11.040.55 诊断设备 标准查询与下载

IEC 60601-1-8:2005 医用电气设备.第1-8部分:安全的一般要求.并列标准.医疗电气设备和医疗电气系统中警报系统的一般要求、试验和指南

The object of this collateral standard is to specify basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is acc

Medical electrical equipment - Part 1-8: General requirements for safety; Collateral standard; General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-2-27:2005 医用电气设备.第2-27部分:心电图监护设备安全专用要求(包含基本性能)

Addition: This Particular Standard specifies the particular safety requirements, including essential performance, for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 2.101 and hereinafter also referred to as EQUIPMENT. This standard is applicable to EQUIPMENT used in a hospital environment. If the EQUIPMENT is used outside the hospital environment, such as in ambulances and air transport, the EQUIPMENT shall comply with this standard. NOTE Additional standards apply to the EQUIPMENT covering specifically use outside the hospital environment. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ecg telemetry systems, ambulatory ("Holter") monitors and other ECG recording devices are outside the scope of this Particular Standard.

Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

ISO 8600-1:2005 光学和光子学.医用内窥镜和内疗器件.第1部分:一般要求

This part of ISO 8600 defines terms and gives requirements for endoscopes and endotherapy devices used in the practice of medicine.

Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements

IEC 62359:2005 声学.声场特性.与医疗诊断超声场有关的热和机械指数测定的试验方法

Is applicable to medical diagnostic ultrasound fields. This standard establishes - parameters related to thermal and non-thermal aspects of diagnostic ultrasonic fields; - methods for the determination of an exposure parameter relating to temperature ris

Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

JIS T 1303:2005 分娩监视装置

この規格は，胎児情報及び妊産婦情報として超音波ドプラ法による胎児心拍数曲線と外測法による陣痛曲線とを連続的に記録紙上に記録できる分べん(娩)監視装置(以下，装置という。)について規定する。

Fetal monitors

JIS Z 4930:2005 X射线骨密度计性能评价用人体模型

この規格は，X線骨密度測定装置の製造又は輸人を目的とした形式試験。性能試験及び日常精度管理を目的として，その性能を評価するためのファントム(以下，ファントムという。)について規定する。

Phantoms for performance evaluation of X-ray bone densitometer

JIS T 1553:2005 光学和光学仪器.医用内窥镜和内疗装置

この規格は，実地医療で使用する内視鏡及び内視鏡用処置具の要求事項について規定する。

Optics and optical instruments -- Medical endoscopes and endotherapy devices

JIS T 4207:2005 红外线耳部温度计

この規格は，人の体温検出を目的にこ(鼓)膜及びその周辺の温度検出に赤外線検出素子を用いた，実測温度測定機能付きで，実測温度又は人体部位の温度に変換してデジタル表示し，内部電源によって作動する耳用赤外線体温計(以下，体温計という。)について規定する。

Infrared ear thermometers

JIS T 4206:2005 带有最大仪表的含汞玻璃临床温度计

この規格は，次の内容をもつガラス製体温計(以下，体温計という。)について規定する。

Clinical Thermometers, mercury-in-glass, with maximum device

JIS T 1140:2005 带最大仪表的临床电子体温计

この規格は，次の内容をもっ電子体温計(以下，“休温計”という。)について規定する。

Clinical electrical thermometers with maximum device

JIS T 1115:2005 非侵入式电子血压计

この規格は，膨張可能なカフを用いて非侵襲的に動脈血圧を測定する非観血式電子血圧計又は非観血式自動血圧計(以下，血圧計という。)，及び附属品の一般原則，性能，有効性並びに機械的・電気的な安全性の要求事項について規定する。また，この規格は，型式承認のための試験方法も規定する。

Non-invasive Automated Sphygmomanometers

JIS T 1506:2005 手持式超声波探头多普勒胎儿心跳探测仪.性能要求、测量和报告方法

この規格は，単一超音波ビームを発生し，連続波超音波又は準連続波超音波を使用したドプラ法によって母体腹壁から胎児心拍動の情報を得るために使われる，手持の探触子によって構成する装置について適用する。

Ultrasonics -- Hand-held probe Doppler foetal heartbeat detectors -- Performance requirements and methods of measurement and reporting

JIS T 0601-2-34:2005 医用电气设备.第2-34部分:直接血压监护设备安全专用要求(包括基本性能)

この規格は，観血式血圧監視用機器及び測定機器(2.101の定義による。以下“機器”という。)に適用する。

Medical electrical equipment -- Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

JIS T 1501:2005 超声波脉冲反射诊断装置性能测量的常规方法

この規格は，超音波パルス反射法によるリアルタイム医用超音波画像診断装置(以下，超音波診断装置という。)で，周波数範囲が0.5～15MHzで作動するように設計製造した超音波診断装置の性能試験方法に関する基木的事項について規定する。

General methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment

ISO 9919:2005 医用电气设备.医用脉动式血氧计的基本安全和性能的特殊要求

IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment (add at the end of 1.1): This International Standard specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for use on humans. This includes any part necessary for normal use, e.g. the pulse oximeter monitor, pulse oximeter probe, probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, that has been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on patients in healthcare institutions as well as on patients in home care. * This International Standard is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient. This International Standard is not applicable to pulse oximeter equipment solely intended for foetal use. This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment. The requirements of this International Standard which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

NF C74-342:2005 医用电气设备.第2-26部分:脑电图机安全的特殊要求

Medical electrical equipment - Part 2-26 : particular requirements for the safety of electroencephalographs.

ASTM E1954-05(2011) 对欺骗进行心理生理测试(测谎器)研究的标准操作规程

1.1 This practice establishes essential and recommended elements in the design, conduct, and reporting of research on psychophysiological detection of deception (polygraph) (PDD). Analog and field research are addressed separately.

Standard Practice for Conduct of Research in Psychophysiological Detection of Deception (Polygraph)

ASTM E1954-05(2017) 对欺骗进行心理生理测试(测谎器)研究的标准实施规程

1.1 This practice establishes essential and recommended elements in the design, conduct, and reporting of research on psychophysiological detection of deception (polygraph) (PDD). Analog and field research are addressed separately. 1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Conduct of Research in Psychophysiological Detection of Deception (Polygraph)

ASTM E2000-05 对被测谎者进行基本教育和培训的标准指南

This practice is intended for use by any individual when reasonably expected to be the subject of litigation. The intent of this guide is to set forth the minimum requirements for education and training of an individual who administers psychophysiological examinations, and who renders an opinion as to attempted deception or truthfulness of a subject who has been tested. Polygraph standards have changed the standards herein represent the current industry standards, individuals who can document that they were trained at a polygraph school which was fully accredited by the American Polygraph Association prior to January 1998, shall be deemed to have met the minimum professional standards for polygraph examiner training at the time they received their initial basic polygraph training. Individuals who received basic polygraph training prior to January 1998 at a polygraph training school which was not fully accredited by the American Polygraph Association standards may be qualified, providing they can document that their basic polygraph training was substantially equivalent in length and curriculum as required for American Polygraph Association polygraph school accreditation.1.1 This guide covers the minimum basic education and training required for an individual involved in the psychological detection of deception in using instruments which measure physiological responses in the areas of breathing or respiration, changes in electrodermal activity, and changes in pulse rate and relative blood pressure. 1.2 For additional standards promulgated by ASTM Committee, see Practice E1954.

Standard Guide for Minimum Basic Education and Training of Individuals Involved in the Detection of Deception (PDD)

ASTM E2063-05(2011) 用于法医生理心理欺骗侦探检查的校准和功能核对标准操作规程

This practice sets forth the minimum requirements for calibration and functionality checks when conducting PDD examinations and related activities. For additional information see Practice E1954 and Guide E2000.1.1 This practice provides guidelines for calibration and instrumentation (both analog and computerized systems) actively used in the psychophysiological detection of deception (verification of truth). As a minimum, such instrumentation shall simultaneously record an individual''s respiratory, exosomatic electrodermal, and cardiovascular activity. 1.2 Analog polygraphs shall be calibrated by the psychophysiological detection of deception (PDD) examiner, manufacturer, or factory-authorized individual. 1.3 Computerized instrumentation shall be calibrated by the manufacturer or factory-authorized individual. 1.4 The PDD examiner or factory-authorized individual shall perform functionality checks to ensure instrumentation is operating properly. 1.5 This practice does not prohibit additional components which may be offered as supplemental measurements of physiological change. Additional recording components (such as movement sensors) may be used in addition to, but not replace, the required minimum components and these additional components shall meet the manufacturer''s specifications for calibration.

Standard Practice for Calibration and Functionality Checks Used in Forensic Psychophysiological Detection of Deception (Polygraph) Examinations