C36 其他专科器械 标准查询与下载

JIS T 3247:2005 设计用于输尿管的导管和导流器配件以及尿道扩张气囊导管

この規格は，経皮，経尿道的又は手術時の尿管?尿道の拡張及び排液,造影，尿路の確保などを日的に，体内に挿入する尿管?尿道用カテーテル(以下，カテーテルという。)及びイントロデューサキットの要求事項について規定する。

Catheters and introducer kits designed for ureter, and uretheral dilatation balloon catheters

JIS T 3249:2005 血液透析用带针头和导管的无菌留置套管

この規格は，滅菌済みの血液透析を含む血液浄化療法に用いるもので，そのまま直ちに使用でき，かつ，1回限りの使用で使い捨てる留置針の要求事項について規定する。

Sterile indwelling cannulas with needle and catheter for hemodialysis

JIS T 3218:2005 中枢静脉导管

この規格は，無菌状態で提供され，薬液などの注入又は血液の採取及び/又は静脈圧測定などの目的に単回使用する中心静脈用カテーテル(以下，カテーテルという。)並びにカテーテルの挿入及び留置のために使用するガイドワイヤ，ダイレータ，せん(穿)刺針，外とう(套)管及びカテーテル挿入用シース(以下，ガイドワイヤ，ダイレータなどという。)の要求事項について規定する。

Central venous catheters

CSA C22.2 No.60601-2-37-03 A1-2005 更正1医疗电气设备.第2-37部分:超声医疗诊断和监护设备安全的特殊要求

This Particular Standard details the requirements to be applied to SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS as defined in 2.101 to 2.105, hereinafter referred to as EQUIPMENT.

Amendment 1 Medical electrical equipment ?Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

ARMY MIL-M-12971 B VALID NOTICE 3-2004 M1瓣膜置换机

MIL-M-12971B remains inactive for new design, however, the document is valid for use.

MECHANISM, VALVE REPLACEMENT, M1

CSA C22.2 No.60601-2-39-04-2004 电气医疗器械- 第2-39部分：腹膜透析装置的特殊安全规则Premiere版；

Medical electrical equipment ?Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment First Edition

Electrical medical devices - Part 2-39: Special safety rules for peritoneal dialysis devices Premiere Edition;

CSA C22.2 No.60601-2-26-04-2004 医疗电气设备-第2-26部分:脑电图检测仪安全的特殊要求.第2版

Appareils électromédicaux Partie 2-26

Medical electrical equipment Part 2-26: Particular requirements for the safety of electroencephalographs Second Edition

DOD MIL-PRF-89038 ADMIN NOTICE 1-2004 压缩的ARC数字栅格图(CADRG)

Comments, suggestions or questions on this specification should be addressed to the National Geospatial-Intelligence Agency, National Center for Geospatial Intelligence Standards (NCGIS), Mail Stop P-24, 12310 Sunrise Valley Drive, Reston, VA 20191-3449,

COMPRESSED ARC DIGITIZED RASTER GRAPHICS (CADRG)

DOD MIL-F-89018 ADMIN NOTICE 2-2004 高程数据火灾寻视器(FFED)

The purpose of this notice is to inform users of the change in name of the preparing activity from the Defense Mapping Agency (DMA) to the National Geospatial-Intelligence Agency (NGA).

FIREFINDER ELEVATION DATA (FFED)

YY/T 0470-2004 一次性使用圆宫型宫内节育器放置器

本标准规定了一次性使用圆宫型宫内节育器放置器的产品分类、要求、试验方法、标志、标签、包装。 本标准适用于一次性使用圆官型宫内节育器放置器。该产品供育龄妇女放置"OCu"圆形、官腔形和圆宫型宫内节育器，且与节育器配套使用。

Hygienic standard for yuangong intrauterine device of specially designed inserter

YY/T 1025-2004 流产吸引管

本标准规定了流产吸引管的分类、要求、试验方法、检验、标志、使用说明书、包装、运输、贮存。 本标准适用于流产吸引管，吸引管装入流产吸引器上，供早期妊娠的孕妇施行人工流产手术用。

Intra-uterine suction curettes

BS EN 60601-2-51:2003 医疗电气设备.记录和分析单道和多道心电描记器的安全性特殊要求(包括主要性能)

Addition: This Particular Standard specifies requirements for the safety, including essential performance, of RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS as defined in 2.101, 2.111, 2.117, 2.123, 2.126, hereinafter referred to as EQUIPMENT. The EQUIPMENT may be attended or unattended. This Particular Standard complements IEC 60601-2-25 and its Amendment 1 (1999).

Medical electrical equipment - Particular requirements for safety - Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

ISO 8871-2:2003 非肠道及制药设备用弹性件.第2部分:鉴别和表征

This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application. This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization

ISO 8871-1:2003 非肠道和制药设备用弹性件.第1部分:含水autoclavates中的萃取物

1 This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use. It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates (see Clause 4) and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of ISO 8871 are regarded as minimum requirements. 2 This part of ISO 8871 is applicable for the categories of elastomeric parts given in Clause 3; specific requirements, however, are laid down in the relevant International Standards dealing with the items or devices listed in Clause 3. Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time. 3 Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates

BS EN 60601-2-4:2003 医疗电气设备.安全的特殊要求.心脏去纤颤器的特殊安全要求

Addition: This Particular Standard specifies requirements for the safety of CARDIAC DEFIBRILLATORS as defined in 2.1.101, hereinafter referred to as EQUIPMENT. This Particular Standard does not apply to implantable defibrillators, remote control DEFIBRIL-LATORS, external transcutaneous pacemakers, or separate stand alone CARDIAC MONITORS (which are standardized by IEC 60601-2-27). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion. Defibrillation waveform technology is evolving rapidly. Published studies indicate that the effectiveness of waveforms varies. The choice of a particular waveform including waveshape, delivered energy, efficacy, and safety has been specifically excluded from the scope of this standard. However, due to the critical importance of the therapeutic waveform, comments have been added to the rationale which address considerations in waveform selection.

Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of cardiac defibrillators

CSA C22.2 No.60601-2-50-03-2003 电子医疗设备 第2-50部分：新生儿光疗设备的特殊安全规则第一版，

This Standard contains basic requirements for products covered by Underwriters Laboratories Inc. (UL) under its Follow-Up Service for this category within the limitations given below and in the Scope section of this Standard. These requirements are base

Electromedical devices - Part 2-50: Special safety rules for phototherapy devices for newborns First Edition,

ISO 8871-3:2003 非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. This part of ISO 8871 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing. It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count

CSA C22.2 No.60601-2-38-03-2003 医疗电气设备.第2部分:医疗电动床安全的特殊要求.第1版

This Particular Standard applies to X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Its scope excludes, in particular:

Medical electrical equipment ?Part 2: Particular requirements for the safety of electrically operated hospital beds First Edition; Update No. 1: 08/2006

CSA C22.2 No.60601-2-37-03-2003 医疗电气设备.第2-37部分:医用超声诊断和监护设备安全的特殊要求.第1版

The content of this Particular Standard has largely been determined to cover ultrasonic medical diagnostic and monitoring EQUIPMENT including ULTRASONIC echo ranging devices (both manual and automatic scanning), Doppler echo EQUIPMENT and combinations t

Medical electrical equipment ?Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment First Edition

CSA C22.2 No.60601-2-12-03-2003 医疗电气设备.第2-12 部分:肺通气器 临界考虑空调机安全的特殊要求.第2版

This is the second edition of CAN/CSA-C22.2 No. 60601-2-12, Medical electrical equipment — Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators, which is an adoption without modification of the identically ti

Medical electrical equipment Part 2-12: Particular requirements for the safety of lung ventilators Critical care ventilators Second Edition