BS EN ISO 11979-8-2015

Ophthalmic implants - Intraocular lenses Part 8: Fundamental requirements

发布日期：2015-02-28  实施日期：2015-02-28

DIN EN ISO 14155-2012

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 (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011

DIN EN ISO 10993-4-2009

医疗器械的生物学评价 第4部分:与血液相互作用的试验选择

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

适用范围：This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.It describesa) a classification of medical and dental devices that are intended for u...

实施日期：2009-10-01

BS ISO 12891-2-2014

外科植入物的检索和分析 检索分析外科植入物

Retrieval and analysis of surgical implants. Analysis of retrieved surgical implants

发布日期：2014-09-30  实施日期：2014-09-30

BS PD ISO/TR 10993-33-2015

Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

发布日期：2015-03-31  实施日期：2015-03-31

BS ISO 14242-1-2014

外科植入物 髋关节假肢的总磨损 磨损的负荷和位移参数 试验用试验机和相应环境条件

Implants for surgery. Wear of total hip-joint prostheses. Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

发布日期：2014-10-31  实施日期：2014-10-31

DIN EN ISO 5840-3-2013

心血管植入物 人工心脏瓣膜 第3部分：用经导管技术植入心脏瓣膜替代物

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013); German version EN ISO 5840-3:2013

发布日期：2013-06-01  实施日期：2013-06-01

ISO 13017 AMD 1-2015

Dentistry - Magnetic attachments AMENDMENT 1 - First Edition

发布日期：2015-11-15  实施日期：2015-11-15

ISO 14708-1-2014

外科植入物.活性可植入医疗设备.第1部分:安全、标记和由制造商提供的信息的一般要求

Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

适用范围：ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in ISO 14708 are type tests and are to be carried out on sample...

发布日期：2014-08-01  实施日期：2014-08-01

ISO 14242-2-2016

Implants for surgery -- Wear of total hip-joint prostheses -- Part 2: Methods of measurement

发布日期：2016-09-01  实施日期：2016-09-01

BS ISO 14243-3-2014

外科植入物 总的髋关节假肢的磨损 位移控制和相应试验环境条件磨损试验机的装载和位移参数

Implants for surgery. Wear of total knee-joint prostheses. Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test

发布日期：2014-10-31  实施日期：2014-10-31

BS EN 16372-2014

Aesthetic surgery services

发布日期：2015-01-31  实施日期：2015-01-31

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：2016-08-01  实施日期：2016-08-01

NF S94-080-3-1997

外科植入物.TA6V钛合金.第3部分:铸造的半成品

Surgical implants. Titanium alloy Ti 6 AI 4V. Part 3 : semi-finished products obtained by casting.

实施日期：1997-01-01

BS EN ISO 21536-2009+A1-2014

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - AMD: April 30, 2014

发布日期：2009-10-31  实施日期：2009-10-31

NF S94-064-2-2012

Implants for surgery - Ceramic materials - Part 2 : composite materials based on a high-purity alumina matrix with zirconia reinforcement.

NF S94-171-1992

Implants for surgery. Partial and total hip joint prostheses. Part 6 : determination of endurance properties of the head and neck region of stemmed femoral components.

DIN ISO 5832-4-2015

Implants for surgery - Metallic materials - Part 4- Cobalt-chromium-molybdenum casting alloy (ISO 5832-4-2014)

发布日期：2015-12-01  实施日期：2015-12-01

BS ISO 18242-2016

Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps

发布日期：2016-08-31  实施日期：2016-08-31

BS ISO 7206-12-2016

Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells

发布日期：2016-09-30  实施日期：2016-09-30