YY/T 1403-2017 (YY/T1403-2017, YYT 1403-2017, YYT1403-2017) & related versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | See Detail | Status | Similar PDF |
| YY/T 1403-2017 | English | 279 |
Add to Cart
|
3 days
|
Requirements of contract sterilization using ethylene oxide
|
YY/T 1403-2017
| Valid |
YYT 1403-2017
|
YY/T 1403-2017: PDF in English (YYT 1403-2017)
YY/T 1403-2017
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 range 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
......
| 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 | 14,162 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Shi Jie Medical Technology (Shanghai) Co., Ltd., Terumo medical products (Hangzhou) Co., Ltd., Shandong Weigao Group Medical Polymer Co., Ltd., the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC 200) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
|