Where relevant, microbial challengetesting under testing conditions that, as far as possible, simulate patient use should be performed during development and documented in this section.
相应地,开发过程中应进行检测条件下的微生物挑战性试验(尽可能模拟病人使用情况)并写入本部分的文件。
2
It could be a challenge, but who said testing was easy?
但这是一项挑战,谁能说测试工作是简单的呢?
3
Several answers have been proposed to address this fundamental question, but none has been proven-and even adequately testing them has proven to be a formidable challenge.