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YY/T 1492-2016: Cardiopulmonary bypass systems--General requirement for coating products
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1492-2016 | English | 219 |
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Cardiopulmonary bypass systems--General requirement for coating products
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YY/T 1492-2016
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Basic data | Standard ID | YY/T 1492-2016 (YY/T1492-2016) | | Description (Translated English) | Cardiopulmonary bypass systems--General requirement for coating products | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 11,194 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1492-2016: Cardiopulmonary bypass systems--General requirement for coating products---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.
Cardiopulmonary bypass systems - General requirements for coating products
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Cardiopulmonary bypass system - General requirements for surface coating products
(ISO 11658..2012, MOD)
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 requirements 2
5 Test methods 3
6 Information provided by the manufacturer 4
Appendix A (informative) The technical differences between this and ISO 11658..2012 and its causes 5
Reference 6
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the re-drafting method to modify the use of ISO 11658..2012 "cardiovascular implants and artificial organs in the extracorporeal circulation system
Blood/tissue contact with the surface coating ".
The main technical differences between this standard and ISO 11658..2012 are as follows.
- the scope of the removal of the temperature range requirements;
Normative reference documents using domestic standards;
--- sterile and pyrogen-free according to our common standards for testing;
--- shelf life (stability of the stability) according to China's common standards for testing;
--- delete the original English version of c), d) terms.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158) centralized.
The drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Dongguan Kewei medical equipment
Limited company.
The main drafters of this standard. Hong Liang Tong, Zhang Yun, Yan Donghuan, Li Aijun, Liu Peng, He Xiaofan.
Introduction
The purpose of this standard is to ensure that the surface coating device in contact with the blood, in terms of safety performance, integrity and function are fully
And the characteristics of the extracorporeal circulation device are properly displayed on the device label. This standard also includes the content that must be reported
Low demand, which will allow users to compare performance characteristics in a standard way.
In order to be used for the evaluation of surface coatings, this standard contains recommended procedures. Surface coverage determination requirements, leaching and biological activity
Sex, if required, surface coating treatment, although these requirements are not specified.
This standard refers to other criteria in which a method for determining the common characteristics of various medical devices can be found.
The standard does not include requirements for animal and clinical research.
The other criteria listed in the normative reference file contain additional requirements.
Cardiopulmonary bypass system - General requirements for surface coating products
1 Scope
This standard specifies the technical requirements, test methods, labeling, marking and other requirements of the surface coating on the cardiopulmonary bypass system. This standard
Suitable for delivery of blood cardiopulmonary bypass devices, in vitro life support devices and surface coating products in contact with blood or tissue.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
(ISO 10993-1..2009, IDT)
GB/T 16886.7-2015 Biological evaluation of medical devices - Part 7. Residue of ethylene oxide (ISO 10993-7.
2008, IDT)
GB 18279.1 Sterilization of health care products Ethylene oxide - Part 1. Development, validation and routine control of sterilization of medical devices
(GB 18279.1-2015, ISO 11135-1..2007, IDT)
GB 18280.1 Sterilization of medical care products - Part 1. Development, validation and routine control of sterilization of medical devices
(GB 18280.1-2015, ISO 11137-1..2007, IDT)
YY 0580-2011 Cardiovascular implants and artificial organs Cardiopulmonary bypass system Arterial line Blood filters (ISO 15675.
2009, MOD)
YY 0603-2015 Cardiovascular Implants and Artificial Organs Cardiac Surgery Hard Shell Regulators/Venous Regulators System (with or without)
Filter) and the vein storage soft bag (ISO 15674..2009, MOD)
YY 0604-2016 Cardiopulmonary bypass system Blood gas exchanger (oxygenator) (ISO 7199..2009, MOD)
Test methods for packaging of sterile medical devices - Part 1. Guidelines for accelerated aging testing (ASTMF
1980..2002, MOD)
Cardiovascular surgery implants and artificial organs Cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
The requirements for the use of pipe fittings (ISO 15676..2005, MOD)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Surface coating
The coating may be bio-derived or non-biological and can be applied directly to the blood contact surface or as an additive during processing
Material.
3.2
Coverage coverage
The effective coverage of the surface coating on the surface of the device in contact with blood or tissue.
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