GB/T 31995-2015 English PDF

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GB/T 31995-2015: Sterilization of health care products -- Radiation -- Substantiation of a selected sterilization dose method VDmax
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 31995-2015	1159	Add to Cart	8 days	Sterilization of health care products -- Radiation -- Substantiation of a selected sterilization dose method VDmax	Valid

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Basic data

Standard ID: GB/T 31995-2015 (GB/T31995-2015)
Description (Translated English): Sterilization of health care products -- Radiation -- Substantiation of a selected sterilization dose method VDmax
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: F54
Classification of International Standard: 27.120.99
Word Count Estimation: 55,559
Date of Issue: 2015-09-11
Date of Implementation: 2016-04-01
Regulation (derived from): National Standard Announcement 2015 No.25
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 31995-2015: Sterilization of health care products -- Radiation -- Substantiation of a selected sterilization dose method VDmax

---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 of health care products - Radiation - Substantiation of a selected sterilization dose method VDmax ICS 27.120.99 F54 National Standards of People's Republic of China Radiation Sterilization of health care products Confirmed that the selected method of sterilization dose VDmax Issued on. 2015-09-11 2016-04-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions Definition 4 product family and holding 2 5 Development and validation of the sterilization dose in the choice of products and experiment 4 6 VDmax method - confirm selected sterilization dose 6 7 sterilization dose audit 10 8 Use VDmax proven method to increase the sterilization dose of 12 9 Working Example 12 Appendix A (informative) verification dose, SIP dose reduction factor, VDmaxSD dose of added value lookup table 15

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard proposed by China National Nuclear Corporation. This standard by the National Standardization Technical Committee on Nuclear Energy (SAC/TC58) centralized. This standard was drafted. Beijing Radiation Application Research Center, the gold irradiation Co., Ltd., Suzhou in East China nuclear radiation Co., Beijing Air Materiel Biam tech Co., Ltd., Beijing Science and Technology Development Co., Ltd. Tyco Mann, Jiangsu amounted to win accelerator Manufacturing Co., Jiangsu Reddy Health and Technology Co. (Nanjing radiation center), China Isotope and Radiation Processing Industry Association Professional Committee of radiation. The main drafters. Zhang Yue, SHEN Ling, Chunlei, Wang Jianchang, Guo Shiyuan, who's livelihood, Li Tong, in the East Xin, Zhang Jinyu, Zhao Yan, Zhu Nankang, left all text, Zhao Yongfu, Wang Bao-chang, Chen Yong.

Introduction

This standard and GB 18280-2015 "Radiation Sterilization of health care products," combination. Health care products sterilization dose selection It is covered by the GB 18280-2015 contents. In GB 18280.2-2015 using proven methods VDmax 25kGy and 15kGy selected as the sterilization dose. This standard GB 18280.2-2015 also provides a proven method of sterilization dose series; the same time the standard of GB 18280.2-2015 feed Line extensions, including a dose of 15kGy, 17.5kGy, 20kGy, 22.5kGy, 25kGy, 27.5kGy, 30kGy, 32.5kGy and 35kGy; each has its own specific sterilization dose average bioburden range. This standard is described in a simple dose proven method, that is, by a selected sterilization dose (e.g. VDmax25 method selected Given 25kGy) to verify that the sterility assurance level (SAL) 10-6 of. This method is not the production batch size or frequency limit System, and the number of units in the irradiated product verification dose experiment remains unchanged. This method GB 18280.2-2015 Method 1 are the same as Resistance to standard distribution (SDR) basis. This standard by the basic principles of assessment and application of computer simulation, the results of this method of sterilization dose proven to be safe and available A clear result. This standard constitute the principles and methods specific VDmax preset with GB 18280.2-2015 Method 1 dose setting phase like. The main difference is the number of product units used in the verification dose experiments. In computer simulations, the value of the change validation SAL Confirm the results have little effect, so the 10 units as a sample product amount was selected for the subsequent scope of the assessment, and ultimately as a sampling plan principle. Radiation Sterilization of health care products Confirmed that the selected method of sterilization dose VDmax

1 Scope

This standard specifies the radiation sterilization of health care products to make a sterility assurance level of 10-6 selected sterilization dose and dose confirmation Audit methods. This standard applies to the entire product unit, in line with the average bioburden average bioburden range of selected doses required for medical care product.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 18280.1-2015 Radiation Sterilization of health care products - Part 1. Development of medical equipment sterilization process, validation and routine Control requirements GB 18280.2-2015 Sterilization of health care products - Radiation - Part 2. Establish sterilization dose GB/T 18280.3-2015 Radiation Sterilization of health care products - Part 3. Dose Measurement Guide Microbiological sterilization method GB/T 19973.1 medical devices - Part 1. Total estimated microorganisms Learn sterilization methods - Part 2 microorganisms GB/T 19973.2 medical devices. sterility test confirmed the sterilization process Requirements YY/T 0287 medical device quality management system for regulatory

3 Terms and Definitions

GB 18280.1-2015, GB 18280.2-2015 and GB/T 18280.3-2015 and as defined in the following terms and definitions apply In this document. 3.1 Medical Devices medicaldevice The human body is designed to achieve the following intended purpose of the apparatus, equipment, apparatus, in vitro diagnostic reagents and calibrators, and other similar materials or Related items, including computer software required. --- Disease diagnosis, prevention, monitoring, treatment or mitigation; --- Injury diagnosis, monitoring, treatment, mitigation or compensation; --- Physical structure or physiological process of inspection, replacement, or adjustment support; --- Support or sustain life; --- Control of conception; --- Disinfection or sterilization of medical devices; --- Based on a sample from the body for inspection, provide information for medical or diagnostic purposes. NOTE. Medical Devices, mainly through acoustic, optical, electrical and other physical get in the way, not by pharmacological, immunological or metabolic get in the way, though, or However, there are ways to participate, but these only play a supporting role. ......

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