11.040.20 输血、输液和注射设备 标准查询与下载

ASTM A908-03(2019) 不锈钢针管的标准规范

1.1 This specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial applications. 1.2 In general, needle tubing describes small-diameter tubing with outside diameters (ODs) in the range of 0.008 to 0.203 in. (0.2 to 5.2 mm) with nominal wall thicknesses in the range of 0.002 to 0.015 in. (0.05 to 0.4 mm). Needle tubing gages are normally 6 through 33. 1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Specification for Stainless Steel Needle Tubing

ASTM F623-19 福利导管的标准性能规范

1.1 This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French sizes 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra. The product is manufactured in various sizes and materials such as latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided non-sterile for sterilization and sterile for single use only. Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification. 1.2 Catheters whose surface has been chemically treated to enhance their lubricity with a coating may be tested to this specification. 1.3 The annexes in this specification include detailed information, such as apparatus or materials for this specification. 1.4 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification. 1.5 Regulatory bodies may require additional information, such as clinical data, to support different design features. 1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.7 Exclusions—Long-term indwelling usage (over 30 days) is encountered with this product, but not commonly, and is therefore considered an exception to this specification. Similarly, the use of such catheters for nonurethral catheterization (such as for nephrostomy, suprapubic cystostomy, ureterostomy, gastrostomy, enemas, and so forth) is excluded from the scope of this specification. Likewise, three lumen catheters, 30-cm3 balloon and pediatric catheters, and catheters whose surface has been enhanced for lubricity using liquids or gels. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1 This performance specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.34 on Urological Materials and Devices. Current edition approved March 1, 2019. Published March 2019. Originally approved in 1981. Last previous edition approved in 2013 as F623–99(2013). DOI: 10.1520/F0623-19. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Performance Specification for Foley Catheter

KS P 8007-2018(2023) 输液泵

Infusion pumps

KS P 8007-2018 输液泵

Infusion pumps

YY/T 0929.2-2018 输液用药液过滤器 第2部分：标称孔径1.2μm药液过滤器白色念珠菌截留试验方法

Medicinal fluid filters for infusion Part 2: Candida albicans retention test method for medicinal fluid filters with nominal pore size 1.2 μm

YY/T 1631.1-2018 输血器与血液成分相容性测定 第1部分：血液成分残留评定

Determination of compatibility between blood transfusion sets and blood components Part 1: Assessment of blood component residues

DIN EN ISO 8637-2:2018 用于血液净化的体外系统 第2部分：用于血液透析器、血液透析滤过器和血液滤过器的体外血液回路（ISO 8637-2:2018）；德文版 EN ISO 8637-2:2018

This International Standard specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This standard is not applicable to: - haemodialysers, haemodiafilters or haemofilters; - plasmafilters; - haemoperfusion devices; - vascular access devices; - blood pumps; - pressure monitors for the extracorporeal blood circuit; - air detection devices; - systems to prepare, maintain or monitor dialysis fluid; - systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1, and requirements for plasmafilters are specified in ISO 8637-3 NOTE Extracoproreal blood tubing sets may also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018

T/SXNA 001-2018 医用注射泵/输液泵临床使用规范

医用注射泵/输液泵临床使用规范流程及要求、常见问题检测及处理方法、仪器保管校准要求。

Using standards for Syringe Pumps and Infusion Pumps

YY/T 1617-2018 血袋用聚氯乙烯压延薄膜

PVC calendered film for blood bags

YY 0585.3-2018 压力输液设备用一次性使用液路及附件 第3部分：过滤器

Disposable fluid circuits and accessories for pressure infusion equipment Part 3: Filters

KS P ISO 14972-2018 无菌封堵器 用于单针外周血管内导管

Sterile obturators for single use with over-needle peripheral intravascular catheters

KS P ISO 14972-2018(2023) 一次性使用无菌密闭器 配针外周血管内导管

Sterile obturators for single use with over-needle peripheral intravascular catheters

KS P 7409-2018 牙科用牙拉刀架

Dentistry — Dental broach holders

KS P 7408-2018 牙科学.牙科骨锉

Dentistry — Dental bone files

KS P ISO 14972:2018 无菌封堵器 用于单针外周血管内导管

Sterile obturators for single use with over-needle peripheral intravascular catheters

KS P 7415-2018 牙科牙龈敷贴器

Dentistry — Gingival applicators

T/ZZB 0693-2018 一次性使用无菌注射针

本标准由温州市标准化研究院牵头组织制定。 本标准主要起草单位：浙江康德莱医疗器械股份有限公司。 本标准参与起草单位：温州市标准化研究院、南昌麦迪康医疗器械厂（排名不分先后）。

Sterile hypodermic needles for single use

YY/T 1618-2018 一次性使用人体静脉血样采集针

Disposable human venous blood sample collection needle

ISO 15747:2018 静脉注射用塑料容器

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5000 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 this document.

Plastic containers for intravenous injections

KS P ISO 8536-13-2018(2023) 医用输液设备─ 第13部分:带流体接触的一次性刻度流量调节器

Infusion equipment for medical use ─ Part 13: Graduated flow regulators for single use with fluid contact