YY 9706.249-2023 English PDFUS$719.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 9706.249-2023: Guidelines for the conduct of tests for distinctness, uniformity and stability - Hypericum (Hypericum L. ) Status: Valid
Basic dataStandard ID: YY 9706.249-2023 (YY9706.249-2023)Description (Translated English): Guidelines for the conduct of tests for distinctness, uniformity and stability - Hypericum (Hypericum L. ) Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: B05 Classification of International Standard: 11.040.55 Word Count Estimation: 34,374 Date of Issue: 2023-01-13 Date of Implementation: 2026-01-15 Issuing agency(ies): State Drug Administration Summary: This standard specifies the basic safety and basic performance requirements for multi-parameter patient monitors. This standard applies to multiparameter patient monitors intended to be connected to a single patient, with two or more physiological monitoring units, intended to be used in professional medical institutions, as well as in emergency medical services settings or home care settings. This standard does not apply to implantable parts of multi-parameter patient monitors. This standard does not specify the requirements for separate physiological monitoring units, such as electrocardiogram (ECG), invasive pressure and pulse oximetry, and its requirements are specified in the relevant special standards from the perspective of stand-alone medical electrical equipment. YY 9706.249-2023: Guidelines for the conduct of tests for distinctness, uniformity and stability - Hypericum (Hypericum L. )---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 11.040.55 CCSC39 Pharmaceutical Industry Standard of the People's Republic of China Replace YY 0668-2008 Medical Electrical Equipment Part 2-49. The basics of multiparameter patient monitors Specific requirements for safety and essential performance (IEC 80601-2-49.2018, MOD) 2023-01-13 release 2026-01-15 implementation Released by the State Drug Administration table of contentsPreface III Introduction IV 201.1 Scope, purpose and related criteria1 201.2 Normative references 2 201.3 Terms and Definitions 3 201.4 General requirements 3 201.5 General requirements for testing of ME EQUIPMENT 4 201.6 Classification of me equipment and me systems4 201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION4 201.8 Protection against electric shock hazards for ME EQUIPMENT 5 201.9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 7 201.10 Protection against unwanted or excessive radiation hazards7 201.11 Protection against extreme temperatures and other hazards7 201.12 Accuracy of controls and instruments and protection against hazardous outputs8 201.13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS8 201.14 Programmable electrical medical systems (PEMS) 8 201.15 Construction of ME EQUIPMENT8 201.16 ME system 9 201.17 Electromagnetic compatibility of me equipment and me systems9 202 Electromagnetic Compatibility Requirements and Tests 9 206 Availability 14 206.101 Basic operating functions 14 208 General requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems 15 Appendix AA (Informative) General Guidelines and Rationale 18 Reference 25 index 26 Figure.201.101 Single patient circuit (6) with multiple physiological monitoring units and multiple patient circuits, each patient circuit is a single Multi-parameter patient monitors for Physiological Monitoring Units (7) 6 Figure 202.101 Test layout for conducted emission, radiated emission and immunity 10 Figure 202.102 Test circuit 12 for measurement of protection against high-frequency surgical equipment according to 202.6.2.1.102 with patient connection Figure 202.103 Test setup for measurement of high-frequency surgical protection according to 202.6.2.1.102 13 Figure 202.104 Test circuit 14 for measurement of protection against high-frequency surgical equipment according to 202.6.2.1.102 with non-conductive applied parts Figure AA.1 Example of a preset multi-parameter patient monitor 18 Figure AA.2 Example of a modular multi-parameter patient monitor 19 Figure AA.3 Example of a multi-parameter patient monitor connected to a central station 19 Figure AA.4 Example of a multi-parameter patient monitor integrated into a ventilator19 Figure AA.5 Single patient circuit with multiple physiological monitoring units and patient cables 21 Table.201.101 Basic performance requirements 3forewordThis 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. The "Medical Electrical Equipment" series of standards are divided into two parts. --- Part 1.General and parallel requirements; --- Part 2.Special requirements. This document is part 2-49. This document replaces YY 0668-2008 "Medical Electrical Equipment Part 2-49.Special Requirements for the Safety of Multi-parameter Patient Monitors" and is in line with Compared with YY 0668-2008, except for editorial changes, the main technical changes are as follows. --- Rearranged according to the structure of GB 9706.1-2020; --- Added basic performance requirements (see.201.4.3.101); --- Add requirements for protection against electrosurgery interference (see 202.6.2.1.102); --- Added requirements for usability (see 206); --- Added requirements for alarm system logs (see 208.6.12). This document uses the redrafted method to revise and adopt IEC 80601-2-49.2018 "Medical Electrical Equipment Part 2-49.Multi-parameter patients Particular requirements for basic safety and essential performance of monitors". The main technical differences between this document and IEC 80601-2-49.2018 and their reasons are as follows. --- Regarding the normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustments The situation is reflected in Chapter.201.2 "Normative References", and the specific adjustments are as follows. ● IEC 60601-1.2012 is replaced by GB 9706.1-2020, which adopts international standards; ● Replace IEC 60601-1-2.2007 with YY 9706.102-2021, which adopts the international standard; ● Replace IEC 60601-1-6.2010 with YY/T 9706.106-2021, which adopts the international standard AMD1.2013; ● Replace IEC 60601-1-8.2006 AMD1.2016 with YY 9706.108-2021, which adopts international standards; ● Replace IEC 60601-2-2.2017 with GB 9706.202-2021, which adopts international standards; ● Replace IEC 60601-2-27.2011 with GB 9706.227-2021, which adopts international standards; ● Replace IEC 60601-2-34.2011 with YY 9706.234-2021, which adopts the international standard; ● Deleted from normative references because IEC 60601-1-11.2015 is not referenced; ● Because IEC 60601-1-12.2014 is not referenced, it is deleted from the normative references. Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the Medical Electronic Instrument Sub-Technical Committee (SAC/TC10/SC5) of the National Standardization Technical Committee for Medical Electrical Appliances. The previous versions of the documents replaced by this document are as follows. ---First published as YY 0668-2008 in.2008; ---This is the first revision, and the file number is changed to YY 9706.249-2023.IntroductionSafety standards for medical electrical equipment, also known as the 9706 series of standards, are proposed to be composed of general standards, collateral standards, specific standards, guidelines and interpretations constitute. ---General standard. The safety standard generally applicable to medical electrical equipment, that is, the equipment that meets the definition of medical electrical equipment meets this basis standard requirement. --- Parallel standard. generally applicable safety standards for medical electrical equipment, but in most cases limited to certain specific functions or characteristics The equipment needs to meet the requirements of these standards. ---Specific standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards. ---Guidelines and interpretations. explanations for the application guidelines and clauses of the relevant requirements in the standards involved. This document addresses the basic safety and essential performance of multiparameter patient monitors. This document modifies and supplements GB 9706.1-2020 (hereinafter referred to as the general standard). This revision brings this document up to date with the latest editions of relevant general standards and collateral standards. The requirements of this specific standard have priority over the general standard. An asterisk (*) used as the first character of a title or the beginning of a paragraph or table title in this document indicates that there is a relevant item in Appendix AA. Project-specific guidelines and rationale. The relevant content of Appendix AA is not only helpful to the correct use of this document, but also when used in clinical practice. After changes or technological developments, the process of revising standards can be accelerated in a timely manner. However, Appendix AA is not part of the requirements of this document. Medical Electrical Equipment Part 2-49. The basics of multiparameter patient monitors Specific requirements for safety and essential performance 201.1 Scope, purpose and relevant standards Except as described below, Chapter 1 of the general standard applies. 201.1.1 *Scope replace. This document specifies the basic safety and essential performance requirements for multi-parameter patient monitors (hereinafter referred to as ME EQUIPMENT or ME SYSTEM). This document applies to multi-parameter patient monitors intended to be connected to a single patient, with two or more physiological monitoring units, which are expected to For use in professional healthcare settings and in emergency medical services settings or home care settings. NOTE. In this document, a pregnant woman and her fetus are considered a single patient. This document does not apply to the implantable part of a multiparameter patient monitor. This document does not specify requirements for individual physiological monitoring units, such as electrocardiography (ECG), invasive pressure and pulse oximetry, which are specified in the relevant dedicated It is stipulated in the standard from the standpoint of stand-alone medical electrical equipment. When multiparameter patient monitors are integrated into other medical electrical equipment or medical When using electrical systems, other relevant standards also apply. Example. A multi-parameter patient monitor incorporated into an intensive care ventilator is also applicable to GB 9706.212. 201.1.2 Purpose replace. The purpose of this document is to establish basic safety and basic performance requirements for multi-parameter patient monitors defined in.201.3.201. 201.1.3 Collateral Standards Supplement. This document refers to Chapter 2 of the General Standard as well as applicable collateral standards listed in Clause.201.2 of this document. YY 9706.102, YY/T 9706.106 and YY 9706.108 should be modified according to Chapter 202, Chapter 206 and Chapter 208 respectively use. GB 9706.103 and IEC 60601-1-9 are not applicable. All other published collateral standards in the 9706 series apply. 201.1.4 Particular standards replace. A particular standard may modify, replace or delete requirements contained in a general standard or a collateral standard as applicable to the multiparameter patient monitoring under consideration. Protective devices, other basic safety and basic performance requirements may also be added. The requirements of a particular standard take precedence over those of a general standard. In this document, GB 9706.1 is referred to as a general standard. Collateral standards are indicated by their standard number. The numbers of chapters and clauses in this document correspond to general standards by adding the prefix "201" (for example,.201.1 in this document corresponds to general standard No. 1 chapter), or by prefixing "20x" to the applicable collateral standard, where x is the end of the International Standard number corresponding to the collateral standard digits (for example, 202.4 in this document corresponds to the parallel standard YY 9706.102, which corresponds to Chapter 4 of the international standard IEC 60601-1-2 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.249-2023_English be delivered?Answer: Upon your order, we will start to translate YY 9706.249-2023_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 YY 9706.249-2023_English with my colleagues?Answer: Yes. 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