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Neurosurgical implants. Marking and packaging of implantable neural stimulators
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Basic data
| Standard ID | YY/T 0684-2008 (YY/T0684-2008) |
| Description (Translated English) | Neurosurgical implants. Marking and packaging of implantable neural stimulators |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C35 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 9,969 |
| Date of Issue | 2008-10-17 |
| Date of Implementation | 2010-01-01 |
| Adopted Standard | ISO 10310-1995, IDT |
| Regulation (derived from) | SFDA [2008] No. 605 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This standard provides for stimulating the nervous system (brain, spinal cord, peripheral nerves and adjacent tissue) implantable neurostimulator marking, labeling, packaging and accompanying documents. This standard also covers an implantable or external access to auxiliary components, including nerve stimulator for start-up or adjustment of an external controller and programmer. This standard does not require application of an implantable neurostimulator indications or contraindications, also does not provide testing or normal operation range of variable parameters. However, this standard should include the relevant information to the clinician for the treatment of patients with each of the implantable pulse generator implanted RF receiver or RF transmitter accompanying documents. |
YY/T 0684-2008: Neurosurgical implants. Marking and packaging of implantable neural stimulators
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Neurosurgical implants.Marking and packaging of implantable neural stimulators
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
YY/T 0684-2008/ISO 10310.1995
Neurosurgical implants implanted
Neurostimulator labeling and packaging
(ISO 10310.1995, IDT)
Posted 2008-10-17
2010-01-01 implementation
State Food and Drug Administration issued
Foreword
This standard is identical with ISO 10310.1995 "Neurosurgical implants implantable neurostimulator labeling and packaging."
Appendix A of this standard is an informative annex.
This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) and focal points.
This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Sun Huili, PROCEEDINGS, Li Yanan, mountains.
YY/T 0684-2008/ISO 10310.1995
Neurosurgical implants implanted
Neurostimulator labeling and packaging
1 Scope
This standard specifies the identifier for stimulating the nervous system (brain, spinal cord, peripheral nerves and adjacent tissue) implantable nerve stimulator, standard
Asked to sign, packaging and accompanying documents.
This standard also covers accessories implantable or external access, including external control is used to start or adjust the neurostimulator
System and programmer.
This standard does not apply the provisions of implantable nerve stimulator indications or contraindications; testing or normal operation variable parameters unspecified
range. But the requirements of this standard shall contain such information related to a patient when used in the treatment of each clinician implantable pulse generator
Accompanying documentation generator, implanted RF receiver or RF transmitter in.
2 Terms and definitions
The following terms and definitions apply to this standard.
2.1
Electrical stimulation of the nervous system (brain, spinal cord, peripheral nerves and adjacent tissue) of equipment, including a pulse generator and its function and control
Necessary for implantable or external access to all auxiliary components of the human body.
2.2
With its own power supply implantable devices, which can generate electrical pulses in a continuous or intermittent manner to stimulate the nervous system.
2.3
External access equipment, used to control or adjust the parameters neurostimulator system.
2.4
Implantable devices without their own power supply, which is a radio frequency (RF) transmitter and antenna rely emitted energy to produce pulses stimulate nerve
system.
2.5
Portable devices, including implantable RF receiver for controlling the pulse generator and modulator circuit.
Note 1. The transmitter typically includes a power supply, an antenna may further include a user adjustable controller and internal use controllers.
2.6
To enable the implantable receiver RF transmit coil.
Note 2. The antennas are typically used on the skin or placed close to the skin, close to the implantable RF receiver position.
2.7
It used to connect the transmitter and antenna, and external body insulated wire or wires, one or both ends with or without integral connector.
YY/T 0684-2008/ISO 10310.1995
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