ISO/IEEE 11073-10419-2016

Health informatics - Personal health device communication - Part 10419: Device specialization — Insulin pump - First Edition

发布日期：2016-06-15  实施日期：2016-06-15

ISO 25539-3-2011

心血管植入物 血管内器械 第3部分:腔静脉过滤器

Cardiovascular implants -- Endovascular devices -- Part 3: Vena cava filters

适用范围：ISO 25539-3:2011 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials,...

发布日期：2011-12-01  实施日期：2011-12-01

EN ISO 14602-2011

Non-active surgical implants. Implants for osteosynthesis. Particular requirements

实施日期：2011-10-01

NF S95-204-2011

Hyperbaric chambers - Specific requirements for fire extinguishing systems - Performance, installation and testing.

ASTM F67-2013

外科植入物设备用非合金钛规格(UNS R50250，UNS R50400，UNS R50550，UNS R50700)

Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250,UNS R50400,UNS R50550,UNS R50700)

实施日期：2013-06-01

EN ISO 25539-3-2011

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters [Superseded: CEN EN 12006-3]

实施日期：2011-12-01

NF S99-014-1-2012

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements.

NF S95-117-3-2009

Inhalational anaesthesia systems - Part 3 : transfer and receiving systems of active anaesthetic gas scavenging systems.

ASTM F1713-2008(2013)

Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)

实施日期：2008-02-01

ASTM F2475-2011

医用装置包装材料生物兼容性评定指南

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

适用范围：The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these device...

实施日期：2011-04-01

NF S94-750-8-2009

Ophthalmic implants - Intraocular lenses - Part 8 : fundamental requirements.

DIN EN ISO 11663-2016

Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014); German version EN ISO 11663:2015

发布日期：2016-02-01  实施日期：2016-02-01

ASTM E1766-2015

Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices

ISO 14889-2013

Ophthalmic optics -- Spectacle lenses -- Fundamental requirements for uncut finished lenses

发布日期：2013-10-01  实施日期：2013-10-01

EN 455-4-2009

医疗专用手套 第4部分: 确定搁置寿命的要求和测试

Medical gloves for single use. Part 4:Requirements and testing for shelf life determination

实施日期：2009-07-01

ISO 16672-2015

Ophthalmic implants -- Ocular endotamponades

发布日期：2015-08-01  实施日期：2015-08-01

ISO 10993-3-2014

医疗器械的生物评定.第3部分:遗传毒性、致癌力和生殖毒性试验

Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

发布日期：2014-10-01  实施日期：2014-10-01

ISO 12891-2-2014

外科植入物的分析和收回.第2部分:收回的金属外科植入物的分析

Retrieval and analysis of surgical implants -- Part 2: Analysis of retrieved surgical implants

适用范围：ISO 12891-2:2014 specifies methods for the analysis of retrieved surgical implants. ISO 12891-2:2014 describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divide...

发布日期：2014-09-01  实施日期：2014-09-01

NF S93-123-4-2011

Infusion equipment for medical use - Part 4 : infusion sets for single use, gravity feed.

ASTM F116-2012

医用螺丝刀刀头标准规格

Standard Specification for Medical Screwdriver Bits

实施日期：2012-10-01