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\u7f8e\u56fdFDA\u201cGeneral Principles of Software Validation; Final Guidance for Industry and FDA Staff\u201d\u548cIEC 60601-1-4\u201cMedical electrical equipment-Part 1-4: General requirements for safety-collateral standard: Programmable electrical medical systems\u201d\u90fd\u662f\u4ece\u8fd9\u4e2a\u89d2\u5ea6\u6765\u8ba8\u8bba\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u7ba1\u7406\u7684\u3002<\/p>\n\n\n\n
\u4e09 \u8f6f\u4ef6\u7ba1\u7406\u548c\u6807\u51c6 <\/p>\n\n\n\n
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2.\u6d4b\u8bd5\u8ba1\u5212\u9636\u6bb5\uff1a\u6d4b\u8bd5\u7ec4\u957f\u5c31\u8981\u6839\u636eSOW\u5f00\u59cb\u7f16\u5199\u300a\u6d4b\u8bd5\u8ba1\u5212\u300b\uff0c\u5176\u4e2d\u5305\u62ec\u4eba\u5458\uff0c\u8f6f\u4ef6\u786c\u4ef6\u8d44\u6e90\uff0c\u6d4b\u8bd5\u70b9\uff0c\u96c6\u6210\u987a\u5e8f\uff0c\u8fdb\u5ea6\u5b89\u6392\u548c\u98ce\u9669\u8bc6\u522b\u7b49\u5185\u5bb9\u3002<\/p>\n\n\n\n
3.\u6d4b\u8bd5\u8bbe\u8ba1\u9636\u6bb5\uff1a\u6d4b\u8bd5\u65b9\u6848\u4e00\u822c\u7531\u5bf9\u9700\u6c42\u5f88\u719f\u7684\u9ad8\u8d44\u6df1\u7684\u6d4b\u8bd5\u5de5\u7a0b\u5e08\u8bbe\u8ba1\uff0c\u6d4b\u8bd5\u65b9\u6848\u8981\u6c42\u6839\u636e\u300aSRS\u300b\u4e0a\u7684\u6bcf\u4e2a\u9700\u6c42\u70b9\u8bbe\u8ba1\u51fa\u5305\u62ec\u9700\u6c42\u70b9\u7b80\u4ecb\uff0c\u6d4b\u8bd5\u601d\u8def\u548c\u8be6\u7ec6\u6d4b\u8bd5\u65b9\u6cd5\u4e09\u90e8\u5206\u7684\u65b9\u6848\u3002<\/p>\n\n\n\n
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4.\u6d4b\u8bd5\u65b9\u6848\u9636\u6bb5\uff1a\u4e3b\u8981\u662f\u5bf9\u6d4b\u8bd5\u7528\u4f8b\u548c\u89c4\u7a0b\u7684\u8bbe\u8ba1\u3002<\/p>\n\n\n\n
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\u5176\u4e2d\u64cd\u4f5c\u6b65\u9aa4\u548c\u9884\u671f\u7ed3\u679c\u9700\u8981\u7f16\u5199\u8be6\u7ec6\u548c\u660e\u786e\u3002<\/p>\n\n\n\n
\u6d4b\u8bd5\u7528\u4f8b\u5e94\u8be5\u8986\u76d6\u6d4b\u8bd5\u65b9\u6848\uff0c\u800c\u6d4b\u8bd5\u65b9\u6848\u53c8\u8986\u76d6\u4e86\u6d4b\u8bd5\u9700\u6c42\u70b9\uff0c\u8fd9\u6837\u624d\u80fd\u4fdd\u8bc1\u5ba2\u6237\u9700\u6c42\u4e0d\u9057\u6f0f\u3002<\/p>\n\n\n\n
\u540c\u6837\uff0c\u6d4b\u8bd5\u7528\u4f8b\u4e5f\u9700\u8981\u8bc4\u5ba1\u3002<\/p>\n\n\n\n
5.\u6d4b\u8bd5\u6267\u884c\u9636\u6bb5\uff1a\u6267\u884c\u6d4b\u8bd5\u7528\u4f8b\uff0c\u53ca\u65f6\u63d0\u4ea4\u6709\u8d28\u91cf\u7684Bug\u548c\u6d4b\u8bd5\u65e5\u62a5\uff0c\u6d4b\u8bd5\u62a5\u544a\u7b49\u76f8\u5173\u6587\u6863\u3002<\/p>\n\n\n\n
…<\/p>\n\n\n\n
\u4e00\u822c\u6d4b\u8bd5\u6d41\u7a0b\uff1a<\/p>\n\n\n\n
1.\u9700\u6c42\u5206\u6790\u9636\u6bb5<\/strong>\uff1a\u53ea\u8981\u5c31\u662f\u5bf9\u4e1a\u52a1\u7684\u5b66\u4e60\uff0c\u5206\u6790\u9700\u6c42\u70b9\u3002<\/p>\n\n\n\n 2.\u6d4b\u8bd5\u8ba1\u5212\u9636\u6bb5<\/strong>\uff1a\u6d4b\u8bd5\u7ec4\u957f\u5c31\u8981\u6839\u636eSOW\u5f00\u59cb\u7f16\u5199\u300a\u6d4b\u8bd5\u8ba1\u5212\u300b\uff0c\u5176\u4e2d\u5305\u62ec\u4eba\u5458\uff0c\u8f6f\u4ef6\u786c\u4ef6\u8d44\u6e90\uff0c\u6d4b\u8bd5\u70b9\uff0c\u96c6\u6210\u987a\u5e8f\uff0c\u8fdb\u5ea6\u5b89\u6392\u548c\u98ce\u9669\u8bc6\u522b\u7b49\u5185\u5bb9\u3002<\/p>\n\n\n\n 3.\u6d4b\u8bd5\u8bbe\u8ba1\u9636\u6bb5<\/strong>\uff1a\u6d4b\u8bd5\u65b9\u6848\u4e00\u822c\u7531\u5bf9\u9700\u6c42\u5f88\u719f\u7684\u9ad8\u8d44\u6df1\u7684\u6d4b\u8bd5\u5de5\u7a0b\u5e08\u8bbe\u8ba1\uff0c\u6d4b\u8bd5\u65b9\u6848\u8981\u6c42\u6839\u636e\u300aSRS\u300b\u4e0a\u7684\u6bcf\u4e2a\u9700\u6c42\u70b9\u8bbe\u8ba1\u51fa\u5305\u62ec\u9700\u6c42\u70b9\u7b80\u4ecb\uff0c\u6d4b\u8bd5\u601d\u8def\u548c\u8be6\u7ec6\u6d4b\u8bd5\u65b9\u6cd5\u4e09\u90e8\u5206\u7684\u65b9\u6848\u3002<\/p>\n\n\n\n \u300a\u6d4b\u8bd5\u65b9\u6848\u300b\u7f16\u5199\u5b8c\u6210\u540e\u4e5f\u9700\u8981\u8fdb\u884c\u8bc4\u5ba1\u3002<\/p>\n\n\n\n 4.\u6d4b\u8bd5\u65b9\u6848\u9636\u6bb5<\/strong>\uff1a\u4e3b\u8981\u662f\u5bf9\u6d4b\u8bd5\u7528\u4f8b\u548c\u89c4\u7a0b\u7684\u8bbe\u8ba1\u3002<\/p>\n\n\n\n \u6d4b\u8bd5\u7528\u4f8b\u662f\u6839\u636e\u300a\u6d4b\u8bd5\u65b9\u6848\u300b\u6765\u7f16\u5199\u7684\uff0c\u901a\u8fc7\u300a\u6d4b\u8bd5\u65b9\u6848\u300b\u9636\u6bb5\uff0c\u6d4b\u8bd5\u4eba\u5458\u5bf9\u6574\u4e2a\u7cfb\u7edf\u9700\u6c42\u6709\u4e86\u8be6\u7ec6\u7684\u7406\u89e3\u3002<\/p>\n\n\n\n \u8fd9\u65f6\u5f00\u59cb\u7f16\u5199\u7528\u4f8b\u624d\u80fd\u4fdd\u8bc1\u7528\u4f8b\u7684\u53ef\u6267\u884c\u548c\u5bf9\u9700\u6c42\u7684\u8986\u76d6\u3002<\/p>\n\n\n\n \u6d4b\u8bd5\u7528\u4f8b\u9700\u8981\u5305\u62ec\u6d4b\u8bd5\u9879\uff0c\u7528\u4f8b\u7ea7\u522b\uff0c\u9884\u7f6e\u6761\u4ef6\uff0c\u64cd\u4f5c\u6b65\u9aa4\u548c\u9884\u671f\u7ed3\u679c\u3002<\/p>\n\n\n\n \u5176\u4e2d\u64cd\u4f5c\u6b65\u9aa4\u548c\u9884\u671f\u7ed3\u679c\u9700\u8981\u7f16\u5199\u8be6\u7ec6\u548c\u660e\u786e\u3002<\/p>\n\n\n\n \u6d4b\u8bd5\u7528\u4f8b\u5e94\u8be5\u8986\u76d6\u6d4b\u8bd5\u65b9\u6848\uff0c\u800c\u6d4b\u8bd5\u65b9\u6848\u53c8\u8986\u76d6\u4e86\u6d4b\u8bd5\u9700\u6c42\u70b9\uff0c\u8fd9\u6837\u624d\u80fd\u4fdd\u8bc1\u5ba2\u6237\u9700\u6c42\u4e0d\u9057\u6f0f\u3002<\/p>\n\n\n\n \u540c\u6837\uff0c\u6d4b\u8bd5\u7528\u4f8b\u4e5f\u9700\u8981\u8bc4\u5ba1\u3002<\/p>\n\n\n\n 5.\u6d4b\u8bd5\u6267\u884c\u9636\u6bb5<\/strong>\uff1a\u6267\u884c\u6d4b\u8bd5\u7528\u4f8b\uff0c\u53ca\u65f6\u63d0\u4ea4\u6709\u8d28\u91cf\u7684Bug\u548c\u6d4b\u8bd5\u65e5\u62a5\uff0c\u6d4b\u8bd5\u62a5\u544a\u7b49\u76f8\u5173\u6587\u6863\u3002<\/p>\n\n\n\n \u6d4b\u8bd5\u6d41\u7a0b\u4f9d\u6b21\u5982\u4e0b\uff1a<\/p>\n\n\n\n 1.\u9700\u6c42\uff1a\u9605\u8bfb\u9700\u6c42\uff0c\u7406\u89e3\u9700\u6c42\uff0c\u4e0e\u5ba2\u6237\u3001\u5f00\u53d1\u3001\u67b6\u6784\u591a\u65b9\u4ea4\u6d41\uff0c\u6df1\u5165\u4e86\u89e3\u9700\u6c42\u3002–testing team<\/p>\n\n\n\n 2.\u6d4b\u8bd5\u8ba1\u5212\uff1a \u6839\u636e\u9700\u6c42\u4f30\u7b97\u6d4b\u8bd5\u6240\u9700\u8d44\u6e90\uff08\u4eba\u529b\u3001\u8bbe\u5907\u7b49\uff09\u3001\u6240\u9700\u65f6\u95f4\u3001\u529f\u80fd\u70b9\u5212\u5206\u3001\u5982\u4f55\u5408\u7406\u5206\u914d\u5b89\u6392\u8d44\u6e90\u7b49\u3002-<\/p>\n\n\n\n testing leader or testing manager<\/p>\n\n\n\n 3.\u7528\u4f8b\u8bbe\u8ba1\uff1a\u6839\u636e\u6d4b\u8bd5\u8ba1\u5212\u3001\u4efb\u52a1\u5206\u914d\u3001\u529f\u80fd\u70b9\u5212\u5206\uff0c\u8bbe\u8ba1\u5408\u7406\u7684\u6d4b\u8bd5\u7528\u4f8b\u3002—testing leader, senior tester<\/p>\n\n\n\n 4.\u6267\u884c\u6d4b\u8bd5\uff1a\u6839\u636e\u6d4b\u8bd5\u7528\u4f8b\u7684\u8be6\u7ec6\u6b65\u9aa4\uff0c\u6267\u884c\u6d4b\u8bd5\u7528\u4f8b\u3002–every tester\uff08\u4e3b\u8981\u662f\u521d\u7ea7\u6d4b\u8bd5\u4eba\u5458\uff09<\/p>\n\n\n\n 5.\u6267\u884c\u7ed3\u679c\u8bb0\u5f55\u548cbug\u8bb0\u5f55\uff1a\u5bf9\u6bcf\u4e2acase\u8bb0\u5f55\u6d4b\u8bd5\u7684\u7ed3\u679c\uff0c\u6709bug\u7684\u5728\u6d4b\u8bd5\u7ba1\u7406\u5de5\u5177\u4e2d\u7f16\u5199bug\u8bb0\u5f55\u3002–every tester\uff08\u4e3b\u8981\u662f\u521d\u7ea7\u6d4b\u8bd5\u4eba\u5458\uff09<\/p>\n\n\n\n 6.defect tracking\uff1a\u8ffd\u8e2aleader\u5206\u914d\u7ed9\u4f60\u8ffd\u8e2a\u7684bug.\u76f4\u5230 bug fixed\u3002–every tester<\/p>\n\n\n\n 7.\u6d4b\u8bd5\u62a5\u544a\uff1a\u901a\u8fc7\u4e0d\u65ad\u6d4b\u8bd5\u3001\u8ffd\u8e2a\uff0c\u76f4\u5230\u88ab\u6d4b\u8f6f\u4ef6\u8fbe\u5230\u6d4b\u8bd5\u9700\u6c42\u8981\u6c42\uff0c\u5e76\u6ca1\u6709\u91cd\u5927bug.<\/p>\n\n\n\n 8.\u7528\u6237\u4f53\u9a8c\u3001\u8f6f\u4ef6\u53d1\u5e03\u7b49\u2026\u2026…<\/p>\n\n\n\n \u5e38\u7528\u7684\u8f6f\u4ef6\u6d4b\u8bd5\u5de5\u5177\u4e00\u822c\u662f\uff1aQTP+LoadRunner+QC <\/p>\n\n\n\n \u8f6f\u4ef6\u6d4b\u8bd5\u4e2d\u8fd8\u9700\u7684\u5de5\u5177\u5982\u4e0b\uff1a <\/p>\n\n\n\n \u529f\u80fd\u6d4b\u8bd5\u5de5\u5177\uff1aQTP(HP),WinRunner(MI),Robort(IBM),QARun(Compuware) <\/p>\n\n\n\n \u6027\u80fd\u6d4b\u8bd5\u5de5\u5177\uff1aLoadRunner(HP),WAS(MS),Robort(IBM)\u3010\u5fc5\u987b\u4e0b\u8f7d\u76f8\u5e94\u7684\u63d2\u4ef6\u624d\u652f\u6301\u6027\u80fd\u65b9\u9762\u7684\u6d4b\u8bd5\u3011\uff0cQALoad(Compuware) <\/p>\n\n\n\n \u6d4b\u8bd5\u7ba1\u7406\u5de5\u5177\uff1aTestDirector\/Quarlity Center\u3010\u8fd9\u4e24\u4e2a\u5de5\u5177\u4e00\u4e2a\u6a2a\u7248\u4e00\u4e2a\u7ad6\u7248\uff0c\u529f\u80fd\u5b8c\u5168\u4e00\u6837\u3011\uff0cRational TestManager \u7f3a\u9677\u8ddf\u8e2a\u5de5\u5177\uff1aBugzilla\u3001Mantis <\/p>\n\n\n\n \u5176\u4ed6\uff1aRational Purify\u3001Rational PureCoverager<\/p>\n\n\n\n \u8f6f\u4ef6\u6d4b\u8bd5\u6b65\u9aa4\uff0c<\/p>\n\n\n\n \u4e00\u822c\u662f\uff1a\u5236\u5b9a\u6d4b\u8bd5\u8ba1\u5212\uff1b\u7136\u540e\u6839\u636e\u6d4b\u8bd5\u8ba1\u5212\u505a\uff1a\u8bbe\u8ba1\u6d4b\u8bd5\u7528\u4f8b\u3001\u5b9e\u65bd\u6d4b\u8bd5\uff08\u9996\u5148\u8981\u642d\u5efa\u6d4b\u8bd5\u7528\u73af\u5883\uff09\u3001\u7ba1\u7406\u6d4b\u8bd5\u65f6\u53d1\u73b0\u7684BUG\u3001\u6d4b\u8bd5\u5b8c\u540e\uff08\u6d4b\u8bd5\u5b8c\uff0c\u5e76\u4e14\u53d1\u73b0\u7684BUG\u4fee\u6b63\u5b8c\uff09\u8981\u505a\u6d4b\u8bd5\u62a5\u544a\uff08\u8fd9\u6837\uff0c\u8be5\u6d4b\u8bd5\u8fc7\u7a0b\u5c31\u7b97\u7ed3\u675f\u4e86\uff0c\u6bcf\u79cd\u7c7b\u578b\uff08\u5355\u5143\u6d4b\u8bd5\u3001\u96c6\u6210\u6d4b\u8bd5\u3001\u7cfb\u7edf\u6d4b\u8bd5\u3001\u9a8c\u8bc1\u6d4b\u8bd5\uff09\u7684\u6d4b\u8bd5\u90fd\u662f\u5982\u6b64\uff09\uff1b<\/p>\n\n\n\n \u6839\u636e\u9879\u76ee\u89c4\u6a21\u5927\u5c0f\u4e0d\u540c\uff0c\u4e0d\u540c\u516c\u53f8\u89c4\u8303\u4e0d\u540c\uff0c\u4f1a\u6709\u8f83\u5927\u5dee\u522b\u7684\uff1b…<\/p>\n\n\n\n \u533b\u7597\u5668\u68b0\uff0c\u662f\u6307\u5355\u72ec\u6216\u8005\u7ec4\u5408\u4f7f\u7528\u4e8e\u4eba\u4f53\u7684\u4eea\u5668\u3001\u8bbe\u5907\u3001\u5668\u5177 \u3001\u6750\u6599\u6216\u8005\u5176\u4ed6\u7269 \u54c1\uff0c\u5305\u62ec\u6240\u9700\u8981\u7684\u8f6f\u4ef6\uff1b\u5176\u7528\u4e8e\u4eba\u4f53\u4f53\u8868\u53ca\u4f53\u5185\u7684\u4f5c\u7528\u4e0d\u662f\u7528\u836f\u7406\u5b66\u3001\u514d\u75ab\u5b66\u6216\u8005\u4ee3\u8c22\u7684\u624b\u6bb5\u83b7\u5f97\uff0c\u4f46\u662f\u53ef\u80fd\u6709\u8fd9\u4e9b\u624b\u6bb5\u53c2\u4e0e\u5e76\u8d77\u4e00\u5b9a\u7684\u8f85\u52a9\u4f5c\u7528\uff1b\u56fd\u4ea7\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8fc7\u7a0b\u9700\u63d0\u4ea4\u7684\u8d44\u6599<\/p>\n\n\n\n (1) \u5883\u5185\u533b\u7597\u5668\u68b0\u6ce8\u518c\u7533\u8bf7\u8868<\/p>\n\n\n\n (2) \u533b\u7597\u5668\u68b0\u751f\u4ea7\u4f01\u4e1a\u8d44\u683c\u8bc1\u660e<\/p>\n\n\n\n (3) \u4ea7\u54c1\u6280\u672f\u62a5\u544a<\/p>\n\n\n\n (4) \u5b89\u5168\u98ce\u9669\u5206\u6790\u62a5\u544a<\/p>\n\n\n\n (5) \u9002\u7528\u7684\u4ea7\u54c1\u6807\u51c6\u53ca\u8bf4\u660e<\/p>\n\n\n\n (6) \u4ea7\u54c1\u6027\u80fd\u81ea\u6d4b\u62a5\u544a<\/p>\n\n\n\n (7) \u533b\u7597\u5668\u68b0\u68c0\u6d4b\u673a\u6784\u51fa\u5177\u7684\u4ea7\u54c1\u6ce8\u518c\u68c0\u6d4b\u62a5\u544a<\/p>\n\n\n\n (8) \u533b\u7597\u5668\u68b0\u4e34\u5e8a\u8bd5\u9a8c\u8d44\u6599<\/p>\n\n\n\n (9) \u533b\u7597\u5668\u68b0\u8bf4\u660e\u4e66<\/p>\n\n\n\n (10) \u4ea7\u54c1\u751f\u4ea7\u8d28\u91cf\u4f53\u7cfb\u8003\u6838\uff08\u8ba4\u8bc1\uff09\u7684\u6709\u6548\u8bc1\u660e\u6587\u4ef6<\/p>\n\n\n\n (11) \u6240\u63d0\u4ea4\u6750\u6599\u771f\u5b9e\u6027\u7684\u81ea\u6211\u4fdd\u8bc1\u58f0\u660e<\/p>\n\n\n\n \u6b65\u9aa4\/\u65b9\u6cd5\uff1a1.\u786e\u5b9a\u7533\u529e\u4ea7\u54c1\u578b\u53f7<\/p>\n\n\n\n 2.\u8fdb\u884c\u4ea7\u54c1\u5206\u7c7b<\/p>\n\n\n\n 3.\u53d7\u7406\u8d44\u6599\u6240\u9700\u8981\u7684\u8bc1\u4ef6<\/p>\n\n\n\n 4.\u719f\u6089\u4f01\u4e1a\u7684\u4ea7\u54c1\u6587\u4ef6<\/p>\n\n\n\n 5.\u6280\u672f\u6807\u51c6\u5236\u5b9a<\/p>\n\n\n\n 6.\u7701\u5c40\u8fdb\u884c\u7533\u62a5\uff0c\u53d6\u5f97\u53d7\u7406<\/p>\n\n\n\n 7.\u533b\u7597\u5668\u68b0\u5ba1\u8bc4\u4e2d\u5fc3\u6280\u672f\u5ba1\u8bc4<\/p>\n\n\n\n 8\u884c\u653f\u5ba1\u6279<\/p>\n\n\n\n 9.\u53d6\u5f97\u8bc1\u4e66\u6ce8\u610f\u4e8b\u9879\uff1a\u533b\u7597\u5668\u68b0\u6ce8\u518c\u5468\u671f\u4e3b\u8981\u5206\u4e3a\u56db\u4e2a\u6bb5\uff1a\u6807\u51c6\u64b0\u5199\u53ca\u5907\u6848\u3001\u8d44\u6599\u51c6\u5907\u65f6\u95f4\u3001\u4ea7\u54c1\u68c0\u6d4b\u65f6\u95f4\u3001SFDA\u8d44\u6599\u5ba1\u67e5\u548c\u6279\u51c6\u65f6\u95f4\u3002<\/p>\n\n\n\n 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