C47 公共医疗设备 标准查询与下载

JIS T 7101 ERRATUM 1:2017 勘误

ERRATUM

ISO 11418-3:2016/Amd 1:2017 药品配制用容器及附件. 第3部分: 固体和液体药剂用螺口玻璃瓶.修改件1

Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms; Amendment 1

ISO 11418-2:2016/Amd 1:2017 药品配制用容器及附件. 第2部分: 糖浆用螺口玻璃瓶.修改件1

Containers and accessories for pharmaceutical preparations - Part 2: Screw-neck glass bottles for syrups; Amendment 1

DIN 13152:2017 包扎材料.急救袋

This document specifies sterile surgical sheets, especially used in first-aid.

Surgical dressings - Surgical sheets

ISO 17664:2017 保健产品的处理.医疗器械制造商为医疗器械提供的信息

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices

DIN EN 60601-2-20:2017 医用电气设备.第2-20部分:婴儿传送培育器的基本安全和主要性能专门要求(IEC 60601-2-20-2009+Cor.-2012+Cor.-2013+A1-2016);德文版本EN 60601-2-20-2009+A11-2011+A1-2016

This Standard specifies the basic safety and essential performance of infant transport incubator equipment. This particular requirements amend und supplement DIN EN 60601-1 (VDE 0750-1)

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009 + Cor.:2012 + Cor.:2013 + A1:2016); German version EN 60601-2-20:2009 + A11:2011 + A1:2016

DIN EN 60601-2-21:2017 医疗电气设备.第2-21部分:婴儿辐射保温箱基本安全及基本性能的详细要求(IEC 60601-2-21-2009+Cor.-2013+A1-2016);德文版本EN 60601-2-21-2009+A11-2011+A1-2016

This consolidated standard of DIN EN 60601-2-21 (VDE 0750-2-21) is the alignment of the amendment of DIN EN 60601-1:2013 and the related collateral standards of DIN EN 60601-1-x series. Additional technical changes may be also included for the alignment of IEC 60601-1-2(electromagnetic phenomena), IEC 60601-1-11(home use) and IEC 60601-1-12 (emergency use).

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009 + Cor.:2013 + A1:2016); German version EN 60601-2-21:2009 + A11:2011 + A1:2016

DIN EN 60601-2-19:2017 医疗电气设备.第2-19部分:婴儿保育箱的基本安全及基本性能用详细要求(IEC 60601-2-19-2009+Cor.-2012+A1-2016);德文版本EN 60601-2-19-2009+A11-2011+A1-2016

This particular standard specifies safety requirements for infant incubators but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009 + Cor.:2012 + A1:2016); German version EN 60601-2-19:2009 + A11:2011 + A1:2016

ISO 15621:2017 尿液和/或粪便的吸收性失禁用品. 通用评估指南

This document gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.

Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation

YY/T 1544-2017 环氧乙烷灭菌安全性和有效性的基础保障要求

Basic guarantee requirements for the safety and effectiveness of ethylene oxide sterilization

YY/T 1403-2017 环氧乙烷分包灭菌的要求

Requirements for ethylene oxide subcontract sterilization

JIS T 9263:2017 助行器具. 助行手推车

Assistive products for walking -- Walking trolleys

ISO 11138-3:2017 医疗保健产品消毒. 生物指标. 第3部分: 湿热灭菌过程生物指标

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the NOTE 2 National or regional regulations can provide requirements for work place safety.

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

DIN 58948-7:2017 消毒.低温消毒器.第7部分:环氧乙烷消毒器及其电源的安装和操作要求

Sterilization - Low temperature sterilizers - Part 7: Requirements for the installation and operation of ethylene oxide sterilizers and their supply sources

DB44/T 1924-2016 衣柜用电子臭氧消毒机

本标准规定了衣柜用电子臭氧消毒机（以下简称：消毒机）的要求、试验方法、检验规则以及标志、包装、运输和贮存。 本标准适用于带有杀菌功能的、以电子臭氧为消毒方式的衣柜消毒机。

Electronic ozone disinfection machine for wardrobe

DIN 13073:2016 营救设备.救护车中起落架和担架紧固用维护设备的尺寸

Rescue systems - Dimensions for maintain systems for fastening of undercarriage and stretcher in ambulances

ISO 11418-1:2016 药品配制用容器及附件. 第1部分: 点滴用玻璃瓶

Containers and accessories for pharmaceutical preparations - Part 1: Drop-dispensing glass bottles

ISO 19054:2005/Amd 1:2016 医疗设备辅助用轨道系统; 修改件1

Rail systems for supporting medical equipment; Amendment 1

ISO 11418-2:2016 药品配制用容器及附件. 第2部分: 糖浆用螺口玻璃瓶

Containers and accessories for pharmaceutical preparations - Part 2: Screw-neck glass bottles for syrups

ISO 11418-3:2016 药品配制用容器及附件. 第3部分: 固体和液体药剂用螺口玻璃瓶

Containers and accessories for pharmaceutical preparations - Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms