YY/T 1748-2021 English PDF (YYT1748-2021)

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YY/T 1748-2021: Neurovascular implants -- Intracranial embolization coils
YY/T 1748-2021
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Neurovascular Implants – Intracranial Embolization Coils
神经血管植入物 颅内弹簧圈
ISSUED ON: SEPTEMBER 06, 2021
IMPLEMENTED ON: SEPTEMBER 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 5
4 General Requirements ... 7
5 Intended Performance ... 8
6 Design Properties ... 8
7 Materials ... 9
8 Laboratory Design Evaluation ... 9
9 Post-Market Supervision ... 15
10 Manufacturing ... 16
11 Sterilization ... 16
12 Packaging ... 16
Appendix A (Informative) Relationship between Design Properties, Design Evaluation
and Potential Failure Mode ... 20
Appendix B (Informative) Laboratory Analytical Test ... 27
Bibliography ... 43
Neurovascular Implants – Intracranial Embolization Coils
1 Scope
This Standard specifies general requirements, design properties and laboratory design
evaluations for coils, pushers and coil systems. This Standard is applicable to coil products for
the treatment of intracranial aneurysms, arteriovenous fistulas, arteriovenous malformations
and other intracranial vascular diseases, as well as the pushers and introducer sheaths that are
matched with them.
This Standard does not apply to coil products for the treatment of other vascular aneurysms.
NOTE 1: Coil products used for other vascular aneurysms may refer to this Standard for implementation.
This Standard does not apply to devices that assist in the release of coils (referred to as releasers,
such as separation control boxes, etc.).
NOTE 2: For the releaser, the relevant standards or technical requirements shall be met. It is possible to
use a releaser as an auxiliary device in the design evaluation of the coil.
This Standard does not deal with drug-related content.
NOTE 3: For the pharmaceutical ingredients included in the product design, it shall be implemented in
accordance with the corresponding laws, regulations and other documents.
NOTE 4: YY/T 0640 specifies general requirements for the performance of passive surgical implants,
this Standard can be used as a supplement to YY/T 0640.
2 Normative References
The following documents are essential to the application of 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/T 14233.1 Test Methods for Infusion Transfusion Injection Equipment for Medical
Use - Part 1: Chemical Analysis Methods
GB/T 16886 (all parts) Biological Evaluation of Medical Devices
GB 18278.1 Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for
the Development, Validation and Routine Control of a Sterilization Process for Medical
Devices
GB 18279.1 Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements
for Development, Validation and Routine Control of a Sterilization Process for Medical
Devices
GB 18280.1 Sterilization of Health Care Products – Radiation - Part 1: Requirements for
Development, Validation and Routine Control of a Sterilization Process for Medical
Devices
GB/T 19633.1 Packaging for Terminally Sterilized Medical Devices - Part 1:
Requirements for Materials, Sterile Barrier Systems and Packaging Systems
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
YY/T 0316 Medical Devices - Application of Risk Management to Medical Devices
YY 0450.1-2020 Accessory Devices for Sterile Single - Use Intravascular Catheters - Part
1: Introducers
YY/T 0640 Non-Active Surgical Implants - General Requirements
YY/T 0695 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization
Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in YY/T 0640 and the
following apply.
3.1 Intracranial embolization coil
The passive surgical implant that is place on the intracranial vascular disease through the
catheter, with a spring-like structure for embolization.
3.2 Coil system
It includes coil, pusher and introducer sheath.
3.3 Primary coil
It is the most basic form of a coil that is formed by winding a metal wire.
3.4 Secondary shape
h) conformity of dimensions to design specifications;
i) component compatibility;
j) magnetic resonance compatibility;
k) visibility;
l) The coil system meets the requirements of the relevant parts of the GB/T 16886 series.
For the instruments that are used in conjunction with the detachment process of the coil, the
risks existing in the joint use of the coil shall be considered. Electrical safety shall be considered
for coils that use electrolytic or thermolytic detachment.
7 Materials
7.1 General
The requirements of YY/T 0640 apply to this Standard.
7.2 Coil
Manufacturers shall evaluate the materials that are used to manufacture the coils.
7.3 Pusher
The pusher should be made of materials that can contact blood. If the pusher is a multi-layer
structure, the outer layer that is expected to be exposed to blood shall be made of materials that
can contact blood.
8 Laboratory Design Evaluation
8.1 General
The requirements of YY/T 0640 apply to this Standard. Risk assessment shall be carried out in
accordance with the requirements of YY/T 0316.
A device evaluation strategy (DES) should be established. DES provides principles for the
selection of test items to evaluate device performance. This principle is based on the design
properties and potential failure modes of the device. DES can be presented in the form of a
table, where the column headings are explained in Table A.1 of Appendix A.
8.2 Sampling
The sampling plan shall ensure that the measurement data for each feature is adequately
representative. The design properties of the verification coil shall be representative of the device
to be released and cover all dimensions.
The samples selected for each test shall represent at least the worst case. The dimension of the
coil, the dimension of the pusher, the way of detachment, and the implantation conditions (e.g.,
target disease size and morphology) shall also be considered. Analysis is required as necessary
to identify the samples most likely to fail under specific implantation conditions.
Sampling should adequately represent normal fluctuations in device characteristics (e.g.,
multiple batches).
Sample selection should provide a reasonable explanation. For all tests, the number of test
samples shall be justified.
For the untested product attributes, reasons for not testing shall be given.
NOTE: Not all tests are applicable to all coil system designs, and manufacturers should determine
applicable tests based on device design properties and DES.
8.3 Sample treatment
All samples shall be sterilized, including multiple sterilizations (if applicable), unless there are
good reasons to use non-sterile samples.
Samples shall be subjected to treatment that may affect the test results before test.
When appropriate, test should be performed in a simulated physiological environment (e.g., a
temperature-controlled water bath)...