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YY/T 1544-2017 English PDF

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US$239.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1544-2017: Ethylene oxide sterilization safety and effectiveness basic supply requirements
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1544-2017	239	Add to Cart	3 days	Ethylene oxide sterilization safety and effectiveness basic supply requirements	Valid

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Basic data

Standard ID: YY/T 1544-2017 (YY/T1544-2017)
Description (Translated English): Ethylene oxide sterilization safety and effectiveness basic supply requirements
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.01
Word Count Estimation: 12,196
Date of Issue: 2017-05-02
Date of Implementation: 2018-04-01
Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 49
Issuing agency(ies): State Food and Drug Administration

YY/T 1544-2017: Ethylene oxide sterilization safety and effectiveness basic supply requirements

---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.
Ethylene oxide sterilization safety and effectiveness basic supply requirements ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Ethylene oxide sterilization Safety and effectiveness of the basic security requirements 2017-05-02 released 2018-04-01 implementation State Food and Drug Administration released Directory Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Quality Management System 1 5 Management responsibilities 2 6 staff requirements 2 Infrastructure 4 8 working environment 5 9 ethylene oxide sterilization system design 5 10 Environmental Monitoring 7 Appendix A (informative) Physical examination 9

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not have the responsibility to identify these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee disinfection and equipment (SAC/TC200) centralized. The main drafting units of this standard. Shandong Xinhua Medical Devices Co., Ltd., Nanjing minimally invasive medical technology Co., Ltd., the national food and drug Quality Supervision, Inspection and Guangzhou Medical Devices Quality Supervision and Inspection Center, Shandong Weigao Group Medical Polymer Co., Ltd. The main drafters of this standard. Li Shuyong, Xu Honglei, Wang Hongmin, Ding Yanqin, Huang Hongxin, Xu Xingang, Yue Fang name. Ethylene oxide sterilization Safety and effectiveness of the basic security requirements

1 Scope

This standard specifies the Ethylene Oxide sterilization system quality management system, management responsibilities, personnel requirements, infrastructure, work environment, epoxy Ethane sterilization system design, environmental monitoring and other requirements. This standard applies to ethylene oxide sterilization, ethylene oxide sterilization provides a safe and effective basis for protection. This standard does not apply to regulate ethylene oxide sterilizer performance, use and ethylene oxide sterilization process requirements.

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 19001 quality management system requirements (GB/T 19001-2008, ISO 9001.2008, IDT) GB 30000.3 Chemical Classification and Labeling - Part 3. Flammable gases GB 30000.18 Chemical Classification and Labeling Section 18. Acute toxicity GB 50016 architectural design code for fire protection GB 50057 lightning protection design specifications GB 50058 explosion hazardous environment power plant design specifications GB 50116 Automatic Fire Alarm System Design Specification GB 50257 electrical installation explosion and fire hazard electrical installations construction and acceptance criteria YY 0503 ethylene oxide sterilizer YY/T 0822 Sterilization with ethylene oxide liquefied gas

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Ethylene oxide sterilization system ethyleneoxidesterilizationsystem Use of ethylene oxide as a sterilization medium sterilization equipment, facilities, software, including supply, venues and other supporting environment General 3.2 Control area controlarea In ethylene oxide sterilization systems, there is a limit to the concentration of ethylene oxide.

4 quality management system

4.1 General requirements This standard is based on the relevant requirements of GB/T 19001, as well as the relevant laws and regulations, the establishment of ethylene oxide sterilization system quality control ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1544-2017_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1544-2017_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 YY/T 1544-2017_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1544-2017_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.