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YY/T 1402-2016 English PDF

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YY/T 1402-2016: Test method to demonstrate the suitability of the process challenge device(PCD) during steam sterilization
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YY/T 1402-2016English319 Add to Cart 4 days [Need to translate] Test method to demonstrate the suitability of the process challenge device(PCD) during steam sterilization Valid YY/T 1402-2016

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Basic data

Standard ID YY/T 1402-2016 (YY/T1402-2016)
Description (Translated English) Test method to demonstrate the suitability of the process challenge device(PCD) during steam sterilization
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C47
Classification of International Standard 11.080.01
Word Count Estimation 16,150
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration

YY/T 1402-2016: Test method to demonstrate the suitability of the process challenge device(PCD) during steam sterilization


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Test method to demonstrate the suitability of the process challenge device (PCD) during steam sterilization ICS 11.080.01 C47 People's Republic of China Pharmaceutical Industry Standard Medical equipment steam sterilization process challenges Applicability of the device test method device (PCD) duringsteamsterilization 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III Introduction IV 1 Scope 1 2 normative reference document 1 3 Terms and definitions 2 4 Principle 2 5 quality management system elements 3 6 Test microbes 4 7 test equipment 4 8 Preparation of test samples and test materials 5 Test process 7 10 test evaluation 9 11 Test Report 10 Appendix A (informative) Process Challenge Device Application Example 11 Reference 12

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard refers to DIN58921..2010 "Confirmation of the applicability of medical device simulators during steam sterilization Medical devices Simulator test "(English version) to develop. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200) will be centralized. The drafting of this standard. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Beijing Kyrgyzstan Yi Technology Limited Company, 3M China Limited. The main drafters of this standard. Gong Wanling, Qian Yingjie, Huang Yuzhe, Hu Changming, Yu Liwei.

Introduction

Steam sterilization is known as a "special process" because the result must be verified by a destructive test. To confirm this The effectiveness of the process must be fully monitored for a range of parameters that can affect the sterilization process. When all of these parameters meet the standard requirements, It can be determined that this process is repeatable. ISO 17665-1 requires that the reprocessing process of the medical device be a confirmed process. YY/T 0802-2010 requires the manufacturer to provide information about the reprocessing of the medical device. The process validation is a document that determines the process of obtaining, recording, and interpreting the results required for a process to produce a product that meets the intended specifications. Procedures. The validation of the sterilization process is largely based on the critical physics associated with the most difficult sterile parts of the sterilization chamber and the sterilized product Parameters, such as sterile items within the steam is not easy to penetrate or temperature rise slower parts. When some have special properties can not pass physical Method for verification, biological or chemical indicators can be used (see ISO 17665-1..2006, 9.4.5 and Appendix D). Conventional public medical sterilization process in the above test there is a certain degree of difficulty, for example, to confirm the process of medical equipment available Less, the test technology is more complex, the results of evaluation takes longer. But the test process if you are not using the real medical device itself, but rather These tests or monitoring will become relatively easy when using alternative devices, test devices, or process challenge devices that conform to this standard. ISO 17665-1..2006, 7.5 specifies the use information for the test device used to replace the medical device. However, only when it is possible to confirm that the test device is more difficult to achieve than the real medical device or its product family in air exclusion and vapor infiltration Sterilization conditions, this validation method is effective (see ISO 17665-1..2006, 3.38). The sterilization effectiveness of the actual load can be demonstrated by testing the test device used to replace the real medical device during the sterilization confirmation process. This standard describes a method of verifying that the test device meets the requirements in the sterilization process. Medical equipment steam sterilization process challenges Applicability of the device test method

1 Scope

This standard specifies that the process challenge device is more difficult to achieve sterilization conditions than the simulated medical device in terms of degassing and vapor permeation Test Methods. The process challenge device is suitable for GB 8599-2008 requirements of large-scale sterilizer and YY 0646-2008 requirements of the small off Bacteria (including B-type cycle). This procedure confirms that a qualified process challenge device is only valid for simulated medical devices. Note 1. Similar medical devices may have completely different internal structures. These differences may affect the degassing and steam penetration, which in turn affects the process challenge The validity of the set. Note 2. The proven process challenge device is used only for the verification process of the degassing and vapor permeation of the simulated medical device. NOTE 3 The process challenge devices specified in this standard may also be used for the development of sterilization processes. NOTE 4 The process challenge devices specified in this standard do not necessarily apply to other requirements of the relevant medical device (see 8.2). This standard does not specify the design and materials of the process challenge device.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB 8599-2008 Large steam sterilizer technical requirements Automatic control type (GB 8599-2008, EN285..2006, NEQ) GB 18281.1 Sterilization products for health care products - Part 1. General principles (GB 18281.1-2000, ISO 11138- 1..1994, IDT) GB 18281.3 Sterilization products for health care products - Part 3. Biological indicators for damp heat sterilization (GB 18281.3- 2000, ISO 11138-3..1995, IDT) GB 18282.1 Sterilization products for medical care products Part 1 General Provisions (GB 18282.1-2000, ISO 11140-1. 1995, IDT) Sterilization counters for medical care products - Part 4. for the identification of alternative BD - type vapor permeation tests GB 18282.4-2009 Two types of indicators (GB 18282.4-2009, ISO 11140-4..2007, IDT) GB/T 19001-2008 Quality management system requirements GB/T 19022-2003 measurement management system measurement process and measurement equipment requirements (GB/T 19022-2003, ISO 10012..2003, IDT) GB/T 19633-2005 Packaging of final sterilized medical devices (GB/T 19633-2005, ISO 11607..2003, IDT) GB/T.19972-2005 Guideline for the selection, use and test of sterilization biological indicators for health care products (GB/T.19972-2005, ISO 14161..2000, IDT) GB/T.19973.1-2015 Sterilization methods for medical devices - Part 1. Determination of the total number of microorganisms on a product (GB/T.19973.1-2005, ISO 11737-1..1995, IDT) GB/T.19973.2-2005 Microbiological methods for sterilization of medical devices - Part 2. Sterility test for confirmation of sterilization (GB/T.19973.2-2005, ISO 11737-2..1998, IDT) GB/T 27025-2008 General requirements for testing and calibration laboratory capabilities (GB/T 207025-2008, ISO /IEC 17025.

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