11.040.20 输血、输液和注射设备 标准查询与下载
共找到 1423 条与 输血、输液和注射设备 相关的标准，共 95 页
IEC PAS 63023:2016 establishes a unique input interface for connection of an external alarming device to haemodialysis equipment. The input interface of the haemodialysis equipment is designed as a simple solution, which takes a single fault condition of the input interface into account, to stop the extracorporeal blood flow in case of needles slipping out from the fistula or graft detected by the external alarming device.
Medical electrical system - Input interface for haemodialysis equipment for use of external alarming device
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- 11.040.20
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- 发布
- 2021-07-01
- 实施
ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.
Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
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- 11.040.20
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- 发布
- 2021-07-01
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This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Standard Specification specifies requirements for FLUID WARMERS as defined in 2.2.101. 1.2 Object Addition: The object of this Standard Specification is to establish requirements for FLUID WARMERS which minimize hazards to PATIENT and OPERATOR and to specify tests by which compliance can be verified.
Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
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- 11.040.20
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- 发布
- 2021-07-01
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1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies. 1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies. 1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.
Test Methods For Intervertebral Body Fusion Devices
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- 11.040.20
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- 发布
- 2021-07-01
- 实施
Transfer sets for pharmaceutical preparations – Requirements and test methods
- ICS
- 11.040.20
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- 发布
- 2021-06-30
- 实施
- 2021-06-30
Small-bore connectors for liquids and gases in healthcare applications – Part 5: Connectors for limb cuff inflation applications
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- 11.040.20
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- 发布
- 2021-06-30
- 实施
- 2021-06-30
What is ISO 22413 about? ISO 22413 is one of a series of documents for transfer sets for pharmaceutical preparations and specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations. The transfer sets consist either of two piercing devices or of a piercing device in combination with a small-bore connector, which can relate to each other in different ways. Transfer sets can have housing. Who is ISO 22413 for? ISO 22413 is applicable to- Manufacturers of Transfer sets for pharmaceutical preparations Medical laboratories Healthcare facilities Research centres Why should you use ISO 22413 ? Transfer sets for pharmaceutical preparations transmit fluids from one container t...
Transfer sets for pharmaceutical preparations. Requirements and test methods
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- 11.040.20
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- 发布
- 2021-06-30
- 实施
- 2021-06-30
Transfer sets for pharmaceutical preparations – Requirements and test methods (ISO 22413:2021)
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- 11.040.20
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- 发布
- 2021-06-30
- 实施
- 2021-06-30
Needle-free injectors for medical use — Requirements and test methods
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- 11.040.20
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- 发布
- 2021-06-28
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Plastic containers for intravenous injections
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- 11.040.20
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- 发布
- 2021-06-28
- 实施
Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers
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- 11.040.20
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- 发布
- 2021-06-28
- 实施
Medical electrical equipment — Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
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- 11.040.20
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- 发布
- 2021-06-28
- 实施
Injection containers and accessories —Part 1: Injection vials made of glass tubing
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- 11.040.20
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- 发布
- 2021-06-28
- 实施
Injection containers and accessories —Part 1: Injection vials made of glass tubing
- ICS
- 11.040.20
- CCS
- 发布
- 2021-06-28
- 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
- 2021-06-28
- 实施
Plastic containers for intravenous injections
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- 11.040.20
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- 发布
- 2021-06-28
- 实施
Needle-free injectors for medical use — Requirements and test methods
- ICS
- 11.040.20
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- 发布
- 2021-06-28
- 实施
Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers
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- 11.040.20
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- 发布
- 2021-06-28
- 实施
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications (IEC 80369-5:2016/COR2:2021)
- ICS
- 11.040.20
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- 发布
- 2021-06-00
- 实施
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
Transfer sets for pharmaceutical preparations - Requirements and test methods
- ICS
- 11.040.20
- CCS
- 发布
- 2021-06-00
- 实施
