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YY 9706.230-2023 English PDF

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US$799.00 · In stock
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YY 9706.230-2023: Technical specification for the low-carbon management and the carbon sequestration accounting and monitoring in bamboo forest
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 9706.230-2023	799	Add to Cart	6 days	Technical specification for the low-carbon management and the carbon sequestration accounting and monitoring in bamboo forest	Valid

Similar standards

LY/T 2407 GB/T 30762 YY 9706.231 YY 9706.233 YY 9706.234

Basic data

Standard ID: YY 9706.230-2023 (YY9706.230-2023)
Description (Translated English): Technical specification for the low-carbon management and the carbon sequestration accounting and monitoring in bamboo forest
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: B60
Classification of International Standard: 11.040.01
Word Count Estimation: 38,383
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 automatic non-invasive blood pressure monitors and their accessories. Include measurement accuracy requirements. This standard applies to automatic non-invasive blood pressure monitors. This standard does not apply to equipment that uses electronic pressure transducers and/or displays in combination with stethoscopes or other manual methods to measure blood pressure (other than automatic non-invasive sphygmomanometers).

YY 9706.230-2023: Technical specification for the low-carbon management and the carbon sequestration accounting and monitoring in bamboo forest

---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 CCSC39 Pharmaceutical Industry Standard of the People's Republic of China Replace YY 0667-2008, YY 0670-2008 Medical electrical equipment part 2-30.automatic non-invasive Particular requirements for basic safety and essential performance of sphygmomanometers (IEC 80601-2-30.2018, MOD) Released on 2023-01-13 2026-01-15 Implementation Released by the State Drug Administration

Preface III Introduction V 201.1 Scope, purpose and related criteria1 201.2 Normative references 2 201.3 Terms and Definitions 3 201.4 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 against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 8 201.10 Protection against unwanted or excessive radiation hazards (sources)8 201.11 Protection against extreme temperatures and other hazards (sources)9 201.12 Accuracy of controls and instruments and protection against hazardous outputs 10 201.13 ME EQUIPMENT HAZARDOUS SITUATIONS AND FAULT CONDITIONS 13 201.14 Programmable electrical medical systems (PEMS) 13 201.15 Construction of ME EQUIPMENT 13 201.16 ME system 14 201.17 Electromagnetic compatibility of me equipment and me systems14 201.101 Cuff requirements 14 201.102 * Connecting tubing and cuff connectors 15 201.103 Unauthorized access 15 201.104 * Maximum inflation time 15 201.105 * Automatic cycle mode 16 201.106 *Clinical Accuracy 19 202 Electromagnetic Compatibility Requirements and Tests 20 206 Availability 22 210 Physiological Closed-loop Controller Development Requirements 22 210.4 General requirements 23 211 Requirements for medical electrical equipment and medical electrical systems used in the home care environment 23 212 Requirements for medical electrical equipment and medical electrical systems used in emergency medical service environments 23 APPENDIX C (INFORMATIVE) GUIDE TO ME EQUIPMENT AND ME SYSTEMS MARKING AND IDENTIFICATION 25 Appendix AA (Informative) Special Guidance and Rationale 28 Reference 34 index 36 Figure.201.101 Overpressure triggers cuff pressure protection device in single fault condition 11 Figure.201.102 Prolonged overvoltage triggers cuff pressure protection device 12 in single fault condition Figure.201.103 Cuff pressure and maximum inflation time, normal state and single fault state 16 Figure.201.104 Cuff pressure under normal conditions in long-term automatic mode 17 Figure.201.105 Long Term Auto Mode Single Fault Condition Cuff Pressure 17 Figure.201.106 Short Term Auto Mode Cuff Pressure 18 Figure.201.107 Self Test Auto Mode Cuff Pressure 19 Figure 202.101 Layout of High Frequency Surgical Equipment Test 21 Figure 202.102 Test device for simulated patient of high-frequency surgical equipment 22 Table.201.101 Basic Performance Requirements for Dispersion 5 Table.201.102 Cuff deflation pressure 9 Table.201.103 Cuff inflation pressure 15 Table.201.C.101 Automatic non-invasive sphygmomanometer or parts external marking 25 Table.201.C.102 Marking of controls and instruments for automatic non-invasive sphygmomanometers or parts 25 Table.201.C.103 Automatic non-invasive blood pressure monitor accompanying documents and overview 26 Table.201.C.104 Automatic non-invasive sphygmomanometer accompanying documents, instructions for use 26 Table.201.C.105 Accompanying documents for automatic non-invasive blood pressure monitors, technical instructions 27 Table AA.101 Summary of requirements for each mode 32

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. This document is Part 2-30 of Medical Electrical Equipment. The "Medical Electrical Equipment" series of standards have published the following parts. --- Part 1.General requirements and parallel requirements; --- Part 2.Special requirements. This document replaces YY 0667-2008 "Medical Electrical Equipment Part 2-30.Safety and Safety of Automatic Circulating Non-invasive Blood Pressure Monitoring Equipment Special Requirements for Basic Performance" and YY 0670-2008 "Non-invasive Automatic Measuring Sphygmomanometer". This document is based on YY 0667-2008, integrating The content of YY 0670-2008 has been updated. Compared with YY 0667-2008, except for structural adjustment and editorial changes, the main technical changes as follows. --- Added basic performance requirements (see.201.4.3); --- Added requirements for usability (see 206); --- Added requirements for physiological closed-loop controllers (see 210); --- Increased the requirements for equipment used in the home care environment (see 211); --- Added requirements for equipment used in emergency medical service environments (see 212). This document uses the redrafted method to revise and adopt IEC 80601-2-30.2018 "Medical Electrical Equipment Part 2-30.Automatic Non-invasive Hemorrhage Particular requirements for basic safety and essential performance of pressure gauges". The main differences between this document and IEC 80601-2-30.2018 are as follows. --- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to my country's technical conditions and adjustments Centrally reflected in.201.2 "Normative Reference Documents", the specific adjustments are as follows. ● IEC 60601-1.2012 is replaced by GB 9706.1-2020, which adopts international standards; ● Replace IEC 60601-1-2.2014 with YY 9706.102-2021, which adopts the international standard; ● Replace IEC 60601-1-6.2010 AMD1.2013 with YY/T 9706.106-2021, which adopts international standards; ● Replace IEC 60601-1-10.2007 with YY/T 9706.110-2021, which adopts international standards; ● Replace IEC 60601-1-11.2015 with YY 9706.111-2021, which adopts international standards; ● Replace IEC 60601-1-12.2014 with YY 9706.112-2021, which adopts the international standard; ● Replace IEC 60601-2-2.2017 with GB 9706.202-2021, which adopts international standards; ● Replaced ISO 80369-1 with YY/T 0916.1, which is equivalent to the international standard; ● Added normative reference document YY 9706.108-2021; ● The normative reference document GB/T 31523.1-2015 has been added. ---The normative reference document ISO 81060-2 uses ISO 81060-2.2018 AMD1.2020. ---.201.3.201 and.201.3.208 add "non-invasive" to the English counterparts, and "non-invasive" in Chinese, which is consistent with the standard name. --- Regarding EMC related content, since the domestic YY 9706.102-2021 adopts IEC 60601-1-2.2007, this document Chapter 202 adjusted the number of chapters, and the content corresponds to YY 9706.102-2021. --- Deleted Appendix BB and Appendix CC. 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. The release status of previous versions of this document and the documents it replaces are as follows. ---First published as YY 0667-2008 in.2008; ---First published as YY 0670-2008 in.2008; --- This is the first revision.

Introduction

Safety 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 that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements. --- Parallel standards. safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special It is only the equipment that needs to meet the requirements of such standards. ---Special standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards standard. ---Guidelines and interpretations. application guidelines and explanations for the relevant requirements of the standards involved. This document specifies the practical minimum safety requirements for the operational safety of automatic non-invasive sphygmomanometers. The requirements are followed by a description of the relevant test. A "Special Guidance and Rationale" regarding the requirements of this document is contained in Appendix AA. We believe that understanding these requirements will not only help It is essential for the correct application of this document, and it can speed up the process of revising the standards due to changes in clinical practice or technological developments in a timely manner. but, Appendix AA is not part of the requirements of this document. Medical electrical equipment part 2-30.automatic non-invasive Particular requirements for basic safety and essential performance of sphygmomanometers 201.1 Scope, Purpose and Related Standards Except for the following, Chapter 1 of GB 9706.1-2020 applies. 201.1.1 Scope replace. This document specifies the basic safety and essential performance requirements for automatic non-invasive blood pressure monitors and their accessories. Include measurement accuracy requirements. This document applies to automatic non-invasive blood pressure monitors (hereinafter referred to as ME equipment). It is through an inflatable cuff, without arterial puncture, non-continuous Blood pressure is measured sequentially. Note 1.The device does not require arterial puncture to perform indirect determination of blood pressure and does not measure blood pressure directly. It simply measures blood pressure. Note 2 to entry. This document covers automated electronic ME equipment, which does not require arterial puncture, for the intermittent indirect measurement of blood pressure, including blood pressure for use in home care settings Monitor. This document does not apply to the use of electronic pressure transducers and/or displays in combination with a stethoscope or other manual methods for the determination of blood pressure (non-automated non-invasive sphygmomanometer) equipment. The requirements for it are specified in ISO 81060-1. Note 3.If the provisions of the chapter or subclause apply only to me equipment or me system, the title and content of the chapter or subclause will state. If not stated, the chapter or article Applies to both me equipment and me systems. Hazards inherent in the intended physiological effects of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by the requirements specified in this document. Except.201.11,.201.105.3.3 and 7.2.13 and 8.4.1 of GB 9706.1-2020. 201.1.2 Purpose replace. The purpose of this document is to establish specific basic safety and essential performance requirements for automatic non-invasive blood pressure 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.201.2 of this document. YY 9706.102, YY/T 9706.106, YY/T 9706.110, YY 9706.111 and YY 9706.112 respectively in Chapter 202, Adopted with modification in Chapters 206, 210, 211, and 212.GB 9706.103-2020 is not applicable. In the 9706 series All other published collateral standards apply. 201.1.4 Particular standards replace. In the 9706 series, Particular Standards may modify, replace or delete General Standards and Collateral Standards, depending on the particular ME EQUIPMENT considered. Included requirements. And other basic safety and basic performance requirements may be supplemented. The requirements of a particular standard take precedence over the general standard. In this document, GB 9706.1-2020 is referred to as the general standard. Collateral standards are indicated by their respective standard 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 standards ......

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Question 1: How long will the true-PDF of YY 9706.230-2023_English be delivered?

Answer: Upon your order, we will start to translate YY 9706.230-2023_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 9706.230-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY 9706.230-2023_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.