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YY/T 0771.4-2015 English PDF

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YY/T 0771.4-2015: Medical devices utilizing animal tissues and their derivatives. Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes
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YY/T 0771.4-2015English374 Add to Cart 3 days [Need to translate] Medical devices utilizing animal tissues and their derivatives. Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes Valid YY/T 0771.4-2015

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Basic data

Standard ID YY/T 0771.4-2015 (YY/T0771.4-2015)
Description (Translated English) Medical devices utilizing animal tissues and their derivatives. Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.100.20
Word Count Estimation 19,112
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Quoted Standard ISO 14160; ISO 22442-1; ISO 22442-2; ISO 22442-3
Adopted Standard ISO/TR 22442-4-2010, IDT
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies) State Food and Drug Administration
Summary This Standard applies to the interpretation of the final draft of the ISO 22442 series of international standards and ISO 14160 standards.

YY/T 0771.4-2015: Medical devices utilizing animal tissues and their derivatives. Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes



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Medical devices utilizing animal tissues and their derivatives.Part 4. Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes ICS 11.100.20 C30 People's Republic of China pharmaceutical industry standards Animal source of medical equipment Part 4. transmissible spongiform encephalopathy (TSE) Factor Removal and/or inactivation analysis and process validation principles Part 4. Principlesforeliminationand/orinactivationoftransmissiblespongiform (ISO /T R22442-4.2010, IDT) Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Foreword

YY/T 0771 "Animal source of medical equipment" sub-section intends to publish the current plans to release the following components. --- Part 1. Application of risk management; --- Part 2. Control sources, collection and disposal; --- Part 3. viruses and transmissible spongiform encephalopathy (TSE) to confirm the removal and inactivation of factors; --- Part 4. removal and/or inactivation of transmissible spongiform encephalopathy and its processes (TSE) confirmed the principle factor analysis. This section YY/T Section 40771 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This part identical with ISO /T R22442-4.2010 "Animal source of medical equipment - Part 4. transmissible spongiform encephalopathy (TSE) because Child removal and/or inactivation process and confirm the principles of analysis. " This section of the international normative documents referenced correspondence between consistency Of the following documents. YY/T 0771.1-2009 animal source of medical equipment - Part 1. Application of Risk Management (ISO 22442-1.2007, IDT) YY/T 0771.2-2009 animal origin medical devices - Part 2. Origin, collection and disposal of control (ISO 22442-2.2007, IDT) YY/T 0771.3-2009 animal origin medical devices - Part 3. viruses and transmissible spongiform encephalopathy (TSE) factor removal and / Or inactivated confirmation (ISO 22442-3.2007, IDT) 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 part is proposed by the China Food and Drug Administration. This part of the National Biological evaluation of medical devices Standardization Technical Committee (SAC/TC248) centralized. This section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Liucheng Hu by Shaohua, Wu Ping.

Introduction

Some medical devices using materials of animal origin. The use of animal tissues and their derivatives in the medical device design and manufacturing, to provide superior performance characteristics of non-animal-derived materials. medical Different treatment equipment, the type and amount of use of materials of animal origin are also different. The main part of these materials may constitute instruments (such as bovine/porcine heart Dirty valve, dental or bone substitute for plastic surgery, hemostasis instrument), may be coated or impregnated with the product (e.g. collagen, gelatin, liver Su) can also be used in the manufacturing process equipment (e.g., oleate and stearate and other derivatives of tallow, fetal bovine serum, enzyme, medium). This document is a confirmation for the design and implementation of the recommendations of the technical analysis provides reports to help identify non-viable animal tissue source of health Whether the treatment process equipment can help reduce the spread of spongiform encephalopathies (TSEs) of iatrogenic transmission (iatrogenic transmission) risk. This document will infectious agents called "TSE factor" instead of prions, with the other portion of the ISO 22442 Points consistent. And the latest information about human tissue TSEs in this document is given, can be extrapolated to other animal tissues. Has been irrefutably demonstrated that human TSE Creutzfeldt-Jakob disease (CJD) of iatrogenic transmission and the use of human dura mater surgery allogeneic Autograft (Hannah, E.DBelay, etal.2001) extraction and use of human pituitary hormones (Mils, JLLBSchonberger, et al.2001) about, both of which are non-viable tissue. Recently, a hemophilia patient autopsy was detected from variant Creutzfeldt-Jakob disease (vCJD) uk/webw/HPAweb dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_100357). In addition, corneal graft spread CJD (Kennedy, Hoganetal, 2001) and a number of vCJD transfusion of packed red blood cells spread (Llewelyn, Hewittetal2004; Peden, Headetal2004; Peden, RitchieandIronside2005) reported. There are more than 210 contacts bovine spongiform encephalopathy (BSE) vCJD cases worldwide factors, most of which are considered edible Infected beef products due. Although, in addition to the discussion of iatrogenic vCJD infection has not been identified by the medical or veterinary product spread BSE agent reports, however, there is no reason to doubt that the use of a ruminant-derived factor BSE infected medical devices can be prone to infection Feeling person. In fact, there are two never vitality sheep tissue extracts of veterinary vaccines spread of sheep/goat TSE in sheep scrapie reported to (WHO2006). Currently no reports of human infection with scrapie factors. Possible spread of the molecular nature of the factors [currently the most widely used full - protein or "prion" theory (Prusiner1982)] or Copy infectious agents in terms of priority or the precise role of the pathogenesis of the different forms of the host-encoded prion disease less than Next to the international consensus, the general use of this part of the World Health Organization "WHO organized the distribution of TSE infectivity Guide" 2006 (WHO 2006) recommended term. The core purpose of this section is in the use of non-viable animal tissue medical devices, in order to reduce the spread of chance Validation of methods TSEs risk provisioning policy. The following files are standard helps correct understanding of this document. --- ISO 22442-1 animal source of medical equipment - Part 1. Application of risk management; --- ISO 22442-2 animal source of medical devices - Part 2. Control sources, collection and disposal; --- ISO 22442-3 animal source of medical devices - Part 3. viruses and transmissible spongiform encephalopathy (TSE) factor removal and/or Confirm inactivated; --- ISO 14160 Sterilization of health care products of animal origin for single use medical devices sterilized with liquid chemical sterilants Process characterization, development, validation and routine control. These documents Appendix Appendix normative and informative but also directly related to the contents of this document. These terms apply to all files In this document. Due to lack of a unified reliable removal of TSEs process steps, the use of low-risk source of animal tissue and is very important. Although not directly applicable from the use of non-viable animal tissues processed medical devices to reduce the risk of TSE confirmation method, United Kingdom Confirm research and US regulators have been removed from the potential contamination of TSE infectivity factor TSE agents in their blood for the expected instrument Highlights of the study sought expert advice and these recommendations may also be utilized in the evaluation method of animal tissue. These points include making With a pre-evaluation has been added TSE exposure of high titer of infectious material selection and experimental infection factor analysis and to take PrPTSE An acceptance study as a pre-screening programs to abandon inappropriate methods. These known methods require the test animals susceptible bioanalytical In suggesting that the virus infection is significantly reduced. To identify whether a method can be used, if feasible, it requires two students TSE agents Analysis of the combination method was analyzed to confirm similar results have. Having sufficient operability of the conclusions drawn in the process Before, these guidelines should be met. Want a proven method to reduce endogenous infectious TSE infected tissue and confirmed a complete The process removes all detectable infectivity, although desirable, but this is still not feasible. Most of the nervous system Outside organizations TSE infectivity titer is very low, while the TSE agents susceptible animals naturally occurring and very few, and not the new species So we are limiting factor for research methods. Standards are no known infectious titer, the lack of infection of human and animal TSEs Knowledge of biological characteristics, is also considered another obstacle to development validation studies [WHO (2006) Appendix 2]. While recognizing that the attempt to raise Supreme bloodborne medical products as well as other human tissue-derived medical products (iatrogenic transmission has been confirmed product) of TSE security side Recognition Act is very slim, but it must be emphasized that may not give up its efforts to improve animal source of medical equipment TSE confirmed the safety of the new method. As described above, wish to draw attention once again, animal tissue and cause any iatrogenic TSE infected person is not directly related to (Minor, Newhametal.2004). However, food-borne BSE and sheep tissues extracted from veterinary vaccines spread to sheep scrapie examples show The risk to people from animals iatrogenic transmission of TSEs, deserves sustained attention. Animal source of medical equipment Part 4. transmissible spongiform encephalopathy (TSE) Factor Removal and/or inactivation analysis and process validation principles

1 Scope

Process to help identify non-viable animal tissue source of medical equipment to help reduce the spread of whether spongiform encephalopathies Risk (TSEs) of iatrogenic transmission, the Department confirmed that analysis into the design and implementation advice. TSE processing method for removing animal tissue used is also advised to reduce human-derived non-viable tissue by the risk of transmission of TSE infection; this Section does not cover this aspect. Some information about the current human tissues and TSEs can apply by analogy to other animal tissues. This section is not expected to ISO 22442-1.2007 Annex C listed have been identified having TSE contamination factor "can suddenly Little risk "of a specific material requirements provide confirmation process. This section is expected to be used to interpret the final draft of the ISO 22442 series of international standards and ISO 14160 standards. This section is based on discussions with the TSE 22442-3 specific factors relevant ISO basis and try to summarize the TSE agents The latest technology in the field of the removal of the current level. With the inactivation and removal of TSE agents in-depth understanding of this document, where feasible, will be Amendments.

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. Validation and routine control of sterilization liquid chemical sterilant sterilized ISO 14160 containing materials of animal origin for single use medical devices System (Sterilizationofsingle-usemedicaldevicesincorporatingmaterialsofanimalorigin-Validationand routinecontrolofsterilizationbyliquidchemicalsterilants) ISO 22442-1 animal source of medical equipment - Part 1. Application of Risk Management (Medicaldevicesutilizinganimaltissues andtheirderivatives-Part 1. Applicationofriskmanagement) ISO 22442-2 animal source of medical devices - Part 2. Origin, collection and disposal of Control (Medicaldevicesutilizingan- imaltissuesandtheirderivatives-Part 2. Controlsonsourcing, colectionandhandling) ISO 22442-3 animal source of medical devices - Part 3. viruses and transmissible spongiform encephalopathy (TSE) factor removal and/or inactivation Confirmation (Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part 3. Validationoftheelimi- nationand/orinactivationofvirusesandTransmissibleSpongiformEncephalopathy (TSE) agents)

3 Terms and Definitions

ISO 22442-1, the terms and definitions ISO 22442-2, ISO 22442-3 and ISO 14160 apply to this document defined. 4 TSE removal of factors. the basic considerations 4.1 General 4.1.1 on TSEs Bovine spongiform encephalopathy (bovinespongiformencephalopathy, BSE) is known to spread disease to humans only

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