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YY/T 1608-2018 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.
YY/T 1608-2018: Radiation sterilization of medical device--Sampling method for verification dose experiments and sterilization dose audits
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1608-2018	279	Add to Cart	3 days	Radiation sterilization of medical device--Sampling method for verification dose experiments and sterilization dose audits	Valid

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Basic data

Standard ID: YY/T 1608-2018 (YY/T1608-2018)
Description (Translated English): Radiation sterilization of medical device--Sampling method for verification dose experiments and sterilization dose audits
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.01
Word Count Estimation: 14,189
Date of Issue: 2018-06-26
Date of Implementation: 2019-07-01
Regulation (derived from): State Drug Administration Announcement No. 40 of 2018
Issuing agency(ies): State Drug Administration

YY/T 1608-2018: Radiation sterilization of medical device--Sampling method for verification dose experiments and sterilization dose audits

---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.
Radiation sterilization of medical device--Sampling method for verification dose experiments and sterilization dose audits ICS 11.080.01 C47 People's Republic of China Pharmaceutical Industry Standard Medical device radiation sterilization Sampling method for verification dose test and sterilization dose review Radiation sterilizationationmedicaldevice-Samplingmethodforverificationdose Published on.2018-06-26 2019-07-01 implementation State Drug Administration issued

Content

Foreword I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Validation dose test and sample size for sterilization dose establishment/dose review 2 Appendix A (Normative Appendix) Sample size for the implementation of the sampling plan and sampling plan 10 Reference 11

Foreword

This standard was 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 issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200). This standard was drafted. Shanghai Jinpengyuan Irradiation Technology Co., Ltd., Shanghai Fuxin Irradiation Technology Co., Ltd., Guangdong Medical Device Quality Volume Supervision and Inspection Institute. The main drafters of this standard. Liu Zhiwei, Chen Qiang, Huang Deqiu, Xie Chunyuan, Zhang Dingyan, Xu Haiying, Gao Yang, Fan Xiang, Li Weiming. Medical device radiation sterilization Sampling method for verification dose test and sterilization dose review

1 Scope

This standard specifies an improved method for sterilization dose selection and review in GB 18280.2-2015, which ensures that the product is achieved. At the same time as the sterility assurance level is expected, the number of required product units can be reduced, and the verification dose test and the sterilization dose review are described. Sample plan. This standard applies to the selection and review of sterilization doses in GB 18280.2-2015 to ensure that the product meets the expected sterility assurance level. sampling.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 18280.1-2015 Sterilizing radiation for health care products - Part 1. Development, validation and routines Control requirements (ISO 11137-1.2006, IDT) GB 18280.2-2015 Sterilizing radiation for health care products - Part 2. Establishing a sterilizing dose (ISO 11137-2.2006, IDT) GB/T.19973.2-2005 Microwaveological methods for the sterilization of medical devices - Part 2 (ISO 11737-2.1998, IDT)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Increasing dose augmentation Measures to increase the sterilization dose based on the results of the sterilization dose audit. 3.2 Bioburden The total number of viable microorganisms on the surface and/or inside of the product and/or sterile barrier system. 3.3 False positive falsepositive The turbidity of the test results is explained by the fact that the product or product share has microbial growth, while the microbial growth is due to contamination by foreign microorganisms. The resulting or turbidity is the result of mutual influence of the product or product share and the test medium. 3.4 Product unit A single medical device, product collection or component within a primary package. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1608-2018_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1608-2018_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 1608-2018_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1608-2018_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.