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Reviewer Guidance for a Premarket Notification Submission for Blood Establishment211 Computer Software

机译：审查员关于血液建立的上市前通知提交指南211计算机软件

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This guidance applies to software products intended for use in the manufacture of211u001eblood and blood components or for the maintenance of data that blood 211u001eestablishment personnel use in making decisions regarding the suitability of 211u001edonors and the release of blood or blood components for transfusion or further 211u001emanufacture.

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年度 1997
页码 1-8
总页数 8
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Blood; Software; Guidelines; Medical devices; Blood donors; Blood transfusion; US211 FDA; Manufacturing;

机译：血液;软件;指南;医疗器械;献血者;输血; Us211 FDa;制造业;

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Reviewer Guidance for a Premarket Notification Submission for Blood Establishment211 Computer Software

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