11.040.20 输血、输液和注射设备 标准查询与下载

T/AHPPA 2-2023 一次性使用无菌血袋微粒污染的测定 光阻法

本文件规定了光阻法测定一次性使用无菌血袋微粒污染的方法原理、测试仪器、试验过程、结果计算和试验报告。 本文件适用于使用光阻法测定一次性使用无菌血袋10 μm及以上粒径的微粒污染。

Determination of particulate contamination for disposable blood transfusion bag— Light obscuration method

YY/T 1856-2023 血液、静脉药液、灌洗液加温器安全通用要求

本文件规定了血液、静脉药液、灌洗液流体加温器的安全通用要求。本文件适用于血液、静脉药液、灌洗液流体加温器。本文件不适用于：非管路用流体加温器，如加温柜、新鲜冷冻血浆/新鲜红细胞解冻装置、电煲加热器；体外/心脏搭桥加温循环系统；集成到透析装置上的加温器。

General safety requirements for blood, intravenous solution, and lavage fluid warmers

ISO 3826-1:2019/Amd 1:2023 人类血液及血液成分用塑料折叠容器.第1部分:常规容器 修改件1

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

ISO 8536-15:2022/Amd 1:2023 医用输液设备第15部分:一次性使用的光保护输液器 修改件1

Infusion equipment for medical use — Part 15: Light-protective infusion sets for single use — Amendment 1

BS EN ISO 21649:2023 医用无针注射系统 要求及测试方法

1   Scope This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems ( NFISs ) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. Excluded from this document are drug delivery methods which: — involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); — generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); — deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the ...

Needle-free injection systems for medical use. Requirements and test methods

BS EN ISO 8536-2:2023 医用输液设备 输液瓶盖

1   Scope This document 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 document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Infusion equipment for medical use. Closures for infusion bottles

EN ISO 8536-2:2023 医用输液设备.第2部分:输液瓶塞

This document 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 document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2023)

EN ISO 21649:2023 医用无针头式注射器.要求和试验方法

This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. Excluded from this document are drug delivery methods which: — involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); — generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); — deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops); — apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); — infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.

Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)

ISO 8536-2:2023 医用输液器具 第2部分:输液瓶塞

This document 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 document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

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

ISO 21649:2023 医用非针头式注射器.要求和试验方法

This document applies to safety and performance and testing requirements for single-use and multiple- use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. Excluded from this document are drug delivery methods which: — involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); — generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); — deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops); — apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); — infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.

Needle-free injection systems for medical use — Requirements and test methods

KS P 3205-2022 上颌窦和额窦插管

Cannula for maxillary antrum and frontal sinus

KS P 1907-1-2022 输液管中药物吸附的测定方法第1部分:硝酸甘油、环孢菌素A、他克莫司

Determination method of drug adsorption in infusion tube — Part 1: Nitroglycerin, Cyclosporin A, Tacrolimus

KS P ISO 8871-2-2022 非肠道和制药装置用弹性部件.第2部分:识别和表征

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

KS P ISO 8536-12-2022 医用输液设备.第12部分:一次性止回阀

Infusion equipment for medical use — Part 12: Check valves for single use

KS P ISO 8536-11-2022 医用输液设备.第11部分:带压力输液设备的一次性输液过滤器

Infusion equipment for medical use — Part 11: Infusion filters for single use with pressure infusion equipment

KS P ISO 8536-8-2022 医用输液设备.第8部分:带压力输液器的一次性输液器

Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus

KS P ISO 8536-10-2022 医用输液设备.第10部分:带压力输液设备的一次性流体管路附件

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

KS P ISO 8536-9-2022 医用输液设备.第9部分:带压力输液设备的一次性流体管路

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

ASTM 51939-22 血液辐照剂量测定的标准实施规程

Standard Practice for Blood Irradiation Dosimetry

ASTM ISO/ASTM51939-22 血液辐照剂量测定的标准实施规程

Standard Practice for Blood Irradiation Dosimetry