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YY/T 0883-2013 English PDF

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YY/T 0883-2013: Specification of process challenge devices and indicator systems for steam penetration testing
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PDF similar to YY/T 0883-2013


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Basic data

Standard ID YY/T 0883-2013 (YY/T0883-2013)
Description (Translated English) Specification of process challenge devices and indicator systems for steam penetration testing
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.01
Word Count Estimation 12,176
Quoted Standard GB/T 6682-2008; GB 8599-2008; GB 18282.3-2009; GB 18282.4-2009; GB/T 24628-2009; YY 0646-2008
Regulation (derived from) State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the steam sterilizer with vacuum stage (pre-vacuum) were steam penetration test equipment used in the process of challenges and requirements of the indicator system, test methods. Steam penetration test referred to in this standard

YY/T 0883-2013: Specification of process challenge devices and indicator systems for steam penetration testing


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Specification of process challenge devices and indicator systems for steam penetration testing ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Steam penetration test process challenge device And indicator system technical requirements Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Table of Contents

Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 requires 2 Test Method 4 5 Appendix A (normative) vapor exposure test equipment and steam 7 Appendix B (normative) hollow load process challenge device and test cycle indicator system 8

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The contents of this standard reference to EN867-5.2001 "sterilizers non-biological indicator systems - Part 5. B-type and S-type small off Bacteria performance indicator system testing and process challenges require device "(in English). 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) and focal point responsible for the interpretation. This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Beijing Mai Di Jincheng medical devices Mechanical limited liability company, Shandong Xinhua Medical Instrument Co., Ltd. The main drafters of this standard. Hu Changming, Lv Liansheng, Wang Hongmin, Huang new. Steam penetration test process challenge device And indicator system technical requirements

1 Scope

This standard specifies the steam sterilizer with vacuum stage (pre-vacuum) were steam penetration test process challenge devices and indicator System requirements, test methods. Steam penetration test of the standard referred to is based on GB 8599-2008 and the YY 0646-2008 Provisions. This standard applies to the process challenge device and indicator system, comprising a porous load process challenge device and load indicator system and the cavity is too Cheng challenge means and indicator systems.

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. Laboratory use specifications and test methods GB/T 6682-2008 Analysis GB 8599-2008 large steam sterilizers technical requirements for automatic control type GB 18282.3-2009 Sterilization of health care products - Chemical indicators - Part 3. Class steam penetration test for BD II Class 2 indicator systems GB 18282.4-2009 Sterilization of health care products - Chemical indicators - Part 4. Class for alternative BD steam penetration test Test two types of indicators GB/T 24628-2009 Sterilization of health care products biological and chemical indicators of test equipment YY 0646-2008 small steam sterilizer automatic control type

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Indicator indicator Indicator to its final application substrate to form a combination. 3.2 Indicator indicatoragent The combination of active substance or active substances. 3.3 Indicator system indicatorsystem Combination indicator and its substrate, followed by testing for a particular load combination. Note. The relationship between the indicator, the indicator, the indicator system, see ISO 11140-1.2005 Appendix E. 3.4 Process challenge device processchalengedevice; PCD For the specific resistance of the sterilization process constitutes a means for evaluation of the effectiveness of the sterilization process. Note. See GB 8599-2008 of 3.12 and 3.11 in YY 0646-2008.

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