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GB 9706.216-2021: Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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GB 9706.216-2021
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Basic data | Standard ID | GB 9706.216-2021 (GB9706.216-2021) | | Description (Translated English) | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment | | Sector / Industry | National Standard | | Classification of Chinese Standard | C45 | | Word Count Estimation | 56,580 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.216-2021: Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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Medical electrical equipment - Part 2-16.Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
ICS 11.040.20
C45
National Standards of People's Republic of China
Replace GB 9706.2-2003
Medical electrical equipment Part 2-16.Hemodialysis,
Hemodiafiltration and hemofiltration equipment
Special requirements for basic safety and basic performance
(IEC 60601-2-16.2018, MOD)
Issued on 2021-08-10 and implemented on 2023-05-01
State Administration of Market Supervision and Administration
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 8
201.6 Classification of ME equipment and ME systems 8
201.7 ME equipment identification, marking and documentation 8
201.8 Protection of ME equipment against electric shock hazard (source) 11
201.9 Protection of ME equipment and ME systems against mechanical hazards 12
201.10 Protection against unwanted or excessive radiation hazards (sources) 12
201.11 Protection against over-temperature and other hazards (sources) 12
201.12 *The accuracy of controllers and instruments and the protection of dangerous outputs 13
201.13 Dangerous conditions and fault states of ME equipment 21
201.14 Programmable Medical Electrical System (PEMS) 21
201.15 Structure of ME equipment 21
201.16 *ME system 22
201.17 Electromagnetic compatibility of ME equipment and ME systems 23
202 Electromagnetic compatibility---requirements and tests 23
208 General requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems 23
209 Environmental Awareness Design Requirements 24
210 Physiological closed-loop controller development requirements 24
211 *Requirements for medical electrical equipment and medical electrical systems used in home care environments 25
Appendix 26
Appendix G (Normative Appendix) Protection against the danger (source) of igniting flammable anesthetic mixtures 27
Appendix AA (informative appendix) special guide and principle description 28
Appendix BB (informative appendix) Examples of hazards (sources), foreseeable sequence of events and dangerous situations of hemodialysis equipment 41
References 50
Foreword
GB 9706 "Medical Electrical Equipment" is divided into 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.Specific requirements for the basic safety and basic performance of electron accelerators with an energy of 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 2-4.Special requirements for the basic safety and basic performance of cardiac defibrillators;
---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 2-22.Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis;
---Part 2-24.Specific requirements for the 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.Special requirements for the basic safety and basic performance of intraoral imaging dental X-ray machines;
---Part 2-66.Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system.
This part is part 2-16 of GB 9706.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB 9706.2-2003 "Medical Electrical Equipment Part 2-16.Hemodialysis, Hemodiafiltration and Hemofiltration
Compared with GB 9706.2-2003, the main technical changes are as follows.
--- Increased the scope of application (see.201.1.1);
---Added the requirements of basic performance (see.201.4.
---Added anticoagulation requirements (see.201.12.4.4.112);
---Added the requirements of the programmable medical electrical system (PEMS) (see.201.14);
---Added the requirements of the ME system (see.201.16);
---Added requirements for testing and guidelines for medical electrical equipment and alarm systems in medical electrical systems (see Chapter 208);
---Added environmental awareness design requirements (see Chapter 209);
---Added the development requirements of the physiological closed-loop controller (see Chapter 210);
---Added requirements for medical electrical equipment and medical electrical systems used in home care environments (see Chapter 211);
--- The requirement for arterial pressure has been deleted (see 51.105, 51.108 in the.2003 edition);
--- Deleted the requirement for hemodiafiltration without buffer (see 51.108, 51.111 in the.2003 edition);
--- Deleted the requirements for temperature and overload control devices (see 56.6 in the.2003 edition);
---Modified the test method of air injection (see.201.12.4.4105, 51.106 in the.2003 edition).
This part uses the redrafting law to amend and adopt IEC 60601-2-16.2018 ``Medical Electrical Equipment Part 2-16.Hemodialysis,
Special requirements for the basic safety and basic performance of hemodiafiltration and hemofiltration equipment".
The technical differences between this part and IEC 60601-2-16.2018 and the reasons are as follows.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace ISO 3744 with GB/T 3767 which is equivalent to adopting international standards;
● Replace IEC 61672-1 with GB/T 3785.1 which is equivalent to adopting international standards;
● Replace IEC 60601-1-2.2014 with YY9706.102-2021 which is modified to adopt international standards;
● Replace IEC 60601-1-8.2006 AMD1.2012 with YY9706.108-2021 which is modified to adopt international standards;
● Replace IEC 60601-1-10.2007 with YY/T 9706.110-2021 which is modified to adopt international standards
AMD1.2013;
● Replace IEC 60601-1-11.2015 with YY9706.111-2021 which is modified to adopt international standards;
● Removed IEC 60601-1-6.2010 AMD1.2013.
--- With regard to electromagnetic compatibility requirements and tests, the applicable parallel standard is changed to YY9706.102-2021 (see Chapter 202).
This section has made the following editorial changes.
---Deleted some non-required notes;
---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 these patents.
This part is proposed and managed by the State Drug Administration.
The previous releases of the standards replaced by this part are as follows.
---GB 9706.2-1991, GB 9706.2-2003.
Introduction
The minimum safety requirements specified in this section are considered to provide for the operation of hemodialysis, hemodiafiltration and hemofiltration equipment
Safe feasibility.
Medical electrical equipment Part 2-16.Hemodialysis,
Hemodiafiltration and hemofiltration equipment
Special requirements for basic safety and basic performance
201.1 Scope, purpose and related standards
1) An asterisk (*) is used as the first character of the title or the beginning of a paragraph or table title, indicating that there are special guidelines and related items in Appendix AA.
Principle description.
In addition to the following, Chapter 1 of the General Standard applies.
201.1.1 *1) Range
replace.
This part of GB 9706 is applicable to the basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment (hereinafter abbreviated as
Called hemodialysis equipment).
This section does not consider the characteristics of the dialysate control system or the dialysate central supply system of the hemodialysis equipment with regenerable dialysate.
Set safety details, but it takes into account the specific safety requirements of this hemodialysis equipment for electrical safety and patient safety.
This section specifies the minimum safety requirements for hemodialysis equipment. These hemodialysis equipment is expected to be used by medical staff,
Used by patients or other trained personnel.
This section includes the expected implementation of hemodialysis, hemodiafiltration and hemofiltration treatments for patients independent of the time and place of treatment
All ME equipment.
If applicable, this section applies to related parts of ME equipment intended for other extracorporeal blood purification treatments.
The specific requirements of this section do not apply to.
---Extracorporeal tubing (see YY0267[3]);
---Dialyzer (see YY0053[2]);
---Dialysate concentrate (see ISO 23500-4.2019[14]);
---Dialysis water supply system (see ISO 23500-2.2019[12]);
---Central fluid supply system for dialysate concentrates (see ISO 23500-4.2019[14]), mixing a large amount of concentrates in the dialysis site
system;
--- Equipment used to implement peritoneal dialysis (see GB 9706.239 [1]).
201.1.2 Purpose
replace.
The purpose of this section is to specify the basic safety and basic performance of hemodialysis equipment.
201.1.3 Parallel standards
Supplement.
This section refers to Chapter 2 of the General Standards and applicable parallel standards listed in.201.2 of this section.
YY9706.102-2021, YY9706.108-2021, YY/T 9706.110-2021 and YY9706.111-2021 are in the 202nd
Chapter, Chapter 208, Chapter 210 and Chapter 211 apply after revision. GB 9706.103 and YY9706.112 are not applicable. IEC 60601-1-
9.2007 AMD1.2013[5] Not applicable (see note in 209).
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