![\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe4\"](\"https:\/\/pic2.zhimg.com\/80\/v2-81ae62b3cc8bfcff63c47da41173bdd5_720w.webp\" "\\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe4\\"")
<\/div>\n
\u56db\u3001\u5173\u4e8e\u57fa\u672c\u6027\u80fd\uff08Essential Performance\uff09\u89e3\u8bfb<\/p>\n
\u6709\u6e90\u533b\u7597\u5668\u68b0\u5b89\u89c4\u548cEMC\u6d4b\u8bd5\u65f6\uff0c\u68c0\u6d4b\u673a\u6784\u4f1a\u8981\u6c42\u5668\u68b0\u9001\u68c0\u4f01\u4e1a\u8bf4\u660e\u5668\u68b0\u7684\u201c\u57fa\u672c\u6027\u80fd\u201d\u3002\u4e0b\u9762\u91cd\u70b9\u89e3\u8bfb\u4ecb\u7ecd\uff1a\u4ec0\u4e48\u662f\u57fa\u672c\u6027\u80fd\u3001\u4e3a\u4ec0\u4e48\u8981\u5b9a\u4e49\u57fa\u672c\u6027\u80fd\u3001\u5982\u4f55\u8bc6\u522b\u57fa\u672c\u6027\u80fd\u3001\u5982\u4f55\u6d4b\u8bd5\u57fa\u672c\u6027\u80fd\u8fbe\u6807\u3001\u5982\u4f55\u7b26\u5408\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
1\u3001\u4f55\u65f6\u5f15\u5165\u57fa\u672c\u6027\u80fd<\/p>\n
\u5b9e\u9645\u4e0a\uff0c\u57fa\u672c\u6027\u80fd(essential performance) \u8fd9\u4e2a\u5b9a\u4e49\u6700\u65e9\u5e76\u4e0d\u662f\u51fa\u73b0\u5728IEC60601-1 3. 0\u4e2d\uff0c\u800c\u662f\u51fa\u73b0\u9996\u5148\u5728IEC 60601-1-2 :2001\u7248\u7684\u5b9a\u4e49\u4e2d\uff0c\u5f53\u65f6\u7684\u5b9a\u4e49\u4e3a: performance characteristics necessary to maintain the residual risk within acceptable limits\u3002 \u8fd9\u4e2a\u5b9a\u4e49\u5f53\u65f6\u5f15\u7528\u7684\u662f\u8fd8\u672a\u66f4\u65b0\u51fa\u7248\u7684IEC60601-1 3.0\u7248(In preparation )\uff0c\u53ef\u4ee5\u770b\u51fa\u57282001\u5e74\u5df2\u7ecf\u5bf9essential performance \u6709\u4e86\u4e00\u4e2a\u521d\u6b65\u7684\u5b9a\u4e49\u3002<\/p>\n
\u800c\u73b0\u5728\u88ab\u66f4\u591a\u7684\u4eba\u63a5\u53d7\u7684\u662fessential performance \u6700\u65e9\u51fa\u73b0\u5728IEC 60601-1: 2005(3.0\u7248\u4e2d)\u3002IEC60601-1\u22362005\uff083.0\u7248\u4e2d\uff09\u4e2d\u5bf9Essential performance\u7684\u5b9a\u4e49\u4e3a\u2236”performance necessary to achieve freedom from unacceptable risk”\u3002\u6b64\u5b9a\u4e49\u5e76\u6ca1\u6709\u5f88\u6e05\u6670\u5730\u8868\u8fbe\u51fa\u6807\u51c6\u7684\u672c\u610f\uff0c\u5bf9\u5236\u9020\u5546\u533a\u5206basic safety\u548cessential performance\u9020\u6210\u4e86\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\u7684\u56f0\u60d1\u3002IEC 60601-1\u7684\u6807\u51c6\u540d\u79f0\u4e5f\u4ece\u201cMEDICAL ELECTRICALEQUIPMENT Part 1: General requirements for safety\u201d\u8f6c\u53d8\u4e3a\u201cMedical electrical equipment – Part 1: General requirements for basic safety and essential performance\u201d \u3002\u4ece\u6807\u9898\u6765\u770b\uff0c\u4f3c\u4e4e\u662f\u628asafety\u62c6\u5206\u6210\u4e86basic safety\u548cessential performance \u3002\u5728\u7b2c\u4e8c\u7248\u4e4b\u524d\u7684\u7248\u672c\u4e2d\u66f4\u5f3a\u8c03\u7684\u662f\u4ea7\u54c1\u7b26\u5408\u5f3a\u5236\u6807\u51c6\u7684\u8981\u6c42\uff0c\u4e0d\u592a\u8003\u8651\u4ea7\u54c1\u7684\u6027\u80fd\u548c\u529f\u80fd\u5b9e\u73b0\uff0c\u6b63\u5982\u6807\u51c6\u6240\u8bf4\u201cThe ability of an electric kettle to boil water is not critical toits safe use!”\uff0c\u4f46\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u6765\u8bf4\uff0c\u5728\u4fdd\u8bc1\u5b89\u5168\u4f7f\u7528( \u7535\u51fb\u9632\u62a4\u3001\u673a\u68b0\u9632\u62a4\u7b49\u7b49)\u7684\u60c5\u51b5\u4e0b\u8fd8\u8981\u8003\u8651\u4e0d\u80fd\u5b9e\u73b0\u7528\u9014\u7684\u98ce\u9669\u3002\u6211\u60f3\u8fd9\u5e94\u8be5\u662fessential performance\u7684\u521d\u8877\u3002<\/p>\n
\u968f\u540eIEC 60601-1\u22362012\uff083.1\u7248\uff09\u5bf9\u6b64\u5b9a\u4e49\u8fdb\u884c\u4e86\u4fee\u8ba2\uff0c\u91cd\u65b0\u5b9a\u4e49\u4e3a\u2236\u201cPerformance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk”\u3002\u5373\u57fa\u672c\u6027\u80fd\u8f83\u5bb9\u6613\u7406\u89e3\u7684\u65b9\u5f0f\u662f\u8003\u8651\u5176\u4e34\u5e8a\u529f\u80fd\u6027\u80fd\u7684\u7f3a\u5931\u6216\u964d\u7ea7\u662f\u5426\u4f1a\u5bfc\u81f4\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\uff0c\u4e0d\u53ef\u63a5\u53d7\u662f\u6307\u4e0d\u6ee1\u8db3\u5236\u9020\u5546\u89c4\u5b9a\u7684\u98ce\u9669\u53ef\u63a5\u53d7\u51c6\u5219\u3002<\/p>\n
\u6839\u636eIEC 60601-1 3.1\u4e2d\u5bf9Essential perfor-mance\u5b9a\u4e49\uff0c\u6211\u4eec\u53ef\u4ee5\u770b\u51fa\u51e0\u4e2a\u7279\u70b9\u2236<\/p>\n
l \u57fa\u672c\u6027\u80fd\u4e3a\u4e34\u5e8a\u529f\u80fd\u7684\u6027\u80fd\uff08Clinical function);<\/p>\n
l \u57fa\u672c\u6027\u80fd\u4e0d\u540c\u4e8ebasic safety\uff08\u6bd4\u5982\u57fa\u672c\u7edd\u7f18\uff09<\/p>\n
l \u4e00\u4e2a\u533b\u7597\u5668\u68b0\u53ef\u4ee5\u6709\u5f88\u591a\u7684\u6027\u80fd\u6216\u529f\u80fd\uff0c\u4f46\u5e76\u4e0d\u662f\u6240\u6709\u6027\u80fd\uff08\u529f\u80fd\uff09\u90fd\u662f\u57fa\u672c\u6027\u80fd\uff0c\u5982\u679c\u7f3a\u5931\u6216\u8d85\u9650\u503c\uff0c\u5f15\u8d77\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\uff0c\u624d\u80fd\u662f\u57fa\u672c\u6027\u80fd\uff1b<\/p>\n
l \u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u662f\u5236\u9020\u5546\u6309\u7167\u98ce\u9669\u63a7\u5236\u7a0b\u5e8f\u8fdb\u884c\u8bc4\u4f30\u7684\uff1b<\/p>\n
l \u539f\u5219\u4e0a\uff0c\u67d0\u4e00\u7c7b\u578b\u7684\u533b\u7597\u5668\u68b0\u53ef\u4ee5\u6ca1\u6709\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
2\u3001\u4ec0\u4e48\u662f\u57fa\u672c\u6027\u80fd<\/p>\n
\u5728IEC60601\u4e2d\u5b9a\u4e49:<\/p>\n
\u201c01d\u201d(3rd ed.) :<\/p>\n
performance necessary to achieve freedom from unacceptable risk.<\/p>\n
\u201cNew\u201d(3.1rd):<\/p>\n
performance of a clinical function\uff0c other thanthat related to BASIC SAFETY\uff0cwhere loss ordegradation beyond thelimits specified by the manufacturerresults in an unacceptable risk.<\/p>\n
IEC60601(3.1rd)\uff08GB9706.1-2020\uff09\u6807\u51c6\u4e2d3.27\u6761\u6b3e\u5b9a\u4e49\uff0c\u57fa\u672c\u6027\u80fd\u662f\u4e0e\u57fa\u672c\u5b89\u5168\u4e0d\u76f8\u5173\u7684\u4e34\u5e8a\u529f\u80fd\u7684\u6027\u80fd\uff0c\u5176\u4e27\u5931\u6216\u964d\u4f4e\u5230\u8d85\u8fc7\u5236\u9020\u5546\u89c4\u5b9a\u7684\u9650\u503c\u4f1a\u5bfc\u81f4\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
\u201c\u57fa\u672c\u6027\u80fd\u201d\u5df2\u7ecf\u4e0d\u662f\u7b80\u5355\u7684\u6027\u80fd\u6216\u8005\u529f\u80fd\u7684\u6982\u5ff5\uff0c\u5176\u5b9a\u4e49\u5df2\u7ecf\u5ef6\u4f38\u5230\u5b89\u5168\u7684\u7406\u5ff5\uff0c\u5f15\u5165\u4e86\u98ce\u9669\u7ba1\u7406\u3002\u7b80\u5355\u6765\u8bf4\u5c31\u662f\u4ea7\u54c1\u7684\u67d0\u4e00\u4e2a\u4e34\u5e8a\u529f\u80fd\uff0c\u800c\u4e0d\u662f\u8d85\u6e29\u3001\u6f0f\u7535\u6d41\u3001\u673a\u68b0\u9632\u62a4\u7b49\u5b89\u5168\u6307\u6807\uff0c\u800c\u662f\u4e00\u4e2a\u5177\u4f53\u7684\u4e34\u5e8a\u529f\u80fd\u6307\u6807\u3002\u8fd9\u4e2a\u5b9a\u4e49\u5305\u542b\u4e24\u5c42\u610f\u601d\uff1a<\/p>\n
1. \u57fa\u672c\u6027\u80fd\u662f\u6307\u5668\u68b0\u7684\u4e34\u5e8a\u529f\u80fd\u7684\u6027\u80fd\u3002 \u5982\u91cd\u75c7\u76d1\u62a4\u6216\u624b\u672f\u5ba4\u76d1\u62a4\u7cfb\u7edf\u4e2d\u62a5\u8b66\u7cfb\u7edf\u7684\u62a5\u8b66\u529f\u80fd\u7684\u6027\u80fd\u5c31\u662f\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
2. \u57fa\u672c\u6027\u80fd\u4e27\u5931\u6216\u964d\u4f4e\u4f1a\u5bfc\u81f4\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002\u5982\u62a5\u8b66\u7cfb\u7edf\u7684\u4e0d\u6b63\u786e\u6216\u8005\u7f3a\u5931\u62a5\u8b66\u4fe1\u53f7,\u4f1a\u5bfc\u81f4-\u533b\u62a4\u4eba\u5458\u4e0d\u6b63\u786e\u7684\u54cd\u5e94\uff0c\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\uff08\u6b7b\u4ea1\uff09\u3002<\/p>\n
\u901a\u7528\u5b89\u5168\u6807\u51c6IEC 60601-1\u4e0d\u4ec5\u7ed9\u51fa\u4e86\u57fa\u672c\u6027\u80fd\u7684\u5b9a\u4e49\uff0c\u540c\u65f6\u4e3a\u66f4\u597d\u5730\u7406\u89e3\u6807\u51c6\uff0c\u4e5f\u7ed9\u51fa\u4e86\u57fa\u672c\u6027\u80fd\u7684\u4f8b\u5b50\uff0c\u5982\u4e0b\u2236<\/p>\n
l \u7ecf\u6ce8\u5c04\u6cf5\u4f7f\u7528\u7684\u836f\u54c1\u7684\u6b63\u786e\u7ba1\u7406\uff0c\u82e5\u4e0d\u7cbe\u786e\/\u9519\u8bef\u7ba1\u7406\uff0c\u4f1a\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
l \u5fc3\u7535\u56fe\u673a\/\u76d1\u62a4\u4eea\u4ece\u9664\u98a4\u5668\u653e\u7535\u540e\u6062\u590d\u7684\u80fd\u529b\uff0c\u82e5\u6062\u590d\u7684\u5931\u6548\uff0c\u5219\u4f1a\u5bfc\u81f4\u533b\u62a4\u4eba\u5458\u4e0d\u6b63\u786e\u7684\u54cd\u5e94\uff0c\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
l \u91cd\u75c7\u76d1\u62a4\u6216\u624b\u672f\u5ba4\u76d1\u62a4\u7cfb\u7edf\u4e2d\u62a5\u8b66\u7cfb\u7edf\u7684\u6b63\u786e\u8fd0\u4f5c\uff0c\u82e5\u4e0d\u6b63\u786e\/\u7f3a\u5931\u62a5\u8b66\u4fe1\u53f7\uff0c\u5219\u4f1a\u5bfc\u81f4\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u533b\u62a4\u4eba\u5458\u4e0d\u6b63\u786e\u7684\u54cd\u5e94\uff0c\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
l \u7528\u4e8e\u8bca\u65ad\u7684ME\u8bbe\u5907\u8bca\u65ad\u4fe1\u606f\u7684\u7ed3\u679c\u6b63\u786e\u6027\uff0c\u5982\u679c\u7ed9\u51fa\u4e0d\u6b63\u786e\u7684\u4fe1\u606f\u4f1a\u5bfc\u81f4\u4e0d\u9002\u5b9c\u7684\u6cbb\u7597\u65b9\u6cd5\uff0c\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
\u4ece\u4e3e\u4f8b\u4e2d\uff0c\u6211\u4eec\u53ef\u4ee5\u770b\u51fa\uff0c\u5728\u57fa\u672c\u6027\u80fd\u5b9a\u4e49\u63d0\u51fa\u4e4b\u524d\uff0c\u901a\u7528\u6807\u51c6\u548c\u4e13\u7528\u6807\u51c6\u4e2d\u89c4\u5b9a\u7684\u67d0\u4e9b\u8981\u6c42\u5df2\u7ecf\u5c5e\u4e8e\u57fa\u672c\u6027\u80fd\u7684\u5b9a\u4e49\u8303\u56f4\u4e86\u3002IEC60601-1 \u7b2c2\u7248\u768450\u548c51\u7ae0\u4ee5\u53ca\u5728IEC60601-2-X\u7684\u67d0\u4e9b\u6761\u6b3e\u8981\u6c42\u95f4\u63a5\u8986\u76d6\u4e86essential performance\u7684\u7406\u5ff5\uff08\u6bd4\u5982\u751f\u7406\u76d1\u6d4b\u8bbe\u5907\u7684\u51c6\u786e\u6027\uff09\u3002<\/p>\n
\u901a\u5e38\u6765\u8bf4\uff0c\u4e0d\u662f\u57fa\u672c\u6027\u80fd\u7684\u4f8b\u5b50\u5982\u4e0b\u2236\u975e\u91cd\u8981\u7684\u751f\u7406\u529f\u80fd\uff1b\u8bb0\u5f55\u7684\u683c\u5f0f\uff0c\u663e\u793a\uff0c\u901a\u4fe1\u534f\u8bae\u7b49\uff1b\u9891\u7387\u54cd\u5e94\u3001\u7535\u6c14\u566a\u58f0\u6c34\u5e73\uff0c\u6570\u636e\u5904\u7406\u80fd\u529b\u7684\u6027\u80fd\uff1b\u9700\u8981\u533b\u52a1\u4eba\u5458\u901a\u8fc7\u57fa\u4e8e\u8bbe\u5907\u4e0a\u7684\u83b7\u5f97\u75c5\u4eba\u539f\u59cb\u6570\u636e\u7684\u8bca\u65ad\u62a5\u544a\u529f\u80fd\uff0c\u5e76\u4e14\u62a5\u544a\u529f\u80fd\u4e0d\u80fd\u81ea\u52a8\u53d1\u8d77\u75c5\u4eba\u6cbb\u7597\u3002<\/p>\n
\u6b64\u5916\uff0c\u5bf9\u4e8e\u540c\u4e00\u4e2a\u6027\u80fd\u53c2\u6570\u6765\u8bb2\uff0c\u53ef\u80fd\u67d0\u4e9b\u60c5\u51b5\u4e0b\u4f5c\u4e3a\u57fa\u672c\u5b89\u5168\u5bf9\u5f85\uff0c\u67d0\u4e9b\u60c5\u51b5\u4e0b\u53c8\u5c5e\u4e8e\u57fa\u672c\u6027\u80fd\u7684\u8303\u7574\uff0c\u6bd4\u5982\u2236\u4e73\u817a\u673a\u8fdb\u884c\u4e73\u817a\u6210\u50cf\u65f6\u9700\u8981\u538b\u8feb\u677f\u538b\u8feb\u4e73\u817a\uff0cIEC 60601-2-45\u6807\u51c6\u8981\u6c42\u538b\u529b\u4e0d\u80fd\u5927\u4e8e300N\uff0c\u8d85\u8fc7\u8fd9\u4e2a\u529b\u5c31\u4f1a\u5bf9\u4e73\u817a\u9020\u6210\u673a\u68b0\u4f24\u5bb3\uff0c\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u8d85\u8fc7\u538b\u529b\u5c31\u662f\u57fa\u672c\u5b89\u5168\uff1b\u4f46\u662f\u4e73\u817a\u6210\u50cf\u5fc5\u987b\u6709\u4e00\u5b9a\u7684\u538b\u529b\uff0c\u5982\u679c\u8fbe\u4e0d\u5230\u538b\u529b\uff08\u6027\u80fd\u964d\u4f4e\uff09\uff0c\u6210\u50cf\u5c31\u4e0d\u6e05\u6670\uff0c\u6240\u4ee5\uff0c\u4e0d\u80fd\u4fdd\u6301\u4e00\u5b9a\u7684\u538b\u529b\u5c31\u662f\u4e00\u4e2a\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
3\u3001\u4e3a\u4ec0\u4e48\u8981\u5b9a\u4e49\u57fa\u672c\u6027\u80fd\uff1f<\/p>\n
\u5728 IEC60601.1 Ed3.0\u603b\u5bfc\u5219\u548c\u7f16\u5236\u8bf4\u660e\u4e86\u4e3a\u4ec0\u4e48\u8981\u5b9a\u4e49\u57fa\u672c\u6027\u80fd\uff1a<\/p>\n
\u539f\u6587\u89e3\u8bfb\uff1a<\/p>\n
\u957f\u4e45\u4ee5\u6765\u4eba\u4eec\u5df2\u7ecf\u610f\u8bc6\u5230\u8bbe\u5907\u4e0d\u6b63\u5e38\u8fd0\u884c\u4f1a\u5bf9\u60a3\u8005\uff0c\u64cd\u4f5c\u8005\u6216\u5176\u4ed6\u4eba\u5458\u9020\u6210\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002\u56e0\u6b64\u201c\u5b89\u5168\u201d\u7684\u6982\u5ff5\u5df2\u4ece\u672c\u6807\u51c6\u7b2c\u4e00\u7b2c\u4e8c\u677f\u7684\u57fa\u672c\u5b89\u5168\u4e8b\u9879\u62d3\u5c55\u5e76\u5305\u542b\u57fa\u672c\u6027\u80fd\u4e8b\u9879\u3002<\/p>\n
\u4e3a\u5b9e\u73b0\u9884\u671f\u4f7f\u7528\uff0c\u8bbe\u5907\u6216\u7cfb\u7edf\u9700\u53d7\u7279\u5b9a\u9650\u5236\u3002\u8fd9\u4e9b\u9650\u5236\u901a\u5e38\u7531\u5236\u9020\u5546\u89c4\u5b9a\u4f46\u4e5f\u80fd\u7531\u672c\u6807\u51c6,IEC60601\u6807\u51c6\u65cf\u4e2d\u7684\u5e76\u5217\u6216\u4e13\u7528\u6807\u51c6\u6240\u89c4\u5b9a\u3002<\/p>\n
\u57fa\u672c\u6027\u80fd\u4e3e\u4f8b\uff1a <\/p>\n
l \u7ecf\u6ce8\u5c04\u6cf5\u4f7f\u7528\u7684\u836f\u54c1\u7684\u6b63\u786e\u7ba1\u7406,\u82e5\u4e0d\u7cbe\u786e\/\u9519\u8bef\u7ba1\u7406,\u4f1a\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
l \u5fc3\u7535\u56fe\u673a\/\u76d1\u62a4\u4eea\u4ece\u9664\u98a4\u5668\u653e\u7535\u540e\u6062\u590d\u7684\u80fd\u529b,\u82e5\u6062\u590d\u7684\u5931\u6548,\u5219\u4f1a\u5bfc\u81f4\u533b\u62a4\u4eba\u5458\u4e0d\u6b63\u786e\u7684\u54cd\u5e94,\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669<\/p>\n
l \u91cd\u75c7\u76d1\u62a4\u6216\u624b\u672f\u5ba4\u76d1\u62a4\u7cfb\u7edf\u4e2d\u62a5\u8b66\u7cfb\u7edf\u7684\u6b63\u786e\u8fd0\u4f5c,\u82e5\u4e0d\u6b63\u786e\/\u7f3a\u5931\u62a5\u8b66\u4fe1\u53f7,\u5219\u4f1a\u5bfc\u81f4-\u533b\u62a4\u4eba\u5458\u4e0d\u6b63\u786e\u7684\u54cd\u5e94,\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
l \u7528\u4e8e\u8bca\u65ad\u7684\u8bbe\u5907\u8bca\u65ad\u4fe1\u606f\u7684\u7ed3\u679c\u6b63\u786e\u6027,\u5982\u679c\u7ed9\u51fa\u4e0d\u6b63\u786e\u7684\u4fe1\u606f\u4f1a\u5bfc\u81f4\u4e0d\u9002\u5b9c\u7684\u6cbb\u7597\u65b9\u6cd5,\u7ed9\u60a3\u8005\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
\u672c\u6807\u51c6\u4e2d\u8bbe\u5907\u4e0e\u57fa\u672c\u5b89\u5168\u65b9\u9762\u76f8\u5173\u7684\u6027\u80fd,\u8bf8\u5982\u57fa\u672c\u7edd\u7f18\u6027\u80fd\u4e0d\u88ab\u7eb3\u5165\u57fa\u672c\u6027\u80fd\u3002IEC60601\u6807\u51c6\u65cf\u4e2d\u7684\u4e13\u7528\u548c\u5e76\u5217\u6807\u51c6\u9884\u671f\u4f1a\u660e\u786e\u7279\u6b8a\u7684\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
\u56e0\u6b64\uff0c\u5b9a\u4e49\u5668\u68b0\u57fa\u672c\u6027\u80fd\u7684\u51fa\u53d1\u70b9\u662f\u5236\u9020\u5546\u5fc5\u987b\u5728\u8bbe\u8ba1\u4ea7\u54c1\u65f6\uff0c\u8003\u8651\u7531\u4e8e\u4e34\u5e8a\u529f\u80fd\u76f8\u5173\u7684\u6027\u80fd\u51fa\u73b0\u95ee\u9898\uff08\u6545\u969c\uff09\u65f6\u5f15\u8d77\u7684\u5b89\u5168\u98ce\u9669\uff0c\u7ed9\u60a3\u8005\u5e26\u6765\u7684\u4e0d\u53ef\u9006\u98ce\u9669\u3002\u800c\u4ee5\u524d\u5668\u68b0\u4ec5\u4ec5\u5f3a\u8c03\u56e0\u4e3a\u8bbe\u8ba1\u3001\u7ed3\u6784\u3001\u5b89\u5168\u6307\u6807\u672c\u8eab\u4e0d\u7b26\u5408\u901a\u7528\u5b89\u5168\u8981\u6c42\u5f15\u8d77\u7684\u5b89\u5168\u98ce\u9669\u3002<\/p>\n
4\u3001\u5982\u4f55\u7406\u89e3\u57fa\u672c\u6027\u80fd<\/p>\n
\u57fa\u672c\u6027\u80fd\u8f83\u5bb9\u6613\u7406\u89e3\u7684\u65b9\u5f0f\u662f\u8003\u8651\u5176\u7f3a\u5931\u6216\u964d\u7ea7\u662f\u5426\u4f1a\u5bfc\u81f4\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
\u6ce8\u610f\u8fd9\u91cc\u7684\u201c\u4e0d\u53ef\u63a5\u53d7\u201d\u5f88\u5bb9\u6613\u7406\u89e3\u4e3a\u5bf9\u4e8e\u60a3\u8005\u6765\u8bf4\u662f\u4e0d\u53ef\u63a5\u53d7\u7684(\u6bd4\u5982\u91cd\u4f24)\uff0c\u4f46\u662f\u5e76\u4e0d\u662f\uff0c\u786e\u5207\u5730\u8bf4\u662f\u4e0d\u5b8c\u5168\u662f\uff0c\u8fd9\u91cc\u7684\u201c\u4e0d\u53ef\u63a5\u53d7\u201d\u662f\u6307\u4e0d\u80fd\u6ee1\u8db3\u5236\u9020\u5546\u89c4\u5b9a\u7684\u98ce\u9669\u53ef\u63a5\u53d7\u51c6\u5219\u3002<\/p>\n
\u5176\u5b9e\u6211\u4eec\u4ece\u4e0a\u9762\u4e8c\u6761\u6b3e\u7684\u5b9a\u4e49\u4e2d\u53ef\u4ee5\u770b\u51fa\u57fa\u672c\u6027\u80fd\u5177\u5907\u4ee5\u4e0b\u51e0\u4e2a\u7279\u70b9:<\/p>\n
1\uff09\u3001\u57fa\u672c\u6027\u80fd\u4e00\u5b9a\u8981\u662f\u4e34\u5e8a\u529f\u80fd(Clinical function) \u7684\u6027\u80fd:<\/p>\n
\u6bd4\u5982\u8840\u6db2\u900f\u6790\u673a\u4e0a\u9762\u4e3a\u4e86\u7f13\u89e3\u900f\u6790\u8fc7\u7a0b\u4e2d\u7684\u65e0\u804a\uff0c\u52a0\u4e86\u72ec\u7acb\u7684\u5355\u5143\u6765\u5b8c\u6210\u97f3\u4e50\u6216\u8005\u671f\u520a\u6717\u8bfb\u529f\u80fd\uff0c\u8fd9\u4e2a\u5c31\u4e0d\u662f\u4e34\u5e8a\u529f\u80fd\uff0c\u66f4\u4e0d\u4f1a\u662f\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
2\uff09\u3001\u57fa\u672c\u6027\u80fd\u4e0d\u540c\u4e8e\u57fa\u672c\u5b89\u5168(basic safety)\uff0c \u5982\u7535\u80fd\u3001\u673a\u68b0\u80fd\u3001\u8f90\u5c04\u80fd\u7b49\u7b49;<\/p>\n
\u4e3e\u4e2a\u4f8b\u5b50\u6765\u8bb2:\u4e73\u817a\u673a\u7684\u538b\u8feb\u677f\u538b\u8feb\u4e73\u817a\u6210\u50cf\uff0c\u6807\u51c6\u8981\u6c42\u538b\u529b\u4e0d\u80fd\u5927\u4e8e300N,\uff0c\u8d85\u8fc7\u8fd9\u4e2a\u529b\u5c31\u4f1a\u6709\u673a\u68b0\u4f24\u5bb3\uff0c\u8fd9\u5c31\u662f\u57fa\u672c\u5b89\u5168;\u4f46\u662f\u4e73\u817a\u6210\u50cf\u5fc5\u987b\u6709\u4e00\u5b9a\u7684\u538b\u529b\uff0c\u5982\u679c\u8fbe\u4e0d\u5230\u538b\u529b\uff0c\u6210\u50cf\u5c31\u4e0d\u6e05\u6670\uff0c\u6240\u4ee5\uff0c\u4fdd\u6301\u4e00\u5b9a\u7684\u538b\u529b\u5c31\u662f\u4e00\u4e2a\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
3\uff09\u3001\u57fa\u672c\u6027\u80fd\u9700\u8981\u6709\u9650\u503c\u89c4\u5b9a(limits) ;<\/p>\n
4\uff09\u3001\u5982\u679c\u8d85\u9650\u503c\uff0c\u5f15\u8d77\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669(\u6362\u8a00\u4e4b\u5c31\u662f\u4e0d\u80fd\u6ee1\u8db3\u5236\u9020\u5546\u89c4\u5b9a\u7684\u98ce\u9669\u53ef\u63a5\u53d7\u51c6\u5219)\uff0c\u624d\u80fd\u662f\u57fa\u672c\u6027\u80fd\uff1a<\/p>\n
\u8fd9\u91cc\u6211\u4eec\u601d\u8003\u4e0b\u91cd\u75c7\u76d1\u62a4\u6216\u624b\u672f\u5ba4\u76d1\u62a4\u7cfb\u7edf\u4e2d\u62a5\u8b66\u7cfb\u7edf\u7684\u62a5\u8b66\u529f\u80fd\u7684\u6027\u80fd\u662f\u4e0d\u662f\u57fa\u672c\u6027\u80fd\u5462?<\/p>\n
\u7b54\u6848\u662f\u7b97\uff0c\u91cd\u75c7\u76d1\u62a4\u6216\u624b\u672f\u5ba4\u76d1\u62a4\u7cfb\u7edf\u4e2d\u62a5\u8b66\u7cfb\u7edf\u7684\u62a5\u8b66\u529f\u80fd\u7684\u6027\u80fd\u5c31\u662f\u57fa\u672c\u6027\u80fd,\u57fa\u672c\u6027\u80fd\u4e27\u5931\u6216\u964d\u4f4e\u4f1a\u5bfc\u81f4\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002\u5982\u62a5\u8b66\u7cfb\u7edf\u7684\u4e0d\u6b63\u786e\u6216\u8005\u7f3a\u5931\u62a5\u8b66\u4fe1\u53f7,\u4f1a\u5bfc\u81f4\u533b\u62a4\u4eba\u5458\u4e0d\u6b63\u786e\u7684\u54cd\u5e94\uff0c\u53ef\u80fd\u4f1a\u81f4\u4f7f\u60a3\u8005\u6b7b\u4ea1\uff0c\u90a3\u4e48\u8fd9\u4e2a\u5c31\u662f\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669(\u4e0d\u80fd\u6ee1\u8db3\u5236\u9020\u5546\u89c4\u5b9a\u7684\u98ce\u9669\u53ef\u63a5\u53d7\u51c6\u5219)\u3002<\/p>\n
\u770b\u5230\u8fd9\u91cc\uff0c\u5982\u679c\u4f60\u80fd\u63d0\u51fa\u7591\u95ee\uff0c\u90a3\u5c31\u66f4\u597d\u4e86\uff0c\u56e0\u4e3a\u8fd9\u4e2a\u89e3\u91ca\u8fd8\u4e0d\u591f\u7ed9\u529b\uff0c\u6211\u4eec\u4e0a\u9762\u8bb2\u5230\u57fa\u672c\u6027\u80fd\u8981\u6709\u4e00\u5b9a\u7684\u9650\u503c\uff0c\u8d85\u8fc7\u9650\u503c\u5f15\u8d77\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u624d\u7b97\u662f\u57fa\u672c\u6027\u80fd\uff0c\u601d\u8003\u4e0b\uff0c\u62a5\u8b66\u8fd8\u7b97\u662f\u57fa\u672c\u6027\u80fd\u5417?\u5b83\u6709\u9650\u503c\u5417?<\/p>\n
\u7b54\u6848\u4f9d\u7136\u662f\u7b97\uff0c\u6ce8\u610f\u6211\u8fd9\u91cc\u63d0\u95ee\u9898\u65f6\u6362\u4e86\u4e00\u4e0b\u6982\u5ff5\uff0c\u6211\u95ee\u7684\u662f\u62a5\u8b66\u7b97\u4e0d\u800c\u4e0d\u662f\u62a5\u8b66\u7684\u6027\u80fd\u7b97\u4e0d\u7b97\uff0c\u663e\u7136\u62a5\u8b66\u662f\u4e00\u4e2a\u529f\u80fd\uff0c\u800c\u57fa\u672c\u6027\u80fd\u4e00\u5b9a\u662f\u6027\u80fd\uff0c\u90a3\u62a5\u8b66\u7684\u6027\u80fd\u7b97\u4e0d\u7b97\u5462?\u6bd4\u5982\u91cd\u75c7\u76d1\u62a4\u5ba4\u7684\u547c\u5438\u673a\u60a3\u8005\u8fde\u7eed3s\u6c27\u6c14\u4e0d\u8db3\u5c31\u62a5\u8b66\uff0c\u8fd9\u4e2a\u65f6\u95f4(\u6c27\u6c14\u538b\u529b<X,\u6301\u7eed3s\u7684\u8bdd\u5c31\u62a5\u8b66)\u662f\u5b83\u7684\u6027\u80fd\uff0c\u6240\u4ee5\u8fd9\u4e2a\u62a5\u8b66\u6027\u80fd\u5c31\u6709\u9650\u503c\uff0c\u8d85\u8fc7\u8fd9\u4e2a\u9650\u503c\u5c31\u4f1a\u51fa\u73b0.\u4e0a\u8ff0\u6240\u8bf4\u7684\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
5\uff09\u3001\u5927\u91cf\u7684\u4ea7\u54c1\uff0c\u53ef\u80fd\u662f\u6ca1\u6709\u4e13\u6807\u7684\uff0c\u53ef\u4ee5\u57fa\u4e8e\u4ee5\u4e0a\u601d\u7ef4\u4e3b\u52a8\u8bc6\u522b\uff0c\u5728\u98ce\u9669\u5206\u6790\u6587\u6863\u4e2d\u8bb0\u5f55\u81ea\u5df1\u7684\u5206\u6790\u7ed3\u679c\uff0c\u5408\u7406\u7684\u5b9a\u4e49\u57fa\u672c\u6027\u80fd\uff0c\u57fa\u4e8e\u529f\u80fd\u964d\u4f4e\u6216\u4e27\u5931\u4f1a\u5bfc\u81f4\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u7684\u5c3a\u5ea6\u3002<\/p>\n
\u6bd4\u5982\u989d\u6e29\u67aa\uff0c\u4f7f\u7528\u8fc7\u7a0b\u4e0d\u63a5\u89e6\u4eba\u4f53\uff0c\u7535\u538b\u4e3a\u76f4\u6d413V\uff0c\u624b\u6301\u5f0f\u8bbe\u5907\uff0c\u8bd5\u60f3\u4e00\u4e0b\u5b83\u80fd\u9020\u6210\u4ec0\u4e48\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\uff0c\u4ed6\u6709\u6ca1\u6709\u57fa\u672c\u6027\u80fd\u5462? <\/p>\n
6)\u3001\u5236\u5546\u9700\u8981\u89c4\u5b9a\u6216\u6309\u7167\u4e13\u6807\u4e2d(IEC 60601-2-XX) \u7684\u89c4\u5b9a\u660e\u786e\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
\u5177\u4f53\u64cd\u4f5c\u5c42\u9762\uff0c\u5982\u679c\u4ea7\u54c1\u6709\u4e13\u6807\uff0c\u53ef\u4ee5\u53bb\u53c2\u8003\u5bf9\u5e94\u7684\u65b0\u7248\u4e13\u6807201.4.3\u8fd9\u4e2a\u201c\u57fa\u672c\u6027\u80fd\u201d\u5b9a\u4e49\u6761\u6b3e\uff0c\u5982\u679c\u8fd9\u4e2a\u6761\u6b3e\u6709\u5b9a\u4e49\uff0c\u57fa\u672c\u4e0a\u53ef\u4ee5\u4f7f\u7528\u4e13\u6807\u5b9a\u4e49\u7684\u57fa\u672c\u6027\u80fd\u3002\u59829706.219\u5a74\u513f\u57f9\u517b\u7bb1\uff0c\u5c31\u6709\u6b64\u7c7b\u5b9a\u4e49\uff0c\u57fa\u672c\u4e0a\u76f4\u63a5\u4f7f\u7528\u4e13\u6807\u5b9a\u4e49\u7684\u57fa\u672c\u6027\u80fd\u5373\u53ef\uff0c\u8be5\u6807\u51c6\u5b9a\u4e49\u4e86\u5a74\u513f\u57f9\u517b\u7bb1\u7684\u57fa\u672c\u6027\u80fd\uff0c\u5982\u4e0b\u56fe\u3002\u5177\u4f53\u662f\u62a5\u8b66\u529f\u80fd\uff0c\u5206\u522b\u662f\u76ae\u80a4\u6e29\u5ea6\u8d85\u9650\u62a5\u8b66\u548c\u7a7a\u6c14\u6e29\u5ea6\u8d85\u9650\u62a5\u8b66\u3002\u4e3a\u4ec0\u4e48\u662f\u62a5\u8b66\u800c\u4e0d\u662f\u6e29\u5ea6\u8d85\u9650\u5236\u7684\u529f\u80fd\u4f5c\u4e3a\u57fa\u672c\u6027\u80fd\u5462\uff0c\u56e0\u4e3a\u6e29\u5ea6\u8d85\u9650\uff0c\u5728\u4ea7\u54c1\u8bbe\u8ba1\u5c42\u9762\u8fd8\u6709\u4e00\u5c42\u62a5\u8b66\u529f\u80fd\u4f5c\u4e3a\u7b2c\u4e8c\u91cd\u9632\u62a4\u9519\u63aa\u65bd\uff0c\u5982\u679c\u6e29\u5ea6\u8d85\u9650\uff0c\u4f46\u662f\u53ca\u65f6\u62a5\u8b66\u4e86\uff0c\u533b\u62a4\u4eba\u5458\u53ef\u4ee5\u53ca\u65f6\u5904\u7406\uff0c\u8ba4\u4e3a\u5927\u6982\u7387\u4e0d\u4f1a\u9020\u6210\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\uff0c\u4f46\u662f\u62a5\u8b66\u529f\u80fd\u4e27\u5931\u4e86\uff0c\u5c31\u4f1a\u5bfc\u81f4\u533b\u62a4\u4eba\u5458\u65e0\u6cd5\u8bc6\u522b\u8d85\u9650\u4e86\uff0c\u6700\u7ec8\u5bfc\u81f4\u4e0d\u53ef\u63a5\u53d7\u98ce\u9669\u3002\u56e0\u6b64\u5b9a\u4e49\u62a5\u8b66\u529f\u80fd\u4e3a\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
![\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe5\"](\"https:\/\/pic1.zhimg.com\/80\/v2-958dd82cdd04afe1b1ac221cff6b143c_720w.webp\" "\\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe5\\"")
<\/div>\n
\u518d\u59829706.252\uff0c\u533b\u7528\u5e8a\uff0c\u6807\u51c6\u5728201.4.3\u8fd9\u4e2a\u6761\u6b3e\u4e0a\u6ca1\u6709\u5b9a\u4e49\uff0c\u56e0\u6b64\u8ba4\u4e3a\u533b\u7528\u5e8a\u6ca1\u6709\u57fa\u672c\u6027\u80fd\u3002\u4f46\u5e76\u4e0d\u4ee3\u8868\u6ca1\u6709\u201c\u57fa\u672c\u529f\u80fd\u201d\u6216\u201c\u4e34\u5e8a\u529f\u80fd\u201d\u3002\u53ea\u662f\u8ba4\u4e3a\u5e8a\u7684\u529f\u80fd\u5931\u6548\uff0c\u4e0d\u4f1a\u5e26\u6765\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\u3002<\/p>\n
5\u3001\u5982\u4f55\u8bc6\u522b\u548c\u5b9a\u4e49\u57fa\u672c\u6027\u80fd\uff1f<\/p>\n
\u5173\u4e8e\u4ec0\u4e48\u4ea7\u54c1\u5e94\u8be5\u6709\u201c\u57fa\u672c\u6027\u80fd\u201d\uff0c\u4ec0\u4e48\u53c2\u6570\u5e94\u8be5\u5b9a\u4e49\u4e3a\u57fa\u672c\u6027\u80fd\uff0c\u6807\u51c6\u5e76\u6ca1\u6709\u660e\u786e\u7684\u8bf4\u6cd5\uff0c\u5168\u662f\u57fa\u4e8e\u98ce\u9669\u7684\u601d\u7ef4\u6765\u8bc6\u522b\uff0c\u56e0\u6b64\u6709\u5f88\u5927\u7684\u4e3b\u89c2\u6027\u3002\u4e00\u4e2a\u533b\u7597\u5668\u68b0\u53ef\u4ee5\u6709\u5f88\u591a\u7684\u6027\u80fd\u6216\u529f\u80fd\uff0c\u4f46\u5e76\u4e0d\u662f\u6240\u6709\u6027\u80fd(\u529f\u80fd)\u90fd\u662f\u57fa\u672c\u6027\u80fd\u3002\u4ea7\u54c1\u7684\u6027\u80fd\u662f\u4e0d\u662f\u57fa\u672c\u6027\u80fd\u53d6\u51b3\u4e8e\u533b\u7597\u5668\u68b0\u7684\u4f7f\u7528\uff0c\u6bd4\u5982\u4e00\u4e2a\u75c5\u4eba\u62ac\u5347\u88c5\u7f6e\u6709\u4e24\u4e2a\u6027\u80fd:\u62ac\u5347\u75c5\u4eba\u548c\u4e0b\u964d\u75c5\u4eba\uff0c\u901a\u8fc7\u98ce\u9669\u5206\u6790\u53ef\u80fd\u8bc1\u660e\u4e0d\u80fd\u62ac\u5347\u75c5\u4eba\u98ce\u9669\u53ef\u63a5\u53d7\uff0c\u4f46\u662f\u4e0d\u80fd\u4e0b\u964d\u75c5\u4eba\u98ce\u9669\u5c31\u4e0d\u53ef\u63a5\u53d7\u3002\u56e0\u6b64\uff0c\u4ec5\u4ec5\u4e0b\u964d\u75c5\u4eba\u529f\u80fd\u662f\u4e00\u4e2a\u57fa\u672c\u6027\u80fd\u529f\u80fd\u3002<\/p>\n
\u6211\u4eec\u5217\u4e3e\u4e00\u4e0b\u4e0d\u540c\u4e13\u6807\u4e2d\u89c4\u5b9a\u7684\u57fa\u672c\u6027\u80fd:<\/p>\n
IEC 60601-2-54\u4e2d\u9488\u5bf9X\u5c04\u7ebf\u673a\u89c4\u5b9a: accuracy of loadingfactors,reproducibility of the radiation output , automatic control system, imaging performance\u4f5c\u4e3aEssential performance IEC 60601-2-45 \u4e2d\u9488\u5bf9\u4e73\u8109\u673a\u89c4\u5b9a: accuracy of 1oading factors,reproducibility of the radiation output , automatic control system\uff0c imaging performance\uff0cmissed tissue at chest wall side\uff0c breast compressiondevice, linearity of air karma over limited intervals of loading factors IEC 60601-2- 44\u4e2d\u9488\u5bf9CT\u89c4\u5b9a: For CT SCANNERS for whichthe INTENDED USE includes COMPUTED TOMOGRAPHY as the principal means of guidance in invasive procedures (e. g.\uff0cinvolving the introduction of a device, such as a needle or a catheter into the body of the PATIENT)<\/p>\n
IEC 60601-2-1\u4e2d\u9488\u5bf9\u52a0\u901f\u5668\u89c4\u5b9a: Protection against unwanted and excessiveradiation HAZARDS \u90fd\u4f5c\u4e3a\u57fa\u672c\u6027\u80fd<\/p>\n
\u4ece\u4e0d\u540c\u7684\u4e13\u6807\u89c4\u5b9a\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u867d\u7136\u90fd\u5c5e\u4e8eX\u5c04\u7ebf\u7c7b\u8bbe\u5907\uff0c\u4f46\u4e0d\u540c\u7684\u4e13\u6807\u5b9a\u4e49\u57fa\u672c\u6027\u80fd\u7684\u89d2\u5ea6\u4e0d\u4e00\u6837\uff0c\u7279\u522b\u662fIEC 60601-2-1\u628a\u6cc4\u9732\u8f90\u5c04\u4f5c\u4e3a\u57fa\u672c\u6027\u80fd\uff0c\u800c60601-2-44\uff0c -2-45\uff0c-2-54\u5e76\u6ca1\u6709\u5c06\u6cc4\u9732\u8f90\u5c04\u4f5c\u4e3a\u57fa\u672c\u6027\u80fd\u3002\u4e0d\u540c\u7684\u6807\u59d4\u4f1a\u5bf9\u57fa\u672c\u6027\u80fd\u7684\u9009\u62e9\u548c\u5b9a\u4e49\u4e5f\u5b58\u5728\u7740\u8bb8\u591a\u4e0d\u4e00\u81f4\u7684\u5730\u65b9\u3002\u4ee4\u4eba\u6b23\u6170\u7684\u662f\uff0cIEC\u6280\u672f\u59d4\u5458\u4f1a\u5df2\u7ecf\u610f\u8bc6\u5230\u8fd9\u79cd\u4e0d\u4e00\u81f4\u7684\u60c5\u51b5\uff0c\u9884\u8ba1\u5728IEC 60601-1\u76844.0\u7248\u4e2d\uff0c\u4f1a\u5bf9\u8fd9\u4e9b\u95ee\u9898\u4e00\u5e76\u8003\u8651\u5e76\u534f\u8c03\u7edf\u4e00\u3002<\/p>\n
\u5b9a\u4e49\u57fa\u672c\u6027\u80fd\u7684\u51fa\u53d1\u70b9\u662f\u5236\u9020\u5546\u5fc5\u987b\u5728\u8bbe\u8ba1\u4ea7\u54c1\u65f6\u8003\u8651\u7531\u4e8e\u4e34\u5e8a\u529f\u80fd\u76f8\u5173\u7684\u6027\u80fd\u51fa\u73b0\u95ee\u9898\u65f6\u5f15\u8d77\u7684\u5b89\u5168\u98ce\u9669\u3002\u5177\u4f53\u64cd\u4f5c\u5c42\u9762\uff0c\u5982\u679c\u4ea7\u54c1\u6709\u4e13\u6807\uff0c\u53ef\u4ee5\u53bb\u53c2\u8003\u5bf9\u5e94\u7684\u65b0\u7248\u4e13\u6807201.4.3\u8fd9\u4e2a\u201c\u57fa\u672c\u6027\u80fd\u201d\u5b9a\u4e49\u6761\u6b3e\uff0c\u5982\u679c\u8fd9\u4e2a\u6761\u6b3e\u6709\u5b9a\u4e49\uff0c\u57fa\u672c\u4e0a\u53ef\u4ee5\u4f7f\u7528\u4e13\u6807\u5b9a\u4e49\u7684\u57fa\u672c\u6027\u80fd\u3002\u5982\u679c\u6807\u51c6\u6ca1\u6709\u5b9a\u4e49\uff0c\u8bc6\u522b\u57fa\u672c\u6027\u80fd\u7684\u8475\u82b1\u5b9d\u5178\u5c31\u662f\u98ce\u9669\u5206\u6790\u3002\u5728\u8fdb\u884c\u98ce\u9669\u5206\u6790\u65f6\uff0c\u5fc5\u987b\u8fdb\u884c\u201c\u57fa\u672c\u6027\u80fd\u201d\u7684\u8bc6\u522b\u8fd9\u4e00\u4e2a\u52a8\u4f5c\u548c\u8fc7\u7a0b\uff0c\u5e76\u4e14\u5728\u98ce\u9669\u5206\u6790\u6587\u6863\u4e2d\u4e88\u4ee5\u8bb0\u5f55\u3002\u8bc6\u522b\u7684\u7ed3\u679c\uff0c\u57fa\u4e8e\u98ce\u9669\u7684\u601d\u7ef4\uff0c\u53ef\u4ee5\u662f\u6709\u57fa\u672c\u6027\u80fd\uff0c\u4e5f\u53ef\u4ee5\u662f\u6ca1\u6709\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
\u57fa\u672c\u6027\u80fd\u7684\u786e\u5b9a\u8fc7\u7a0b\u5982\u4e0b\uff1a<\/p>\n
1).\uff08\u5236\u9020\u5546\uff09\u5728\u521d\u59cb\u7684\u98ce\u9669\u5206\u6790\u4e2d\uff0c\u9664\u4e86\u786e\u5b9a\u5668\u68b0\u5fc5\u987b\u8981\u8fbe\u5230\u7684\u9884\u671f\u7528\u9014\u4e0e\u57fa\u672c\u5b89\u5168\u76f8\u5173\u7684\u6027\u80fd\u5916\uff0c\u5236\u9020\u5546\u9700\u8bc6\u522b\u4e34\u5e8a\u529f\u80fd\u7684\u6027\u80fd\uff0c\u8fd9\u5bf9\u4e8e\u5b9e\u73b0\u9884\u671f\u7528\u9014\u662f\u5fc5\u987b\u7684\uff0c\u6216\u8005\u80fd\u591f\u5f71\u54cd\u8bbe\u5907\u7684\u5b89\u5168\u6027\u3002<\/p>\n
2). \uff08\u5236\u9020\u5546\uff09\u8981\u8fd9\u4e9b\u8bc6\u522b\u51fa\u7684\u6027\u80fd\uff0c\u5e76\u89c4\u5b9a\u6b63\u5e38\u72b6\u6001\u548c\u5355\u4e00\u6545\u969c\u72b6\u6001\u4e0b\u7684\u6027\u80fd\u9650\u503c\u3002<\/p>\n
3). \u5236\u9020\u5546\u8981\u8bc4\u4f30\u786e\u5b9a\u7684\u6027\u80fd\u4e27\u5931\u6216\u964d\u4f4e\u8d85\u8fc7\u5236\u9020\u5546\u89c4\u5b9a\u7684\u9650\u503c\u540e\u5bfc\u81f4\u7684\u98ce\u9669\u3002\u5982\u679c\u98ce\u9669\u662f\u4e0d\u53ef\u63a5\u53d7\u7684\uff0c\u90a3\u4e48\u6b64\u6027\u80fd\u5373\u53ef\u786e\u8ba4\u5668\u68b0\u7684\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
4). \u5236\u9020\u5546\u5e94\u5b9e\u65bd\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u4ee5\u51cf\u5c11\u56e0\u57fa\u672c\u6027\u80fd\u4e27\u5931\u6216\u964d\u4f4e\u800c\u5bfc\u81f4\u7684\u98ce\u9669\uff0c\u4f7f\u5176\u8fbe\u5230\u53ef\u63a5\u53d7\u7684\u6c34\u5e73\u3002<\/p>\n
5). \u4e00\u65e6\u786e\u5b9a\u4e3a\u57fa\u672c\u6027\u80fd\uff0c\u5236\u9020\u5546\u5e94\u5b9e\u65bd\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u4ee5\u51cf\u5c11\u56e0\u57fa\u672c\u6027\u80fd\u4e27\u5931\u6216\u964d\u4f4e\u800c\u5bfc\u81f4\u7684\u98ce\u9669\uff0c\u4f7f\u5176\u8fbe\u5230\u53ef\u63a5\u53d7\u6c34\u5e73\u3002<\/p>\n
6).\u98ce\u9669\u63a7\u5236\u63aa\u65bd\uff1a\u5982\u751f\u547d\u7ef4\u6301\u7cfb\u7edf\uff0c\u5176\u57fa\u672c\u6027\u80fd\u5c31\u662f\u4fdd\u6301\u529f\u80fd\u6b63\u5e38\u6765\u7ef4\u6301\u751f\u547d\u3002\u98ce\u9669\u5206\u6790\u8bc6\u522b\u51fa\u5982\u679c\u65ad\u7535\u9020\u6210\u529f\u80fd\u7684\u4e27\u5931\u4f1a\u5f15\u8d77\u60a3\u8005\u7684\u6b7b\u4ea1\u3002\u56e0\u6b64\u8bbe\u8ba1\u4e0a\u8981\u8003\u91cf\u65ad\u7535\u5907\u7528\u7535\u6e90\u8bbe\u8ba1\u3001\u65ad\u7535\u62a5\u8b66\u6216\u8fdc\u7a0b\u65e0\u7ebf\u62a5\u8b66\u63aa\u65bd\u3002<\/p>\n
\u6700\u540e\u5f3a\u8c03\u4e00\u70b9\uff0c\u5e76\u4e0d\u662f\u6240\u6709\u7684\u5668\u68b0\u90fd\u6709\u201c\u57fa\u672c\u6027\u80fd\u201d\u3002<\/p>\n
\u57fa\u672c\u6027\u80fd\u7684\u5b9a\u4e49\u975e\u5e38\u91cd\u8981\uff0c\u4f1a\u5f71\u54cd\u5230\u7535\u78c1\u517c\u5bb9\u6297\u6270\u5ea6\u6d4b\u8bd5\u7684\u63a5\u6536\u51c6\u5219\uff0c\u4e5f\u4f1a\u5173\u7cfb\u523014\u7ae0PEMS\u53ef\u7f16\u7a0b\u533b\u7528\u7535\u6c14\u7cfb\u7edf\u662f\u5426\u5e94\u91c7\u53d6\u76f8\u5173\u63aa\u65bd\u7684\u7a0b\u5ea6\u3002\u56e0\u6b64\u4e00\u5b9a\u8981\u6070\u5f53\u7684\u5b9a\u4e49\u57fa\u672c\u6027\u80fd\u3002\u90a3\u4e48\u4f5c\u4e3a\u4f01\u4e1a\uff0c\u5e94\u8be5\u7efc\u5408\u8003\u8651\u4e0a\u8ff0\u98ce\u9669\u5b9a\u51fa\u81ea\u5df1\u7684\u98ce\u9669\u53ef\u63a5\u53d7\u51c6\u5219\uff0c\u518d\u4f9d\u7167\u5982\u4e0b\u6b65\u9aa4\u53bb\u5224\u65ad\u662f\u5426\u4e3a\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
1)\u3001\u662f\u4e0d\u662f\u4e0e\u57fa\u672c\u5b89\u5168\u76f8\u5173\u7684\uff0c\u5982\u679c\u662f\uff0c\u6bd4\u5982\u57fa\u672c\u7edd\u7f18\uff0c\u4e0d\u7528\u5f80\u4e0b\u8d70\uff0c\u4e00\u5b9a\u4e0d\u662f\u57fa\u672c\u6027\u80fd;<\/p>\n
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3)\u3001\u5224\u65ad\u8be5\u6027\u80fd\u662f\u4e0d\u662f\u6709\u9650\u503c\uff1a\u5982\u679c\u6ca1\u6709\uff0c\u4e00\u5b9a\u4e0d\u662f\u57fa\u672c\u6027\u80fd\uff0c\u5982\u679c\u6709\u9650\u503c\uff0c\u6267\u884c4;<\/p>\n
4)\u3001\u8be5\u6027\u80fd\u964d\u4f4e\u6216\u4e27\u5931\u5230\u9650\u503c\u4ee5\u4e0b\u662f\u5426\u4f1a\u5bfc\u81f4\u4e0d\u53ef\u63a5\u53d7\u7684\u98ce\u9669\uff0c\u8fd9\u91cc\u5c31\u8981\u7ed3\u5408\u4e0a\u9762\u5df2\u7ecf\u5236\u5b9a\u7684\u98ce\u9669\u53ef\u63a5\u53d7\u51c6\u5219\u8fdb\u884c\u5224\u5b9a\uff0c\u5982\u679c\u98ce\u9669\u4f9d\u7136\u53ef\u63a5\u53d7\uff0c\u5c31\u4e0d\u662f\u57fa\u672c\u6027\u80fd\uff0c\u53cd\u4e4b\uff0c\u8be5\u6027\u80fd\u5c31\u5224\u5b9a\u4e3a\u57fa\u672c\u6027\u80fd\u3002<\/p>\n
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l \u5f62\u6210\u98ce\u9669\u7ba1\u7406\u6587\u4ef6\u3002<\/p>\n
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![\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe\"](\"https:\/\/pic2.zhimg.com\/80\/v2-32c39e1843c1bbf28b00c9a40f24f51d_720w.webp\" "\\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe\\"")
<\/div>\n ![\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe1\"](\"https:\/\/pic4.zhimg.com\/80\/v2-5f82352ed403091298cee31db8dd4697_720w.webp\" "\\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe1\\"")
<\/div>\n ![\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe2\"](\"https:\/\/pic3.zhimg.com\/80\/v2-7c12b7d6fe97f92cb7383d90c29db0e2_720w.webp\" "\\"\u533b\u7528\u7535\u6c14\u8bbe\u5907\u57fa\u672c\u5b89\u5168\u548c\u57fa\u672c\u6027\u80fd\uff089706\uff09\u89e3\u8bfb\u63d2\u56fe2\\"")
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