YY/T 1778.1-2021 English PDFUS$499.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1778.1-2021: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process Status: Valid
Basic dataStandard ID: YY/T 1778.1-2021 (YY/T1778.1-2021)Description (Translated English): Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C46 Word Count Estimation: 24,275 Issuing agency(ies): State Drug Administration YY/T 1778.1-2021: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process---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. (Part 1 of the anger evaluation experiment in the breathing part of medical applications.) ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard Biocompatibility evaluation of respiratory gas pathways in medical applications Part 1.Evaluation and testing in the risk management process (ISO 18562-1.2017, IDT) Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration directory Preface I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Basic principles of biocompatibility evaluation of medical devices 5 4.1 Overview 5 4.2 Type test 6 4.3 Biocompatibility Hazard (Source) Identification 6 4.4 Scope of risk assessment6 4.5 Biocompatibility Evaluation Plan7 4.6 Trial selection 7 4.7 Follow-up evaluation8 5 Contamination of breathing gas in the gas path 8 5.1 * Continuous use time 8 5.2 Particulate Matter (PM) Emissions9 5.3 Volatile Organic Compound (VOC) Emissions 9 5.4 Leachables in condensate 10 6 Adjust for different patient groups10 6.1 General considerations10 6.2 Adjustment for body weight 10 6.3 *The allowable concentration is derived from the tolerable exposure level 10 7 * Derivation allows limit of 11 7.1 General Process 11 7.2 Medical devices for short-term exposure (≤24h) 12 7.3 Medical devices for long-term exposure (>24h but < 30d) 12 7.4 Medical devices for permanent contact (≥30d) 12 8 Risk Benefit Analysis 12 9 Assessment of Biocompatibility of Medical Devices 13 Appendix A (Informative Appendix) Principles and Guidelines 14 Appendix B (Informative Appendix) Basic Numbering Principle 16 Appendix C (Informative Appendix) Terminology --- Alphabetical index of terms used in the text 17 Reference 19 forewordYY/T 1778 "Biocompatibility Evaluation of Respiratory Gas Pathways in Medical Applications" consists of the following parts. --- Part 1.Evaluation and testing in the risk management process; --- Part 2.Particulate matter emission test; --- Part 3.Volatile organic compound (VOC) emission test; --- Part 4.Leachables test in condensate. This part is Part 1 of YY/T 1778. This section is drafted in accordance with the rules given in GB/T 1.1-2009. This part uses the translation method identically to ISO 18562-1.2017 "Biocompatibility Evaluation of Respiratory Gas Pathways in Medical Applications No. 1" Part. Evaluation and Testing in Risk Management Processes. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This part is proposed by the State Drug Administration. This part is under the jurisdiction of the National Standardization Technical Committee of Anesthesia and Respiratory Equipment (SAC/TC116). This section is drafted by. Shandong Medical Device Product Quality Inspection Center, Shanghai Medical Device Testing Institute, Beijing Yihe Jiaye Medical Technology Co., Ltd. The main drafters of this section. Liu Aijuan, Wang Wei, Chen Xingwen, Shen Yong, Yu Hongyi, Chen Bei, Sun Yupeng, Hou Li, Liu Liang.IntroductionThis section presents the risk of air flow delivering potentially harmful substances to the patient, reflecting a high degree of scientific knowledge, aimed at improving the the safety of the user. The purpose of this section is to explain how the risk management process of medical devices throughout the evaluation and development cycle pathway for biological evaluation. The method described requires a combination of review and evaluation of existing data from all sources, selection and appendix as necessary. Add test. In general, the GB/T 16886 series covers biological evaluation methods for medical devices. However, the GB/T 16886 series does not charge Describes how to perform a biological evaluation of the gas pathway of a medical device. Before the preparation of this part, the regulatory agency interprets Table A.1 of GB/T 16886.1-2011 as the material in the gas passage that can communicate with the patient Indirect contact, it is therefore appropriate to test them equivalent to the parts of the medical device that come into contact with tissue. Such an interpretation may lead to questionable benefits testing, may also result in undetected potential hazards (sources). It is pointed out in GB/T 16886.1-2011 that this standard is not intended to provide a strict set of test methods, because it may affect new medical devices Unnecessary restrictions on the development and use of machinery. GB/T 16886.1-2011 also pointed out that in some cases proved to be special applications Under these conditions, experts in the field of production or in the field of use can establish special tests and indicators in specific standards. This series of standards is designed to meet the GB/T 16886.1-2011 does not fully specify the need for how to evaluate gas passage products. This section is intended to provide guidance on how to conduct biological evaluations based on prioritization of chemical analysis assays and in vitro models to Animal numbers and exposure doses are minimized. The initial version of this series of standards covered only the most common potentially hazardous substances. Some people think that it is better to publish a well-established file, so that most of the known harmful substances can be detected. Due to the use of the Threshold of Toxicological Concern (TTC) method, this In addition to assessing the most common potentially harmful substances, the standard may also be used to assess the emissions from the gas path of respiratory medical devices. Safety for almost all compounds, with the exception of very few compounds (eg, PCBs, dioxins). Planned for subsequent revisions and additional sections how to evaluate uncommon substances. In this part of the text, "*" is added before the title, paragraph and table title, indicating that there are further explanations and explanations for the relevant content in Appendix A. illustrate. Biocompatibility evaluation of respiratory gas pathways in medical applications Part 1.Evaluation and testing in the risk management process1 ScopeThis section specifies the general principles to be followed when evaluating the biocompatibility of medical device materials that make up the gas pathway, including. --- In the process of risk management, medical devices intended to be used in various environments to supply gas or other substances to patients through the respiratory tract Basic principles to be followed in the biological risk assessment of gas access products on equipment, its components or accessories; --- General classification of gas passages according to the nature and duration of contact with the gas flow; --- evaluation of existing data from all sources; --- identification of defects in available data sets based on risk analysis; --- Identification of other data sets required for gas pathway biosafety analysis; --- Assessment of the biological safety of the gas pathway. This section does not specify. --- how to assess the biological hazard (source) caused by a mechanical failure, unless the failure poses a risk of toxicity (for example, by particles). --- How to detect specific tests for potentially harmful substances entering the inhalable airflow, and develop acceptance criteria for these substances. Note 1.See other parts of YY/T 1778 (ISO 18562) for specific tests for the detection of potentially harmful substances entering the inhalable airflow. ---How to carry out biological evaluation of the surfaces of medical devices in direct contact with patients. Note 2.See GB/T 16886 series for the evaluation requirements for direct contact with the surface of medical devices. This section applies to medical devices, components or accessories containing gas passages, including but not limited to. ventilators, anesthesia workstations (including gas body mixer), breathing systems, oxygen storage devices, oxygen concentrators, nebulizers, low pressure hose assemblies, humidifiers, heat and moisture exchangers, breathing gas body monitors, respiratory monitors, masks, oral devices, resuscitators, breathing circuits, respiratory filters and Y-tubes and are expected to be All breathing accessories used with these medical devices. This section also applies to the closed chamber of the incubator, including the mattress and the inner surface of the oxygen mask. Note 3.This section deals with medical devices throughout their expected service life under normal use, and takes into account the effects of all processing or reprocessing. Note 4.This section deals with the potential contamination of the gas flow in the medical device gas path that may lead to the patient. Note 5.This section does not involve contamination that already exists in the gas from the gas source during normal use of the medical device. Note 6.YY/T 1778 (ISO 18562) (all parts) does not involve contamination of the medical gas pipeline system (including the check valve at the pipeline outlet) of medical devices, Contamination of the outlet of the pressure regulator connected or integrated with the medical gas cylinder, or air source pollution such as indoor air entering the medical device. Note 7.In the future, more sections may be added to conduct biological tests on other relevant aspects, including due to the addition of drugs and anesthetics to the airflow Other contamination issues that can be caused by the gas path. Note 8.The preparation of this section is to guide the evaluation of compliance with the basic principles of safety and performance shown in Appendix B.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 undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.1-2011 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process (ISO 10993-1.2009, IDT) GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17.Establishment of allowable limits for leachables (ISO 10993- 17.2002, IDT) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1778.1-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1778.1-2021_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 1778.1-2021_English with my colleagues?Answer: Yes. 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