DIN EN ISO 5840-2-2016

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)

发布日期：2016-05-01  实施日期：2016-05-01

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

EN ISO 16443-2014

Dentistry - Vocabulary for dental implants systems and related procedure

实施日期：2014-07-01

EN ISO 11979-7-2014

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations

实施日期：2014-09-01

ISO 5832-4-2014

外科植入物.金属材料.第4部分:钴铬钼铸造合金

Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy

适用范围：ISO 5832-4:2014 specifies the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting alloy for use in the manufacture of surgical implants.

发布日期：2014-09-01  实施日期：2014-09-01

ISO 16671-2015

Ophthalmic implants -- Irrigating solutions for ophthalmic surgery

发布日期：2015-08-01  实施日期：2015-08-01

DIN ISO 5832-11-2015

Implants for surgery - Metallic materials - Part 11- Wrought titanium 6-aluminium 7-niobium alloy (ISO 5832-11-2014)

发布日期：2015-12-01  实施日期：2015-12-01

BS ISO 15676-2016

Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

发布日期：2016-08-31  实施日期：2016-08-31

DIN EN ISO 25539-3-2012

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 (ISO 25539-3:2011); German version EN ISO 25539-3:2011

ISO 11979-7-2014

眼科植入物.眼内晶状体透镜.第7部分:门诊调查

Ophthalmic implants -- Intraocular lenses -- Part 7: Clinical investigations

适用范围：ISO 11979-7:2014 specifies particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).

发布日期：2014-09-01  实施日期：2014-09-01

ISO 17853-2011

植入物材料的磨损 聚合物和金属材料磨屑 分离和表征

Wear of implant materials -- Polymer and metal wear particles -- Isolation and characterization

适用范围：ISO 17853:2011 specifies methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate ...

发布日期：2011-03-01  实施日期：2011-03-01

ISO 14155-2011

以人为对象的医疗器械临床调查 良好的临床规程

Clinical investigation of medical devices for human subjects. Good clinical practice

适用范围：This International Standard addresses good clinical practice for the design, conduct, recording and reportingof clinical investigations carried out in human subjects to assess the safety or performance...

发布日期：2011-01-21  实施日期：2011-01-21

ISO 5840-1-2015

Cardiovascular implants -- Cardiac valve prostheses -- Part 1: General requirements

发布日期：2015-09-01  实施日期：2015-09-01

DIN EN ISO 12836-2015

Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2015); German version EN ISO 12836:2015

发布日期：2015-11-01  实施日期：2015-11-01

BS ISO 7206-13-2016

Implants for surgery - Partial and total hip joint prostheses Part 13: Determination of resistance to torque of head fixation of stemmed femoral components

发布日期：2016-07-31  实施日期：2016-07-31

DIN 96042-2006

Medical instruments - Packaging - Technical specification

实施日期：2006-12-01

NF S94-166-6-2014

Implants for surgery - Partial and total hip joint prostheses - Part 6 : endurance properties testing and performance requirements of neck region of stemmed femoral components

BS ISO 12891-1-2015

Retrieval and analysis of surgical implants. Retrieval and handling

发布日期：2015-06-30  实施日期：2015-06-30

NF S90-361-1990

外科医疗器材.股骨上端用有粗糙表面的不锈钢钉板

Medico-surgical equipment. Rough-surfaced stainless steel nail plates for the upper end of the thighbone. Materials and dimensions.

实施日期：1990-03-01

ISO 11979-2-2014

眼科植入.眼内镜片.第2部分:光学特性和试验方法

Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods

适用范围：ISO 11979-2:2014 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative ...

发布日期：2014-08-01  实施日期：2014-08-01