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- 一次性医用耗材物理性能检测
一次性医用耗材物理性能检测
| GB/T 15810 | 一次性无菌皮下注射器 | Sterile hypodermic syringes for single use |
| YY/T 0497 | 一次性无菌胰岛素注射器 | Sterile insulin syringe for single use |
| YY/T 0573.2 | 一次性无菌皮下注射器 第2部分:电动注射泵用注射器 | Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| YY/T 0573.3 | 一次性无菌皮下注射注射器 第3部分:固定剂量免疫用自动禁用注射器 | Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed dose immunization |
| YY/T 0573.4 | 单次使用无菌皮下注射器 第4部分:防止重复使用的注射器 | Sterile hypodermic syringes for single used - Part 4: Syringes with re-use prevention frature |
| ISO 7886-1 | 一次性无菌皮下注射器 第1部分:手动注射器 | Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| ISO 7886-2 | 一次性无菌皮下注射器 第2部分:电动注射泵用注射器 | Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps |
| ISO 7886-3 | 一次性无菌皮下注射器 第3部分:固定剂量免疫用自动禁用注射器 | Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization |
| ISO 7886-4 | 一次性无菌皮下注射器 第4部分:防止重复使用的注射器 | Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature |
| GB/T 15811 | 一次性无菌皮下注射针头 | Sterile hypodermic needles for single use |
| ISO 7864 | 一次性无菌皮下注射针 要求和试验方法 | Sterile hypodermic needles for single use - Requirements and test methods |
| GB/T 15812.1 | 非血管内导管 第1部分:通用性能的试验方法 | Catheters other than intravascular catheters－ Part 1: Test methods for common properties |
| EN 1618 | 非血管内导管 第1部分:通用性能的试验方法 | Catheters other than intravascular catheters — Test methods for common properties |
| GB/T 18457 | 用于制造医疗器械的不锈钢针管 | Stainless steel needle tubing for the manufacture of medical devices |
| ISO 9626 | 医疗器械制造用不锈钢针管 要求和试验方法 | Stainless steel needle tubing for the manufacture of medical devices —Requirements and test methods |
| GB 8368 | 单次使用的输液器-重力输送 | Infusion sets for single use - Gravity feed |
| YY 0286.3 | 专用输液器 第3部分:一次性耐光输液器 | Special infusion sets- Part 3: Light-resistant infusion sets for single use |
| YY 0286.4 | 专用输液器 第4部分:与压力输液器一起使用的一次性输液器 | Special infusion sets- Part 4: Single-use infusion equipment for use with pressure infusion apparatus |
| YY 0286.5 | 专用输液器 第5部分:一次性使用的瓶式和袋式输液器 | Special infusion sets- Part 5: Bottle-type and bag-type infusion sets for single use |
| YY 0286.6 | 专用输液器 第6部分:带分级流量调节器的一次性输液器 | Special infusion sets - Part 6: Infusion sets for single use with graduated flow regulator |
| ISO 8536-4 | 医用输液设备 第4部分:重力给药单用输液装置 | Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed |
| ISO 8536-8 | 医用输液器 第8部分:与压力输液器一起使用的一次性输液器 | Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus |
| ISO 8536-12 | 医用输液设备 第12部分:止回阀 | Infusion equipment for medical use - Part 12: Check valves |
| ISO 8536-13 | 医用输液设备 第13部分:接触液体的一次性分级流量调节器 | Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact |
| GB/T 1962.1 | 注射器、针头和某些其他医疗设备用6% (Luer)锥度的锥形配件 第1部分:一般要求 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part1: General requirement |
| GB/T 1962.2 | 注射器、针头和某些其他医疗设备用带6% (Luer)锥度的锥形配件 第2部分:锁定配件 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings |
| ISO 80369-1 | 医疗保健应用中液体和气体用小孔连接器 第1部分:一般要求 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| ISO 20695 | 肠内喂养系统 设计和试验 | Enteral feeding systems - Design and testing |
| EN ISO 20695 | 肠内喂养系统 设计和试验 | Enteral feeding systems - Design and testing |
| ISO 20696 | 一次性无菌导尿管 | Sterile urethral catheters for single use |
| EN ISO 20696 | 一次性无菌导尿管 | Sterile urethral catheters for single use |
| ISO 20697, EN ISO 20697 | 一次性无菌引流导管及辅助装置 | Sterile drainage catheters and accessory devices for single use |
| ISO 20698, EN ISO 20698 | 神经轴应用导管系统 无菌和一次性导管和附件 | Catheter systems for neuraxial application - Sterile and single-use catheters and accessories |
| YY/T1040.1 | 麻醉和呼吸设备 锥形连接器。第1部分:锥形和插座 | Anaesthetic and respiratory equipment-Conical connectors -Part 1: Cones and sockets |
| ISO 5356-1 | 麻醉和呼吸设备 锥形连接器。第1部分:锥形和插座 | Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets |
| YY 0337.1 | 气管导管第1部分:-常用导管和连接器 | Tracheal tubes Part 1: - Commonly-used tubes and connectors |
| ISO 5361 | 麻醉和再吸收设备-气管管和连接器 | Anaesthetic and resorpiraty equipment -Tracheal tubes and connectors |
| YY 0338.1 | 气管造口管 第1部分:成人用管和连接器 | Tracheostomy tubes - Part 1：Tubes and connectors for adults |
| ISO 5366 | 麻醉和呼吸设备 气管造口管和连接器 | Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors |
| YY/T 0339 | 用于呼吸道的抽吸导管 | Suction catheters for use in the respiratory tract |
| ISO 8836 | 用于呼吸道的抽吸导管 | Suction catheters for use in the respiratory tract |
| YY 0461 | 用于麻醉设备和呼吸机的呼吸管 | Breathing tubes intended for use with aneasthetic apparatus and ventilators |
| ISO 5367 | 麻醉和呼吸设备 呼吸装置和连接器 | Anaesthetic and respiratory equipment - Breathing sets and connectors |
| YY/T 0985 | 麻醉和呼吸设备 喉上气道和接头 | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
| ISO 11712 | 麻醉和呼吸设备 喉上气道和接头 | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors |
| YY 0325 | 一次性无菌导尿管 | Sterile urethral catheter for single use |
| EN 13868 | 导管 单管导管和医用导管扭结的试验方法 | Catheters - Test methods for kinking of single lumen catheters and medical tubing |
| EN 13726-1 | 初级伤口敷料的试验方法. 第1部分：吸收特性 | Test methods for primary wound dressings - Part 1:Aspects of absorbency |
| EN 13726-2 | 初级伤口敷料试验方法.第2部分：可渗透薄膜敷料湿气蒸发传输率 | Test methods for primary wound dressings - Part 2:moisture vapour transmission rate of permeable film dressings |
| EN 13726-3 | 初级伤口敷料的试验方法.第3部分：防水性能 | Test methods for primary wound dressings - Part 3: Waterproofness |
| EN 13726-4 | 初级伤口敷料的试验方法.第4部分：一致性 | Test methods for primary wound dressings - Part 4: Conformability |
