Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of SAC/TC 110/SC 2 Subcommittee on Cardiovascular Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China.
Cardiovascular implants - Cardiac occluder
1 Scope
The application scope of this standard includes cardiac occluders implanted via catheter for the treatment of cardiac defects and other lesions, mainly including atrial septal occluder, ventricular septal occluder, patent ductus arteriosus occluder and patent foramen ovale occluder.
This standard specifies the requirements for cardiac occluder based on the current level of medical knowledge. As for safety, this standard expresses requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information provided by the manufacturer.
This standard is applicable to the delivery system that is part of the release of a cardiac occluder.
This standard does not cover degradation of bioabsorbable and polymer products and coatings and other time-dependent contents.
This standard does not cover procedures and devices used for pre-implantation of cardiac occluder system, such as J-type guide wires and balloon measurement.
This standard does not include devices used for left atrial appendage occlusion.
Except for sterilization, this standard does not include requirements for the evaluation of animal tissue products.
YY/T 0640-2016 specifies the general requirements for the performance of Non-active surgical implants, and this standard can be regarded as a supplement to YY/T 0640-2016.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB 18279 Medical devices - Validation and routine control of ethylene oxide sterilization
GB 18280 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
GB/T 19633 Packaging for terminally sterilized medical devices
GB/T 19974 Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0640-2016 Non-active surgical implants - General requirements
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this standard, the terms and definitions established in YY/T 0640-2016 as well as the followings apply.
3.1
cardiac occluder system
system including cardiac occluder and delivery system
3.2
delivery system
system or device used to deliver and release a cardiac occluder to its intended target location, which usually consists of a loader, dilator, sheath, delivery cable and other components
Note: After the cardiac occluder is deployed in place, the delivery system will be removed.
3.3
cardiac occluder
non-active surgical implant placed in a cardiac defect, abnormal access or special opening, etc. and occluding that location to achieve a blockage of abnormal blood flow, mainly including atrial septal occluder, ventricular septal occluder, patent ductus arteriosus occluder and patent foramen ovale occluder
3.3.1
atrial septal occluder
cardiac occluder for the treatment of atrial septal defect
Note: Although patent foramen ovale is a type of atrial septal defect, patent foramen ovale occluder is not a type of atrial septal occluder.
3.3.2
ventricular septal occluder
cardiac occluder for treating ventricular septal defects
3.3.3
patent ductus arteriosus occluder
cardiac occluder for treating continuous patent ductus arteriosus
3.3.4
patent foramen ovale occluder
cardiac occluder for occluding opening of patent foramen ovale
3.4
sheath/dilator
a kit, usually containing a sheath and dilator, used to create access to deliver a cardiac occluder
3.5
loader
used for storing cardiac occluder and, after being connected to the sheath, pushing the cardiac occluder in it into the sheath
3.6
delivery cable
device connecting to a cardiac occluder that pushes the cardiac occluder along the sheath to the intended implantation site and releases it, disconnects and withdraws
3.7
membrane
membraneous material that play a role of choke flow in a cardiac occluder
Note: Some cardiac occluder may be designed and constructed without a membrane.
4 General requirements
4.1 Classification
The type (see 3.3), constituent materials, and any surface-modifying substance of a cardiac occluder shall be indicated.
4.2 Size (unit in millimeters)
The manufacturer shall consider the following applicable sizes:
a) diameter of each disk surface;
b) diameter of the waist;
c) height of the waist;
d) other characteristic structure size.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 5 Intended performance 6 Design attributes 7 Materials 8 Design evaluation 9 Post-marketing surveillance 10 Manufacture 11 Sterilization 12 Packaging Annex A (Informative) Analyses and tests in laboratory Annex B (Informative) In vivo evaluation before clinical test Annex C (Informative) Clinical evaluation Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of SAC/TC 110/SC 2 Subcommittee on Cardiovascular Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China.
Cardiovascular implants - Cardiac occluder
1 Scope
The application scope of this standard includes cardiac occluders implanted via catheter for the treatment of cardiac defects and other lesions, mainly including atrial septal occluder, ventricular septal occluder, patent ductus arteriosus occluder and patent foramen ovale occluder.
This standard specifies the requirements for cardiac occluder based on the current level of medical knowledge. As for safety, this standard expresses requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging, and information provided by the manufacturer.
This standard is applicable to the delivery system that is part of the release of a cardiac occluder.
This standard does not cover degradation of bioabsorbable and polymer products and coatings and other time-dependent contents.
This standard does not cover procedures and devices used for pre-implantation of cardiac occluder system, such as J-type guide wires and balloon measurement.
This standard does not include devices used for left atrial appendage occlusion.
Except for sterilization, this standard does not include requirements for the evaluation of animal tissue products.
YY/T 0640-2016 specifies the general requirements for the performance of Non-active surgical implants, and this standard can be regarded as a supplement to YY/T 0640-2016.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB 18279 Medical devices - Validation and routine control of ethylene oxide sterilization
GB 18280 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
GB/T 19633 Packaging for terminally sterilized medical devices
GB/T 19974 Sterilization of health care products - General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0640-2016 Non-active surgical implants - General requirements
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this standard, the terms and definitions established in YY/T 0640-2016 as well as the followings apply.
3.1
cardiac occluder system
system including cardiac occluder and delivery system
3.2
delivery system
system or device used to deliver and release a cardiac occluder to its intended target location, which usually consists of a loader, dilator, sheath, delivery cable and other components
Note: After the cardiac occluder is deployed in place, the delivery system will be removed.
3.3
cardiac occluder
non-active surgical implant placed in a cardiac defect, abnormal access or special opening, etc. and occluding that location to achieve a blockage of abnormal blood flow, mainly including atrial septal occluder, ventricular septal occluder, patent ductus arteriosus occluder and patent foramen ovale occluder
3.3.1
atrial septal occluder
cardiac occluder for the treatment of atrial septal defect
Note: Although patent foramen ovale is a type of atrial septal defect, patent foramen ovale occluder is not a type of atrial septal occluder.
3.3.2
ventricular septal occluder
cardiac occluder for treating ventricular septal defects
3.3.3
patent ductus arteriosus occluder
cardiac occluder for treating continuous patent ductus arteriosus
3.3.4
patent foramen ovale occluder
cardiac occluder for occluding opening of patent foramen ovale
3.4
sheath/dilator
a kit, usually containing a sheath and dilator, used to create access to deliver a cardiac occluder
3.5
loader
used for storing cardiac occluder and, after being connected to the sheath, pushing the cardiac occluder in it into the sheath
3.6
delivery cable
device connecting to a cardiac occluder that pushes the cardiac occluder along the sheath to the intended implantation site and releases it, disconnects and withdraws
3.7
membrane
membraneous material that play a role of choke flow in a cardiac occluder
Note: Some cardiac occluder may be designed and constructed without a membrane.
4 General requirements
4.1 Classification
The type (see 3.3), constituent materials, and any surface-modifying substance of a cardiac occluder shall be indicated.
4.2 Size (unit in millimeters)
The manufacturer shall consider the following applicable sizes:
a) diameter of each disk surface;
b) diameter of the waist;
c) height of the waist;
d) other characteristic structure size.
Contents of YY/T 1553-2017
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-marketing surveillance
10 Manufacture
11 Sterilization
12 Packaging
Annex A (Informative) Analyses and tests in laboratory
Annex B (Informative) In vivo evaluation before clinical test
Annex C (Informative) Clinical evaluation
Bibliography
