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