GB/T 44353.1-2024 English PDFUS$594.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 44353.1-2024: Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management Status: Valid
Basic dataStandard ID: GB/T 44353.1-2024 (GB/T44353.1-2024)Description (Translated English): Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C30 Classification of International Standard: 11.100.20 Word Count Estimation: 30,385 Date of Issue: 2024-08-23 Date of Implementation: 2025-09-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 44353.1-2024: Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management---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. ICS 11.100.20 CCSC30 National Standard of the People's Republic of China Animal-derived medical devices Part 1.Risk management applications (ISO 22442-1.2020,IDT) Released on 2024-08-23 2025-09-01 Implementation State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Risk Management Process 3 4.1 General Requirements 3 4.2 Risk Analysis 3 4.2.1 Identification of qualitative and quantitative characteristics relevant to medical device safety 3 4.2.2 Identification of hazards and hazardous situations 4 4.3 Risk Assessment 4 4.4 Risk Control 4 4.4.1 General requirements 4 4.4.2 Risk Control of Viruses and TSE Factors 5 4.4.3 Risk control of other hazards 5 4.4.4 Residual risk assessment 5 4.5 Acceptability evaluation of comprehensive residual risk 6 4.5.1 General requirements 6 4.5.2 File 6 4.6 Production and post-production information systems 6 Appendix A (Informative) Guidelines for the application of this document 7 A.1 General Principles 7 A.2 Applicable to materials from animal sources 7 A.3 Applicable to materials supplied by third parties 7 Appendix B (Informative) Partial Risk Management Process Flowchart for Medical Devices Using Animal Materials 8 Appendix C (Normative) Special requirements for risk management of TSE factors in specific animal materials 9 C.1 General requirements 9 C.2 Collagen 9 C.3 Gelatin extracted from skin and bones 9 C.3.1 General 9 C.3.2 Leather as raw material 10 C.3.3 Bone as starting material10 C.3.4 Manufacturing method 10 C.4 Cow blood derivative 10 C.4.1 General 10 C.4.2 Traceability11 C.4.3 Geographical origin11 C.4.4 Stunning methods11 C.5 Animal fat derivatives 11 C.6 Animal charcoal 11 C.7 Milk and milk derivatives 11 C.8 Wool and its derivatives 12 C.9 Amino Acid 12 C.10 Peptone 12 Appendix D (Informative) TSE risk management related information 13 D.1 General Principles13 D.2 Human risks13 D.3 TSE factor risk management 13 D.3.1 Principle 13 D.3.2 Animal species used (see ISO 22442-2) 13 D.3.3 Geographical origin (see ISO 22442-2) 13 D.3.4 Attributes of the original organization 14 D.3.5 Slaughter and processing control (see ISO 22442-2) 19 D.3.6 Methods for inactivating or removing TSE factors (see ISO 22442-3) 19 D.3.7 Risk of exposure to TSE 19 Reference 21ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is Part 1 of GB/T 44353 “Medical devices of animal origin”. GB/T 44353 has been published in the following parts. --- Part 1.Application of risk management; --- Part 2.Control of sources, collection and disposal. This document is equivalent to ISO 22442-1.2020 "Medical devices of animal origin - Part 1.Application of risk management". The following minimal editorial changes were made to this document. --- Added Note 2 in 3.6. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248). This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, China Food and Drug Inspection Institute, Hangzhou Qiming Medical Medical Equipment Co., Ltd. and Shanghai Songli Biotechnology Co., Ltd. The main drafters of this document are. Sun Xiaoxia, Wan Min, Duan Xiaojie, Jin Linhe, He Hongbing, Chen Liang, Zhu Fuyu, Liu Meirong, and Chen Xingxing.IntroductionSome medical devices use materials of animal origin. The use of animal tissues and their derivatives in the design and manufacture of medical devices to provide properties that are superior to those of non-animal derived materials. The range and amount of animal-derived materials used in medical devices vary. These materials may constitute a major part of the device (e.g., bovine/porcine heart valve membranes, bone substitutes for dental or orthopedics, hemostatic devices), may be a coating or impregnation agent for the product (such as collagen, gelatin, heparin), or may Can be used in device manufacturing processes (such as animal fat derivatives such as oleate and stearate, fetal bovine serum, enzymes, culture media). ISO 14971 is a general standard that specifies the procedures for manufacturers to identify hazards and dangerous situations associated with medical devices, including in vitro medical devices. The process of estimating and evaluating the risks associated with these hazards, controlling these risks and monitoring the risk control throughout the life cycle of medical devices This document provides additional requirements and guidance for evaluating the effectiveness of products made from non-viable or inactivated animal tissues or their derivatives. Medical devices manufactured. This document is intended to cover medical devices including active implantable medical devices (such as implantable infusion pumps). This document does not apply to in vitro diagnostic devices. This document is not a "stand-alone" standard and should only be used in conjunction with ISO 14971. Note. Meeting the specified requirements of this document is considered to be in compliance with this document. The guidance given in the notes and informative annexes is not normative and is not intended as a checklist. GB/T 44353 consists of four parts. --- Part 1.Application of risk management. The purpose is to specify the identification of medical products made with animal-derived materials (non-viable or inactivated). Hazards and hazardous situations associated with medical devices (excluding in vitro diagnostic medical devices), and the estimation, evaluation and control of the resulting risks controls, and procedures for monitoring the effectiveness of those controls. --- Part 2.Control of sources, collection and disposal. The purpose is to specify the animals and Control requirements for the source, collection and disposal (including storage and transportation) of tissues. --- Part 3.Confirmation of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. or products derived from animal tissues during the production of medical devices for the removal of viruses and transmissible spongiform encephalopathy agents and/or Inactivation confirmation. --- Part 4.Principles of removal and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and process confirmation analysis. Can the processing of medical devices derived from non-viable animal tissue help reduce the nosocomial transmission of transmissible spongiform encephalopathies? Provide advice on the design and conduct of confirmation analyses for risks. Animal-derived medical devices Part 1.Risk management applications1 ScopeThis document applies to medical devices manufactured with animal-derived materials (non-viable or inactivated), and does not apply to in vitro diagnostic medical devices. This document, in conjunction with ISO 14971, specifies the procedures for identifying the hazards and hazardous situations associated with such devices and for assessing the resulting risks. In addition, this document provides procedures for weighing the residuals defined in ISO 14971. This document provides guidance on the decision-making process for adopting dynamic devices and the acceptability of the residual risks when compared with the expected clinical benefits of existing devices. Requirements and guidance for risk management of typical hazards of medical devices manufactured from plant tissues or their derivatives, including. a) Contamination by bacteria, mold or yeast; b) Viral contamination; c) contamination by transmissible spongiform encephalopathy (TSE) agents; d) Undesirable pyrogenic, immunological or toxicological reactions caused by the material. Similar principles may apply to parasites or other unclassified pathogens. Except for some specific derivatives mentioned in Appendix C, this document does not give acceptance levels because these depend on many factors and it is impossible to Appendix C gives the values of animal fat derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids. Acceptable level of TSE risk. This document does not address the quality management system that controls all stages of the production of medical devices. This document does not cover medical devices that use human tissue. NOTE 1 It is not a requirement of this document to operate a comprehensive quality management system during production. For control of all stages of production or reprocessing of medical devices, see Quality Management. System standard (see ISO 13485). Note 2.Guidance on the application of this document is given in Appendix A.2 Normative referencesThe contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. ISO 10993-1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process Note. GB/T 16886.1-2022 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process (ISO 10993-1. 2018, IDT) Note. GB/T 42062-2022 Application of medical device risk management to medical devices (ISO 14971.2019, IDT) Note. GB/T 44353.2-2024 Medical devices of animal origin Part 2.Control of origin, collection and disposal (ISO 22442-2.2020, IDT) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 44353.1-2024_English be delivered?Answer: Upon your order, we will start to translate GB/T 44353.1-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 44353.1-2024_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 44353.1-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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