序号 名 称 品 名 举 例 固体激光手术设备（Nd:YAG、Ho:YAG、Er:YAG、红宝石、蓝宝石、翠绿宝石）、气体激光手术设备（CO2、金蒸汽、准分子、氩离子）、3B类和4类半导体激光治疗仪、氮分子激光治疗仪、眼科激光光凝机、眼晶体激光乳化设备、激光血管焊接机 激光眼科诊断仪、眼科激光扫描仪、 管理类别 1 激光手术和治疗设备 Ⅲ Ⅲ 2 激光诊断仪器 激光肿瘤光谱诊断装置、激光荧光肿瘤诊断仪、2类激光诊断仪、激光血液分析仪、激光检测仪、激光多普勒血流计 He-Ne激光血管内照射治疗仪、其他激光源内照射治疗仪 激光显微手术器、LASIK用角膜板层刀 氦氖激光治疗机（包括具有扩束装置的照射仪）、氦镉激光治疗机、3A类半导体激光治疗机、激光针灸治疗仪 Ⅱ 3 介入式激光诊治仪器 Ⅲ 4 激光手术器械 Ⅲ 5 弱激光体外治疗仪器 Ⅱ 6 注 干色激光打印机 按GB7247激光辐射防护安全要求1类、2类、3A类激光为弱激光 3B、4类为强激光 I

17

2. 植入性医疗器械的历史和现状

Early Civilizations implanted devices and biomaterials

2500+ yrs. ago - Egyptians, Romans, Chinese and Aztecs

– Glass eyes and wooden teeth have also been in common use through much of recorded history

Au, wood, ivory and gems used t o replace teeth and fill bone defects – 1759 – records of wooden peg and twisted thread used to unite edges of a brachial artery

1860 - Lister – aseptic techniques made practical applications of biomaterials possible

– “Catgut and silk” sutures used (pig and cow submucosa-based sutures are still used for vaginal histerectomy- high extensibility and rapid absorption) – 1908 – aluminium plates were used to cover skull defects – Early 1900s – use of natural rubbers and “celluloid” – PTFE (Teflon) began use for cardiac valves and vascular grafts

18

– 1939 – PE introduced for plastic surgery

– Silicone elastomers began use during world war 2 – 1947 – PMMA bone cement first use

– 1958 – PVC introduced for heart assist pumps

Perhaps 40-50 years of formal clinical history

Originally driven by resourceful and entrepreneurial “hero surgeons”

50s – “Biocompatible” polymers developed

60s, 70s – Urgency to address immediate patient needs and get devices into clinical use asap

Rigorous long-term clinical testing of new biomaterials not performed

Some ignorance as to the importance of device component processing route (incl. method of sterilisation) on the long-term durability performance of the implant

Did you know?

In World War II, warplane pilots who were injured by fragments of aircraft canopy (PMMA plastic) did not suffer adverse chronic reactions

Acrylate-based chemistry is now used extensively in

19

biomaterials for contact lenses, bone cement and drug delivery

http://www.medtronic.com 80s – “Cleaned up” commodity materials used extensively – Lycra, Teflon, Polythene, GoreTex, Silastic, Dacron etc etc – Growing Biomaterials research community

“Inert support” mindset in use, emphasis on integrity of implant and

minimisation of corrosion/ degradation

“Biomaterials Crisis” – Early 90s – Increased litigation $$$$$$$$$

– Large companies such as Dow and Du-Pont withdraw medical-grade materials

– Tightening of regulations – Food and Drug Administration (FDA)

1987 definition of a biomaterial (Williams)

– “A biomaterial is a nonviable material used in a medical device, intended to interact with biological systems”

1994 definition of a biomaterial (Greco) – the word “nonviable” is removed

20