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YY/T 0054-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
CCS C 45
Replacing YY/T 0054-2010
Hemodialysis Equipment
血液透析设备
ISSUED ON: JANUARY 13, 2023
IMPLEMENTED ON: JANUARY 15, 2026
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4
1 Scope ... 7
2 Normative References ... 7
3 Terms and Definitions ... 8
4 Classification ... 8
5 Requirements ... 8
5.1 Normal working conditions of the equipment ... 8
5.2 Flow control ... 9
5.3 Dialysate composition ... 11
5.4 Filtration-sterilization system ... 11
5.5 Control and protection of dialysate conductivity ... 12
5.6 Temperature control ... 13
5.7 Pressure monitoring ... 14
5.8 Dialysate flow, temperature and conductivity stability ... 15
5.9 Blood leakage protection system ... 15
5.10 Prevent air from entering ... 15
5.11 pH measuring device ... 16
5.12 Network power supply interruption ... 16
5.13 Degassing function ... 16
5.14 Waste liquid protection ... 16
5.15 Disinfection ... 16
5.16 Operating noise ... 18
5.17 Appearance and structure ... 18
5.18 Safety requirements ... 19
5.19 Environmental test ... 19
6 Test Methods ... 19
6.1 Test working conditions ... 19
6.2 Flow control test ... 20
6.3 Dialysate composition test ... 25
6.4 Filtration-sterilization system test ... 25
6.5 Dialysate conductivity control and protection test ... 26
6.6 Temperature control system test ... 28
6.7 Pressure monitoring test ... 29
6.8 Dialysate flow, temperature, conductivity stability test ... 30
6.9 Blood leakage protection system test ... 31
6.10 Test to prevent air from entering ... 32
6.11 pH measuring device test ... 33
6.12 Network power supply interruption test ... 33
6.13 Degassing function test ... 33
6.14 Waste liquid protection test ... 33
6.15 Disinfection test ... 34
6.16 Working noise test ... 37
6.17 Appearance and structural testing ... 37
6.18 Safety requirements test ... 37
6.19 Environmental test ... 37
Hemodialysis Equipment
1 Scope
This Document specifies the classification and requirements of hemodialysis equipment and
describes its test methods.
This Document applies to hemodialysis equipment with automatic preparation of dialysis fluid
(hereinafter referred to as equipment).
This Document does not apply to:
--- Hemodialysis water treatment equipment;
--- Peritoneal dialysis equipment;
--- Hemoperfusion, plasma exchange, and plasma adsorption equipment;
--- Continuous blood purification equipment;
--- Central liquid supply system;
--- Hemodialysis equipment with regenerable dialysate.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in this Document. For the dated documents, only the versions with the dates
indicated are applicable to this Document; for the undated documents, only the latest version
(including all the amendments) is applicable to this Document.
GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
GB 9706.216 Medical electrical equipment - Part 2-16: Particular requirements for the
basic safety and essential performance of hemodialysis, hemodiafiltration and
hemofiltration equipment
GB/T 14710 Environmental requirement and test methods for medical electrical
equipment
YY 0598 Concentrates for hemodialysis and related therapies
YY 1272-2016 Dialysis fluid filter
a) Ambient temperature: 10℃~30℃ or as specified by the manufacturer;
b) Relative humidity: ≤70% or as specified by the manufacturer;
c) Atmospheric pressure: 86kPa~106kPa or as specified by the manufacturer;
d) Power supply: a.c. 220 × (1±10%) V, 50 × (1±2%) Hz or as specified by the manufacturer;
e) Inlet water temperature: as specified by the manufacturer;
f) Inlet water pressure: as specified by the manufacturer.
5.2 Flow control
5.2.1 Blood flow error
The blood flow of the device shall comply with the following provisions:
a) The blood flow control range of the device shall comply with the manufacturer's
specifications;
b) The blood flow control error of the device shall comply with the manufacturer's
specifications;
c) If applicable, the display error of blood flow shall comply with the manufacturer's
specifications.
NOTE 1: Blood flow lower than the set value is considered unfavorable for typical treatment. Therefore,
the goal of this experiment is to find the maximum negative blood flow error; and it is generally
considered that the negative error of the control error is no less than -10%.
NOTE 2: Fatigue of pump tubing segments may reduce blood flow.
NOTE 3: Blood flow in a peristaltic pump may be affected by input negative pressure.
5.2.2 Dialysate flow error
The dialysate flow of the equipment shall comply with the following provisions:
a) The dialysate flow control range of the equipment shall comply with the manufacturer’s
specifications;
b) The dialysate flow control error of the equipment shall comply with the manufacturer's
specifications.
NOTE: When the dialysate flow rate is lower than the set value, it is considered unfavorable for
typical treatment; and the negative error is generally considered to be no less than -10%.
5.2.3 Net dehydration control
5.2.3.1 Net dehydration error
The net dehydration of the equipment shall comply with the following provisions:
a) Net dehydration of the equipment shall be achieved in accordance with the manufacturer's
specifications;
b) Within the nominal net dehydration rate range of the equipment, the allowable error of
the net dehydration rate shall be ±5% or ±100mL/h, whichever is the larger absolute
value;
c) Under normal working conditions, for a typical 4-hour dialysis treatment, the display
error of the cumulative net dehydration volume of the equipment shall not exceed
±400mL.
NOTE: The net dehydration rate control error and cumulative net dehydration volume error for
underweight patients are determined by the manufacturer's risk analysis.
5.2.3.2 Net dehydration deviation
For a typical 4-hour dialysis treatment, at any time during the treatment period, the difference
between the actual cumulative net dehydration volume and the expected cumulative net
dehydration volume shall be within ±400mL.
NOTE: The net dehydration deviation error for underweight patients is determined by the manufacturer's
risk analysis.
5.2.3.3 Safety of net dehydration
When the equipment is running, the following provisions shall be satisfied to ensure the safety
of net dehydration:
a) The equipment shall display real-time net dehydration parameters and completed net
dehydration volume;
b) The settings of net dehydration parameters shall be confirmed.
5.2.4 Replacement fluid flow error
For online equipment, the equipment's replacement fluid flow control range and control error
shall comply with the manufacturer's specifications.
NOTE: Replacement fluid flow below the set value is considered detrimental to typical treatment.
5.2.5 Control and protection of heparin pump
b) Unless additional protective measures are determined by the risk management process,
the equipment shall be able to detect the integrity of the non-disposable filtration
sterilization system before treatment;
c) It shall be ensured that the recommended disinfection procedures do not affect the
performance of the filtration-sterilization system.
NOTE 1: The filtrate of the filtration-sterilization system may not necessarily meet the quality
requirements of the final replacement fluid.
NOTE 2: If necessary, the filtration performance of a single filter can be tested offline.
5.5 Control and protection of dialysate conductivity
5.5.1 Resolution and indication error
The resolution and indication error of the equipment shall comply with the following provisions:
a) The display resolution shall be no greater than 0.1mS/cm;
b) The indication error shall comply with the manufacturer's specifications.
5.5.2 Conductivity control function
The conductivity control function of the equipment shall comply with the following provisions:
a) The conductivity control error shall comply with the manufacturer's specifications;
b) If the equipment is equipped with dialysate conductivity feedback control function, then:
--- The equipment control system shall be equipped with at least one dialysate
conductivity measuring device that is independent of any protection system;
--- Under normal circumstances, when the measured value of dialysate conductivity
deviates from the expected value, the conductivity feedback control function shall
be able to ensure that the conductivity control error meets the requirements of 5.5.2
a).
5.5.3 Conductivity protection function
The conductivity protection function of the equipment shall comply with the following
provisions:
a) The equipment protection system shall be equipped with at least one dialysate
conductivity measuring device independent of any control system;
b) The equipment shall test the effectiveness of the conductivity measuring device of the
protection system:
--- Each time before entering treatment mode, the equipment shall be able to test the
effectiveness of the conductivity measuring device of the protection system, or
--- Conduct an effectiveness test at least once a day before entering the treatment mode,
and measures shall be taken to ensure the continued effectiveness of the conductivity
measuring device of the protection system during the treatment process.
c) During treatment, when the measured value of the dialysate conductivity measuring
device of the protection system exceeds the alarm limit, the equipment shall activate
audible and visual alarm signals to prevent the flow of dialysate to the dialyzer (or filter),
and (or) prevent replacement fluid from flowing into the blood; and the conductivity
value measured at the dialyzer inlet when alarming does not exceed ±5% of the expected
value;
d) During the treatment process, the conductivity over-limit protection function is not
allowed to be turned off;
e) The equipment shall have measures to prevent misplacement of dialysate concentrate;
f) If the equipment is equipped with a dialysate conductivity feedback control function, the
equipment shall also have protection measures independent of the feedback control
system. After the concentration of the concentrated solution exceeds the range specified
by the manufacturer, the equipment shall stop feedback control and activate the audible
visual alarm signal; and prevent the dialysate from flowing to the dialyzer (or filter),
and/or prevent the replacement fluid from flowing into the blood.
NOTE: Unlimited feedback control of dialysate conductivity may be risky.
5.6 Temperature control
5.6.1 Temperature control range and error
5.6.1.1 Dialysate temperature control range and error
The dialysate temperature control range and error of the equipment shall comply with the
following provisions:
a) The dialysate temperature control range shall comply with the manufacturer's
specifications. Unless reasonably justified during the manufacturer's risk management
process, the dialysate temperature control range shall not exceed 33°C~42°C;
b) The dialysate temperature control error shall comply with the manufacturer's
specifications, and the temperature control error within the range of 35 ℃ ~ 38 ℃ shall
not exceed ±0.5 ℃.
5.6.1.2 Replacement fluid temperature control range and error
b) There shall be high and low limit alarms, and the alarm value tolerance shall comply with
the manufacturer's provisions.
c) In treatment mode, when the arterial pressure exceeds the alarm limit, the equipment shall
activate audible and visual alarm signals, stop the blood pump operation, and/or prevent
replacement fluid from flowing into the blood, and reduce ultrafiltration to a minimum.
5.8 Dialysate flow, temperature and conductivity stability
The working performance of the equipment shall be stable and meet the following requirements
during 4 hours of continuous operation:
a) Dialysate flow fluctuation ≤10%;
b) Dialysate temperature fluctuation ≤1°C;
c) Dialysate conductivity fluctuation ≤1mS/cm.
5.9 Blood leakage protection system
The equipment shall be equipped with a blood leakage protection system. Under the specified
maximum dialysate flow, ultrafiltration flow, and replacement fluid flow (if applicable), the
maximum alarm limit of the blood leakage rate shall be ≤0.35mL/min [hematocrit of blood
(Hct) is 32%], the protection system shall be able to activate audible and visual alarm signals
and prevent further leakage of blood into the dialysate.
5.10 Prevent air from entering
5.10.1 Air detection measures
Equipment shall have air detection measures to prevent air from entering the patient:
--- Air detection measures against the detection sensitivity of large volumes of air shall
comply with the manufacturer's specifications. When the value specified by the
manufacturer is exceeded, the device shall activate audible and visual alarm signals and
prevent blood flow to the patient.
--- Air detection measures shall have the function of detecting continuous air entry.
5.10.2 Prevent air from entering the patient
The equipment shall be capable of preventing the entry of large volumes of air and continuous
air in excess of the manufacturer's specifications from entering the patient, and safeguards shall
be capable of activating audible and visual alarm signals and preventing blood flow to the
patient.
NOTE 1: If the arterial line has a blood return function, there is also a risk of air entering the patient,
including large volumes of air and continuous air.
NOTE 2: The bubble detection method and the liquid level detection method can be used to detect large
volumes of air and continuous air entry. If either of them cannot be used alone to detect large volumes of
air and continuous air, they can be used in combination.
5.11 pH measuring device
If the equipment has a pH measuring device, the measurement error of the equipment's pH
measuring device shall comply with the manufacturer's specifications.
5.12 Network power supply interruption
The network power supply interruption function of the equipment shall comply with the
following provisions:
a) When the network power supply is interrupted, the equipment shall be able to ensure that
the blood pump during the treatment process continues to work for no less than 15 min;
and the blood circuit system shall continue to maintain working status;
NOTE: The blood circuit system includes blood pumps, heparin pumps, blood circuit protection
systems, veinous clamps, etc.
b) The equipment shall be able to prevent accidental shutdown caused by mis-operation of
switches other than the mains power switch during treatment.
5.13 Degassing function
The equipment shall have a degassing function for water or liquid inlet.
5.14 Waste liquid protection
The equipment's waste system shall prevent used waste fluid from flowing back into the
dialyzer.
5.15 Disinfection
5.15.1 General requirements
The equipment shall ensure that the dialysate pipeline is disinfected without dead zones.
5.15.2 Thermal disinfection
If the equipment has a thermal disinfection function, it shall comply with the following
provisions:
a) The manufacturer should specify the thermal disinfection parameters for the inner
surfaces of each part of the dialysate pipeline of the equipment, including:
c) The equipment shall have the function of monitoring abnormal effective concentration of
disinfectant and/or abnormal temperature. When an abnormality occurs, the equipment
shall activate audible and visual alarm signals at least before entering the next treatment;
d) The equipment shall have the function of monitoring the integrity of the disinfection
program. When the disinfection program is unexpectedly interrupted and the disinfection
program is not completed:
--- The equipment shall start the flushing process and prompt that the disinfection is not
completed;
--- Or re-disinfect;
e) After disinfection is completed, the residual amount of disinfectant shall comply with the
manufacturer's specifications;
f) If the equipment uses different suction inlets to inhale different disinfectants, measures
shall be taken to prevent incorrect connection of the disinfectants.
NOTE 2: Disinfectant refers to the original solution before dilution, and disinfectant refers to the
solution diluted to achieve an effective disinfection concentration.
NOTE 3: The activity of sodium hypochlorite and peracetic acid increases with temperature, but
too high a temperature may cause the disinfectant to degrade, weaken its bactericidal activity, and
may produce harmful substances.
5.16 Operating noise
There shall be no abnormal noise when the equipment is working, and the noise shall be no
greater than 62dB (A-weighted).
NOTE: Abnormal noise does not include alarm sounds.
5.17 Appearance and structure
The appearance and structure of the equipment shall comply with the following provisions:
a) The appearance of the equipment shall be correct, the surface shall be clean, the color
shall be uniform, and there shall be no defects such as scratches or cracks;
b) The panel of the equipment shall be free of coating peeling and rust, and the words and
signs on the panel shall be clearly visible;
c) The plastic parts of the equipment shall be free from blistering, cracking, deformation and
spillage of filling material;
d) The control and adjustment mechanism of the equipment shall be flexible and reliable,
6.2 Flow control test
6.2.1 Blood flow error test
Compliance is checked under the following test conditions:
a) When the equipment is running in treatment mode, the actual blood flow control range of
the equipment shall meet the requirements of 5.2.1 a);
b) Carry out the test as follows:
Test 1:
--- Install the unused pump pipe section to the equipment according to the instruction
manual and let it run for at least 30 min;
--- Inject 37℃ liquid (for example: water) into the extracorporeal pipeline;
--- Set the blood flow of the equipment to 400mL/min, or if not possible, to the maximum
possible blood flow;
--- Adjust the pre-pump arterial pressure to -200mmHg;
--- Measure blood flow 3 times, each measurement takes 3 min; and if applicable, record
the value displayed by the device at the same time;
--- Calculate the arithmetic mean of three actual measurement values as the measurement
value;
--- The control error calculated from the measured value and the set value shall meet the
requirements of 5.2.1 b);
--- If applicable, the display error calculated from the equipment display value and the
measured value shall meet the requirements of 5.2.1 c);
Continue to test 2:
--- Set the equipment’s blood flow to the midpoint of the nominal range;
--- Set the pre-pump arterial pressure to -200mmHg;
--- Measure blood flow 3 times, each measurement takes 3 min; and if applicable, record
the value displayed by the equipment at the same time;
--- Calculate the arithmetic mean of three actual measurement values as the measurement
value;
--- The control error calculated from the measured value and the set value shall meet the
......
YY 0054-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 45
Replacing YY 0054-2003
Haemodialysis equipment
血液透析设备
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Classification and basic parameters ... 6
5 Requirements ... 7
6 Test methods ... 14
7 Inspection rules ... 25
8 Marks, instructions for use, packaging, transport and storage ... 26
Appendix A ... 30
Foreword
All technical contents of this Standard are mandatory.
This Standard replaces YY 0054-2003 “Haemodialysis, haemodiafiltration and
haemofiltration equipment”.
Main technical differences between this Standard and the previous version are
as follows.
- Modify the standard name to “Haemodialysis equipment”;
- Add the requirements for dialysate concentration control and monitoring
system;
- Add the requirements for conductivity stability;
- Add the requirements for on-line equipment;
- Add the requirements for disinfection;
- Delete the requirements for dialysate pressure monitoring;
- Delete the requirements for cleaning and disinfection protection, which
are contained in GB 9706.2;
- Delete the requirements for leakage, which are contained in GB 9706.2;
- Delete the requirements for alarm sound, which are contained in GB
9706.2;
- Delete the requirements for biological evaluation, which are contained in
GB 9706.1-2007.
Appendix A of this Standard is informative.
Since the date of implementation of this Standard, it replaces YY 0054-2003.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of and interpreted by National
Technical Committee of Standardization for Medical Cardiopulmonary Bypass
Equipment.
The drafting organizations of this Standard. Guangdong Medical Devices
Quality Surveillance and Test Institute of State Food and Drug Administration,
AND Shan Wai Shan Science & Technology Co., Ltd.
Main drafters of this Standard. Wang Peilian, Chen Jiaye, Chen Yuen, Zhong
Shengkui, Gao Guangyong, and Zeng Fanfeng.
This Standard replaces the following previous versions.
- YY 0054-1991;
- YY 0054-2003.
Haemodialysis equipment
1 Scope
This Standard specifies haemodialysis equipment’s terms and definitions,
classifications and basic parameters, requirements, test methods, inspection
rules, marks, instructions for use, packaging, transport, as well as storage
requirements.
This Standard is applicable to automatic dosing hemodialysis equipment
(hereinafter referred to as the “equipment”).
This Standard is not applicable to.
- Water treatment equipment of hemodialysis use;
- Peritoneal dialysis equipment;
- Hemoperfusion, plasmapheresis, and plasma adsorption device;
- Continuous blood purification equipment;
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. For dated references,
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods (GB/T 191-
2008, ISO 780.1997, MOD)
GB/T 9706.1 Medical electrical equipment - Part 1. General requirements for
safety (GB 9706.1-2007, IEC 60601-1.1988+A1+A2, IDT)
GB/T 9706.2 Medical electrical equipment - Part 2-16. Particular
requirements for the safety of haemodialysis, haemodiafiltration and
haemofiltration equipment (GB 9706.2-2003, IEC 60601-2-16.1998, IDT)
GB/T 9969 General Principles for Preparation of Instructions for Use of
Industrial Products
GB/T 13074 Terms of blood purification
GB/T 14710 Environmental requirement and test methods for medical
electrical equipment
YY/T 0466.1 Devices - symbols to be used with medical device labels,
labelling and information to be supplied (YY/T 0466.1-2009, ISO 15223.2007,
IDT)
YY 0598 Concentrates for haemodialysis and related therapies (YY 0598-
2006, ISO 13958.2002, MOD)
The Pharmacopoeia of the People's Republic of China (2005 Edition)
3 Terms and definitions
Terms and definitions determined in GB 9706.2 and GB/T 13074 are applicable
to this Standard.
3.1 Automatically preparation of dialyzing fluid
The process of prescription output that is consistent with clinical dialysis when
the equipment respectively absorbs concentrated dialysate or relevant
concentrates and dialysis water, then proportionally mix them by the automatic
system of the equipment.
3.2 Online equipment
The equipment that is based on the dialysate well configured by the equipment,
that is further purified by endotoxin filter so as to meet the standard of
intravenous fluid, and is used as the substitution fluid for hemodiafiltration /
hemofiltration.
3.3 Volume-control of ultrafiltration
The ultrafiltration control method that is to adjust the amount of dehydration by
controlling dewatering capacity.
4 Classification and basic parameters
4.1 Classification
The equipment shall be classified according to function.
a) Hemodialysis type;
b) Hemodiafiltration type;
- Online;
- Non-online.
4.2 Basic parameters
4.2.1 Dialysate flow
For different-class equipment, the dialysate flow shall comply with the following
provisions.
a) The maximum dialysate flow of hemodialysis and non-online
hemodiafiltration equipment shall not be less than 500 mL/min;
b) The maximum dialysate flow of online hemodiafiltration equipment shall
not be less than 700 mL/min.
4.2.2 Ultrafiltration mode
It shall be capacity ultrafiltration control type.
4.2.3 Liquid supply mode
It shall be automatic dosing.
5 Requirements
5.1 Normal operating conditions of the equipment
The equipment shall work properly when it meets the following conditions.
a) Ambient temperature. 10°C ~ 30°C or the one specified by the
manufacturer;
b) Relative humidity. ≤ 70% or the one specified by the manufacturer;
c) Atmospheric pressure. 86 kPa ~ 106 kPa or the one specified by the
manufacturer;
d) Power supply. a.c. 220 × (1±10%) V, 50 × (1±2%) Hz or the one specified
by the manufacturer;
e) Water temperature. according to the manufacturer's instructions;
f) Water pressure. according to the manufacturer's instructions.
5.2 Flow control
5.2.1 Blood flow error
The equipment’s blood flow error shall comply with the manufacturer’s
instructions.
Note 1. Negative error of blood flow should not be less than -10%.
Note 2. Fatigue of blood pump will make blood flow reduced.
Note 3. Peristaltic pump blood flow will be affected by input negative pressure.
5.2.2 Dialysate flow error
The equipment’s dialysate flow error shall comply with the manufacturer’s
instructions.
Note 1. When dialysate flow is less than the set value, it shall be regarded as poor
treatment.
Note 2. Negative error of dialysate flow shall not be less than -10%.
5.2.3 Dehydration control
5.2.3.1 Dehydration error
When the equipment is within the nominal range of dehydration, its dehydration
tolerance shall be ±5% or ±100 Ml/h; take the greater absolute value.
5.2.3.2 Dehydration deviation
At any time during treatment, the amount of dehydration shall be within ±400
mL.
5.2.3.3 Dehydration safety
During equipment operation, it shall meet the following provisions so as to
ensure the dehydration safety.
a) The equipment shall display real-time parameters of dehydration;
b) The setting of dehydration parameters shall be verified.
5.2.4 Substitution fluid flow error (if any)
Substitution fluid flow error of the equipment shall comply with the instructions
of the manufacturer.
5.2.5 Heparin flow control and monitoring
5.2.5.1 Heparin flow error
Heparin flow error of the equipment shall comply with the provisions of the
manufacturer.
5.2.5.2 Heparin injection monitoring
When heparin injection is completed or it is injected till a preset time, the
equipment shall send out a sound-optic prompt.
5.2.5.3 Heparin pump overload or incorrect rate monitoring
When heparin pump is overloaded or the rate is incorrect, the equipment shall
send out an sound-optic alarm.
5.3 Dialysate composition
Dialysate composition shall comply with the instructions of the manufacturer.
Note. The equipment shall have device to extract dialysate sample online.
5.4 Substitution fluid (applicable to online equipment)
5.4.1 Requirements for substitution fluid
Bacterial endotoxin of substitution fluid shall not exceed 0.03 EU/mL.
Note. The equipment shall have online device to extract substitution fluid sample.
5.4.2 Substitution fluid filtration - sterilization system
Substitution fluid filtration - ster...
......
Standard ID | YY 0054-2023 (YY0054-2023) | Description (Translated English) | (Hemodialysis equipment) | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of International Standard | 11.040.40 | Word Count Estimation | 22,280 | Date of Issue | 2023-01-13 | Date of Implementation | 2026-01-15 | Administrative Organization | National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC 158) | Proposing organization | State Drug Administration | Issuing agency(ies) | State Drug Administration | Summary | This standard specifies the classification and requirements of hemodialysis equipment, and describes the test methods. This standard applies to hemodialysis equipment with automatic liquid preparation. This standard does not apply to hemodialysis water treatment equipment, peritoneal dialysis equipment, hemoperfusion, plasma exchange, plasma adsorption equipment, continuous blood purification equipment, central liquid supply system, and hemodialysis equipment with regenerable dialysate. | Standard ID | YY 0054-2010 (YY0054-2010) | Description (Translated English) | Haemodialysis equipment | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C45 | Classification of International Standard | 11.040.40 | Word Count Estimation | 19,195 | Date of Issue | 2010-12-27 | Date of Implementation | 2012-06-01 | Older Standard (superseded by this standard) | YY 0054-2003 | Quoted Standard | GB/T 191; GB 9706.1; GB 9706.2; GB/T 9969; GB/T 13074; GB/T 14710; YY/T 0466.1; YY 0598; Chinese Pharmacopoeia 2005 | Drafting Organization | Guangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | Administrative Organization | National Technical Committee of Standardization for medical pump device | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | China Food and Drug Administration | Summary | This standard specifies the hemodialysis equipment terms and definitions, classifications and basic parameters, requirements, test methods, test rules, signs, instructions and packaging, transportation and storage requirements. This standard applies to automatic dosing hemodialysis equipment (hereinafter referred to as the device). This standard does not apply to: Hemodialysis water treatment equipment, peritoneal dialysis equipment, hemoperfusion, plasmapheresis, plasma adsorption equipment, continuous blood purification equipment. | Standard ID | YY 0054-2003 (YY0054-2003) | Description (Translated English) | Haemodialysis, haemodiafiltration and haemofiltration equipment | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C45 | Classification of International Standard | 11.040.30 | Word Count Estimation | 12,128 | Date of Issue | 2003/6/20 | Date of Implementation | 2004/1/1 | Older Standard (superseded by this standard) | YY 0054-1991 | Drafting Organization | State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center | Administrative Organization | National Medical Extracorporeal Circulation Equipment Standardization Technical Committee | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration |
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