浙江省医疗器械检验所（国家食品药品监督管理局杭州医疗器械质量监督检验中心）（简称SHMT）成立于1989 年，专业从事医疗器械质量检测工作。SHMT依据GB/T15481:2000(idt ISO/IEC 17025:1999)建立了完整的质量管理体系，已经通过了国家计量认证、中国实验室国家认可委员会认可、国家食品药品监督管理局对医疗器械检测机构的资格认可，及国际权威机构德国TUV莱茵公司的认可。SHMT是国家级医疗器械检测中心之一，也是浙江省食品药品监督管理局直属技术检验机构。

    SHMT拥有400多台（套）进口和国产的医疗器械检测仪器和环境试验设备。建立了医用电气设备安全实验室，具备了对医用电气设备全项安全的检测能力。还建有十万级无菌检验室、阳性对照室及百级的限度试验室，以及十万级的动物实验室。可进行医疗器械产品的无菌、致敏、皮肤刺激、细胞毒性等生物学评价试验。SHMT技术力量雄厚，检测设备精良，特别是医用光学、激光检验实验室在国内处领先地位。

   SHMT主要承担国家和浙江省对医疗器械产品的监督检验、产品认证检验、注册检验及企业各种委托检验工作。还承担与医疗器械相关的检测技术、标准和法律法规的培训服务。

   SHMT是国家标准化管理委员会和国家食品药品监督管理局批准的医疗器械标准化技术归口单位，负责全国医用光学和仪器标准化分技委秘书处工作，对医用光学、医用激光产品的国家标准、行业标准进行制、修订及归口管理，是国际标准化组织ISO/TC172/SC7、SC5部分的国内归口单位。同时，浙江省医疗器械专业标准化技术委员会也设立在SHMT 内。

   SHMT以“检测科学、公正可靠；服务优良、尽职高效；求实创新、争创一流”为宗旨，不断增强顾客的满意度，使SHMT成为一个有特色、有创新、与国际接轨的一流实验室。
 

Introduction

       Zhejiang institute for the control of Medical Device (State Food and Drug Administration Medical Device Supervising and Testing Center of Hangzhou) (SHMT for short) is founded in 1989, which is in engages in testing of medial devices. In accordance with GB/T15481:2000(idt ISO/IEC17025:1999), SHMT establishes   comprehensive quality control system, and respectively accredited by China National Accreditation Board for Laboratories(CNAL), Metrology Accreditation(MA), State Food and Drug Administration (Medical Device) and German TUV Inc., SHMT is one of the statelevel quality  Supervision and inspection Centers of the country, and she is the technical supporting unit directly affiliated to Zhejiang Food and Drug Administration.
       SHMT boasts of more than 400 sets of imported and homemade testing instruments of various types as well as equipment for environmental test. And SHMT builds up safety laboratory for medical electrical devices, possesses the testing capability for all items of safety test for medical electrical devices. Furthermore, SHMT has class 10,000 and class 100,000 lustration test lab of sterilization, limit and positive control, and class 100,000 level animal lab for rabbits, guinea pigs and mice. Therefore many medical devices tests can be conducted in SHMT, such as, sterilization, sensitization, irritation, cytotoxicity, protect solution anticorrosion, etc. Based on strong technical capability and high quality equipment, tests for various types of medical products are effectively fulfilled and the optical and laser laboratories take the lead in our country at the present time.
       SHMT engages in supervision testing, compulsory accreditation testing and registration testing as well as different types of tests entrusted by enterprises. In addition, SHMT takes in hand the teaching service about the test technology, standards and rule of law relevant to the medical devices.
       SHMT is the standardization technical attributive body for medical devices approved by State Standardize Committee and State Food and Drug Administration, act as the Technical Committee Secretariat of state medical optics and instrument standardization, and domestic responsible department of part of international standardization organizations (ISO/TC172/SC7, SC5), SHMT is responsible for the national standards and professional standards of medical optics and medical laser products. In addition, SHMT also acts as Zhejiang Technical Committee Secretariat of   medical device.
      Aiming at the tenet of “by scientific testing, impartial and credible data; excellent service, responsible and high efficient service; factualistic and innovative attitude, finally let SHMT be the best laboratory”. SHMT fulfilled the clients as best as possible and try to keep paces with time and pursue consistent exploration and innovation.