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GB 9706.224-2021: Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
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Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
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GB 9706.224-2021
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Basic data | Standard ID | GB 9706.224-2021 (GB9706.224-2021) | | Description (Translated English) | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers | | Sector / Industry | National Standard | | Classification of Chinese Standard | C31 | | Word Count Estimation | 50,568 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.224-2021: Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
---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.
Medical electrical equipment - Part 2-24.Particular requirements for the basic safety and essential performance of infusion pumps and controllers
ICS 11.040.20
CCSC31
National Standards of People's Republic of China
Replace GB 9706.27-2005
Medical electrical equipment Part 2-24.Infusion pumps and
Basic safety and basic performance of infusion controller
Dedicated requirements
(IEC 60601-2-24.2012,MOD)
Released on 2021-12-01
2023-05-01 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅲ
Introduction Ⅴ
201.1 Scope, purpose and related standards 1
201.2 Normative references 2
201.3 Terms and Definitions 3
201.4 General requirements 5
201.5 General requirements for testing of ME equipment 6
201.6 Classification of ME equipment and ME systems 6
201.7 ME equipment identification, marking and documentation 6
201.8 Protection of ME equipment against electric shock hazard 8
201.9 Protection of ME equipment and ME systems against mechanical hazards 9
201.10 Protection against unwanted or excessive radiation hazards (sources) 9
201.11 Protection against over-temperature and other hazards (sources) 9
201.12 Accuracy of controllers and instruments and protection against dangerous outputs 10
201.13 Dangerous conditions and fault states of ME equipment 23
201.14 Programmable Medical Electrical System (PEMS) 23
201.15 Structure of ME equipment 23
201.16 ME System 24
201.17 Electromagnetic compatibility of ME equipment and ME systems 24
202 Electromagnetic compatibility---requirements and tests 25
206 Availability 25
208 Testing and guidelines for alarm systems in medical electrical equipment and medical electrical systems 26
Appendix 29
Appendix AA (informative) Special guide and principle explanation 30
Reference 41
Figure.201.101 Analysis cycle 13
Figure.201.102 Test device for different types of infusion pumps 14
Figure.201.103 The rising curve based on the data collected during the first 2h of the test period. Figure 15
Figure.201.104 The horn curve diagram made based on the data collected during the second hour of the test cycle 15
Figure.201.105 The horn curve based on the data collected in the last hour of the infusion line replacement interval Figure 15
Figure.201.106 Rise in the stable cycle phase Figure 16
Figure.201.107 The horn curve made according to the test data at the end of the stabilization period 16
Figure.201.108 The rising curve of the semi-continuous output pump in the stable period Figure 17
Figure.201.109 The semi-continuous pump horn curve based on the data at the end of the stabilization period Figure 17
Figure.201.110 Test device 22 for determining the obstruction alarm threshold and pill dose 22
Figure AA.1 Rising Figure 34
Figure AA.2 Horn Figure 35
Figure AA.3 Calculation of Ep (max.) and Ep (min.) 37
Figure AA.4 Sampling plan 38
Figure AA.5 Observation window 38
Figure AA.6 Distribution of the original variable X 39
Figure AA.7 Distribution of observation windows 40
Figure AA.8 Statistics Horn Figure 40
Table.201.101 Basic performance requirements for distribution 5
Table.201.102.201.12.1.102 to.201.12.1.107 set flow rate, pill dose and test device 8
Table 202.101 Test level 25
Table 208.101 Alarm status priority and related situations 26
Table 208.102 *Pulse characteristics of audible alarm signals 27
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 of Standardization Documents"
Drafting.
This document is part 2-24 of GB 9706 "Medical Electrical Equipment". GB 9706 has released the following parts.
---Part 1.General requirements for basic safety and basic performance;
---Part 1-3.General requirements for basic safety and basic performance Parallel standard. Radiation protection of diagnostic X-ray equipment;
---Part 2-1.Special requirements for the basic safety and basic performance of electron accelerators with energy from 1MeV to 50MeV;
---Part 2-2.Special requirements for the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;
---Part 2-3.Special requirements for basic safety and basic performance of shortwave treatment equipment;
---Part 2-5.Special requirements for the basic safety and basic performance of ultrasonic physical therapy equipment;
---Part 2-6.Special requirements for the basic safety and basic performance of microwave therapy equipment;
---Part 2-8.Special requirements for the basic safety and basic performance of therapeutic X-ray equipment with an energy of 10kV to 1MV;
---Part 2-11.Special requirements for the basic safety and basic performance of gamma beam therapy equipment;
---Part 2-12.Special requirements for the basic safety and basic performance of intensive care ventilators;
---Part 2-13.Special requirements for the basic safety and basic performance of the anesthesia workstation;
---Part 2-16.Specific requirements for the basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;
---Part 2-17.Special requirements for the basic safety and basic performance of automatic control brachytherapy after-installation equipment;
---Part 2-18.Specific requirements for the basic safety and basic performance of endoscopic equipment;
---Part 2-19.Special requirements for basic safety and basic performance of infant incubators;
---Part 2-24.Special requirements for basic safety and basic performance of infusion pumps and infusion controllers;
---Part 2-25.Special requirements for basic safety and basic performance of electrocardiograph;
---Part 2-26.Special requirements for the basic safety and basic performance of EEG machines;
---Part 2-27.Special requirements for basic safety and basic performance of ECG monitoring equipment;
---Part 2-28.Special requirements for the basic safety and basic performance of medical diagnostic X-ray tube components;
---Part 2-29.Specific requirements for the basic safety and basic performance of radiotherapy simulators;
---Part 2-36.Special requirements for the basic safety and basic performance of in vitro lithotripsy equipment;
---Part 2-37.Special requirements for the basic safety and basic performance of ultrasonic diagnostic and monitoring equipment;
---Part 2-39.Special requirements for the basic safety and basic performance of peritoneal dialysis equipment;
---Part 2-43.Special requirements for the basic safety and basic performance of interventional X-ray equipment;
---Part 2-44.Special requirements for the basic safety and basic performance of X-ray computed tomography equipment;
---Part 2-45.The basic safety and basic performance of mammography equipment and mammography stereotaxic devices
Require;
---Part 2-54.Special requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment;
---Part 2-60.Special requirements for basic safety and basic performance of dental equipment;
---Part 2-63.Special requirements for the basic safety and basic performance of extraoral imaging dental X-ray machines;
---Part 2-65.Specific requirements for the basic safety and basic performance of dental X-ray machines for intraoral imaging.
This document replaces GB 9706.27-2005 "Medical Electrical Equipment Part 2-24.Special Requirements for the Safety of Infusion Pumps and Infusion Controllers"
Compared with GB 9706.27-2005, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
---Added the definition of enteral nutrition pump and enteral nutrition pump in the range (see.201.1.1,.201.3.204);
--- Deleted the drop-speed infusion pump and the drop-speed infusion controller in the range (see 1.1 in the.2005 edition);
--- Added the inapplicable scope, that is, the equipment covered by ISO 28620 is not within the scope of this document (see.201.1.1);
---Added the definition of the maximum selectable speed and the minimum selectable speed (see.201.3.212,.201.3.213);
---Added basic performance requirements (see.201.4.3.11);
---The requirement for the number of samples has been increased (see.201.5.2);
---Added requirements for water or particulate matter intruding into ME equipment and ME systems (see.201.11.6.5);
--- Changed the application scope of the power supply/power supply network interruption technology alarm status (see.201.11.8.101, 49.2 in the.2005 edition);
---Added usability requirements and defined common functions (see Chapter 206);
---Added the requirements for special alarms (see Chapter 208).
This document uses the redrafting method to modify and adopt IEC 60601-2-24.2012 "Medical Electrical Equipment Part 2-24.Infusion Pumps and Infusion
Special requirements for basic safety and basic performance of hydraulic controllers.
The technical differences between this document and IEC 60601-2-24.2012 and the reasons 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.
The situation is collectively reflected in.201.2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace ISO 3696.1987 with GB/T 6682-2008 which is modified to adopt international standards;
● Replace ISO 8536-4 with GB 8368, which is modified to adopt international standards;
● Replace IEC 60601-1.2005 AMD1.2012 with GB 9706.1-2020 which is modified to adopt international standards;
● Replace IEC 60601-1-2.2014 with YY9706.102-2021 which is modified to adopt international standards;
● Replace IEC 60601-1-6.2010 with YY/T 9706.106-2021 which is modified to adopt international standards;
● Replace IEC 60601-1-8.2006 with YY9706.108-2021 which is modified to adopt international standards;
● Added reference to GB/T 4208;
● ISO 7864 has been deleted.
---The value of the rise time in row 4 of table 208.102 is modified to "10%~40% of td", which is consistent with YY9706.108-2021
Consistent.
The following editorial changes have been made to this document.
--- Note for the term.201.3.206, the liquid flow method adds a type "5 Type. Programmable Pump".
--- Modify "201.12.1.108" in.201.12.1.101 to "201.12.1.107". Editing error, not in the IEC original text
"201.12.1.108" Article.
---201.12.1.102, amend "see Figure AA.3.1 and Figure AA.3.3" to "see Figure AA.1 and Figure AA.2". IEC original edition
Edit error.
---Adjusted the formula number, revised formula (13) ~ formula (25) to formula (7) ~ formula (18), and changed the formula (18) in the original IEC text
Combined with formula (19) into one formula, formula (19) is deleted.
---Adjusted the numbering of the figure, the figure is numbered from.201.101.
---GB 15811 and ISO 28620 have been added to the references.
---The term index of the international standard text has been deleted.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents.
This document was proposed and managed by the State Drug Administration.
The previous releases of this document and the documents it replaced are as follows.
---First released in.2005 as GB 9706.27-2005;
Introduction
Medical electrical equipment safety standards are also known as the 9706 series of standards, which consist of general standards, parallel standards, special standards, guidelines and interpretations.
---General standards. Medical electrical equipment should be generally applicable to safety standards, that is, equipment that meets the definition of medical electrical equipment should meet this
Basic standard requirements.
---Parallel standards. Medical electrical equipment should be generally applicable to safety standards, but in most cases it is limited to certain specific functions or features.
Sexual equipment only needs to meet the requirements of such standards.
---Special standards. safety standards that a certain type of medical electrical equipment should apply, and not all medical electrical equipment have special
standard.
---Guidelines and explanations. application guidelines and explanations for the relevant requirements in the standards involved.
In the GB 9706 series of standards, in addition to the published standards and this document, the standards that have been included in the plan are as follows.
---Part 2-4.Special requirements for basic safety and basic performance of cardiac defibrillators. The purpose is to establish the basic
Special requirements for safety and basic performance.
---Part 2-22.Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis. The purpose is
Establish special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis.
---Part 2-66.Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system. The purpose is to build listening
Specific requirements for basic safety and basic performance of equipment and hearing equipment systems.
This document deals with the safety of infusion pumps and infusion controllers. This document has revised and supplemented GB 9706.1-2020 "Medical Electrical Equipment
Preparation Part 1.General Requirements for Basic Safety and Basic Performance. The relationship with GB 9706.1-2020 and its parallel standards is in
It is explained in.201.1.3.
The safe use of infusion pumps and infusion controllers is first and foremost the operator's responsibility. It is also necessary to realize that the operation and operation of medical electrical equipment
The person should be trained, and only operate in accordance with the manufacturer's instructions to ensure the safe use of the equipment. Minimal security
The full requirement is to provide a practical level of safety during operation. The manufacturer is responsible for ensuring the implementation of the requirements of this document.
In this document, the asterisk (*) is used as the first character of the title or the beginning of the paragraph or table title, which means that there is a related item in Appendix AA.
Dedicated guides and principle explanations related to the project.
Medical electrical equipment Part 2-24.Infusion pumps and
Basic safety and basic performance of infusion controller
Dedicated requirements
201.1 Scope, purpose and related standards
In addition to the following, Chapter 1 of the general standard applies.
201.1.1 Scope
replace.
This document specifies the enteral camps defined in.201.3.204,.201.3.206,.201.3.207,.201.3.220,.201.322 and.201.323.
Requirements for supporting pumps, infusion pumps, portable infusion pumps, injection/container pumps, volumetric infusion controllers, volumetric infusion pumps.
This document applies to the basic safety and basic performance of infusion pumps and volumetric infusion controllers, hereinafter referred to as ME equipment.
Since the characteristics of the infusion pipeline itself will affect the basic safety and basic performance of the infusion pump and the volumetric infusion controller, this
The document is applicable to the infusion line to a certain extent. However, this document does not make requirements or requirements for other aspects of the infusion pipeline.
test.
If a chapter or article clearly states that it is only applicable to ME equipment or ME systems, the title and text of the chapter or article will explain. like
If this is not the case, the relevant chapters or articles apply to both ME equipment and ME systems.
Except for clauses 7.2.13 and 8.4.1 required by the general standard, the expected physiological function of the ME equipment or ME system within the scope of this standard
There are no specific requirements in this standard for inherent hazards.
Note. See the requirements of General Standard 4.2.
This document does not apply to the following equipment.
a) Equipment dedicated to diagnostics or similar purposes (e.g., angiography or other pumps permanently controlled or managed by the operator);
b) Extracorporeal blood circulation equipment;
c) Implantable devices;
d) ME equipment specially used for urodynamic diagnosis (use a catheter to fill the bladder with water and measure its pressure-volume relationship);
e) ME equipment for the diagnosis of male impotence detection (in order to maintain the erection of the penis, a preset pressure is required to be
The amount of fluid injected to maintain this pressure. cavernoscopy, cavernography);
f) Equipment covered by ISO 28620.
201.1.2 Purpose
replace.
The purpose of this document is to establish the intestinal
Basic safety and basicity of internal nutrition pumps, infusion pumps, portable infusion pumps, injection/container pumps, volumetric infusion controllers, volumetric infusion pumps
Can ask.
201.1.3 Parallel standards
Supplement.
This document refers to the applicable parallel standards listed in Chapter 2 of the General Standard and Clause.201.2 of this document.
YY9706.102, YY/T 9706.106 and YY9706.108 are respectively applicable after chapter 202, chapter 206 and chapter 208 are revised.
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