C36 其他专科器械 标准查询与下载

ASTM F2311-03 治疗上用皮肤代用品分类的标准指南

1.1 This guide defines terminology and provides a system of classification for products that can be substituted for human or animal skin grafts (or grafts of the dermal or epidermal component tissues of skin) in medical and surgical therapies. This guide is intended to include (or be expandable to) possible future tissue engineered skin technology that could provide novel or superior therapeutic properties to those of natural skin grafts.1.2 As much as possible, terminology is based on medical dictionary definitions.1.3 Substitutes for skin grafts are classified by clinical utility only; the classification is independent of the technology used to make a skin substitute, its components, or whether the sources of components include human or animal tissue or other biological or non-biological materials.1.4 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 requirements prior to use.

Standard Guide for Classification of Therapeutic Skin Substitutes

BS EN 13544-2:2002 呼吸治疗设备.管道和连接件

This part of EN 13544 specifies requirements for tubing to be used with equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the equipment i.e. nipples and screw threaded connectors. This tubing is mainly used with oxygen, air or mixtures of these gases. The interface specifications are given to ensure interchangeability of respiratory therapy equipment thereby enabling patients to receive continuous treatment in all these clinical situations. Weight-bearing screw-threaded connectors are specified for use at the outlet of e.g. flowmeters to which devices such as humidifiers or nebulizers can be attached. NOTE This standard does not specify the devices where these connectors have to be used. It is expected that specific device standards will specify the devices where these connectors are going to the used e.g. EN ISO 10651-4, EN 738-1 and EN 13220.

Respiratory therapy equipment - Tubing and connectors

BS EN 13868:2002 导尿管.单腔导尿管和医用管蜷缩的试验方法

This European Standard specifies test methods for kinking properties for single lumen catheters and medical tubing, as presented for clinical use, when bent in a single plane. It is recognized that other forces e.g. twisting will influence the behaviour of the product, but no standard test methods are yet available. It is also recognized that such tubing can be used to transport liquids or gases. However, water is used as a standard test medium, as the purpose of this standard is to ensure uniformity in the evaluation of tubing kink properties. NOTE This method is designed for single-lumen tubing but can also be used for multi-lumen tubing. It should be ensured that the bending is done in the worst case direction, unless this would not present a possible real life situation.

Catheters - Test methods for kinking of single lumen catheters and medical tubing

CSA C22.2 No.60601-2-30-02-2002(R2006) 医疗电气设备.第2-30部分:自动循环无创血压监护设备安全性的详细要求

This Particular Standard specifies requirements for the safety, including essential performance, of AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 2.102, hereinafter referred to as EQUIPMENT. The EQUIPMENT may be attended or unattended. This Particular Standard does not apply to blood pressure measuring equipment which uses finger transducers or to semi-automatic blood pressure measuring equipment, typically in which each determination needs to be initiated manually.

Medical Electrical Equipment ?Part 2-30: Particular Requirements for the Safety, Including Essential Performance, of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment Second Edition

CSA C22.2 No.60601-2-30-02-2002 医疗电气设备-第2-30部分:自动循环无创血压监护设备安全的特殊要求,包括基本性能.第2版.IEC 60601-2-30:1999

Medical Electrical Equipment ?Part 2-30: Particular Requirements for the Safety, Including Essential Performance, of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment Second Edition; IEC 60601-2-30:1999

Medical Electrical Equipment ?Part 2-30: Particular Requirements for the Safety, Including Essential Performance, of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment Second Edition; IEC 60601-2-30:1999

DOD MIL-C-43179 C REINST NOTICE 2-2002 人类遗体转移容器

MIL-C-43179C dated 30 June 1989 is hereby reinstated and may be used for acquisition.

CASE, TRANSFER, HUMAN REMAINS

BS EN 13532:2002 自测试用的体外诊断医疗装置的一般要求

This European Standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.

General requirements for in vitro diagnostic medical devices for self-testing

BS EN 13612:2002 体外诊断医疗装置的性能评估

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific evaluation plans see Bibliography. Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs. In particular, this standard applies to IVD MDs to - show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, - establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to - satisfy the requirements of a quality system for design validation.

Performance evaluation of in vitro diagnostic medical devices

BS EN 13640:2002 体外诊断试剂的稳定性试验

This European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stability data in the - determination of IVD reagent shelf-life including transport stability; - determination of stability of the IVD reagent in use after the first opening of the primary container (e. g. on-board stability); - monitoring of stability of IVD reagents already placed on the market; - verification of stability after IVD reagent modifications that may affect stability. This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles.

Stability testing of in vitro diagnostic reagents

YY 0336-2002 一次性使用无菌阴道扩张器

本标准规定了一次性使用无菌阴道扩张器的产品分类与命名、要求、试验方法、检验规则、标志、使用说明书及包装、运输、贮存的要求。 本标准适用于扩张器，该产品供妇产科检查用。

Sterile vagina dilator for single use

CSA Z94.4-02-2002 呼吸器的选择,使用和保养 更新第1号-2

Lignes Directrices Pour La Gestion De La Qualite De L?Air A L?Interieur Des Batiments A Usage De Bureaux Fiche No 1-2

Choix, utilisation et entretien des respirateurs Mise ?jour no 1-2

CSA C22.2 No.60601.2.41-02-2002 医疗电气设备.第2-41部分:外科照明设备和诊断照明设备安全的特殊要求.第1版

Medical electrical equipment ?Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis First Edition

Medical electrical equipment ?Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis First Edition

CSA C22.2 No.60601-2-39-02-2002 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；

L’Association canadienne de normalisation (CSA), sous les auspices de laquelle cette Norme nationale a été préparée, a re?u ses lettres patentes en 191 9 et son accréditation au sein du Système de Normes nationales par le Conseil canadien des normes e

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

BS EN 13544-1:2001 呼吸医疗设备.雾化系统及其元件

The scope given in clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1 This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system. This European Standard includes gas-powered nebulizers which may be derived from e.g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic) or manually-powered nebulizers. NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185 "Humidifiers". This European Standard does not include nebulizers precharged with a specific medicinal product and not for universal application.

Respiratory therapy equipment - Nebulizing systems and their components

CSA C22.2 No.60601-2-30-01-2001 电子医疗设备 第2部分：间接、自动和定期血压监测设备的特殊安全规则第一版； IEC 60601-2-22:1995

L’Association canadienne de normalisation (CSA), sous les auspices de laquelle cette Norme nationale a été préparée, a re?u ses lettres patentes en 191 9 et son accréditation au sein du Système de Normes nationales par le Conseil canadien des normes e

Electromedical Devices - Part 2: Special Safety Rules for Devices for Monitoring Blood Pressure Taken Indirectly, Automatically and Periodically First Edition; IEC 60601-2-22:1995

CSA C22.2 No.601.2.19-92-1992(R2001) 修改件1 医用电气设备.第2部分:婴儿保育箱安全性的详细要求

This Amendment was reviewed by the CSA Technical Committee on Consumer and Commercial Products under the jurisdiction of the Strategic Resource Group and was formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the Technical Committee on Applications of Electricity in Health Care under the jurisdiction of the Strategic Steering Committee on Health Care Technology.

Amendment 1 Medical electrical equipment - Part 2: Particular requirements for safety of baby incubators

DOD MIL-C-42066 A-2000 有轮的垃圾搬运器

This specification covers a wheeled, litter carrier for military field use. It is designed for individual issue and intended for use as described in section 6 of this specification.

CARRIER, LITTER, WHEELED

DOD MIL-PRF-89038 (2)-2000 压缩的ARC数字栅格图(CADRG)

This amendment forms part of MIL-PRF-89038, dated 6 October 1994, and is approved for use by all Departments and Agencies of the Department of Defense.

COMPRESSED ARC DIGITIZED RASTER GRAPHICS (CADRG)

NF S93-071/A1:1999 一次性使用无菌膀胱导管

Sterile urethral catheters for single use.

CSA C22.2 No.60601.2.36-98-1998(R2007) 医疗电气设备.第2部分:体外感应碎石机安全性的详细要求

This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1 .101. The applicability of this Particular Standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this Standard, because they are treated in other applicable IEC standards. While this Particular Standard has been developed for EQUIPMENT intended for use in LITHOTRIPSY, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal PRESSURE PULSE equipment, this Standard may be used as a guideline.

Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy First Edition; General Instruction No 1