DIN EN ISO 5840-2-2015

Cardiovascular implants - Cardiac valve prostheses - Part 2- Surgically implanted heart valve substitutes (ISO 5840-2-2015); German version EN ISO 5840-2-2015

发布日期：2015-12-01  实施日期：2015-12-01

EN ISO 10993-15-2009

Biological evaluation of medical devices. Part 15:Identification and quantification of degradation products from metals and alloys

实施日期：2009-06-01

NF Z84-839-2-2011

Electromagnetic compatibility and Radio spectrum Matters (ERM) - Short Range Devices (SRD) - Ultra Low Power Active Medical Implants (ULP-AMI) and Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MH

DIN EN ISO 11979-8-2011

眼科植入物 人工晶体 第8部分：基础要求

Ophthalmic implants. Intraocular lenses. Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2009 + A1:2011

EN ISO 11953-2010

Dentistry. Implants. Clinical performance of hand torque instruments

实施日期：2010-06-01

ISO 12417-1-2015

Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products -- Part 1: General requirements

发布日期：2015-10-01  实施日期：2015-10-01

ISO 18241-2016

Cardiovascular implants and extracorporeal systems -- Cardiopulmonary bypass systems -- Venous bubble traps

发布日期：2016-08-01  实施日期：2016-08-01

BS ISO 5832-11-2014

外科植入物 金属材料 锻造钛6铝7铌合金?

Implants for surgery. Metallic materials. Wrought titanium 6-aluminium 7-niobium alloy

发布日期：2014-09-30  实施日期：2014-09-30

DIN EN ISO 22794-2009

牙科 口腔和上颌面外科中骨填补物与增加物用可植入材料 技术文件的内容

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

适用范围：This International Standard applies to implantable materials, whether resorbable or non-resorbable, used asdental devices for filling and augmenting bones in oral and maxillofacial surgery. Products th...

实施日期：2009-11-01

NF S94-750-3-2013

Ophthalmic implants - Intraocular lenses - Part 3 : mechanical properties and test methods.

NF C99-130-2-1-2011

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1 : specific assessment for workers with cardiac pacemakers.

DIN EN ISO 10993-5-2009

医疗器械的生物学评价 第5部分:体外细胞毒性试验

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

适用范围：This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.These methods specify the incubation of cultured cells in contact with a device and/or extracts of a...

实施日期：2009-10-01

BS ISO 13779-6-2015

Implants for surgery. Hydroxyapatite. Powders

发布日期：2015-01-31  实施日期：2015-01-31

EN ISO 16443-2014

Dentistry - Vocabulary for dental implants systems and related procedure

实施日期：2014-07-01

DIN EN ISO 11979-8-2015

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2015

发布日期：2015-09-01  实施日期：2015-09-01

EN ISO 11979-7-2014

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations

实施日期：2014-09-01

DIN EN 50527-1-2011

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Part 1:General; German version EN 50527-1:2010

ISO 27185-2012

心脏节律管理设备 与心脏节律管理设备标签和提供的信息一起使用的符号 一般要求

Cardiac rhythm management devices -- Symbols to be used with cardiac rhythm management device labels, and information to be supplied -- General requirements

适用范围：ISO 27185:2011 specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. A listing is given of existing symbols tha...

发布日期：2012-02-01  实施日期：2012-02-01

BS ISO 5841-2-2014

外科植入物 心脏起搏器 对使用脉冲发生器或导线的人群的临床使用报告?

Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads

发布日期：2014-08-31  实施日期：2014-08-31

ISO/TS 13498-2011

牙科 齿骨内植入物系统的种植体/连接件关节的抗扭试验

Dentistry. Torsion test of implant body/connecting part joints of endosseous dental implant systems

发布日期：2011-07-21  实施日期：2011-07-21