YY 0054-2023 PDF English
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| YY 0054-2023 | English | 365 |
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Specification for management of ecological and environmental archives - - Ecological and environmental protection of construction project
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| YY 0054-2010 | English | 145 |
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Haemodialysis equipment
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| YY 0054-2003 | English | 479 |
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Haemodialysis, haemodiafiltration and haemofiltration equipment
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| YY 0054-1991 | English | 279 |
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(Hemodialysis apparatus)
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YY 0054-2023: Specification for management of ecological and environmental archives - - Ecological and environmental protection of construction project
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0054-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.40
CCS C 45
Replacing YY/T 0054-2010
Hemodialysis Equipment
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
Foreword
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for
Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents.
This Document replaced YY 0054-2010 Hemodialysis Equipment. Compared with YY 0054-
2010, this Document mad ethe major technical changes as follows besides the structural
adjustments and editorial modifications.
--- Change the "Scope" (see Clause 1 of this Edition; Clause 1 of the 2010 Edition);
---Change the "Normative References" (see Clause 2 of this Edition; Clause 2 of the 2010
Edition);
--- Change the "Terms and Definitions" (see Clause 3 of this Edition; Clause 3 of the 2010
Edition);
---Change the "Classification and Basic Parameters" (see Clause 4 of this Edition; Clause 4
of the 2010 Edition);
--- Change the requirements and test methods for "blood flow error" (see 5.2.1 and 6.2.1 of
this Edition; 5.2.1 and 6.2.1 of the 2010 Edition);
--- Change the requirements and test methods for "dialysate flow error" (see 5.2.2 and 6.2.2
of this Edition; 5.2.2 and 6.2.2 of the 2010 Edition);
--- Change the requirements and test methods for "net dehydration control" (see 5.2.3 and
6.2.3 of this Edition; 5.2.3 and 6.2.3 of the 2010 Edition);
--- Change the requirements and test methods for "replacement fluid flow error" (see 5.2.4
and 6.2.4 of this Edition; 5.2.4 and 6.2.4 of the 2010 Edition);
--- Change the requirements and test methods for "control and protection of heparin pumps"
(see 5.2.5 and 6.2.5 of this Edition; 5.2.5 and 6.2.5 of the 2010 Edition);
--- Change the requirements and test methods for "dialysate composition" (see 5.3 and 6.3
of this Edition; 5.3 and 6.3 of the 2010 Edition);
--- Change the requirements and test methods for "filtration-sterilization system" (see 5.4
and 6.4 of this Editon; 5.4 and 6.4 of the 2010 Edition);
--- Change the requirements and test methods for " control and protection of dialysate
conductivity " (see 5.5 and 6.5 of this Edition; 5.5 and 6.5 of the 2010 Edition);
--- Change the requirements and test methods for "temperature control" (see 5.6 and 6.6 of
this Edition; 5.6 and 6.6 of the 2010 Edition);
--- Change the requirements for "venous pressure monitoring" (see 5.7.2 of this Edition;
5.7.2 of the 2010 Edition);
--- Add the requirements and test methods for "arterial pressure alarm action" [see 5.7.3 c)
of this Edition];
--- Change the requirements and test methods for "blood leakage protection system" (see 5.9
and 6.9 of this Edition; 5.9 and 6.9 of the 2010 Edition);
--- Change the requirements and test methods for "prevention of air ingress" (see 5.10 and
6.10 of this Edition; 5.10 and 6.10 of the 2010 Edition);
--- Change the expression of the requirements for "pH measuring device" (see 5.11 of this
Edition; 5.11 of the 2010 Edition);
---Delete the requirements and test methods for "weighing scale" (see 5.12 and 6.12 of the
2010 Edition);
--- Change the requirements and test methods for "network power supply interruption" (see
5.12 and 6.12 of this Edition; 5.13 and 6.13 of the 2010 Edition);
--- Change the expression of requirements for "disinfection" (see 5.15 of this Edition; 5.16
of the 2010 Edition);
--- Add requirements for some contents in "appearance and structure" (see 5.17 of this
Edition);
--- Change the requirements and test methods for "environmental test" (see 5.19 of this
Edition; 5.20 of the 2010 Edition);
--- Change the test method for "transmembrane pressure indication error" (see 6.7.1.1 of this
Edition, 6.7.1.1 of the 2010 Edition);
--- Add the test method for "arterial pressure alarm action" [see 6.7.3 b) of this Edition];
--- Change the test method for "dialysate flow, temperature, conductivity stability" (see 6.8
of this Edition; 6.8 of the 2010 Edition);
--- Change the test method for "blood leakage protection system test" (see 6.9 of This Edition;
6.9 of the 2010 Edition);
---Delete "Inspection Rules" and "Marking, Instruction Manual, Packaging, Transportation
and Storage" (see Clauses 7 and 8 of the 2010 Edition).
Please note some contents of this Document may involve patents. The issuing agency of this
Document shall not identify these patents.
This Document was proposed by National Medical Products Administration.
This Document shall be under the jurisdiction of National Technical Committee on
Extracorporeal Circuit Equipment of Standardization Administration of China (SAC/TC 158).
The historical editions replaced by this Document are as follows.
--- YY 0054-1991 Hemodialysis Equipment was first-time published in 1991l
--- YY 0054-2003 Hemodialysis, Hemodiafiltration and Hemofiltration Equipment;
--- YY 0054-2010 Hemodialysis Equipment;
--- It is the third-time revised hereby.
Hemodialysis Equipment
1 Scope
This Document specifies the classification and requirements of hemodialysis equipment and
describes its test methods.
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
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in GB 9706.216 and the
following apply.
The process that the equipment automatically controls the ratio of hemodialysis concentrate
and dialysis water to prepare dialysate that meets clinical requirements.
4 Classification
The equipment can be divided into hemodialysis type and hemodiafiltration type.
5 Requirements
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.
For online equipment, the equipment's replacement fluid flow control range and control error
shall comply with the manufacturer's specifications.
6 Test Methods
Run hemodialysis mode and take dialysate samples after the equipment is stable. Inspect
according to the test method specified in YY/T 0598; and compare it with the setting value of
the dialysate composition that can be set on the equipment; the result shall meet the
requirements of 5.3.
Carry out the environmental test of the equipment according to the relevant provisions in GB/T
14710.The inspection terms after the environmental test shall be specified by the manufacturer,
and the results shall meet the provisions of 5.19.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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