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YY/T 1263-2015: Evaluation of materials of medical device subject to dry heat sterilization
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YY/T 1263-2015: Evaluation of materials of medical device subject to dry heat sterilization

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

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Select material 2 5 product design and processing 3 6 Material Testing 3 Appendix A (informative) dry heat sterilization compatibility with a particular material 5 Reference 10

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. Shandong Xinhua Medical Instrument Co., Ltd., Guangzhou, the State Food and Drug Administration Medical Devices Quality supervision Governor Inspection Center. The main drafters of this standard. Xie Xinyi, Wanghong Min, Hu Changming, Huang new, Huang Xiulian, Lvpeng Ju. Materials Evaluation for dry heat sterilization of medical devices

1 Scope

This standard specifies the material selection, design and processing, materials testing. Dry heat sterilization for the selection of material provides evaluation guidelines adaptability. This standard applies to the use of materials Evaluation dry heat sterilized medical devices. Note 1. This standard also applies to heat the material to the original. Note 2. The standard of the content is general information designed to provide guidance for the successful implementation of material evaluation. When using this standard should not be material grounds, not Proper evaluation.

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 and testing 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 Dry heat sterilization dryheatstirilization Sterilization process by convection, conduction, heat radiation, infrared and other ways of incineration is at least one process parameter, and no sterilizing agent residue Equipment needs a relatively simple and reliable sterilization process. 3.2 The glass transition glasstransition In an amorphous polymer or amorphous region a partially crystalline polymer from (or to) the formation of a sticky or rubbery (Or from) a hard and brittle state of irreversible change. 3.3 Melting temperature melttemperture Tm Melting temperature or melting temperature of the plastic. 3.4 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. 3.5 Real-time aging realtimeaging Under normal environmental conditions to assess the medical equipment store features change over time. ...