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YY/T 1403-2017 English PDF

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YY/T 1403-2017: Requirements of contract sterilization using ethylene oxide
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Basic data

Standard ID YY/T 1403-2017 (YY/T1403-2017)
Description (Translated English) Requirements of contract sterilization using ethylene oxide
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.01
Word Count Estimation 14,171
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 38
Issuing agency(ies) State Food and Drug Administration

YY/T 1403-2017: Requirements of contract sterilization using ethylene oxide

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Requirements of contract sterilization using ethylene oxide ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Ethylene oxide subcontracting sterilization requirements 2017-03-28 Posted 2018-04-01 implementation State Food and Drug Administration released Directory Foreword Ⅲ Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Subcontractor sterilization options 1 5 Written agreement between the product manufacturer and the subcontractor 2 6 confirm the program 4 7 Biological Indicators, Process Challenge Devices and Sample Disposal 4 8 sterilization process documents 5 9 routine sterilization process control 6

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 bear the responsibility of identifying 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. This standard was drafted. Shi Jie Medical Technology (Shanghai) Co., Ltd., Terumo medical products (Hangzhou) Co., Ltd., Shandong Granville Group Medical Polymer Co., Ltd., the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Xu Haiying, Hu Changming, Song Xiushan, Lin Yuqing, Yan Yun Qi, Jiayong ago.

Introduction

ISO 11135-1-2007 Sterilization of health products - Ethylene oxide - Part 1. Development, validation and routine maintenance of medical device sterilization processes Requirements for regulatory control (English version) and ISO /T S11135-2.2008 Sterilization of health products - Ethylene oxide - Part 2. ISO 11135-1 Application Guide (English version) is being translated into SAC/TC200 equivalent to China's national standards GB 18279.1 and GB/T 18279.2. AAMI (The Association for the Advancement of Medical Instrumentation) has four standard aims ISO 11135-1-2007 Guide to the use of, respectively. AAMITIR14.2009 ethylene oxide subcontracting sterilization; AAMITIR15.2009 Ethylene oxide sterilization physical requirements; AAMITIR16.2000 Ethylene Oxide Sterilization Requirements; AAMITIR28.2009 Ethylene Oxide Sterilization Product Addition and Process Equivalent. For the better implementation of GB 18279.1, SAC/TC200 has made reference to the above four AAMI standards, According to our national conditions of the industry standards. Among them, the standard reference AAMITIR14.2009 developed, the choice of sub-sterilization sterilization, product manufacturers and sub-sterilization sterilization book Surface protocols, validation procedures, biological indicators, disposal of process challenge devices and samples, sterilization process documentation, routine sterilization process control, etc. Give guidance to facilitate the better implementation of GB 18279.1. Ethylene oxide subcontracting sterilization requirements

1 Scope

This standard specifies the requirements for subcontracting sterilization of ethylene oxide, designed for the implementation of subcontracting sterilization of medical device manufacturers GB 18279.1 provide guidance. Other guidance information can refer to GB/T 18279.2. This standard does not include the medical institutions using ethylene oxide subcontracting sterilization 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. Sterilization of ethylene oxide by GB 18279.1 Healthcare products - Part 1. Development, validation and routine control of sterilization of medical devices (GB 18279.1-2015, ISO 11135-1.2007, IDT) GB/T 18279.2 Sterilization of Healthcare Products - Ethylene Oxide - Part 2. Application Guidance GB 18279.1 (GB/T 18279.2- 2015, ISO 11135-2.2008, IDT) YY/T 1302.2-2015 Physical and microbiological requirements for ethylene oxide sterilization - Part 2. Requirements for microorganisms

3 Terms and definitions

GB 18279.1 and GB/T 18279.2 as defined in the following terms and definitions apply to this document. 3.1 Bacteriostatic/fungistatic test bacteriostasis/fungistasistest Experiments with the selected microorganisms demonstrate whether there are substances that inhibit the multiplication of the microorganisms. 3.2 Subcontractor sterilizer contractterilizer The subcontracting facility is designed to provide subcontracting services for medical devices manufactured by medical device manufacturers. Note. This definition applies to all facilities that provide medical device sterilization services and also to internal sterilization of medical device manufacturers (ie manufacturing and sterilization integration Factory). 3.3 Manufacturer manufacturer Manufacturing, Manufacturing, Assembly and Finished Products, including any form of repackaging, relabeling. 3.4 Verification An evaluation performed to ensure the current operation or suitability of the system.

4 package sterilization business choice

4.1 Evaluation of sterilization sites First, the manufacturer should determine whether to choose the subcontractor sterilization or internal sterilization. Manufacturers should fully understand the choice of sterilization field

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