Sterile, single-use hydrocephalus shunts and components
1 Scope
This standard specifies safety and performance requirements for sterile, single-use 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 and 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 referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
YY 0334 General specification for surgical implants made of silicone elastomer
YY/T 0640-2008 Non-active surgical implants - General requirement (ISO 14630:2005, IDT)
ASTM F 2503-05 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
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
limbo-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 implanted
3.7
ventriculo-artrial drainage
drainage of cerebro-spinal fluid CSF from the ventricles into the right atrium of the heart
3.8
ventriculo-peritoneal drainage
drainage of cerebro-spinal fluid CSF from the ventricles into the peritoneum
4 General requirements for shunts
4.1 General
The sample size shall be justified and stated.
4.2 Radiopacity
All external parts of the shunt or accessory device shall be radiopaque or shall carry radiopaque markers.
All parts of the shunt shall be identifiable via X-ray examination.
Note: See YY/T 0586-2005 for the evaluation of radiopacity. When the test is performed according to Method A in the standard, that the optical density contrast is not less than 0.10 is considered to meet the requirements.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for shunts
5 Specific requirements for components
6 Marking and labeling of shunts
7 Packaging
8 Information supplied by the manufacturer
Annex NA (Informative) Technical deviations between this standard and ISO 7197: 2006 and their justifications
Bibliography
