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YY 9706.277-2023 English PDF

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US$779.00 · In stock
Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 9706.277-2023: Investor suitability management for securities institution - Investor rating data requirements
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 9706.277-2023	779	Add to Cart	6 days	Investor suitability management for securities institution - Investor rating data requirements	Valid

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JR/T 0197 JR/T 0154 JR/T 0153 YY 9706.280 YY 9706.284 YY 9706.279

Basic data

Standard ID: YY 9706.277-2023 (YY9706.277-2023)
Description (Translated English): Investor suitability management for securities institution - Investor rating data requirements
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: A11
Classification of International Standard: 11.040.01
Word Count Estimation: 37,351
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 essential performance of robotic-assisted surgical equipment (RASE) and robotic-assisted surgical systems (RASS). This standard applies to robotic-assisted surgical equipment (RASE) and robotic-assisted surgical systems (RASS), and also applies to the interaction conditions and interface conditions of RASE and RASS.

YY 9706.277-2023: Investor suitability management for securities institution - Investor rating data requirements

---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 11.040.01 CCSC30 Pharmaceutical Industry Standard of the People's Republic of China Medical Electrical Equipment Part 2-77. Robotic Assisted Surgical Devices Particular requirements for basic safety and essential performance (IEC 80601-2-77.2019, MOD) Released on 2023-01-13 2026-01-15 Implementation Released by the State Drug Administration

Preface III 201.1 Scope 1 201.2 Normative references 2 201.3 Terms and Definitions 2 201.4 General requirements 4 201.5 General requirements for testing of ME EQUIPMENT 5 201.6 Classification of me equipment and me systems5 201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 5 201.8 Protection against electric shock hazards for ME EQUIPMENT8 201.9 *Protection of me equipment and me systems against mechanical hazards9 201.10 Protection against unwanted or excessive radiation hazards (sources)11 201.11 Protection against extreme temperatures and other hazards (sources)11 201.12 Accuracy of controls and instruments and protection against hazardous outputs12 201.13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 12 201.14 Programmable electrical medical systems (PEMS) 13 201.15 Construction of ME EQUIPMENT 13 201.16 *ME system 13 201.17 *Electromagnetic compatibility of me equipment and me systems13 202 Electromagnetic Compatibility - Requirements and Tests 13 206 *Availability 14 Appendix 15 Appendix D (Informative) Symbols 16 Appendix AA (Informative) Special Guidance and Rationale 17 Appendix BB (informative) Equations for Calculating Overall System Stopping Performance and Minimum Distance 27 Appendix CC (informative) RASE stop function 29 Appendix DD (informative) Alternative methods for demonstrating the structural integrity of RASE during the expected service life30 Appendix EE (informative) Examples of immunity test methods for high-frequency surgical equipment emissions 33 Reference 36

foreword

This 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 2-77. This document is modified to adopt IEC 80601-2-77.2019 "Medical Electrical Equipment Part 2-77.Robotic Assisted Surgery Particular requirements for basic safety and essential performance of equipment". The technical differences between this document and IEC 80601-2-77.2019 and their reasons are as follows. --- Replaced IEC 60601-1.2005 AMD1.2012 with the normative reference GB 9706.1-2020, between the two documents The degree of consistency is modified to adapt to the technical conditions of our country and increase operability; --- Replaced IEC 60601-1-2014 with normatively referenced YY 9706.102-2021, the degree of consistency between the two documents To be modified to adapt to the technical conditions of our country; --- Replaced IEC 60601-1-6010 AMD1.2013 with the normatively referenced YY/T 9706.106-2021, between the two documents The degree of consistency among them is modified to adapt to the technical conditions of our country; --- Deleted IEC 62366-1.2015; --- Deleted 206.4.2 and 206.5, the revision of IEC 60601-1-6 in the original IEC is limited to changing the version number of the referenced standard And add informative notes to the new version of the referenced standard, which will be consistent with YY/T 9706.106-2021 after deletion. The following editorial changes have been made to this document. ---Changed the editorial errors of the original text of IEC (see.201.3.216 Note 2 and.201.9.2.2.4.4); ---Appendix EE.3.2 and Appendix EE.3.3 have added informative notes. 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 sponsored by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5) Focus on. Medical Electrical Equipment Part 2-77. Robotic Assisted Surgical Devices Particular requirements for basic safety and essential performance 201.1 Scope Except as described below, Chapter 1 of the general standard applies. 201.1.1 Scope replace. This document specifies Robotic Assisted Surgical Equipment (RASE) and Robotic Assisted Surgical Systems (RASS) for basic security and basic performance. This document applies to Robotic Assisted Surgical Equipment (RASE) and Robotic Assisted Surgical Systems (RASS), hereinafter collectively referred to as ME EQUIPMENT and ME SYSTEM. This document also applies to the interaction conditions and interface conditions of me equipment and me systems. If a clause or clause expressly states that it applies only to me equipment or me systems, the title and text of the clause or clause shall state so. if not this In either case, the relevant clause or subclause applies to both me equipment and me systems. If RASE or RASS or its annexes belong to the scope of other specific standards, in addition to this document, the specific standards also apply. For example. GB 9706.202 for high-frequency surgical equipment, GB 9706.218 for endoscopic equipment, and GB 9706.218 for laser equipment IEC 60601-2-22, GB 9706.237 for ultrasound equipment, YY 9706.246 for operating tables, etc. 201.1.2 Purpose replace. The purpose of this document is to establish specific guidelines for robotically assisted surgical equipment and robotically assisted surgical systems. Basic safety and basic performance requirements 201.1.3 * Collateral Standard 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 9706.102-2021 and YY/T 9706.106-2021 shall apply after modification in Chapter 202 and Chapter 206 respectively. GB 9706.103-2021, IEC 60601-1-9.2007/AMD1.2013 and YY 9706.111-2021 are not applicable. 201.1.4 Particular standards replace. In the 9706 series of standards, specific standards may modify, replace or delete general standards and collateral standards according to the specific me equipment under consideration. The requirements contained in the standard, and other basic safety and basic performance requirements may be supplemented. Particular standard requirements take precedence over general standards. In this document, GB 9706.1-2020 is referred to as the general standard. Collateral standards are indicated by their respective document numbers. 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 ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 9706.277-2023_English be delivered?

Answer: Upon your order, we will start to translate YY 9706.277-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 9706.277-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY 9706.277-2023_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. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.