11.040.20 输血、输液和注射设备 标准查询与下载
共找到 1427 条与 输血、输液和注射设备 相关的标准，共 96 页
Single-use Huber needles used for implantable drug-supplying devices
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-10-21
- 实施
- 2014-10-01
本标准规定了评价两端带固定装置的一次性使用输尿管支架特性的仲裁试验方法,这些支架应用于短期将尿液从肾脏引流至膀胱。这类支架的直径通常为3.7 Fr~14.0 Fr,长度为8 cm~30 cm,由硅橡胶、聚氨酯和其他聚合物制成,并以非无菌形式和一次性无菌形式供应。该产品会有长期留置(超过30 d)的情况,但并不常见,因此本标准不包括这种情况。同样,本标准也不包括非输尿管应用(如肾造口术和回肠造口术)的输尿管支架。由于医院的灭菌设备、灭菌过程对支架特性产生的影响存在差异性,所以本标准也不适用于非无菌输尿管支架。
Test methods for ureteral stents
- ICS
- 11.040.20
- CCS
- C40
- 发布
- 2013-10-21
- 实施
- 2014-10-01
本标准规定了一次性使用注射用过滤器的分类与标记、材料、物理要求、化学要求、生物要求、标志、包装。本标准适用于一次性使用注射用过滤器(以下简称过滤器),过滤器与注射器具配套使用,应用于临床治疗中肌肉注射、静脉注射药物,以及向液体瓶内添加药物等,用于过滤药液中的不溶性微粒。
Single-use filter for syringe
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-10-21
- 实施
- 2014-10-01
本标准应用于在临床和相关医疗环境下的患者个人使用的一次或多次使用的无针注射器的安全、性能和试验要求。注射器的剂量腔通常是丢弃式的,在一次使用或有限次数使用后将其更换。有时它与注射机械装置是分离的并且通常称为“药筒”、“安瓿”、“注射器”、“胶囊”或者“圆盘”。反之,剂量腔也可以是永久的内腔,其使用性能在失效期限内能够保持有效。不适用于本标准的是关于药物的给药方式:--使无针注射装置本身的一部分的穿刺进入或通过皮肤或黏膜(比如针头、尖部、微针、植入式缓慢释放药物装置);--产生气溶胶、液滴、粉末或其他形式用于吸入、吹人、鼻腔或口腔沉积(比如喷雾、吸人器、微小装置);--皮肤或黏膜表面的沉积液、粉末或其他物质被动地扩散或被人体摄入(比如透皮吸收贴片、液滴);--应用于声能或电磁能(比如超声或离子导入装置);--应用于累加或测量进入或通过人工管路、导管、和/或其本身进入人体的针头的药物的输液系统。
Needle-free injectors for medical use.Requirements and test methods
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-10-21
- 实施
- 2014-10-01
本标准规定了一次性使用低阻力注射器(以下简称注射器)的定义、术语、要求、试验方法、包装、标识。本标准适用于麻醉穿刺包的器械配套使用或高粘度药物注射的手动注射器。
Low resistance syringe for single use
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-10-21
- 实施
- 2014-10-01
本标准规定了一次性使用植入式给药装置专用针(包括输液针和注射针)的要求,以保证与植入式给药装置和输注装置相适应。本标准为专用针所用材料的性能及其质量规范提供了指南。本标准不涉及专用针防针刺安全要求。
Single-use Huber needles used for implantable drug-supplying devices
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-10-21
- 实施
- 2014-10-01
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004); German version EN ISO 8536-5:2013
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-10
- 实施
This part of ISO 11418 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. This part of ISO 11418 is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use. NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
- ICS
- 11.040.20
- CCS
- 发布
- 2013-09-09
- 实施
This part of ISO 11418 specifies the form, dimensions and capacities of glass vials for pharmaceutical preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers. This part of ISO 11418 applies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products.
Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
- ICS
- 11.040.20
- CCS
- 发布
- 2013-09-09
- 实施
This part of ISO 11418 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. This part of ISO 11418 is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use. NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups
- ICS
- 11.040.20
- CCS
- 发布
- 2013-09-09
- 实施
Scope is not provided for this standard
Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies
- ICS
- 11.040.20
- CCS
- 发布
- 2013-09-09
- 实施
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013); German version EN ISO 3826-1:2013
- ICS
- 11.040.20
- CCS
- C44
- 发布
- 2013-09
- 实施
This part of ISO 3826 specifies requirements, including performance requirements, for plasticscollapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle,and with optional transfer tube(s), for the collection,
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers
- ICS
- 11.040.20
- CCS
- 发布
- 2013-08-30
- 实施
- 2013-08-30
Plastics collapsible containers for human blood and blood components - Part 1: conventional containers
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-08-10
- 实施
- 2013-08-10
Standard Practice for Blood Irradiation Dosimetry
- ICS
- 11.040.20
- CCS
- 发布
- 2013-08-08
- 实施
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010 + Amd 1:2013); German version EN ISO 8536-4:2013 + A1:2013
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-07
- 实施
Plastics collapsible containers for human blood and blood components. Conventional containers
- ICS
- 11.040.20
- CCS
- C44
- 发布
- 2013-06-30
- 实施
- 2013-06-30
Infusion equipment for medical use. Check valves
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-06-30
- 实施
- 2013-06-30
Dieser Teil von ISO 3826 legt Anforderungen einschlieslich der geforderten Leistungsmerkmale fest fur nicht beluftete, sterile Kunststoffbeutel, die mit Entnahmeschlauch, einem oder mehreren Einstechstutzen, integrierter Blutentnahmekanule und wahlweise mit Uberleitungsschlauch oder -schlauchen ausgestattet sind und die zur Aufnahme, Lagerung, Aufbereitung, zum Transport, zur Trennung und Verabreichung von Blut und Blutbestandteilen bestimmt sind. Die Kunststoffbeutel konnen, je nach vorgesehener Verwendung, Antikoagulans und/oder Stabilisatorlosung enthalten. Dieser Teil von ISO 3826 ist auch anwendbar auf Mehrfachsysteme von Kunststoffbeuteln, die sich z. B. aus zwei, drei, vier oder mehr Einheiten zusammensetzen. Soweit nichts anderes vorgegeben ist, gelten alle in diesem Teil von ISO 3826 festgelegten Prufungen fur den gebrauchsfertigen Kunststoffbeutel. Dieser Teil von ISO 3826 gilt nicht fur Kunststoffbeutel mit einem integrierten Filter.
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2013-06-01
- 实施
- 2013-06-01
