C46 手术室设备 标准查询与下载

DB44/T 1726-2015 医用压缩雾化器

本标准规定了医用压缩雾化器(以下简称雾化器)主要性能要求和试验方法。 本标准适用于通过气体压缩机产生的压缩气体为驱动源来产生及传输气雾的医用压缩雾化器。该雾化器用于液态药物雾化供患者吸入。 本标准不适用于医用超声雾化器。

medical compression nebulizer

DIN EN ISO 23747:2015 麻醉和呼吸设备.自然呼吸的人肺部功能评估用最大呼气流量计(ISO 23747-2015),德文版本EN ISO 23747-2015

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015); German version EN ISO 23747:2015

BS EN ISO 10079-1:2015 医疗吸引设备.电动吸引设备

Medical suction equipment. Electrically powered suction equipment

ISO 10079-1:2015 医疗吸引设备.第1部分:电动吸引设备

Medical suction equipment - Part 1: Electrically powered suction equipment

EN ISO 13356:2015 植入手术.基于钇稳定四方氧化锆陶瓷材料(Y-TZP)(ISO 13356:2015)

Diese Internationale Norm legt die Anforderungen und dazugehörigen Prüfverfahren für ein biokompatibles und biostabiles keramisches Knochenersatzmaterial auf der Grundlage von yttriumstabilisiertem tetragonalem Zirkoniumoxid (yttria tetragonal zirconia polycristal, Y-TZP) fest, das als Material für chirurgische Implantate verwendet wird.

Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)

BS EN ISO 23747:2015 麻醉和呼吸设备 用于评估自主呼吸人体肺功能的峰值呼气流量计

Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

ISO 23747:2015 麻醉和呼吸设备.自然呼吸者肺功能评定用呼气峰值流量计

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

EN ISO 23747:2015 麻醉和呼吸设备.自然呼吸的人肺部功能评估用最大呼气流量计(ISO 23747:2015)

Diese Internationale Norm legt Anforderungen für SPIROMETER FÜR DEN EXSPIRATORISCHEN SPITZENFLUSS (PEFM) fest, die zur Beurteilung der Lungenfunktion bei spontan atmenden Menschen bestimmt sind. Diese Internationale Norm gilt für alle MEDIZINPRODUKTE, die den EXSPIRATORISCHEN SPITZENFLUSS bei spontan atmenden Menschen als Teil eines medizinischen Systems zur Messung der Lungenfunktion oder als Einzelgerät messen. Planung und Auslegung von Produkten, für die diese Internationale Norm gilt, berücksichtigen die Umweltauswirkungen des Produkts während seines Lebenszyklus. Umweltgesichtspunkte werden in Anhang E behandelt. ANMERKUNG Zusätzliche Gesichtspunkte der Umweltauswirkungen werden in ISO 14971 behandelt.

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)

ISO 17510:2015 医疗器械.睡眠窒息呼吸治疗.面罩和应用附件

This International Standard applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear). Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the typical elements of this International Standard together with the sleep apnoea breathing therapy equipment of ISO 80601-2-70 that form a sleep apnoea breathing system. This International Standard does not cover oral appliances.

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

KS P 8425-2015 牙科.窦膜提升仪

Dentistry — Test methods for determining fluorescence of dental restorative materials

DIN EN ISO 5356-1:2015 麻醉和呼吸设备.圆锥形接头.第1部分:锥体和锥套(ISO 5356-1-2015);德文版本EN ISO 5356-1-2015

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015); German version EN ISO 5356-1:2015

BS PD ISO/TS 16976-2:2015 呼吸保护装置.人体因素.人体测量术

Respiratory protective devices. Human factors. Anthropometrics

EN 45502-1:2015 植入手术.主动植入式医疗设备.第1部分:通用安全要求,标记和制造商提供的信息

This part of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This part of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This part of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 2 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 3 In this part of EN 45502, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

BS ISO 18835:2015 吸入麻醉系统 抽吸麻醉系统

Inhalational anaesthesia systems. Draw-over anaesthetic systems

ISO 18835:2015 吸入麻醉系统.过麻醉系统

Inhalational anaesthesia systems - Draw-over anaesthetic systems

BS EN ISO 5356-1:2015 麻醉和呼吸设备 锥形连接器 锥体和插座

Anaesthetic and respiratory equipment. Conical connectors. Cones and sockets

YY/T 1040.1-2015 麻醉和呼吸设备 圆锥接头 第1部分:锥头与锥套

YY/T 1040的本部分规定了用于连接麻醉和呼吸设备(如呼吸系统、麻醉气体净化系统和蒸发器)的锥头与锥套的尺寸与测量的要求。本部分给出了下列圆锥接头的要求:——用于小儿呼吸系统的8.5 mm规格的接头;——呼吸系统中通用的15 mm和22 mm规格的接头;——22 mm锁接接头(包括性能要求);——蒸发器用23 mm规格接头,该规格不适用于呼吸系统;——用于呼吸系统和麻醉气体净化系统连接的30 mm规格的接头。本部分未规定医疗器械与其辅助器件已经形成的连接。圆锥接头的适用性要求未包括在本部分内,但这些要求已或将在相应的医用设备和附件标准中给出。

Anaesthetic and respiratory equipment.Conical connectors.Part 1:Cones and sockets

ISO 5356-1:2015 麻醉和呼吸设备.锥形接头.第1部分:锥体和锥套

This part of ISO 5356 specifies dimensional and gauging requirements for cones and sockets intended for connecting anaesthetic and respiratory equipment, e.g. in breathing systems, anaesthetic gas scavenging systems, and vaporizers. The cones and sockets are therefore not regarded as devices in their own right. This part of ISO 5356 gives requirements for the following cones and sockets: — 8,5 mm and 11,5 mm sizes intended for use in neonatal and paediatric breathing systems; — 15 mm and 22 mm sizes intended for general use in breathing systems; — 22 mm latching sockets (including performance requirements); — 23 mm size intended for use with vaporizers, but not for use in breathing systems; — 30 mm size intended for the connection of a breathing system to an anaesthetic gas scavenging system. This part of ISO 5356 does not specify the medical devices and accessories on which these cones and sockets are to be provided. Requirements for the application of cones and sockets are not included in this part of ISO 5356, but are or will be given in the relevant International Standards for specific medical devices and accessories. NOTE Requirements for screw-threaded weight-bearing connectors are specified in ISO 5356-2.

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets

EN ISO 5356-1:2015 麻醉剂和呼吸设备.锥形连接器.第1部分:锥体和插孔(ISO 5356-1:2015)

Dieser Teil von ISO 5356 legt Anforderungen an Mase und Lehren fur mannliche und weibliche Konen fest, die fur Anschlusse bei Anasthesie- und Beatmungsgeraten verwendet werden, z. B. in Atemsystemen, Anasthesiegas-Fortleitungssystemen und Verdampfern. Mannliche und weibliche Konen werden deshalb nicht als eigenstandige Medizinprodukte angesehen. Dieser Teil von ISO 5356 legt Anforderungen fur folgende mannliche und weibliche Konen fest: 8,5 mm und 11,5 mm zur Verwendung in Atemsystemen fur Neugeborene und Kinder; 15 mm und 22 mm zur allgemeinen Verwendung in Atemsystemen; weibliche 22-mm-Schnappkonen (einschlieslich Leistungsanforderungen); 23 mm zur Verwendung mit Verdampfern, nicht jedoch zur Verwendung in Atemsystemen; 30 mm zum Anschluss eines Atemsystems an ein Anasthesiegas-Fortleitungssystem. Die medizinischen Gerate und das Zubehor, fur die/das diese mannlichen und weiblichen Konen vorgesehen sind, werden nicht in diesem Teil von ISO 5356 festgelegt. Anforderungen an die Verwendung von mannlichen und weiblichen Konen sind nicht Bestandteil von diesem Teil von ISO 5356; diese Anforderungen sind jedoch in den entsprechenden Internationalen Normen fur bestimmte medizinische Gerate und medizinisches Zubehor enthalten bzw. werden in diese aufgenommen. ANMERKUNG Anforderungen an gewichtstragende konische Konnektoren mit Schraubgewinde sind in ISO 5356-2 festgelegt.

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)

DIN EN ISO 5367:2015 麻醉和呼吸器. 呼吸组和连接器 (ISO 5367-2014); 德文版本EN ISO 5367-2014

Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014); German version EN ISO 5367:2014