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ASTM F1415-92
Standard Specification for Pulse Oximeters
7 стр.
Заменен
Печатное изданиеЭлектронный (pdf)
93.60 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
Сборник (ASTM):
13.02 Medical and Surgical Materials and Devices (II): F2502–Latest; Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment / Медицинские и хирургические материалы и приборы (II): F2502-Latest; Скорая медицинская помощь; Поиск и Спасение; Оборудование для анестезии и искусственного дыхания
Тематика:
Medical Services
Описание
Область применения

1.1 The scope given in Clause 1 of IEC 601-1 applies except that 1.1 shall be replaced by the following:

1.1.1 This specification includes requirements for the safety and performance of pulse oximeters, as defined in 3.8 intended for use in approximating the saturation of arterial hemoglobin, non-invasively, from a light signal transmitted through the tissue, taking into account the pulsatile nature of volume changes with blood flow.

1.2 The field of application includes, but is not limited to: intraoperative and perioperative use; adult critical care application; pediatric and neonatal application; and general determination of saturation on hospitalized and non-hospitalized patients.

1.3 Pulse oximeters intended for use in laboratory research applications and "bench" type oximeters that require a blood sample from the patient are outside the scope of this specification.

Ключевые слова:
alarms; anesthesia; intensive care; intraoperative use; neonatal use; oximeters; pediatrics; perioperative use; pulse oximeters; respiratory therapy; pulse oximeters