输血、输液和注射设备标准-分析测试百科网

YY 0485-2020 一次性使用心脏停跳液灌注器

Disposable cardioplegia infusion set

ICS: 11.040.20
CCS: C45
发布: 2020-06-30
实施: 2021-12-01

YY/T 0286.4-2020 专用输液器第4部分:一次性使用压力输液设备用输液器

Special infusion sets Part 4: Infusion sets for single-use pressure infusion equipment

ICS: 11.040.20
CCS: C31
发布: 2020-06-30
实施: 2021-06-01

BS EN ISO 8871-2:2020 注射用和药用设备的弹性部件识别和表征

What is ISO 8871-2 about? ISO 8871 discusses elastomeric parts for parenterals and for devices for pharmaceutical use. ISO 8871-2 layouts identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and chemical test procedures specified in ISO 8871-2 permits the determination of the typical characteristics of elastomeric parts including coatings and surface treatments. Depending upon the type of elastomer and its application, an appropriate set of tests is selected. Who is ISO 8871-2 for? ISO 8871-2 on Elastomeric parts for pharmaceutical use is useful for: Manufacturers of elastomeric parts for parenteral Manufacturers of elastomeric parts devices for pharmaceutical use Pharmacies and medical laboratories Regulatory authorities Why should you use

Elastomeric parts for parenterals and for devices for pharmaceutical use - Identification and characterization

ICS: 11.040.20
CCS
发布: 2020-06-30
实施: 2020-06-30

EN ISO 8871-2:2020 非肠道及制药设备用弹性件.第2部分:识别和表征

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)

ICS: 11.040.20
CCS
发布: 2020-06-03
实施: 2020-09-30

ISO 8871-2:2020 肠胃外和药物使用装置的弹性部件 - 第2部分:鉴定和表征

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization

ICS: 11.040.20
CCS
发布: 2020-05-14
实施

BS EN ISO 8536-4:2020 医用输液设备-一次性使用、重力输液输液器

What is ISO 8536-4 about? ISO 8536 discusses infusion equipment for medical use. ISO 8536-4 outlines requirements for single-use, gravity feed infusion sets for medical use to ensure their compatibility with containers for infusion solutions and intravenous equipment. The secondary aims of ISO 8536-4 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. Who is ISO 8536-4 for? ISO 8536-4 on i nfusion sets for single use is useful for: Manufacturers of infusion medical equipment

Infusion equipment for medical use - Infusion sets for single use, gravity feed

ICS: 11.040.20
CCS
发布: 2020-03-31
实施: 2020-03-31

YY/T 0286.6-2020 专用输液器第6部分：一次性使用刻度流量调节式输液器

Special Infusion Sets Part 6: Disposable Scaled Flow Adjustable Infusion Sets

ICS: 11.040.20
CCS: C31
发布: 2020-03-31
实施: 2021-04-01

T/CAME 11-2020 去白细胞混合浓缩血小板的制备和质量控制

本标准规定了去白细胞混合浓缩血小板的制备、质量控制、标识、标签、储存、运输要求。本标准适用于去白细胞混合浓缩血小板的制备和质量控制。

Preparation and quality controls for leukocyte-reduced pooled platelet concentrates

ICS: 11.040.20
CCS: c30
发布: 2020-02-13
实施: 2020-02-13

EN ISO 8536-4:2020 医用输液设备.一次性使用的重力输液式输液器

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 (ISO 8536-4:2019)

ICS: 11.040.20
CCS
发布: 2020-01-29
实施: 2020-04-30

ISO 28620:2020 医疗器械 - 非电驱动便携式输液装置

This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called “device”. It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial and intravascular or hypodermic applications. NOTE Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administered regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient. These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient. This document does not apply to — electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24, — devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the ISO 11608 series, — implantable devices, — enteral devices, — transdermal delivery devices, and — devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).

Medical devices — Non-electrically driven portable infusion devices