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
Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features
- ICS
- 11.040.20
- CCS
- 发布
- 2019-11-25
- 实施
Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers
- ICS
- 11.040.20
- CCS
- 发布
- 2019-11-25
- 实施
Plastic containers for intravenous injections
- ICS
- 11.040.20
- CCS
- 发布
- 2019-11-25
- 实施
Single-use containers for human venous blood specimen collection
- ICS
- 11.040.20
- CCS
- 发布
- 2019-11-25
- 实施
Single-use containers for human venous blood specimen collection
- ICS
- 11.040.20
- CCS
- 发布
- 2019-11-25
- 实施
Medical electrical equipment — Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
- ICS
- 11.040.20
- CCS
- 发布
- 2019-11-25
- 实施
1 Scope This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers. This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
Injection containers and accessories - Injection vials made of glass tubing
- ICS
- 11.040.20
- CCS
- 发布
- 2019-10-31
- 实施
- 2019-10-31
This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics 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 can contain anticoagulant and/or preservative solutions, depending on the application envisaged. This document 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 document apply to the plastics container as prepared ready for use. This document is not applicable to plastics containers with an integrated filter.
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)
- ICS
- 11.040.20
- CCS
- 发布
- 2019-10-16
- 实施
- 2020-01-31
This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers. This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018)
- ICS
- 11.040.20
- CCS
- 发布
- 2019-10-16
- 实施
- 2020-01-31
This document 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 document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
- ICS
- 11.040.20
- CCS
- 发布
- 2019-09-18
- 实施
This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics 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 can contain anticoagulant and/or preservative solutions, depending on the application envisaged. This document 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 document apply to the plastics container as prepared ready for use. This document is not applicable to plastics containers with an integrated filter.
Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers
- ICS
- 11.040.20
- CCS
- 发布
- 2019-09-15
- 实施
本标准规定了一次性使用低阻力注射器(以下简称“注射器” )的术语和定义、结构与命名、基本要求、技术要求、试验方法、检验规则、标志、包装、运输和贮存、质量承诺。 本标准适用于麻醉穿刺包器械配套使用、供人体皮下、肌肉、静脉注射药液、抽取液体用的注射器。
Low resistance syringe for single use
- ICS
- 11.040.20
- CCS
- C2770
- 发布
- 2019-08-29
- 实施
- 2020-01-03
Correlation method between bubble point pressure and bacterial retention capacity of filters for infusion equipment
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2019-05-31
- 实施
- 2020-06-01
Method for determination of cyclohexanone dissolution in infusion and blood transfusion equipment
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2019-05-31
- 实施
- 2020-06-01
YY 0286的本部分规定了药液过滤器过滤介质标称孔径”为2.0μm～5.0μm的一次性使用精密过滤输液器(以下简称输液器)的要求。 本部分适用于一次性使用精密过滤输液器。
Special infusion sets.Part 1:Infusion sets with precision filteers for single use
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2019-05-31
- 实施
- 2020-12-01
YY 0585的本部分适用于压力为200kPa以下的输液设备用一次性使用无菌液路。 YY 0585的本部分包括以下项目： a) 注射泵管路(SPL)； b) 连接管路(CL)； c) 与注射插管为一体的管路(LIC)。
Fluid lines for use with pressure infusion equipment and accessories for single use - Part 1: Fluid lines
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2019-05-31
- 实施
- 2020-12-01
YY 0585的本部分适用于一次性使用无菌液路和YY 0286.4规定的压力输液器用的附件。 YY 0585的本部分包括： a) 两路开关（2SC）、三路开关（3SC）、四路开关（4SC）和多联开关（SM）； b) 带有注射座的装置（UIS）或带防回流阀的装置（UCV）； c) 塞子（S）或连接器（A）。
Fluid lines for use with pressure infusion equipment and accessories for single use-Part 2:Accessories
- ICS
- 11.040.20
- CCS
- C31
- 发布
- 2019-05-31
- 实施
- 2020-12-01
NEW! IEC 60601-2-16:2018 is available as IEC 60601-2-16:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition: a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015; b) widening of the scope; c) editorial improvements; d) addition of requirements for anticoagulant delivery means; e) other few small technical changes.
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
- ICS
- 11.040.20
- CCS
- 发布
- 2019-05-24
- 实施
- 2019-08-24 (7)
What is ISO 15747- Plastic containers for intravenous injections about? ISO 15747 is an international standard that discusses plastic containers for intravenous injections to ensure the safe handling of intravenous injections. ISO 15747 specifies requirements for the safe handling and the physical, chemical and biological testing of plastic containers for parenteral. ISO 15747 applies to plastic containers for parenteral having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. Note: In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over ISO 15747. Who is ISO 15747- Plastic containers for intravenous injections for? ISO 15747
Plastic containers for intravenous injections
- ICS
- 11.040.20
- CCS
- 发布
- 2019-03-31
- 实施
- 2019-03-31
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)
- ICS
- 11.040.20
- CCS
- 发布
- 2019-03-27
- 实施
- 2019-06-30
