YY/T 0487-2010 English PDF (YYT0487-2010)

This Standard specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.

YY/T 0487-2010
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YY
ICS 11.040.40
C 48
Pharmaceutical Industry Standard
of the People’s Republic of China
Replacing YY/T 0487-2004
Sterile, single-use hydrocephalus shunts and
components
(ISO 7197.2006 Neurosurgical implants - Sterile,
single-use hydrocephalus shunts and components, MOD)
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 6
2 Normative references ... 6
3 Terms and Definitions ... 7
4 General requirements for shunts ... 8
5 Specific requirements for components ... 10
6 Marking and labelling of shunts... 11
7 Packaging ... 11
8 Information supplied by the manufacturer ... 11
Appendix NA ... 13
Bibliography ... 14
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Foreword
This Standard was drafted in accordance with rules given in GB/T 1.1-2009. This Standard replaces YY 0487-2004 “Sterile, single-use hydrocephalus shunts and components”.
Compared with YY 0487 2004, there are significant differences in terms of the technical contents and editorial aspect.
This Standard modifies and adopts ISO 7197.2006 "Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components". The differences with the adopted international standard are listed in Appendix NA.
This Standard shall be under the jurisdiction of Jinan Medical Device Quality Supervision and Inspection Center of China Food and Drug Administration. Drafting organization of this Standard. Shandong Medical Devices Product Quality Inspection Center.
The main drafters of this Standard. Wu Ping, Wang Jinhong and Song Jinzi. Page 4 of 14
Introduction
A shunt is defined as an artificial connection of two compartments inside the body. For the treatment of hydrocephalus, the ventriculo-atrial shunt has been introduced initially to control the intraventricular pressure in the brain of the patients. Today ventriculo-peritoneal shunts are preferably implanted. In special cases, a Jumbo-peritoneal shunt is implanted. Normally a hydrocephalus shunt includes a valve which determines the resulting intraventricular pressure in the brain of the patients and influences the flow rate through the shunt.
The following types of valve are currently commercially available.
a) Conventional differential-pressure valves (DP-valves) are designed as ball-in-cone valves, membrane valves or silicone slit valves.
They have one characteristic opening pressure. If the difference pressure between inlet and outlet exceeds this opening pressure the device opens. After opening, the different types of DP-valve show a wide range of different flow characteristics. Differences due to a changed posture of the patient have no intended impact on the function of the devices.
b) Adjustable DP-valves act like conventional DP-valves.
In contrast to non-adjustable devices they introduce the possibility of a non-invasive readjustment of the opening characteristic after implantation. They do not take into account changes due to a changed posture of the patient.
c) Gravitation valves or hydrostatic devices take into account the changed physics in a shunt due to a changed posture of the patient.
These devices aim to avoid an unphysiological negative intraventricular pressure in the upright position of the patient, which might be the consequence of the hydrostatic pressure in shunts with adjustable or not adjustable DP-valves. There are three different hydrostatic devices commercially available. flow-reducing devices, valves with a so-called "anti-siphon-device" or "siphon-control-device" and gravity-assisted devices.
d) Other adjustable valves, e.g..
- gravitation valves. adjustable hydrostatic devices present in addition to the characteristics of hydrostatic devices (group 4) with the possibility of a non- invasive readjustment of the opening performance of the device;
- adjustable anti-siphon-device valves;
- adjustable flow-reducing valves.
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Sterile, single-use hydrocephalus shunts and
components
1 Scope
This Standard specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.
This Standard gives no recommendation concerning the superiority of a certain type of valve.
For manufacturing, it defines the mechanical and technical requirements. This Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.
The benefit of this Standard for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture. This Standard does not apply to active implants for the treatment of hydrocephalus. 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) are applicable to this Standard.
YY 0334 General specification for surgical implants made of silicone elastomer YY/T 0640-2008 Non-active surgical implants-General requirements (ISO
14630.2005, IDT)
ASTM F 2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply. 3.1
accompanying documents
Document accompanying a medical device, or an accessory, and containing important information for the user, operator, installer or assembler of the medical device, particularly regarding safety supplied by the manufacturer.
NOTE. Adapted from ISO 14971.2000.
3.2
hydrocephalus
State of excessive accumulation of cerebro-spinal fluid CSF with the ventricular system of the head due to a disturbance of secretion, flow or absorption.
3.3
hydrocephalus shunt
Single-use device(s) typically consisting of an inflow catheter, a pressure-controlling device, and an outflow catheter intended to regulate the pressure of cerebro-spinal fluid CSF.
3.4
instructions for use
Parts of accompanying documents provided by the manufacturer, giving the necessary information for safe and proper use.
3.5
lumbo-peritoneal drainage
Drainage of cerebro-spinal fluid CSF from the lumbar sub-arachnoid spaces into the peritoneum.
3.6
patient identification card
Card identifying its holder and issuer, which carries data on the hydrocephalus shunt Page 9 of 14
and the accompanying documents.
4.6 Pressure-flow characteristics of the valve, the components and the pre- assembled shunt
The pressure-flow characteristics of the valve shall be tested and monitored in the relevant flow range of (5 to 50) ml/h. A graph showing the pressure/flow characteristics shall be included in the accompanying documents.
The manufacturer shall state if the complete system (catheter, reservoir and other devices) causes fundamental changes in the pressure/flow characteristics. In this case, graphs showing the pressure/flow characteristics of the complete shunt and the components shall be included.
NOTE. Fundamental change would be additional resistance due to an inner diameter of the catheter smaller than 1 mm (see 5.2).
If the device shows a posture-dependent function, the basic characteristic for the most important positions should be shown (see 5.1.3).
If the characteristic of the device depends on the subcutaneous pressure, the effects on the valve performance should be shown in the relevant ranges [see 8.2 g)]. 4. 7 Identification of shunts in vivo
The type of the valve as well as the direction of flow shall be detectable non-invasively. A method for the identification of the valve shall be given In the instructions for use and In the patient identification card. For adjustable devices, an X-ray image related to the basic understanding of the pressure settings shall be included in this information. 4.8 Ability to withstand ove...