C47 公共医疗设备 标准查询与下载

BS EN 16442:2015 经加工的不耐热内窥镜用控制环境存储柜

Controlled environment storage cabinet for processed thermolabile endoscopes

YY/T 1265-2015 适用于湿热灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择湿热灭菌的材料适应性提供评价指南。 本标准适用于采用湿热灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to moist heat sterilization

YY/T 1302.1-2015 环氧乙烷灭菌的物理和微生物性能要求　第1部分：物理要求

Physical requirements and microbiological performance of ethylene oxide sterilization—Part 1: Physical aspects

YY/T 1264-2015 适用于臭氧灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择臭氧灭菌工艺材料适应性提供评价指南。本标准适用于采用臭氧灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to ozone sterilization

YY/T 1266-2015 适用于过氧化氢灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择过氧化氢灭菌的材料适应性提供评价指南。本标准适用于采用过氧化氢灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to hydrogen peroxide sterilization

YY/T 1268-2015 环氧乙烷灭菌的产品追加和过程等效

本标准规定追加新产品或有变化的产品于原有确认的环氧乙烷灭菌过程中,使用不同设备时灭菌过程的等效性。本标准适用于经环氧乙烷(EO)灭菌法处理、采用传统放行或参数放行的医疗器械。本标准适用的环氧乙烷灭菌情况包括:a)在已经确认的环氧乙烷灭菌过程中增加新产品;b)评估已确认产品的变更;c)已确认的过程转移到不同的场地或设备;d)评估灭菌过程的等效性。尽管本标准预期应用于医疗器械,但其内容也适用于其他相关的产品或材料。

Product adoption and process equivalence for ethylene oxide sterilization

YY/T 1302.2-2015 环氧乙烷灭菌的物理和微生物性能要求 第2部分:微生物要求

YY/T 1302的本部分规定了环氧乙烷灭菌微生物方面的过程定义、确认、过程有效性维护等。 本部分适用于医疗器械及其他相关产品或材料的环氧乙烷灭菌过程，为环氧乙烷(EO)灭菌过程的开发和确认中的各种微生物方面问题提供了解决方法。本部分还为采用ISO 11135-1：2007和ISO/TS 11135-2:2008标准的医疗器械制造商(包括使用外包灭菌工厂或外包灭菌操作的制造商)提供额外的应用指南。 YY/T 1302的本部分未包括可能对产品生物负载和灭菌过程有影响的各个因素。

Physical requirements and microbiological performance of ethylene oxide sterilization.Part 2:Microbiological aspects

YY/T 1263-2015 适用于干热灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择干热灭菌的材料适应性提供评价指南。本标准适用于采用干热灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to dry heat sterilization

YY/T 1267-2015 适用于环氧乙烷灭菌的医疗器械的材料评价

本标准规定了材料选择、设计和加工、材料试验。为选择环氧乙烷灭菌的材料适应性提供评价指南。 本标准适用于采用环氧乙烷灭菌的医疗器械的材料评价。

Evaluation of materials of medical device subject to ethylene oxide sterilization

ISO 80601-2-13:2011/Amd 1:2015 医用电气设备.第2-13部分:麻醉工作区的基本安全和基本性能的特定要求.修改件1

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation; Amendment 1

ISO 11418-5:2015 药剂容器及附件 第5部分:滴瓶组件

This part of ISO 11418 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations. This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1. Dropper assemblies are applicable to primary packs used in direct contact with the drug. NOTE The potency, purity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

Containers and accessories for pharmaceutical preparations - Part 5: Dropper assemblies

IEC 60601-2-52:2015 医疗电气设备.第2-52部分:医用病床基本安全及基本性能的详细要求

Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

EN 16442:2015 放置加工感热内窥镜的受控环境存储柜

This European Standard specifies the performance requirements applying to cabinets designed to store, or store and dry, thermolabile endoscopes following automated or manual processing. The storage cabinets are designed to provide a controlled environment for storage of endoscope(s), with or without channels, and when necessary drying of the endoscope(s), including the endoscope(s) channels. The controlled environment provided by the storage cabinet ensures that during storage there is no deterioration of the microbiological quality of the endoscope. The drying function is intended to supplement, if necessary, any drying provided as part of the automated or manual processing cycle. This European Standard specifies storage cabinets which flush the channels and the external surfaces of endoscopes with air. NOTE 1 The storage cabinet is one of the means that can allow the safe use of the endoscope for an extended period from the time of processing and improve availability for emergency use. NOTE 2 Thorough drying of an endoscope in a washer-disinfector can require a prolonged cycle time; the use of a storage cabinet including a drying function can enhance throughput of the endoscopes. The cabinet is not intended to provide any cleaning or disinfection function. This European Standard does not include the use of other chemicals for drying and maintaining the quality of endoscopes during storage

Controlled environment storage cabinet for processed thermolabile endoscopes

DIN EN 13060:2015 小型蒸汽灭菌器.德文版本EN 13060-2014

Small steam sterilizers; German version EN 13060:2014

NF S98-020:2015 小型蒸汽灭菌器

La présente Norme européenne spécifie les exigences de performance et les méthodes d'essai relatives aux petits stérilisateurs à la vapeur d'eau et aux cycles de stérilisation utilisés à des fins médicales ou pour des matériels susceptibles d'entrer en contact avec du sang ou des fluides corporels.

Small steam sterilizers

DIN EN ISO 5359:2015 麻醉剂和呼吸设备.医用气体的低压软管组件(ISO 5359-2014);德文版本EN ISO 5359-2014

Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO 5359:2014); German version EN ISO 5359:2014

JJG 913-2015 浮标式氧气吸入器检定规程

本规程适用于浮标式氧气吸入器(以下简称吸入器),包括氧气瓶用吸入器和墙式吸入器的首次检定、后续检定和使用中检查。

Buoy Type Oxygen Inhalers

DIN 32986:2015 触觉字母和标记. 盲文和浮雕式字母的表示和应用要求

Tactile lettering and labeling- Requirements on the presentation and application of Braille and raised lettering

GOST R 51265-2015 残疾人士康复用器具, 仪器和设备. 通用技术要求

Appliances, apparatus and equipment for rehabilitation of individuals with disabilities. General technical requirements

GOST R ISO 16021-2015 吸尿辅助器. 从使用者和护理人员的角度评估一次性成人尿失禁用吸尿辅助器的基本原则

Urine-absorbing aids. Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers