C31 一般与显微外科器械 标准查询与下载

YY/T 0285.5-2018 血管内导管　一次性使用无菌导管　第5部分：套针外周导管

Intravascular catheters—Sterile and single-use catheters—Part 5:Over-needle peripheral catheters

JIS T 3268:2018 一次性使用无菌血管内导管

Sterile, single-use intravascular catheters

JIS T 3228:2018 一次性活检针

Biopsy needles for single use

JIS T 3320:2018 一次性无菌管塞

Sterile stopcocks for single use

JIS T 3322:2018 与硬膜外导管一起使用的一次性无菌麻醉过滤器

Sterile single use anesthesia filters for use with epidural catheter

DIN EN ISO 6710:2017 人体静脉血样采集用一次性容器(ISO 6710-2017);德文版本EN ISO 6710-2017

This document specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This document also applies to receptacles containing media for blood culture.

Single-use containers for human venous blood specimen collection (ISO 6710:2017); German version EN ISO 6710:2017

DIN 13451:2017 医疗器械.约瑟夫氏剪刀

The project defines dimensions and marking of scissors type Joseph, angled to side, as used in surgery, public health service or armed forces. The project defines dimensions and marking of scissors type Joseph, angled to side, as used in surgery and public health service.

Medical instruments - Scissors type Joseph

DIN 13171:2017 医疗器械.Adson-Brown外科组织镊

The project defines dimensions and marking of tissue forceps type Adson-Brown, angled to side, as used in surgery and public health service.

Medical instruments - Tissue forceps type Adson-Brown

DIN 13112-1:2017 医疗器械.第1部分:不镶硬质合金的解剖剪

The project defines dimensions and marking of scissors for preparations without carbide inserts, as used in surgery and public health service.

Medical instruments - Part 1: Scissors for preparations without carbide inserts

JIS T 3261:2017 无菌一次性使用的导管导引器

Sterile single-use catheter introducers

JIS T 3260:2017 扩张器

Dilators

DIN 13172:2017 医疗器械.德巴基氏血管镊子

Standardization of dimensions, material, requirements, designation and marking of the vessel forceps type De Bakay for use in surgery.

Medical instruments - Vessel forceps type De Bakey

DIN 13452:2017 医疗器械.基尔氏剪刀

The project defines dimensions and marking of scissors type Kilner, angled to side, as used in surgery, public health service.

Medical instruments - Scissors type Kilner

JIS T 3262:2017 导引器注射针和导引器导管

Introducer needles and introducer catheters

ISO 13926-2:2017 笔系统.第2部分:医用注射笔活塞螺旋帽

This document specifies the material, performance requirements and labelling and gives recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use. 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.

Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use

DIN 58252-1:2017 医疗器械.第1部分:不镶硬质合金的直形外科剪刀

This document defines dimensions and marking of surgical scissors, straight without carbide inserts, angled to side, as used in surgery and public health service.

Medical instruments - Part 1: Surgical scissors, straight without carbide inserts

DIN 58254:2017 医疗器械.切口剪刀

This document defines dimensions and marking of scissors for incisions, as used in public health Service.

Medical instruments - Scissors for incisions

DIN EN ISO 10555-6:2017 血管内导管.一次性使用无菌导管.第6部分:皮下植入端口(ISO 10555-6-2015);德文版本EN ISO 10555-6-2017

This part of EN ISO 10555 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.This part of EN ISO 10555 does not specify requirements, performance, and user safety issues related to non-coring needles.

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015); German version EN ISO 10555-6:2017

BS ISO 10936-1:2017 光学和光子学 手术显微镜 要求及测试方法

Optics and photonics. Operation microscopes. Requirements and test methods

DIN ISO 8536-6:2017 医用输液设备 第6部分：输液瓶冷冻干燥瓶盖（ISO 8536-6:2016）

This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. Freeze drying closures can pick up water during shipping, storage, washing and steam sterilization cycles, which is difficult to remove in a subsequent drying cycle. As a consequence, the freeze drying closures are usually loaded with residual moisture. Depending upon the mass of the freeze-dried product and the degree of its sensitivity to water, the residual moisture in the rubber material can spoil the freeze-dried preparation during storage. These specific process requirements have been addressed in this part of ISO 8536 by specifying relevant requirements for freeze drying closures including a test method on determination of residual moisture.

Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)