11.040.20 输血、输液和注射设备 标准查询与下载

ISO 3826-1:2013 人体血液及血液成分用塑料可折叠容器.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.

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

DS/EN ISO 22413:2013 药物制剂用传输装置 要求和试验方法

ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

Transfer sets for pharmaceutical preparations - Requirements and test methods

DS/EN ISO 8536-4/A1:2013 医用输液设备 第4部分：一次性使用输液器，重力输液

This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.Secondary aims of this part of ISO 8536 are to

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

GSO ISO 8536-1:2013 医用输液装置 第1部分：玻璃输液瓶

This part of ISO 8536 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.

Infusion equipment for medical use - Part 1: Infusion glass bottles

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 9997:2013 牙科注射剂

This International Standard specifies requirements and test methods for dental cartridge syringes which are reusable dental syringes of the aspirating, non-aspirating and self-aspirating types using cartridges with dental local anaesthetics. This International Standard is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure.

Dental Cartridge Syringes

GSO ISO 1135-3:2013 医用输血设备 第3部分 血液采集套件

This part of ISO 1135 specifies requirements for types of blood­ taking sets for medical use in order to ensure functional inter­ changeability of transfusion equipment. The materials and the components of the sets are validated by various test methods (type tests) and, in addition, tests are per­ formed for the release of lots of finished sets (lot tests). The manufacturer shall select appropriate test methods to com­ ply with the requirements laid down in this part of ISO 1135. Secondary aims of this part of ISO 1135 ar e to provide a) specifications relating to the quality and performance of materials used in transfusion equipment ; b) a unified presentation of terms and designations for such equipment. In some countries, the national pharmacopoeia or other na­ tional regulations are legally binding and take precedence over this part of ISO 1135. This part of ISO 1135 specifies requirements applicable to sterilized blood-taking sets intended for single use and for a single donor only. single donor onl

Transfusion equipment for medical use - Part 3: Blood-taking set

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 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

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 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 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 8536-8:2013 医疗用泵装置 第8部分：与压力泵装置一起使用的泵装置

This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).

Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus

GSO ISO 8536-2:2013 医用输液装置 第2部分：输液瓶塞

This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8536 are intended for single use only.

Infusion equipment for medical use - Part 2: Closures for infusion bottles

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 9187-1:2013 医用注射器 第1部分：注射用安瓿

This part of ISO 9187 specifies materials, dimensions, capacities, performance and packaging requirements for three forms of glass ampoule (forms B, C and D) for injectable pharmaceutical products. It is applicable to ampoules with and without a colour break-ring; the provision of ampoules with a colour break-ring, and the choice of colour of the break-ring, is subject to agreement between the manufacturer and user. Ampoules complying with this part of ISO 9187 are intended for single use only.

Injection equipment for medical use - Part 1: Ampoules for injectables

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 22413:2013 药物制剂的运输方式 要求和测试方法

This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

Transfer sets for pharmaceutical preparations - Requirements and test methods

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 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