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Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
Automaticky preložený názov:
Štandardné špecifikácie pre lebečnej trakčné kliešte a Halo externých spinálnej imobilizačné zariadenie
NORMA vydaná dňa 1.10.2014
Označenie normy: ASTM F1831-97(2014)
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.10.2014
Kód tovaru: NS-51743
Počet strán: 10
Približná hmotnosť: 30 g (0.07 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Keywords:
cranial traction tongs, halo external fixation device, magnetic resonance imaging (MRI) compatibility,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
1. Scope | ||
1.1 This specification covers standards a manufacturer shall meet in the designing, manufacturing, testing, labeling, and documenting of halo and tong external spinal immobilization devices, but it is not to be construed as production methods, quality control techniques, manufacturer's lot criteria, or clinical recommendations. 1.2 This specification represents the best currently available test procedures at this time and is a minimum safety and performance standard. 1.3 This specification covers only those halo and tong devices intended for use on humans for therapeutic purposes. This specification assumes the user is well-trained in the procedures and maintenance of halo and tong application and has the ability to determine if an abnormality is treatable by these procedures. 1.4 This specification describes those devices commonly known as halo external fixation devices and what is known as cranial traction tongs. 1.5 Cranial traction tongs and halo devices are used to achieve and maintain optimal spinal alignment, in order to enhance fusion and decrease neurological deficit. 1.6 Monitoring the progress of treatment after application of these devices is important, this should be done in accordance with the manufacturer's recommendation and guidelines pertaining to the specific device. 1.7 The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given in parentheses are for information only. 1.8 The following precautionary statement pertains
only to the test method portions Sections 10 – 15 of this specification:
IEC 601-1 Medical Electrical Equipment Available
from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036. |
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