YY/T 0771.2-2020 English PDFUS$319.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0771.2-2020: Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling Status: Valid YY/T 0771.2: Historical versions
Basic dataStandard ID: YY/T 0771.2-2020 (YY/T0771.2-2020)Description (Translated English): Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C30 Classification of International Standard: 11.100.20 Word Count Estimation: 17,161 Date of Issue: 2020 Date of Implementation: 2021-04-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies the control requirements for the source, collection and disposal (including storage and transportation) of animals and tissues for medical devices manufactured from materials of animal origin, excluding in vitro diagnostic medical devices. The risk management process requirements given in YY/T 0771.1-2020 apply. This standard does not cover medical devices using human tissue. This standard does not specify a quality management system that controls the entire process of medical device production. YY/T 0771 does not deal with the overall quality management system in production, but specifies the requirements for certain elements of the quality management system, paying attention to the quality management system standards for controlling the entire process of medical device production or reprocessing (see YY/T 0287). The elements of the quality management system required by this standard can form a quality management system that conforms to YY/T 0287 YY/T 0771.2-2020: Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling---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. Medical devices utilizing animal tissues and their derivatives--Part 2. Controls on sourcing, collection and handling ICS 11.100.20 C30 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 0771.2-2009 Medical devices of animal origin Part 2. Control of source, collection and disposal (ISO 22442-2..2015, MOD) 2020-03-31 release 2021-04-01 Implementation Issued by the State Drug Administration ContentsForeword Ⅲ Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 General requirements 2 5 Source 3 6 Collection 4 7 Disposal 5 8 Storage and transportation 5 Appendix A (Normative Appendix) Additional requirements for bovine-derived materials 6 A.1 Introduction 6 A.2 General aspects 6 A.3 Possibility of infection by source animals 6 A.4 Infectivity of source tissue 9 A.5 Measures to prevent cross contamination 9 Appendix B (Informative Appendix) Certification and Certification 10 B.1 Example of issuing a certificate 10 B.2 Examples of health certificates issued by veterinarians 11 Appendix C (Informative Appendix) Veterinary Services 12 Reference 13ForewordYY/T 0771 "Medical Devices of Animal Origin" consists of the following parts. --- Part 1. Risk management applications; --- Part 2. Control of source, collection and disposal; --- Part 3. Confirmation of removal and inactivation of viral and transmissible spongiform encephalopathy (TSE) factors; --- Part 4. Principles for the removal and/or inactivation of factors of transmissible spongiform encephalopathy (TSE) and its process confirmation analysis. This part is part 2 of YY/T 0771. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY/T 0771.2-2009 "Medical devices of animal origin Part 2. Control of source, collection and disposal", and Compared with YY/T 0771.2-2009, the technical differences are mainly concentrated in "Scope" and "Appendix A". "Appendix B" and "Appendix C" and the previous edition There are no technical differences. In addition to editorial changes, the main technical changes are as follows. --- Modify the "Scope"; --- Added normative references; --- Clarify the normatively quoted standards in 4.2 and change "all parts" to "YY/T 0771.1, YY/T 0771.3, YY/T 0771.4 This section "; --- Modified Appendix A. This part uses the redrafting method to modify and adopt ISO 22442-2..2015 "Medical devices of animal origin Part 2. Source, collection and disposal Control. The technical differences between this part and ISO 22442-2..2015 and the reasons are as follows. --- With regard to normative quotation documents, this standard has been adjusted with technical differences to adapt to China's technical conditions and adjustments The situation is reflected in Chapter 2 "Regulatory Reference Documents", with specific adjustments as follows. ● Replaced ISO 22442-1..2015 with YY/T 0771.1-2020 modified to adopt international standards; ● Added references to YY/T 0287, YY/T 0771.3 and YY/T 0771.4. Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents. This part is proposed by the State Drug Administration. This part is under the jurisdiction of the National Medical Device Biological Evaluation Standardization Technical Committee (SAC/TC248). This section was drafted. Shandong Medical Device Product Quality Inspection Center. The main drafters of this section. Wang Xin, Fan Chunguang, Zhu Fuyu. The previous versions of the standards replaced by this part are as follows. --- YY/T 0771.2-2009.IntroductionSome medical devices use materials of animal origin. Animal tissue and its derivatives are used in the design and manufacture of medical devices to provide characteristics that are superior to non-animal matrix materials. Medical device The range of materials and animal-derived materials in the machine is very wide, and these materials can form the main part of the device (such as cattle/porcine heart valves, used in the oral cavity Bone substitutes for hematology or orthopedics, hemostatic devices), coating or infiltration of products (e.g. collagen, gelatin, heparin) or used in device manufacturing processes (e.g. Animal fat derivatives such as oleate and stearate, fetal bovine serum, enzymes, culture medium). The sources of tissues and derivatives used in medical devices are generally obtained by the manufacturer from various animals, such as cattle, sheep or commercially available breeding animals Things (including fish). Some professional factories also process animal-derived materials into finished products (such as gelatin), which are used as raw materials for final medical devices. Meeting the requirements of this part can be regarded as complying with this part of YY/T 0771. The guidelines given in the notes and informative appendix are Material information is not a checklist provided to auditors. Medical devices of animal origin Part 2. Control of source, collection and disposal1 ScopeThis part of YY/T 0771 specifies the source, collection and disposal of animals and tissues of medical devices made of animal-derived materials The control requirements (including storage and transportation) do not include in vitro diagnostic medical devices. Risk management given in YY/T 0771.1-2020 Process requirements apply. Note 1. The selection of animal sources is particularly important for the risk management of spreading spongiform encephalopathy (TSE). This part of YY/T 0771 does not include medical devices that use human tissue. This part of YY/T 0771 does not specify a quality management system that controls the entire process of medical device production. YY/T 0771 does not involve the overall quality management system in production, but specifies the requirements for certain elements of the quality management system. Regarding the quality management system standards that control the entire process of medical device production or reprocessing (see YY/T 0287). Quality management required by this part The system elements can form a part in accordance with YY/T 0287 quality management system. Note 2. The basic principle of YY/T 0771 application is to give appropriate consideration to the requirements and recommendations in all three partial standards.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document. YY/T 0287 Medical device quality management system is used for regulatory requirements (YY/T 0287-2017, ISO 13485..2016 IDT) YY/T 0771.1-2020 Medical devices of animal origin Part 1. Risk management applications (ISO 22442-1..2015, MOD) YY/T 0771.3 Medical Devices of Animal Origin Part 3. Virus and Transmissible Spongiform Encephalopathy (TSE) Factor Removal and Inactivation Confirmation (YY/T 0771.3-2009, ISO 22442-3..2007, IDT) YY/T 0771.4 Medical devices of animal origin Part 4. Medical devices of animal origin Part 4. Transmissible spongiform encephalopathy (TSE) Principles for removal and/or inactivation of factors and process confirmation analysis (YY/T 0771.4-2015, ISO /T R22442-4..2010, IDT)3 Terms and definitionsThe terms and definitions defined in YY/T 0771.1-2020 and the following apply to this document. 3.1 Collect colection Remove the tissue from the animal. 3.2 Low-risk herd Closed herd Herds that have met the following conditions for at least 8 years. a) There is a documented veterinary surveillance; ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0771.2-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 0771.2-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0771.2-2020_English with my colleagues?Answer: Yes. 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