Dennis J E
Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD, USA.
J Laser Appl. 1997 Dec;9(6):301-5. doi: 10.2351/1.4745474.
Federal law requires that all laser products that are imported into or introduced into commerce in the United States comply with the performance standard published in the Code of Federal Regulations (CRF), Title 21, Parts 1040.10 and 1040.11, administered by the Center for Devices and Radiological Health (CDRH), US Food and Drug Administration. Although it contains somewhat different requirements for hazard classification, engineering controls and labeling, the ANSI Z136.1 standard defers to the CDRH standard. The CDRH standard became effective in August, 1976 and was amended, in 1978 and also in 1985. In the early 1990s, US experts met to formulate an approach to bring the requirements of the CDRH standard and those of the International Electrotechnical Commission (IEC) standard, IEC 825, into closer agreement in order to lower barriers to international trade and to remove any excessive compliance burdens on manufacturers. In 1993, the CDRH published, formally in the Federal Register and informally, a Notice of Intent to amend the CDRH standard. Responses to those notices have now been analyzed and informal draft amendments were distributed in 1996. This draft is now being prepared for formal issuance as a Notice of Proposed Rulemaking. Meanwhile, the IEC standard was amended in 1993 and republished as IEC 825-1; these amendments created considerable controversy since they resulted in over classification of the hazard of many products, especially light emitting diodes (LEDs) that have a large divergence and increased source dimensions. Additional amendments are now being developed to correct this problem. The CDRH has carefully monitored developments in the IEC and actively participated in its proceedings as a guide in developing its own proposal. This paper describes the major changes that are being proposed for the CDRH standard and presents some rationale for the major changes. The more significant changes include expansion of applicability to include LEDs, reduced emission durations for classification, revised measurement for hazard classification, reduced performance requirements for lower power visible radiation products, and revised requirements for medical products.
联邦法律要求，所有进口到美国或在美国投入商业使用的激光产品必须符合由美国食品药品监督管理局设备与放射卫生中心（CDRH）管理的《联邦法规汇编》（CRF）第21篇第1040.10和1040.11部分中公布的性能标准。尽管美国国家标准学会（ANSI）Z136.1标准在危险分类、工程控制和标签方面有一些不同的要求，但它遵从CDRH标准。CDRH标准于1976年8月生效，并在1978年和1985年进行了修订。20世纪90年代初，美国专家会面商讨制定一种方法，以使CDRH标准的要求与国际电工委员会（IEC）标准IEC 825的要求更加一致，从而降低国际贸易壁垒，并消除制造商过多的合规负担。1993年，CDRH在《联邦公报》上正式发布并非正式地发布了一份修订CDRH标准的意向通知。现已对这些通知的回复进行了分析，并于1996年分发了非正式的修订草案。该草案目前正准备作为拟议规则制定通知正式发布。与此同时，IEC标准于1993年进行了修订，并重新发布为IEC 825-1；这些修订引发了相当大的争议，因为它们导致许多产品的危险分类过度，尤其是那些发散角大且光源尺寸增加的发光二极管（LED）。目前正在制定额外的修订以纠正这一问题。CDRH仔细监测了IEC的进展情况，并积极参与其程序，以此作为制定自身提案的指导。本文描述了CDRH标准拟议的主要变化，并阐述了主要变化的一些理由。更显著的变化包括扩大适用范围以涵盖LED、缩短分类的发射持续时间、修订危险分类的测量方法、降低低功率可见光辐射产品的性能要求以及修订医疗产品的要求。
