|
US$459.00 ยท In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0267-2025: Extracorporeal systems for blood purification - Extracorporeal blood and fluidcircuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Status: Valid YY 0267: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0267-2025 | English | 459 |
Add to Cart
|
4 days [Need to translate]
|
Extracorporeal systems for blood purification - Extracorporeal blood and fluidcircuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
| Valid |
YY 0267-2025
|
| YY 0267-2016 | English | 379 |
Add to Cart
|
4 days [Need to translate]
|
Hemodialysis and related therapies. Extracorporeal blood circuit for blood purification devices
| Valid |
YY 0267-2016
|
| YY 0267-2008 | English | 639 |
Add to Cart
|
3 days [Need to translate]
|
Cardiovascular implants and artificial organs. Extracorporeal blood circuit for blood purification devices
| Obsolete |
YY 0267-2008
|
| YY 0267-1995 | English | 239 |
Add to Cart
|
2 days [Need to translate]
|
Extracorporeal blood circuit for blood purification devices
| Obsolete |
YY 0267-1995
|
PDF similar to YY 0267-2025
Basic data | Standard ID | YY 0267-2025 (YY0267-2025) | | Description (Translated English) | Extracorporeal systems for blood purification - Extracorporeal blood and fluidcircuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 22,270 | | Date of Issue | 2025-02-26 | | Date of Implementation | 2028-03-01 | | Older Standard (superseded by this standard) | YY 0267-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements for disposable extracorporeal blood circuits/fluid circuits (hereinafter referred to as extracorporeal blood circuits/fluid circuits) and accessories for blood purification treatments such as hemodialysis, hemodiafiltration, hemofiltration, and hemoconcentration, and describes the corresponding test methods. This standard applies to disposable extracorporeal blood circuits/fluid circuits and accessories for blood purification treatments such as hemodialysis, hemodiafiltration, hemofiltration, and hemoconcentration. This standard does not apply to: hemodialyzers, hemodiafiltration devices, or hemofilters; plasma separators; blood perfusion devices; vascular access devices. | YY 0267-2025: Extracorporeal systems for blood purification - Extracorporeal blood and fluidcircuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
---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.
CCSC45
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0267-2016
Blood purification extracorporeal circulation system hemodialyzer, blood
For dialysis filters, hemofilters and hemoconcentrators
Extracorporeal blood/fluid circuit
Published on February 26, 2025, implemented on March 1, 2028
The State Drug Administration issued
Table of contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirement 2
4.1 Biological evaluation 2
4.2 Sterility 2
4.3 Bacterial endotoxins 2
4.4 Mechanical properties 2
4.5 Features 5
4.6 Particle contamination 6
4.7 Chemical properties 6
4.8 Validity Period 7
5 Test methods 7
5.1 Overview 7
5.2 Biological evaluation 7
5.3 Sterility 7
5.4 Bacterial endotoxins 7
5.5 Mechanical properties 7
5.6 Functional characteristics 12
5.7 Particle pollution 13
5.8 Chemical properties 13
5.9 Validity Period 14
Appendix A (Informative) Technical differences between this document and ISO 8637-2.2024 and their causes 15
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 replaces YY 0267-2016 "Extracorporeal Blood Circuit for Hemodialysis and Related Therapeutic Blood Purification Devices" and
Compared with YY 0267-2016, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- The document name and scope have been changed, and the expressions related to the product name in the clauses have been modified accordingly;
--- Changed the sterility requirements (see 4.2, 4.2 of the.2016 edition);
--- Deleted the pyrogen requirements/test methods (see 4.3 and 5.4 of the.2016 edition);
--- Added bacterial endotoxin requirements/test methods (see 4.3, 5.4);
--- Changed the structural integrity requirements/test methods (see 4.4.1, 5.5.1, 4.4.1, 5.5.1 of the.2016 edition);
--- Changed the joint requirements/test methods (see 4.4.2~4.4.4, 5.5.2~5.5.4, 4.4.2~4.4.4, 5.5.2~
5.5.4);
--- Changed the color code requirements (see 4.4.5, 4.4.5 of the.2016 edition);
--- Added requirements/test methods for venous bubble trap functional components (see 4.4.8.2, 5.5.8.2);
--- Changed the sensor protector requirements/test methods (see 4.4.9, 5.5.9, 4.4.9, 5.5.9 of the.2016 edition);
--- Added pipe body design requirements/test methods (see 4.4.10, 5.5.10);
--- Changed the pump pipe performance requirements/test methods (see 4.5.2~4.5.3, 5.6.1~5.6.2, 4.4.10, 5.5.10 of the.2016 edition);
--- Added functional characteristics requirements/test methods (see 4.5, 5.6);
--- Changed the blood circuit compliance requirements/test methods (see 4.5.9, 5.6.8, 4.5, 5.6 of the.2016 edition);
--- Changed the particulate contamination test method (see 5.7, 5.7 of the.2016 edition);
--- Changed the chemical performance requirements/test methods (see 4.7, 5.8, 4.7, 5.8 of the.2016 edition);
--- Changed the validity period requirements/test methods (see 4.8, 5.9, 4.8, 5.9 of the.2016 edition);
--- The sampling port test method has been changed (see 5.5.6, 5.5.6 of the.2016 edition);
--- Deleted the marking requirements (see Chapter 6 of the.2016 edition);
--- Deleted the design guidance (see Appendix A of the.2016 edition).
This document is modified to adopt ISO 8637-2.2024 "Blood purification extracorporeal circulation system Part 2.Hemodialyzer, hemodiafiltration
Extracorporeal blood and fluid circuits for blood filters, blood filters and blood concentrators.
The technical differences between this document and ISO 8637-2.2024 and their reasons are shown in Annex A.
The following editorial changes were made to this document.
--- The document name and scope of application have been changed to adapt to the actual clinical situation.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158).
The previous versions of this document and the documents it replaces are as follows.
---First issued in.1995 as YY 0267-1995, first revised in.2008, and second revised in.2016;
---This is the third revision.
Blood purification extracorporeal circulation system hemodialyzer, blood
For dialysis filters, hemofilters and hemoconcentrators
Extracorporeal blood/fluid circuit
1 Scope
This document specifies the use of disposable blood purification devices for hemodialysis, hemodiafiltration, hemofiltration, hemoconcentration and other blood purification treatments.
The requirements for the extracorporeal blood circuit/fluid circuit (hereinafter referred to as the extracorporeal blood circuit/fluid circuit) and its accessories describe the corresponding test methods.
This document is applicable to disposable devices used in conjunction with blood purification treatments such as hemodialysis, hemodiafiltration, hemofiltration, and hemoconcentration.
Extracorporeal blood/fluid circuit and accessories.
This document does not apply to.
---Hemodialyzer, hemodiafilter or hemofilter;
---Plasma separator;
--- Blood perfusion device;
--- Vascular access devices.
Note 1.For the requirements of hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators, see YY 0053.
Note 2.For the requirements of plasma separators, see YY 0465.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 6682 Specifications and test methods for water used in analytical laboratories (GB/T 6682-2008, ISO 3696.1987, MOD)
GB 9706.216-2021 Medical electrical equipment Part 2-16.Basic equipment for hemodialysis, hemodiafiltration and hemofiltration equipment
Particular requirements for safety and essential performance (IEC 60601-2-16.2018, MOD)
GB/T 13074 Terminology of Blood Purification
GB/T 14233.1-2022 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB 15811 Single-use sterile injection needles (GB 15811-2016, ISO 7864.1993, NEQ)
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process (GB/T 16886.1-
2022,ISO 10993-1.2018,IDT)
GB/T 19335-2022 General technical requirements for single-use blood circuit products
YY/T 0681.1 Test methods for sterile medical device packaging Part 1.Guide to accelerated aging tests
YY/T 0916.7 Small-bore connectors for medical liquids and gases Part 7.Connectors for intravascular or subcutaneous applications
(YY/T 0916.7-2024,ISO 80369-7.2021,IDT)
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
The terms and definitions defined in GB/T 13074 apply to this document.
|