C38 普通诊察器械 标准查询与下载

BS EN 12470-4:2000+A1:2009 临床体温计.第4部分:连续测量用电子体温计的性能

This part of EN 12470 specifies the metrological and technical requirements for electrical thermometers for continuous measurements. This European Standard applies to devices that are operated by an electrical power supply either by mains or internal power sources. The devices can be equipped to accommodate secondary indicators, printing devices, and other auxiliary devices. The metrological requirements for such accessories are not covered by this European Standard. Thermometers intended to measure skin temperatures are not covered by this European Standard. This European Standard does not intend to exclude the use of any device based on other measuring principles that provides an equivalent performance in continuously measuring body temperature. NOTE Devices can have functions which are covered by different parts of EN 12470. In this case, it is the responsibility of the manufacturer to indicate by which part of EN 12470 the function is covered, e.g. electrical thermometer with maximum device and exchangeable temperature probes.

Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement

CSA C22.2 No.60601-2-22-01-2001 医疗电气设备-第2部分:心动电流描记器安全的特殊要求.CEI 60-2-22:1995

Compatibilite Electromagnetique (CEM) Partie 2

Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment Second Edition; IEC 601-2-22:1995

BS EN 591:2001 专业用体外诊断仪器的使用说明

This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments. NOTE 2 This standard can also be applied to accessories. This standard is not applicable to field repair instructions.

Instructions for use for in vitro diagnostic instruments for professional use

DIN ISO 8600-4:2001 光学和光学仪器.医用内窥镜和内窥镜附件.第4部分:插入部分最大宽度测定

The document specifies a methods of measurement of the maximum width of the insertion portion of medical endoscopes and certain endoscopic accessoires, using either millimetre or French size indication.#,,#

Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 4: Determination of maximum width of insertion portion (ISO 8600-4:1997)

CSA Z180.1-00-2000 压缩空气呼吸器和系统.第4版本.通用指令第1号 2-3号更新

Compressed Breathing Air and Systems Fourth Edition; General Instruction No 1; Update No 2

Air Comprime Respirable Et Systemes Connexes Quatrieme Edition; Fiche No 1; Mise A Jour No 2-3

BS EN 12470-1:2000+A1:2009 医用体温计.第1部分:最大装置玻璃管液体金属体温计

This Part of EN 12470 specifies performance requirements and test methods for clinical liquid-in-glass thermometers with maximum device and applies only to thermometers filled with metallic liquid. NOTE 1 Note that in some European countries the use of mercury is prohibited in clinical thermometers. NOTE 2 Substances other than metallic liquids can be used in the manufacturing of liquid-in-glass thermometers. No reference is made to these in this European standard because there is no experience of clinical thermometers which use other substances. This European Standard does not apply to clinical thermometers designed for special applications (e.g. thermometers for premature babies, ovulation thermometers) which, owing to their measurement range, scale interval or maximum permissible error, fall outside the scope of this standard.

Clinical thermometers Ð Part 1: Metallic liquid-in-glass thermometers with maximum device

ASTM E1112-00(2011) 间歇测定病人温度用电子温度计的标准规范

1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. 1.2 This specification does not cover infrared thermometers. Specification E1965 covers specifications for IR thermometers. 1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.4 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the users of this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

ASTM E1112-00(2006) 间歇测定病人温度用电子温度计的标准规格

1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures.1.2 This specification does not cover infrared thermometers. Specification E 1965 covers specifications for IR thermometers.1.3 The values stated in SI units are to be regarded as the standard.The following precautionary caveat pertains only to the test method portion, Section 5, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the users of this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

DIN EN ISO 11070:1999 一次性无菌管内导管导引器

Sterile single-use intravascular catheter introducers (ISO 11070:1998); German version EN ISO 11070:1999

BS EN 12286:1999 体外诊断医疗设备.生物有机体试样数量测量.参考测量过程说明

This European Standard specifies requirements for the drafting of a reference measurement procedure. NOTE It is intended that an experienced laboratory worker, following a measurement procedure written in accordance with this European Standard can be expected to produce results with an uncertainty of measurement not exceeding the stipulated range. This European Standard is applicable to any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure.

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

ASTM F1992-99 与软性内窥镜一起使用的可重复使用的耐热内窥镜辅助仪器(EAI)再加工的标准实施规程

1.1 This practice covers reusable, heat-stable endoscopic accessory instruments (EAI) designed to be inserted into flexible endoscopes and clearly defined in the user instructions as devices intended for reuse among patients. The EAIs covered by this practice may or may not have lumens or loosely joined surfaces, may or may not have access ports for flushing, and may or may not be capable of being completely disassembled prior to reprocessing.1.2 This practice is not intended to be applied to the reprocessing of single-use, disposable EAIs specifically designed and labeled as such by their manufacturers.1.3 This practice is not intended to address reprocessing of heat-sensitive EAIs, for example, those not capable of withstanding heat sterilization. Reprocessing of each heat-sensitive EAI must be considered on an individual basis according to specific instructions from the manufacturers of the EAI and the low-temperature sterilization device.1.4 This practice is intended to complement, not replace, the instructions provided by product manufacturers. EAI manufacturers should provide properly validated instruction and labeling necessary for users to understand the basic design, specifications, nomenclature, and components of specific accessories and to properly inspect, prepare, use, reprocess, and store these instruments.1.5 Endoscopic technique and the medical aspects of endoscopy are not covered in this practice.1.6 This practice details the basic steps necessary to reprocess a heat-stable EAI and render it patient-ready.1.7 A patient-ready EAI is one that has been thoroughly cleaned using a validated cleaning procedure, rinsed with water to remove residual detergent, lubricated (if necessary) and drained to remove excess lubricant, dried, packaged, heat sterilized and stored to prevent from being compromised sterility before use.1.8 This practice describes only manual reprocessing and does not address cleaning of an EAI by an automated reprocessing device.1.9 To ensure the proper adherence to this practice, reprocessing personnel should meet certain requirements as specified in to .1.10 This practice does not address the steps necessary for the reprocessing of flexible endoscopes (see Practice F 1518).This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes

ASTM F1992-99(2007) 与软性内窥镜一起使用的可重复使用的耐热内窥镜辅助仪器(EAI)再加工的标准实施规程

EAIs may have design features such as coiled metal sheaths, pivoting joints, opposed surfaces, and internal lumens or wires which make visual inspection for cleanliness difficult if not impossible. By nature of their design requirements, EAIs are more difficult to reprocess than many other types of medical instruments. Because EAIs are used to diagnose and treat disease in both immunocompetent and immunocompromised individuals, care must be taken to ensure that only patient-ready devices are used for examination. The use of EAIs in patients having diagnosed or suspected infections such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) is not contraindicated. Further, EAIs need not be dedicated for use only in these patients. Persons responsible for reprocessing must understand the specifications, nomenclature, function of component parts, and interior design of EAIs in order to render them patient-ready. Persons responsible for reprocessing EAIs should follow this practice and associated labeling and instructions from manufacturers after each endoscopic procedure to ensure that the EAI will be patient-ready. Reprocessing of EAIs should be the specific responsibility of appropriately trained personnel. Temporary employees without the requisite training should not be given these responsibilities. The responsibility for reprocessing of EAIs should not be delegated from person to person unless each has the appropriate training for the position. Reprocessing personnel should have the ability to read, understand, and implement instructions from manufacturers and regulatory agencies as they relate to EAI reprocessing. Reprocessing personnel should have the opportunity to become completely familiar with the mechanical aspects of the devices. They may gain this knowledge through study of the manufacturer''s information and demonstration by representatives. Reprocessing personnel should be made fully aware of the potential chemical and infectious hazards for patients and health care personnel associated with the reprocessing of EAIs. Training should include: A thorough background in infection control principles and concepts based on written in-house infection control procedures. A thorough background regarding the potential for negative patient outcomes resulting from lapses in compliance with written reprocessing guidelines, Familiarization with Occupational Safety and Health Administration (OSHA) regulations and in-house policies regarding the appropriate and safe handling of chemical reprocessing agents and equipment used during reprocessing of EAIs, and Information on the safe handling of EAIs contaminated with patient tissue and fluids after use, including familiarization with principles and practices of standard (universal) precautions. Note 18212;Although healthcare workers and patients may benefit from adhering to the regulatory guidelines issued by federal and state OSHA agencies, these guidelines are directed only toward healthcare worker safety and health. They may not be sufficiently inclusive for optimum safety and health of patients. Therefore, contemporary infection control guidelines should be consulted in addition to OSHA guidelines. This practice is not intended to replace the reprocessing instruction provided by the manufacturers of EAIs or suggest specific equipment or chemical reagents to be used for reprocessing. Rather, it is to be used together with manufacturers'' instructions that provide specific instructions for specific products. See Appendix X1.1. This practice is not intended to cover endoscopic techniques, patient care, or other medical aspects of flexible endoscopy. This practice does not include instruction for reprocessing flexible endoscopes.1.1 This practice co......

Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes

JIS T 1304:1998 心电描记器监视设备

この規格は，主として心拍リズムを検出し異常をとらえるために，心電図を長時間にわたって監視することを目的とする心電図監視装置(以下，監視装置という。)について規定する。

Electrocardiographic monitoring equipment

CSA CEI-C22.2NO601.2.26CAN/CS-1998 医疗电气设备-第2部分:脑电图仪的安全特殊要求.第1版

Appareils Electromedicaux -Partie 2: Regles Particulieres De Securite Pour Les Electroencephalographes Premiere Edition

Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Electroencephalograph.First Edition

CSA CEI-C22.2NO601.2.34CAN/CS-1998 医疗电气设备-第2部分:直接取样血压监视器的安全特殊要求.第1版.CEI 601-2-34:1994

Appareils Electromedicaux - Partie 2: Regles Particulieres De Securite Pour Les Appareils De Surveillance De La Pression Sanguine Prelevee Directement Premiere Edition; CEI 601-2-34: 1994

Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Direct Sampling Blood Pressure Monitor.First Edition.CEI 601-2-34:1994

CSA CEI-C22.2-NO601.2.23-CAN-1998 医疗电气设备-第2部分:经皮肤的部分压力监视器的安全特殊要求.第1版.CEI 60-2-23:1994

Appareils Electromedicaux -Partie 2: Regles Particulieres De Securite Pour Les Appareils De Surveillance De La Pression Partielle Transcutanee Premiere Edition; CEI 60-2-23: 1994

Medical Electrical Equipment-Part 2: Particular Requirements for the Safety of Partial Pressure Monitors Touching Skin.First Edition.CEI 60-2-23:1994

ASTM E1104-98(2009) 医用温度计测头罩和护壳的标准规范

1.1 This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used within the standards are provided. 1.2 The requirements contained herein are intended to ensure adequate isolation of the patient from the temperature-measuring device. In addition, the safety and health of the patient shall not be adversely affected. When used in accordance with the manufacturers instructions, the probe cover, sheath, and temperature measuring device shall remit correct temperature readings as required in Specifications E 667 and E 1112.

Standard Specification for Clinical Thermometer Probe Covers and Sheaths

ASTM E1965-98(2009) 间歇测定病人体温用的红外温度计的标准规范

1.1 This specification covers electronic instruments intended for intermittent measuring and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor. 1.2 The specification addresses assessing subject's body internal temperature through measurement of thermal emission from the ear canal. Performance requirements for noncontact temperature measurement of skin are also provided. 1.3 The specification sets limits for laboratory accuracy and requires determination and disclosure of clinical accuracy of the covered instruments. 1.4 Performance and storage limits under various environmental conditions, requirements for labeling and test procedures are established. Note 18212;For electrical safety consult Underwriters Laboratory Standards. Note 28212;For electromagnetic emission requirements and tests refer to CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment. 1.5 The values of quantities stated in SI units are to be regarded as the standard. The values of quantities in parentheses are not in SI and are optional. 1.6 The following precautionary caveat pertains only to the test method portion, Section 6, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

BS EN 1060-3:1997 非侵入式血压计.机电式血压计量设备的补充要求

To be read in conjunction with BS EN 1060-1:1996

Non-invasive sphygmomanometers - Supplementary requirements for electro-mechanical blood pressure measuring systems

BS EN 1060-3:1997+A2:2009 非侵入式血压计.机电式血压计量设备的补充要求

This Part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm, the wrist and the thigh. It also specifies requirements for their accessories and gives test methods. This Part of EN 1060 applies to electro-mechanical blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically. Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment are specified in EN 60601-2-30:1995. This Part of EN 1060 is to be used in conjunction with EN 1060-1.

Non-invasive sphygmomanometers - Supplementary requirements for electro-mechanical blood pressure measuring systems