人工晶状体行业标准解析

A summary of the standards for intraocular lenses

目的深入了解人工晶状体标准对保证临床应用安全有效的作用。方法通过对标准条款的引申介绍了具体条款对安全有效性控制的作用和可能产生的危害,加深对标准条款意义的理解。结果达到对标准各条款在临床安全有效性控制方面具有重要性的认同。结论目前人工晶状体行业标准基本能够保证人工晶状体产品植入的安全有效性。

Objective To understand the role that the standards for intraocular lenses has in ensuring clinical safety and effectiveness. Information related to the standards for IOLs was reviewed and analyzed in terms of its effectiveness and safety in clinical use, as well as the potential hazards.Results The information is adequate and the standards for IOLs are adequately understood. Conclusion The standards for IOLs are adequate for current clinical use in satisfying expected effectiveness and safety.