11.040.20 输血、输液和注射设备 标准查询与下载

GSO ISO 15010:2013 输液和输液瓶用一次性悬挂装置 要求和测试方法

This International Standard specifies requirements for hanging devices for transfusion bottles in accordance with ISO 1135-1 and infusion bottles in accordance with ISO 8536-1 . The hanging devices are intended for single use only. The purpose of this International Standard is to establish a safe hanging device for transfusion and infusion bottles during administering of their contents.

Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods

GSO ISO 8871-3:2013 用于肠外营养和药物使用装置的柔性橡胶部件 第3部分：释放颗粒数量的估计

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

GSO ISO 8362-3:2013 注射容器和附件 第3部分 注射瓶铝盖

This part of ISO 8362 specifies aluminium caps for injection vials as described in ISO 8362-1 and ISO 8362-4.

Injection containers and accessories - Part 3: Aluminium caps for injection vials

GSO ISO 8536-10:2013 医用输液设备 第10部分：与压力输液设备一起使用的流体管路附件

This part of ISO 8536 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8. This part of ISO 8536 includes: a) Two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC) and stopcocks manifold (SM); NOTE Designation of a stopcock depends on the number of connections. The number of possible functional positions can be expressed by addition of a complementary note, using a diagonal stroke and a numeral indicating the number of possible stopcock positions, e.g. 3/4-way stopcock for three-way stopcock with four possible positions. b) units with injection site (UIS) or check valve (UCV); c) stoppers (S) or adapters (A).

Infusion equipment for medical use - Part 10: Accessories for fluid lines for use with pressure infusion equipment

GSO ISO 10985:2013 输液瓶和注射瓶的铝盖和塑料盖 要求和测试方法

This International Standard specifies general requirements and test methods for caps made of aluminiumplastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4. The purpose of this International Standard is to specify caps that provide: a) guarantee of originality of the closure up to the point of administration; b) compression of the sealing element (rubber closure) on to the sealing surfaces of the infusion and/or injection bottles; c) protection of the sealing element against soiling and mechanical damage; d) simple and injury-free opening of the closure in order to expose the penetration area of the rubber closure and/or to permit total removal of the cap.

Caps made of aluminium-plastics combinations for infusion bottles and injection vials - Requirements and test methods

GSO ISO 8362-5:2013 注射容器和配件 第5部分：注射瓶冷冻干燥盖

This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362 are intended for single use only.

Injection containers and accessories - Part 5: Freeze drying closures for injection vials

GSO ISO 15759:2013 医疗输液设备 带有柔性橡胶插入衬里的塑料盖 适用于采用滴灌密封 (BFS) 工艺制造的容器

This International Standard specifies the dimensional and functional requirements for plastics caps with inserted elastomeric liners, attached to the infusion container (BFS container) by welding or by collar technique. These caps are intended for use in the packaging and handling of liquid drugs for parenteral delivery.

Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process

GSO ISO 8871-2:2013 用于肠外营养和药物使用装置的柔性橡胶部件 第2部分：定义和特性

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

GSO ISO 8536-12:2013 医用泵装置 第12部分：止回阀

This part of ISO 8536 applies to sterilized check valves intended for single use and used with infusion equipment for gravity-feed infusion and/or with pressure infusion apparatus.

Infusion equipment for medical use - Part 12: Check valves

GSO ISO 9187-2:2013 医用注射仪器 第2部分：单点切割（OPC）安瓿

This part of ISO 9187 specifies materials, dimensions and requirements for forms of one-point-cut (OPC) ampoules (forms B, C and D) for injectables. Ampoules complying with this part of ISO 9187 are intended for single use only.

Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules

GSO ISO 15137:2013 输液瓶和注射瓶的自粘悬挂装置 要求和测试方法

This International Standard specifies requirements and test methods for self-adhesive hanging devices (SAHD) used in combination with infusion containers, e.g. infusion glass bottles (see ISO 8536-1). The purpose of this International Standard is to establish a safe SAHD for prescribed infusion containers while administering their content so as to ensure a safe application for the patient and for the user.

Self-adhesive hanging devices for infusion bottles and injection vials - Requirements and test methods

GSO ISO 8871-4:2013 肠外营养用弹性橡胶零件和药用器械 第4部分：生物学要求和试验方法

This part of ISO 8871 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods

GSO ISO 6710:2013 用于静脉血样本采集的一次性容器

This International Standard specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers. It does not specify requirements for blood collection needles or needle holders. NOTE 1 This International Standard replaces the require­ ments for non-evacuated containers previously specified in ISO 4822, Single use blood specimen containers up to 25 ml capacity, which has been withdrawn 25 ml capacity, which has been withdraw

Single-use containers for venous blood specimen collection

GSO ISO 15375:2013 医用输液瓶 多种用途的悬挂装置 要求和测试方法

This International Standard specifies requirements for permanent suspension devices, fixed to infusion racks or set-up devices, for infusion bottles that confirm to the requirements of ISO 8536-1. The suspension devices are intended for multiple use. The purpose of this International Standard is to establish a safe suspension device for infusion bottles during administering of their contents.

Medical infusion bottles - Suspension devices for multiple use - Requirements and test methods

GSO ISO 8536-7:2013 医用输液器 第7部分：输液瓶用铝塑盖

This part of ISO 8536 specifies caps made of aluminium-plastics combinations intended for use on infusion glass bottles which are in accordance with ISO 8536-1.

Infusion equipment for medical use - Part 7: Caps made of aluminium-plastics combinations for infusion bottles

GSO ISO 8536-9:2013 医疗用泵装置 第9部分：与压力泵装置一起使用的液体管线

This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO 8536: a) syringe pump lines (SPL); b) connecting lines (CL); c) lines with integrated injection cannula (LIC).

Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment

GSO ISO 1135-4:2013 医用输血设备 第4部分 一次性使用输血包

This part of ISO 1135 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 1135.

Transfusion equipment for medical use - Part 4: Transfusion sets for single use

GSO ISO 8871-5:2013 注射用和药用设备的弹性部件 第5部分：功能要求和测试

This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing

GSO ISO 8872:2013 输液、输液和注射瓶用铝盖 一般要求和测试方法

This International Standard specifies general requirements and test methods for aluminium caps for injection vials, and for infusion and transfusion bottles.

Aluminium caps for transfusion, infusion and injection bottles - General requirements and test methods

GSO ISO 3826-1:2013 用于人类血液和血液成分的可折叠塑料容器 第1部分：常规容器

This part of ISO 3826 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle and with optional transfer tube(s), for the collection, storage, processing, transport, separation and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged. This part of ISO 3826 is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple or multiple units. Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastics container as prepared ready for use. This part of ISO 3826 is not applicable to plastics containers with an integrated filter.

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers