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YY/T 1267-2015 PDF English

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YY/T 1267-2015: Evaluation of materials of medical device subject to ethylene oxide sterilization
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Basic data

Standard ID YY/T 1267-2015 (YY/T1267-2015)
Description (Translated English) Evaluation of materials of medical device subject to ethylene oxide sterilization
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.01
Word Count Estimation 13,180
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Quoted Standard GB/T 16886.1; GB 18279; YY 0503; YY/T 0822; YY/T 0884-2013
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies) State Food and Drug Administration
Summary This Standard specifies the material selection, design and processing, materials testing. Ethylene oxide sterilization for the selection of material provides evaluation guidelines adaptability. This Standard applies to the use of ethylene oxide sterilization of medical devices for material evaluation.

YY/T 1267-2015: Evaluation of materials of medical device subject to ethylene oxide sterilization




---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.
Evaluation of materials of medical device subject to ethylene oxide sterilization ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Suitable for ethylene oxide sterilization of medical devices Material Evaluation Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Table of Contents

Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Material Selection 2 5 product design and processing 3 6 Material Testing 4 Appendix A (informative) compatibility with the ethylene oxide sterilization particular material 5 Reference 9

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized. This standard was drafted. Hangzhou gifted Nick disinfection Equipment Co., Ltd., the State Food and Drug Administration of Quality Supervision, Guangzhou Medical Devices Inspection Center, Guangzhou Improve Medical Technology Co., Ltd. The main drafters of this standard. Lu Wenjuan, Huang Xiulian, Zhou Qingqing, Xu Gang. Suitable for ethylene oxide sterilization of medical devices Material Evaluation

1 Scope

This standard specifies the material selection, design and processing, materials testing. Ethylene oxide sterilization for the selection of material suitability reviews guide. This standard applies to the use of ethylene oxide sterilization of medical devices for material evaluation. Note. The contents of the standard general information designed to provide guidance for the successful implementation of material appraisal. This standard should not be grounds, in the use of materials not into Line suitable material identification.

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/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test GB 18279 ethylene oxide sterilization of medical devices Validation and routine control YY 0503 ethylene oxide sterilizers YY/T 0822 liquefied gas sterilization with ethylene oxide Material Evaluation YY/T 0884-2013 suitable for radiation sterilization of health care products

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Accelerated aging acceleratedaging Medical equipment stored at high temperature and/or other strengthening environmental conditions to simulate real-time within a short period of time the process of aging. 3.2 Biocompatible material materialbiocompatibility Constituent material or packaging material does not expose the instrument unhealthy consequences. 3.3 Shelf life shelflife Under typical storage conditions, to ensure product functionality and biocompatibility no unacceptable effects or the length of selection time The length of time of the failure. 3.4 Real-time aging realtimeaging Under normal environmental conditions to assess the medical equipment store features change over time. ...

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