11.040.25 标准查询与下载

GSO ISO 80369-7:2024 医疗保健应用中用于液体和气体的小口径连接器 第7部分：血管内或皮下应用的连接器

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 See Annex A. NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); - infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications

GSO ISO 7886-3:2024 一次性使用无菌皮下注射器 第3部分：固定剂量免疫用自毁注射器

This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature. This document does not specify the design of the auto-disable syringe feature. This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.

Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization

GSO ISO 3749:2024 玻璃注射器 可萃取钨的测定

This document specifies an analytical method to quantitatively determine the water-soluble amount of tungsten (W) from the inner surface of glass syringes. The method can be applied to Luer cone, staked needle or Luer lock syringes.

Glass syringes — Determination of extractable tungsten

GSO ISO 11608-6:2024 医用针头注射系统 要求和试验方法 第6部分：体内输送系统

This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needle-based injection systems (NISs) for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. NOTE 1   Although technically a device using a soft cannula is not “needle-based”, the soft cannula is placed by a needle and can be included in this classification. NOTE 2    Some requirements and methods are already established and included in other parts of the ISO 11608 series. Infusion pumps that are designed for continuous delivery at a specific rate required to achieve and/or maintain a desired plasma medicinal product concentration are excluded from this document. However, while this document is not intended to directly apply to these pump products, it does contain requirements and test methods that can be used to help design and evaluate them. NOTE 3 They are covered by IEC 60601-2-24 (if electronic) or ISO 28620 (if non-electronic).

Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems

GSO ISO 7886-4:2024 一次性使用无菌注射器 第4部分：具有防止重复使用功能的注射器

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document. NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature

GSO ISO 7886-2:2024 一次性使用无菌皮下注射器 第2部分：电动注射泵用注射器

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps

BS ISO 23217:2024 用于儿科患者自我给药的注射系统 设计要求和指南

Injection systems for self-administration by paediatric patients. Requirements and guidelines for design

BS ISO 10555-7:2023 导管内血管 无菌和一次性导管 外周插入中心导管

Intravascular catheters. Sterile and single-use catheters - Peripherally inserted central catheters

BS EN ISO 10555-1:2023 血管内导管 无菌和一次性导管 一般要求

1   Scope This document specifies general requirements for intravascular catheters , supplied sterile and intended for single use, for any application. This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.

Intravascular catheters. Sterile and single-use catheters - General requirements

BS EN ISO 10555-4:2023 血管内导管 无菌一次性导管 球囊扩张导管

Intravascular catheters. Sterile and single-use catheters - Balloon dilatation catheters

23/30464911 DC BS EN ISO 23908 锐器伤害防护 要求和测试方法 用于血液检测、监测、采样和医疗物质的一次性针头、导管导引器和针头的锐器保护机制……

BS EN ISO 23908. Sharps injury protection. Requirements and test methods. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance…

23/30468100 DC BS ISO 10555-8 血管内导管 无菌和一次性导管 第8部分：体外血液处理导管

BS ISO 10555-8. Intravascular catheters. Sterile and single-use catheters - Part 8. Catheters for extracorporeal blood treatment

23/30461328 DC BS EN ISO 80369-6 用于医疗保健应用中的液体和气体的小口径连接器 第6部分：神经应用连接器

BS EN ISO 80369-6. Small bore connectors for liquids and gases in healthcare applications - Part 6. Connectors for neural applications

23/30437907 DC BS ISO 6559 传统中医 无菌一次性三刃针

BS ISO 6559. Traditional Chinese Medicine. Sterile Three-Edge Needle for Single Use

BS EN ISO 80369-3:2016+A1:2019 适用于医疗保健应用中液体和气体的小口径连接器 肠内应用连接器

Small-bore connectors for liquids and gases in healthcare applications - Connectors for enteral applications

BS EN ISO 11608-5:2023 医用针头注射系统 要求和测试方法 自动化功能

1   Scope This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions ( NIS-AUTO ). General requirements are provided for all automated functions . In addition, specific requirements are provided for the following automated functions : a) medicinal product preparation (e.g. reconstitution); b) needle preparation ; c) needle hiding ; d) priming; e) dose setting ; f) needle insertion ; g) injection depth control ; h) injection of the medicinal product; i)...

Needle-based injection systems for medical use. Requirements and test methods - Automated functions

23/30437554 DC BS ISO 11040-7 预充式注射器 第 7 部分：准备充装的灭菌分装注射器的包装系统

BS ISO 11040-7. Prefilled syringes - Part 7. Packaging systems for sterilized subassembled syringes ready for filling

EN ISO 11608-5:2023 医疗用注射系统,要求和测试方法.第5部分:自动化功能

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)

23/30471829 DC BS ISO 23217.2 用于儿科患者自我给药的注射系统 设计指南

BS ISO 23217.2. Injection systems for self-administration by paediatric patients. Guidelines for design

23/30430984 DC BS ISO 11040-4 预充式注射器 第 4 部分：注射用玻璃桶和准备充装的灭菌分装注射器

BS ISO 11040-4. Prefilled syringes - Part 4. Glass barrels for injectables and sterilized subassembled syringes ready for filling