong Province Center for Disease Control and Prevention. The standard drafters. Xu Yan, Wu Xiaosong, Zhang flow, Chen Yueying, Sun Wei, Sun Jun, Duan Yabo, Tan Zhi, Shi Shaoyi, Wang Hongmin, Chu Hongliang, Liu Yunming, Wang Xiaolei, Sun Qihua. Test method for chemical indicators of ethylene oxide sterilization

1 Scope

This standard specifies the definition, classification, technical requirements and test methods for ethylene oxide sterilization chemical indicators. This standard applies to the inspection of ethylene oxide sterilization chemical 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. GB/T 19633 Final sterilization of medical equipment packaging Disinfection technical specifications (2002 edition) Ministry of Health ISO 11140-1..2005 Sterilization of medical products - Chemical indicators - Part 1. General (Sterilization ofhealthcare products-chemicalindicators

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Color reagent indicatoragent Activity [a combination of a substance or an active substance that can undergo a specific change in physical and/or chemical changes under certain conditions]. 3.2 Chemical Indicator Chemicalindicator The developer and its substrate form a desired product in a predetermined form. 3.3 End endpoint By the manufacturer, the visible changes that occur after the indicator is exposed to a predetermined physical and/or chemical condition. 3.4 Parameter value parameter Used to control some (or several) specific values of the ethylene oxide sterilization process, where time, temperature, relative humidity and ethylene oxide concentration are determined Meaning as a key parameter. 3.5 Calibration value statedvalue; SV Set the evaluation parameter value or range of parameter values to cause the indicator to react.

4 classification

4.1 Process indicators This type of chemical indicator is used to confirm the sterilization process. ......

Image

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 33418-2016_English be delivered?

Answer: Upon your order, we will start to translate GB/T 33418-2016_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 33418-2016_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 33418-2016_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.