YY/T 1463-2016 English PDF

US$139.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1463-2016: Sterilization validation of medical device. Guidance on selecting a microbial challenge and inoculation sites
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1463-2016	139	Add to Cart	3 days	Sterilization validation of medical device. Guidance on selecting a microbial challenge and inoculation sites	Valid

Similar standards

YY 1277   YY/T 1623   YY/T 1302.1   YY/T 1957   YY/T 1464   

Basic data

Standard ID: YY/T 1463-2016 (YY/T1463-2016)
Description (Translated English): Sterilization validation of medical device. Guidance on selecting a microbial challenge and inoculation sites
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.01
Word Count Estimation: 7,755
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Quoted Standard: GB 18279.1-2015; GB 18281.1-2015
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration
Summary: This standard applies to medical device manufacturers for sterilization confirmation tests, and not for routine sterilization tests. This standard does not apply to microbiological challenges or contamination processes in the confirmation or disinfection of medical device cleaning effects.

YY/T 1463-2016: Sterilization validation of medical device. Guidance on selecting a microbial challenge and inoculation sites

---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.
Sterilization validation of medical device.Guidance on selecting a microbial challenge and inoculation sites ICS 11.080.01 C47 People's Republic of China Pharmaceutical Industry Standard Sterilization of medical devices Selection of microbiological challenges and guidelines for bacteria 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

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. Guangzhou Yang Pu Medical Technology Co., Ltd., Taier Mao Medical Products (Hangzhou) Co., Ltd., Shi Jie medical technology (Shanghai) Co., Ltd., Nanjing minimally invasive Medical Technology Co., Ltd., the State Food and Drug Administration Guangzhou medical equipment quality supervision and inspection center. The main drafters of this standard. Xu Honglei, Weng Hui, Xu Xinggang, Xu Haiying, Miao Xiaolin, Zhou Zhilong. Sterilization of medical devices Selection of microbiological challenges and guidelines for bacteria

1 Scope

This standard selects the appropriate microbiological challenge for the sterilization confirmation process, the appropriate site of the bacteria, the method of infection, and the recovery of the bacteria Of the technology to provide the appropriate guide. This standard applies to medical device manufacturers for sterilization confirmation tests, and not for routine sterilization tests. This standard does not apply to microbiological challenges or contamination processes in the confirmation or disinfection of medical device cleaning effects.

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 18279.1-2015 Sterilization of health care products Ethylene oxide - Part 1. Development, validation and identification of sterilization processes for medical devices Conventional control requirements Health care products - Sterilization - Biological indicators - Part 1. General rules GB 18281.1-2015

3 terms and definitions

GB 18279.1 and GB 18281.1 and the following terms and definitions apply to this document. 3.1 Biological indicator A specific test system for a specific sterilization process. 3.2 Bacterial vector inoculatedcarrier A specific number of viable test microorganisms are contained on or in a particular material. 3.3 Stained liquid Suspension suspension Contains the liquid of the surviving test microorganism. Note. Normally, the two phrases of the bacterial suspension and the stained bacteria can be used. 3.4 Substrate Substrate Microbial challenge process, the product or carrier contact with the bacterial suspension site.

4 Microbiological Challenge Types and Selection Criteria

4.1 When selecting specific microbes and bacteria for microbiological challenges, consider the following principles. ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1463-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1463-2016_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 YY/T 1463-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1463-2016_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.