EN ISO 5832-2-2012

Implants for surgery. Metallic materials. Part 2:Unalloyed titanium

实施日期：2012-05-01

DIN EN 45502-2-2-2008

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

实施日期：2009-09-01

ANSI/AAMI/ISO 15675-2009

Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters

实施日期：2009-01-01

EN ISO 16672-2003

Ophthalmic implants. Ocular endotamponades ISO 16672:2003

实施日期：2003-02-01

YY/T 0473-2004

外科植入物 聚交酯共聚物和共混物体外降解试验

Implants for surgery-Copolymers and blends based on polylactide-In vitro degradation testing

实施日期：2005-01-01

DIN ISO 5834-1-2007

Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form (ISO 5834-1:2005)

实施日期：2007-06-01

DIN ISO 5832-7-2001

外科植入物.金属材料.第7部分:可锻和冷成形的钴-铬-镍-钼铁合金

Implants for surgery; metallic materials; part 7: forgeable and cold-formed cobalt-chromium-nickel molybdenum-iron alloy

BS ISO 15675-2009

心血管植入物和人造器官 心肺旁路系统 动脉管血液过滤器

Kardiovaskul?re Implantate und künstliche Organe. Herz-Lungen-Bypass-Systeme. Arterielle Reihen-Blutfilter Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood ...

实施日期：2009-11-30

BS EN ISO 25539-2-2009

Cardiovascular implants. Endovascular devices. Vascular stents

发布日期：2010-02-28  实施日期：2010-02-28

BS DD ISO/TS 10993-20-2006

Biologische Beurteilung von Medizinprodukten. Prinzipien und Verfahren für die Immuntoxikologische Prüfung von Medizinprodukten Biological evaluation of medical devices. Part 20:Principles and methods for immunotoxicology testing of medical devices ?valuation biologique des dispositifs médicaux. Principes et méthodes relatifs aux essais d'immunotoxicologie des dispositifs médicaux

实施日期：2006-09-29

EN ISO 21534-2009

Non-active surgical implants. Joint replacement implants. Particular requirements

实施日期：2009-05-01

GB/T 18375.2-2001

假肢 下肢假肢的结构检验 第2部分：试验样品

Prosthetics--Structural testing of lower-limb prostheses--Part 2:Test samples

发布日期：2001-05-23  实施日期：2001-12-01

YY 0580-2005

心血管植入物及人工器官—心肺转流系统—动脉管路血液过滤器

Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial line blood filters

实施日期：2006-12-01

YY/T 0816-2010

外科植入物 缝合及其他外科用柔性金属丝

Implants for surgery-Malleable wires for use as sutures and other surgical applications

发布日期：2011-05-23  实施日期：2012-06-01

ANSI/AAMI/ISO 10993-7-2008

Biological evaluation of medical devices. Part 7:Ethylene oxide sterilization residuals includes errata:January 22,2010 [:Aami tir19 amd 1,aami tir19]

实施日期：2008-01-01

BS ISO 5838-1-2013

外科植入物 金属骨针和钢丝 通用要求

Implants for surgery. Metallic skeletal pins and wires. General requirements

发布日期：2013-03-31  实施日期：2013-03-31

DIN EN ISO 13356-2013

Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2008)

发布日期：2013-08-01  实施日期：2013-08-01

DIN EN 302195-1-2004

电磁兼容和无线电光谱物质(ERM) 9-315 kHz频率范围内配极小功率和附件的活性医用植入物用无线电设备 第1部分:技术参灵敏和试验方法

Electromagnetic compatibility and Radio spectrum Matters (ERM) - Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories - Part 1: ...

ASTM F2581-2007

外科植入物用锻制氮增强11锰-17铬-3钼低镍不锈钢合金棒材和线材规格(UNS S29225)

Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium- 3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)

实施日期：2007-01-01

YY/T 0340-2009

外科植入物基本原则

Implats for surgery Fundamental principles

发布日期：2009-12-30  实施日期：2011-06-01