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美国国会于１９９６年通过了涉及食品、药品和化妆品法令的医疗器械修正案。该新的法律允许ＦＤＡ制定法规性标准来控制这些器械可能对职业安全卫生及病人产生的危害。ＦＤＡ不久就认识到，制定强制性标准不是解决此问题的有效方法。在人力、物力有限的各组织内，有太多的...
The U.S. Congress passed the Medical Device Amendments involving the Food, Drugs and Cosmetics Act in 1996. The new law allows the FDA to develop regulatory standards to control the hazards these devices may cause to occupational safety and health and patients. The FDA soon realized that the establishment of mandatory standards is not an effective solution to this problem. In organizations with limited manpower and material resources, there are too many ...