YY/T 0684-2008 English PDFUS$359.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0684-2008: Neurosurgical implants. Marking and packaging of implantable neural stimulators Status: Obsolete
Basic dataStandard 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: 9,930 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---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.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 ForewordThis 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 packaging1 ScopeThis 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 definitionsThe 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 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0684-2008_English be delivered?Answer: Upon your order, we will start to translate YY/T 0684-2008_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0684-2008_English with my colleagues?Answer: Yes. 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