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YY 0580-2024: Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
Status: Valid YY 0580: Evolution and historical versions
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Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
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YY 0580-2024
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| YY 0580-2011 | English | 329 |
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Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
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YY 0580-2011
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| YY 0580-2005 | English | 479 |
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Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial line blood filters
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YY 0580-2005
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PDF similar to YY 0580-2024
Basic data | Standard ID | YY 0580-2024 (YY0580-2024) | | Description (Translated English) | Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 26,277 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0580-2011 | | Issuing agency(ies) | State Drug Administration | YY 0580-2024: Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
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ICS 11.040.55
CCSC45
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0580-2011
Cardiovascular implants and artificial organs Cardiopulmonary bypass systems
Arterial Line Blood Filter
(ISO 15675.2016, MOD)
Released on 2024-07-08
2027-07-20 Implementation
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
5 Test methods 4
Appendix A (Informative) Technical differences between this document and ISO 15675.2016 and ISO 15675.2016/AMD1.2020 and their
Reason 8
Appendix B (Informative) Connector Example 10
References 19
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 0580-2011 "Cardiovascular Implants and Artificial Organs Cardiopulmonary Bypass System Arterial Line Blood Filters" and
Compared with YY 0580-2011, in addition to structural adjustments and editorial modifications, the main technical changes are as follows.
--- Deleted some terms (see 3.4, 3.5, 3.6, 3.9 of the.2011 edition);
--- Changed the definitions of some terms (see 3.5);
--- Changed the requirements for joints (see 4.2.3, 4.2.3 of the.2011 edition);
--- Added particle indicators (see 4.2.4, 5.3.4);
--- The test methods for sterility, pyrogen-free and connectors have been changed (see 5.2.1, 5.3.3, 5.2.1, 5.3.5 of the.2011 edition);
--- Changed the preparation requirements of the test solution for bubble removal capability (see 5.4.5.1, 5.4.4.1 of the.2011 edition);
--- Deleted the information and packaging provided by the manufacturer (see Chapter 6 and Chapter 7 of the.2011 edition).
This document is modified to adopt ISO 15675.2016 “Cardiovascular implants and artificial organs - Arterial blood filtration in cardiopulmonary bypass systems”
ISO 15675.2016/AMD1.2020 "Connectors", the clauses that have changed with ISO 15675.2016/AMD1.2020 have been approved.
The pages are indicated by double vertical lines (‖) in the blank space outside the page number.
This document has technical differences compared to ISO 15675.2016 and ISO 15675.2016/AMD1.2020.
The provisions involved in the.2016 differences are marked with a vertical line (|) in the blank space outside the page number. The corresponding technical
A summary of technical differences and their causes.
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.2005 as YY 0580-2005, first revised in.2011;
---This is the second revision.
Cardiovascular implants and artificial organs Cardiopulmonary bypass systems
Arterial Line Blood Filter
1 Scope
This document specifies the requirements for single-use sterile arterial line blood filters (hereinafter referred to as filters) and describes the corresponding tests
method.
This document applies to filters used in cardiopulmonary bypass surgery and does not apply to blood circuits in cardiopulmonary bypass systems.
Note. The filter is used to filter out various particles in human blood during cardiopulmonary bypass surgery, such as blood clots, debris, air embolism and other potentially dangerous
of substance.
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 14233.1 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process (GB/T 16886.1-
2011,ISO 10993-1.2009,IDT)
GB/T 16886.4 Biological evaluation of medical devices Part 4.Selection of tests for interaction with blood (GB/T 16886.4-
2003,ISO 10993-4.2002,IDT)
GB/T 16886.11 Biological evaluation of medical devices Part 11.Systemic toxicity tests (GB/T 16886.11-2011,
ISO 10993-11.2006, IDT)
GB 18278.1 Sterilization of health care products by moist heat Part 1.Development, validation and routine control of sterilization processes for medical devices
Request (GB 18278.1-2015, ISO 17665-1.2006, IDT)
GB 18279.1 Sterilization of healthcare products with ethylene oxide Part 1.Development, validation and routine control of sterilization processes for medical devices
System requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT)
GB 18280.1 Radiation sterilization of health care products Part 1.Development, validation and routine control of sterilization processes for medical devices
Request (GB 18280.1-2015, ISO 11137-1.2006, IDT)
GB/T.19974 Sterilization of health care products - Characteristics of sterilization factors and development, validation and routine control of sterilization processes for medical devices
General requirements (GB/T.19974-2018, ISO 14937.2009, IDT)
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)
YY/T 1556-2017 Test method for particulate contamination of medical infusion, blood transfusion and injection equipment
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
The following terms and definitions apply to this document.
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