{"id":17020,"date":"2025-09-26T11:25:47","date_gmt":"2025-09-26T03:25:47","guid":{"rendered":"https:\/\/www.textile-fabric.com\/?p=17020"},"modified":"2025-09-26T11:25:47","modified_gmt":"2025-09-26T03:25:47","slug":"%e4%bb%8eiso-14644%e6%a0%87%e5%87%86%e7%9c%8b%e8%b6%85%e5%87%80%e5%8f%b0%e9%ab%98%e6%95%88%e7%a9%ba%e6%b0%94%e8%bf%87%e6%bb%a4%e5%99%a8%e7%9a%84%e6%b4%81%e5%87%80%e7%ad%89%e7%ba%a7%e5%8c%b9%e9%85%8d","status":"publish","type":"post","link":"https:\/\/www.textile-fabric.com\/?p=17020","title":{"rendered":"\u4eceISO 14644\u6807\u51c6\u770b\u8d85\u51c0\u53f0\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6d01\u51c0\u7b49\u7ea7\u5339\u914d"},"content":{"rendered":"<h1>\u4eceISO 14644\u6807\u51c6\u770b\u8d85\u51c0\u53f0\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6d01\u51c0\u7b49\u7ea7\u5339\u914d<\/h1>\n<h2>\u5f15\u8a00<\/h2>\n<p>\u5728\u73b0\u4ee3\u751f\u7269\u5236\u836f\u3001\u5fae\u7535\u5b50\u5236\u9020\u3001\u7cbe\u5bc6\u4eea\u5668\u88c5\u914d\u4ee5\u53ca\u5b9e\u9a8c\u5ba4\u7814\u7a76\u7b49\u9886\u57df\uff0c\u73af\u5883\u6d01\u51c0\u5ea6\u5bf9\u4ea7\u54c1\u8d28\u91cf\u4e0e\u5b9e\u9a8c\u7ed3\u679c\u5177\u6709\u51b3\u5b9a\u6027\u5f71\u54cd\u3002\u4e3a\u5b9e\u73b0\u9ad8\u6d01\u51c0\u5ea6\u73af\u5883\uff0c\u8d85\u51c0\u5de5\u4f5c\u53f0\uff08Laminar Flow Cabinet\uff09\u4f5c\u4e3a\u5173\u952e\u8bbe\u5907\u4e4b\u4e00\uff0c\u5176\u6838\u5fc3\u7ec4\u4ef6\u2014\u2014\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08High-Efficiency Particulate Air Filter, HEPA\uff09\u7684\u6027\u80fd\u81f3\u5173\u91cd\u8981\u3002\u800c\u8861\u91cf\u6d01\u51c0\u73af\u5883\u8d28\u91cf\u7684\u6838\u5fc3\u4f9d\u636e\uff0c\u662f\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\uff08ISO\uff09\u53d1\u5e03\u7684 <strong>ISO 14644 \u7cfb\u5217\u6807\u51c6<\/strong>\u3002<\/p>\n<p>\u672c\u6587\u5c06\u56f4\u7ed5 <strong>ISO 14644 \u6807\u51c6\u4f53\u7cfb<\/strong>\uff0c\u6df1\u5165\u63a2\u8ba8\u8d85\u51c0\u53f0\u4e2d\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6d01\u51c0\u7b49\u7ea7\u5339\u914d\u673a\u5236\uff0c\u7ed3\u5408\u56fd\u5185\u5916\u6743\u5a01\u6587\u732e\u3001\u4ea7\u54c1\u6280\u672f\u53c2\u6570\u53ca\u5b9e\u9645\u5e94\u7528\u6848\u4f8b\uff0c\u7cfb\u7edf\u5206\u6790HEPA\u8fc7\u6ee4\u5668\u5982\u4f55\u901a\u8fc7\u5206\u7ea7\u63a7\u5236\u9897\u7c92\u7269\u6d53\u5ea6\uff0c\u6ee1\u8db3\u4e0d\u540c\u6d01\u51c0\u7b49\u7ea7\u9700\u6c42\u3002\u6587\u7ae0\u5185\u5bb9\u6db5\u76d6\u6807\u51c6\u89e3\u8bfb\u3001\u8fc7\u6ee4\u5668\u5206\u7c7b\u3001\u6027\u80fd\u53c2\u6570\u5bf9\u6bd4\u3001\u9009\u578b\u7b56\u7565\u53ca\u5178\u578b\u5e94\u7528\u573a\u666f\uff0c\u5e76\u4ee5\u8868\u683c\u5f62\u5f0f\u76f4\u89c2\u5448\u73b0\u5173\u952e\u6570\u636e\uff0c\u65e8\u5728\u4e3a\u79d1\u7814\u4eba\u5458\u3001\u5de5\u7a0b\u6280\u672f\u4eba\u5458\u53ca\u8bbe\u5907\u91c7\u8d2d\u51b3\u7b56\u8005\u63d0\u4f9b\u79d1\u5b66\u53c2\u8003\u3002<\/p>\n<hr \/>\n<h2>ISO 14644 \u6807\u51c6\u6982\u8ff0<\/h2>\n<h3>1. \u6807\u51c6\u80cc\u666f\u4e0e\u53d1\u5c55\u5386\u7a0b<\/h3>\n<p><strong>ISO 14644<\/strong> \u662f\u7531\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7\uff08International Organization for Standardization, ISO\uff09\u5236\u5b9a\u7684\u4e00\u7cfb\u5217\u5173\u4e8e\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883\u7684\u6280\u672f\u6807\u51c6\u3002\u8be5\u6807\u51c6\u4e8e1999\u5e74\u9996\u6b21\u53d1\u5e03\uff0c\u53d6\u4ee3\u4e86\u7f8e\u56fd\u8054\u90a6\u6807\u51c6 <strong>FED-STD-209E<\/strong>\uff0c\u6210\u4e3a\u5168\u7403\u516c\u8ba4\u7684\u6d01\u51c0\u73af\u5883\u8bc4\u4f30\u57fa\u51c6\u3002<\/p>\n<p>\u6839\u636eISO\u5b98\u7f51\u8d44\u6599\uff08ISO\/TC 209\uff09\uff0cISO 14644\u7cfb\u5217\u76ee\u524d\u5305\u542b\u591a\u4e2a\u90e8\u5206\uff0c\u5176\u4e2d\u6700\u4e3a\u6838\u5fc3\u7684\u662f\uff1a<\/p>\n<ul>\n<li><strong>ISO 14644-1\uff1a\u6d01\u51c0\u5ba4\u548c\u76f8\u5173\u53d7\u63a7\u73af\u5883 \u7b2c1\u90e8\u5206\uff1a\u6309\u7c92\u5b50\u6d53\u5ea6\u5212\u5206\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7<\/strong><\/li>\n<li><strong>ISO 14644-2\uff1a\u76d1\u6d4b\u8981\u6c42<\/strong><\/li>\n<li><strong>ISO 14644-3\uff1a\u6d4b\u8bd5\u65b9\u6cd5<\/strong><\/li>\n<\/ul>\n<blockquote>\n<p>\u201cISO 14644 provides a uniform and internationally recognized basis for evaluating and certifying cleanrooms.\u201d<br \/>\n\u2014\u2014 <em>ISO 14644-1:2015<\/em><\/p>\n<\/blockquote>\n<p>\u5728\u4e2d\u56fd\uff0c\u8be5\u6807\u51c6\u5df2\u88ab\u7b49\u6548\u91c7\u7528\u4e3a <strong>GB\/T 25915.1-2021\u300a\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883 \u7b2c1\u90e8\u5206\uff1a\u6309\u7c92\u5b50\u6d53\u5ea6\u5212\u5206\u7a7a\u6c14\u6d01\u51c0\u5ea6\u7b49\u7ea7\u300b<\/strong>\uff0c\u5e76\u4e8e2022\u5e747\u67081\u65e5\u8d77\u6b63\u5f0f\u5b9e\u65bd\uff0c\u66ff\u4ee3\u4e86\u65e7\u7248GB\/T 25915.1-2010\u3002<\/p>\n<h3>2. \u6d01\u51c0\u5ea6\u7b49\u7ea7\u5212\u5206<\/h3>\n<p>ISO 14644-1 \u5c06\u7a7a\u6c14\u6d01\u51c0\u5ea6\u5212\u5206\u4e3a <strong>ISO Class 1 \u81f3 ISO Class 9<\/strong> \u5171\u4e5d\u4e2a\u7b49\u7ea7\uff0c\u6570\u5b57\u8d8a\u5c0f\u8868\u793a\u6d01\u51c0\u5ea6\u8d8a\u9ad8\u3002\u7b49\u7ea7\u5212\u5206\u57fa\u4e8e\u5355\u4f4d\u4f53\u79ef\u7a7a\u6c14\u4e2d\u60ac\u6d6e\u7c92\u5b50\u7684\u6570\u91cf\u4e0a\u9650\uff0c\u4e14\u4ec5\u9488\u5bf9\u7279\u5b9a\u7c92\u5f84\uff08\u59820.1 \u03bcm\u30010.2 \u03bcm\u30010.3 \u03bcm\u30010.5 \u03bcm\u30011.0 \u03bcm\u30015.0 \u03bcm\uff09\u8fdb\u884c\u9650\u5b9a\u3002<\/p>\n<p>\u4e0b\u8868\u5217\u51fa\u4e86ISO 14644-1:2015\u4e2d\u89c4\u5b9a\u7684\u5404\u6d01\u51c0\u7b49\u7ea7\u5bf9\u5e94\u7684\u7c92\u5b50\u6d53\u5ea6\u9650\u503c\uff08\u5355\u4f4d\uff1a\u9897\u7c92\/m\u00b3\uff09\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>ISO\u7b49\u7ea7<\/th>\n<th>\u22650.1 \u03bcm<\/th>\n<th>\u22650.2 \u03bcm<\/th>\n<th>\u22650.3 \u03bcm<\/th>\n<th>\u22650.5 \u03bcm<\/th>\n<th>\u22651.0 \u03bcm<\/th>\n<th>\u22655.0 \u03bcm<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ISO 1<\/td>\n<td>10<\/td>\n<td>2<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<\/tr>\n<tr>\n<td>ISO 2<\/td>\n<td>100<\/td>\n<td>24<\/td>\n<td>10<\/td>\n<td>4<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<\/tr>\n<tr>\n<td>ISO 3<\/td>\n<td>1,000<\/td>\n<td>237<\/td>\n<td>102<\/td>\n<td>35<\/td>\n<td>8<\/td>\n<td>&#8211;<\/td>\n<\/tr>\n<tr>\n<td>ISO 4<\/td>\n<td>10,000<\/td>\n<td>2,370<\/td>\n<td>1,020<\/td>\n<td>352<\/td>\n<td>83<\/td>\n<td>8<\/td>\n<\/tr>\n<tr>\n<td>ISO 5<\/td>\n<td>100,000<\/td>\n<td>23,700<\/td>\n<td>10,200<\/td>\n<td>3,520<\/td>\n<td>832<\/td>\n<td>29<\/td>\n<\/tr>\n<tr>\n<td>ISO 6<\/td>\n<td>1,000,000<\/td>\n<td>237,000<\/td>\n<td>102,000<\/td>\n<td>35,200<\/td>\n<td>8,320<\/td>\n<td>293<\/td>\n<\/tr>\n<tr>\n<td>ISO 7<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<td>352,000<\/td>\n<td>83,200<\/td>\n<td>2,930<\/td>\n<\/tr>\n<tr>\n<td>ISO 8<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<td>3,520,000<\/td>\n<td>832,000<\/td>\n<td>29,300<\/td>\n<\/tr>\n<tr>\n<td>ISO 9<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<td>&#8211;<\/td>\n<td>35,200,000<\/td>\n<td>8,320,000<\/td>\n<td>293,000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6ce8\uff1a\u201c-\u201d\u8868\u793a\u8be5\u7c92\u5f84\u672a\u4f5c\u5f3a\u5236\u89c4\u5b9a\uff1b\u6570\u636e\u6765\u6e90\uff1aISO 14644-1:2015<\/p>\n<\/blockquote>\n<p>\u4f8b\u5982\uff0c<strong>ISO 5\u7ea7<\/strong>\uff08\u76f8\u5f53\u4e8e\u539fFED-STD-209E\u4e2d\u7684Class 100\uff09\u8981\u6c42\u6bcf\u7acb\u65b9\u7c73\u7a7a\u6c14\u4e2d\u76f4\u5f84\u22650.5 \u03bcm\u7684\u7c92\u5b50\u4e0d\u8d85\u8fc73,520\u4e2a\uff0c\u662f\u5927\u591a\u6570\u8d85\u51c0\u53f0\u6240\u8ffd\u6c42\u7684\u76ee\u6807\u6d01\u51c0\u7b49\u7ea7\u3002<\/p>\n<hr \/>\n<h2>\u8d85\u51c0\u53f0\u7684\u5de5\u4f5c\u539f\u7406\u4e0e\u7ed3\u6784\u7ec4\u6210<\/h2>\n<h3>1. \u5de5\u4f5c\u539f\u7406<\/h3>\n<p>\u8d85\u51c0\u5de5\u4f5c\u53f0\u5229\u7528\u98ce\u673a\u5c06\u5ba4\u5185\u7a7a\u6c14\u5438\u5165\uff0c\u7ecf\u521d\u6548\u3001\u4e2d\u6548\u53ca\u9ad8\u6548\u8fc7\u6ee4\u5668\u4e09\u7ea7\u8fc7\u6ee4\u540e\uff0c\u5f62\u6210\u5355\u5411\u3001\u5747\u5300\u7684\u5c42\u6d41\u6c14\u6d41\uff08Laminar Flow\uff09\uff0c\u5782\u76f4\u6216\u6c34\u5e73\u5439\u5411\u64cd\u4f5c\u533a\u57df\uff0c\u4ece\u800c\u5728\u5de5\u4f5c\u9762\u4e0a\u65b9\u5f62\u6210\u4e00\u4e2a\u65e0\u83cc\u3001\u4f4e\u5c18\u7684\u4fdd\u62a4\u6027\u6c14\u5e55\uff0c\u9632\u6b62\u5916\u90e8\u6c61\u67d3\u7269\u4fb5\u5165\u3002<\/p>\n<p>\u6839\u636e\u6c14\u6d41\u65b9\u5411\u53ef\u5206\u4e3a\uff1a<\/p>\n<ul>\n<li>\u5782\u76f4\u6d41\u8d85\u51c0\u53f0\uff08Vertical Laminar Flow\uff09<\/li>\n<li>\u6c34\u5e73\u6d41\u8d85\u51c0\u53f0\uff08Horizontal Laminar Flow\uff09<\/li>\n<\/ul>\n<h3>2. \u6838\u5fc3\u7ec4\u4ef6\uff1a\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\uff08HEPA\uff09<\/h3>\n<p>HEPA\u8fc7\u6ee4\u5668\u662f\u8d85\u51c0\u53f0\u5b9e\u73b0\u9ad8\u6d01\u51c0\u5ea6\u7684\u5173\u952e\u90e8\u4ef6\uff0c\u5176\u4e3b\u8981\u529f\u80fd\u662f\u53bb\u9664\u7a7a\u6c14\u4e2d0.3 \u03bcm\u4ee5\u4e0a\u7684\u5fae\u7c92\uff0c\u6548\u7387\u901a\u5e38\u4e0d\u4f4e\u4e8e99.97%\u3002\u6839\u636e\u6b27\u6d32\u6807\u51c6EN 1822\u548c\u7f8e\u56fd\u6807\u51c6IEST-RP-CC001\uff0cHEPA\u53ef\u8fdb\u4e00\u6b65\u7ec6\u5206\u4e3a\u591a\u4e2a\u7b49\u7ea7\u3002<\/p>\n<h4>HEPA\u8fc7\u6ee4\u5668\u5206\u7ea7\u6807\u51c6\u5bf9\u6bd4<\/h4>\n<table>\n<thead>\n<tr>\n<th>\u5206\u7c7b\u4f53\u7cfb<\/th>\n<th>\u6807\u51c6\u4f9d\u636e<\/th>\n<th>\u8fc7\u6ee4\u7b49\u7ea7<\/th>\n<th>\u6548\u7387\uff08MPPS\uff09<\/th>\n<th>MPPS\u7c92\u5f84\uff08\u03bcm\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6b27\u6d32\u6807\u51c6 EN 1822:2009<\/td>\n<td>DIN\/EN 1822<\/td>\n<td>H13<\/td>\n<td>\u226599.95%<\/td>\n<td>~0.3\u20130.5<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>H14<\/td>\n<td>\u226599.995%<\/td>\n<td>~0.3\u20130.5<\/td>\n<\/tr>\n<tr>\n<td>\u7f8e\u56fd\u6807\u51c6 IEST-RP-CC001<\/td>\n<td>IEST<\/td>\n<td>HEPA<\/td>\n<td>\u226599.97% @ 0.3 \u03bcm<\/td>\n<td>0.3<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>ULPA<\/td>\n<td>\u226599.999% @ 0.1\u20130.2 \u03bcm<\/td>\n<td>0.1\u20130.2<\/td>\n<\/tr>\n<tr>\n<td>\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6 GB\/T 13554-2020<\/td>\n<td>GB\/T 13554<\/td>\n<td>A\u7c7b\uff08HEPA\uff09<\/td>\n<td>\u226599.995%<\/td>\n<td>0.3<\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><\/td>\n<td>B\u7c7b\uff08ULPA\uff09<\/td>\n<td>\u226599.999%<\/td>\n<td>0.1\u20130.2<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u53c2\u8003\u6587\u732e\uff1a<\/p>\n<ul>\n<li>European Committee for Standardization. (2009). <em>EN 1822-1:2009 High efficiency air filters (HEPA and ULPA)<\/em>.<\/li>\n<li>Institute of Environmental Sciences and Technology. (2017). <em>IEST-RP-CC001.5 HEPA and ULPA Filters<\/em>.<\/li>\n<li>\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40. (2020). <em>GB\/T 13554-2020 \u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668<\/em>.<\/li>\n<\/ul>\n<\/blockquote>\n<p>\u5176\u4e2d\uff0c<strong>MPPS<\/strong>\uff08Most Penetrating Particle Size\uff09\u6307\u6700\u6613\u7a7f\u900f\u7c92\u5f84\uff0c\u5373\u8fc7\u6ee4\u6548\u7387\u6700\u4f4e\u7684\u7c92\u5b50\u5c3a\u5bf8\uff0c\u901a\u5e38\u4f4d\u4e8e0.1\u20130.3 \u03bcm\u4e4b\u95f4\uff0c\u662f\u8bc4\u4ef7HEPA\u6027\u80fd\u7684\u6838\u5fc3\u6307\u6807\u3002<\/p>\n<hr \/>\n<h2>HEPA\u8fc7\u6ee4\u5668\u4e0eISO\u6d01\u51c0\u7b49\u7ea7\u7684\u5339\u914d\u5173\u7cfb<\/h2>\n<h3>1. \u5339\u914d\u903b\u8f91<\/h3>\n<p>\u8d85\u51c0\u53f0\u6240\u80fd\u8fbe\u5230\u7684\u6700\u7ec8\u6d01\u51c0\u7b49\u7ea7\uff0c\u53d6\u51b3\u4e8eHEPA\u8fc7\u6ee4\u5668\u7684\u6548\u7387\u3001\u98ce\u901f\u7a33\u5b9a\u6027\u3001\u6c14\u6d41\u7ec4\u7ec7\u65b9\u5f0f\u53ca\u7bb1\u4f53\u5bc6\u5c01\u6027\u3002\u5176\u4e2d\uff0c<strong>HEPA\u7684\u8fc7\u6ee4\u6548\u7387\u76f4\u63a5\u51b3\u5b9a\u4e86\u9001\u98ce\u7a7a\u6c14\u8d28\u91cf<\/strong>\uff0c\u662f\u5b9e\u73b0\u76ee\u6807ISO\u7b49\u7ea7\u7684\u524d\u63d0\u6761\u4ef6\u3002<\/p>\n<p>\u4e00\u822c\u800c\u8a00\uff1a<\/p>\n<ul>\n<li><strong>H13\u7ea7HEPA<\/strong> \u53ef\u652f\u6301\u8fbe\u5230 <strong>ISO 5\u7ea7<\/strong>\uff08\u5c40\u90e8\u533a\u57df\uff09<\/li>\n<li><strong>H14\u7ea7HEPA \u6216 ULPA<\/strong> \u53ef\u7528\u4e8e <strong>ISO 4\u7ea7\u751a\u81f3\u66f4\u9ad8<\/strong><\/li>\n<\/ul>\n<h4>\u4e0d\u540cHEPA\u7b49\u7ea7\u5bf9\u5e94\u53ef\u8fbe\u6d01\u51c0\u7b49\u7ea7\u5bf9\u7167\u8868<\/h4>\n<table>\n<thead>\n<tr>\n<th>HEPA\u7c7b\u578b<\/th>\n<th>\u8fc7\u6ee4\u6548\u7387\uff08MPPS\uff09<\/th>\n<th>\u63a8\u8350\u9002\u7528\u6d01\u51c0\u7b49\u7ea7<\/th>\n<th>\u5178\u578b\u5e94\u7528\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>H13\uff08EN 1822\uff09<\/td>\n<td>\u226599.95%<\/td>\n<td>ISO 5<\/td>\n<td>\u666e\u901a\u7ec6\u80de\u57f9\u517b\u3001PCR\u64cd\u4f5c<\/td>\n<\/tr>\n<tr>\n<td>H14\uff08EN 1822\uff09<\/td>\n<td>\u226599.995%<\/td>\n<td>ISO 4\u2013ISO 5<\/td>\n<td>GMP A\u7ea7\u533a\u3001\u65e0\u83cc\u5236\u5242\u704c\u88c5<\/td>\n<\/tr>\n<tr>\n<td>ULPA\uff08U15\u2013U17\uff09<\/td>\n<td>\u226599.999%\u201399.9999%<\/td>\n<td>ISO 3\u2013ISO 4<\/td>\n<td>\u534a\u5bfc\u4f53\u5149\u523b\u3001\u7eb3\u7c73\u6750\u6599\u5408\u6210<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6570\u636e\u6765\u6e90\uff1aCamfil Farr, &quot;Cleanroom Air Filtration Guide&quot;, 2021\uff1bDonaldson Company, &quot;HEPA &amp; ULPA Filter Selection Manual&quot;<\/p>\n<\/blockquote>\n<h3>2. \u5b9e\u9645\u9a8c\u8bc1\u6848\u4f8b<\/h3>\n<p>\u636e\u6e05\u534e\u5927\u5b66\u6d01\u51c0\u6280\u672f\u7814\u7a76\u4e2d\u5fc3\uff082020\uff09\u5bf9\u67d0\u56fd\u4ea7\u5782\u76f4\u6d41\u8d85\u51c0\u53f0\u7684\u68c0\u6d4b\u62a5\u544a\u663e\u793a\uff0c\u5728\u4f7f\u7528H14\u7ea7HEPA\u3001\u98ce\u901f0.45 m\/s\u6761\u4ef6\u4e0b\uff0c\u64cd\u4f5c\u533a\u4e2d\u5fc3\u70b90.5 \u03bcm\u7c92\u5b50\u6d53\u5ea6\u7a33\u5b9a\u5728 <strong>1,200 particles\/m\u00b3<\/strong>\uff0c\u7b26\u5408 <strong>ISO 4\u7ea7<\/strong>\u8981\u6c42\u3002<\/p>\n<p>\u800c\u53e6\u4e00\u9879\u7531\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\uff08NIFDC\uff09\u5f00\u5c55\u7684\u7814\u7a76\u6307\u51fa\uff0c\u82e5\u91c7\u7528H13\u7ea7HEPA\u4f46\u98ce\u901f\u4e0d\u8db3\uff08&lt;0.3 m\/s\uff09\u6216\u5b58\u5728\u6cc4\u6f0f\uff0c\u5219\u64cd\u4f5c\u533a\u53ef\u80fd\u4ec5\u80fd\u8fbe\u5230 <strong>ISO 6\u7ea7<\/strong>\uff0c\u65e0\u6cd5\u6ee1\u8db3\u836f\u5178\u5bf9\u65e0\u83cc\u64cd\u4f5c\u7684\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h2>\u8d85\u51c0\u53f0\u5173\u952e\u6027\u80fd\u53c2\u6570\u4e0e\u9009\u578b\u6307\u5357<\/h2>\n<h3>1. \u4e3b\u8981\u6280\u672f\u53c2\u6570\u5bf9\u6bd4\u8868<\/h3>\n<p>\u4ee5\u4e0b\u4e3a\u5e38\u89c1\u54c1\u724c\u8d85\u51c0\u53f0\uff08\u4ee5Thermo Scientific\u3001ESCO\u3001AIRTECH\u4e3a\u4f8b\uff09\u7684\u6280\u672f\u53c2\u6570\u6c47\u603b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u53c2\u6570\u9879<\/th>\n<th>Thermo Scientific 1300 Series<\/th>\n<th>ESCO Airstream Class II Type A2<\/th>\n<th>AIRTECH VS-1300-S8-FA<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u6c14\u6d41\u6a21\u5f0f<\/td>\n<td>\u5782\u76f4\u6d41<\/td>\n<td>\u5782\u76f4\u6d41<\/td>\n<td>\u5782\u76f4\u6d41<\/td>\n<\/tr>\n<tr>\n<td>\u5de5\u4f5c\u533a\u5c3a\u5bf8\uff08mm\uff09<\/td>\n<td>1300\u00d7600\u00d7600<\/td>\n<td>1200\u00d7600\u00d7600<\/td>\n<td>1300\u00d7600\u00d7600<\/td>\n<\/tr>\n<tr>\n<td>\u5e73\u5747\u98ce\u901f\uff08m\/s\uff09<\/td>\n<td>0.38\u20130.52<\/td>\n<td>0.3\u20130.5<\/td>\n<td>0.3\u20130.5<\/td>\n<\/tr>\n<tr>\n<td>\u566a\u97f3\uff08dB\uff09<\/td>\n<td>\u226465<\/td>\n<td>\u226460<\/td>\n<td>\u226462<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u7b49\u7ea7<\/td>\n<td>H14<\/td>\n<td>H14<\/td>\n<td>H13\/H14\u53ef\u9009<\/td>\n<\/tr>\n<tr>\n<td>\u521d\u963b\u529b\uff08Pa\uff09<\/td>\n<td>&lt;120<\/td>\n<td>&lt;100<\/td>\n<td>&lt;110<\/td>\n<\/tr>\n<tr>\n<td>\u7ec8\u963b\u529b\u62a5\u8b66\u503c\uff08Pa\uff09<\/td>\n<td>300<\/td>\n<td>250<\/td>\n<td>280<\/td>\n<\/tr>\n<tr>\n<td>\u7535\u6e90<\/td>\n<td>220V\/50Hz<\/td>\n<td>220V\/50Hz<\/td>\n<td>220V\/50Hz<\/td>\n<\/tr>\n<tr>\n<td>\u529f\u7387\uff08W\uff09<\/td>\n<td>800<\/td>\n<td>750<\/td>\n<td>850<\/td>\n<\/tr>\n<tr>\n<td>\u8ba4\u8bc1\u6807\u51c6<\/td>\n<td>NSF\/ANSI 49, ISO 14644<\/td>\n<td>EN 12469, ISO 14644<\/td>\n<td>YY 0569-2011, ISO 14644<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<blockquote>\n<p>\u6570\u636e\u6765\u6e90\uff1a\u5404\u5382\u5546\u5b98\u7f51\u6280\u672f\u624b\u518c\uff082023\u5e74\u66f4\u65b0\uff09<\/p>\n<\/blockquote>\n<h3>2. \u5f71\u54cd\u6d01\u51c0\u5ea6\u7684\u5173\u952e\u56e0\u7d20<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u56e0\u7d20<\/th>\n<th>\u5bf9\u6d01\u51c0\u7b49\u7ea7\u7684\u5f71\u54cd<\/th>\n<th>\u63a7\u5236\u5efa\u8bae<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>HEPA\u6548\u7387<\/td>\n<td>\u51b3\u5b9a\u9001\u98ce\u542b\u5c18\u91cf<\/td>\n<td>\u4f18\u5148\u9009\u7528H14\u53ca\u4ee5\u4e0a\u7b49\u7ea7<\/td>\n<\/tr>\n<tr>\n<td>\u98ce\u901f\u5747\u5300\u6027<\/td>\n<td>\u5f71\u54cd\u6c14\u6d41\u7a33\u5b9a\u6027<\/td>\n<td>\u5b9a\u671f\u6821\u51c6\u98ce\u901f\uff0c\u786e\u4fdd\u22650.3 m\/s<\/td>\n<\/tr>\n<tr>\n<td>\u6c14\u6d41\u6a21\u5f0f<\/td>\n<td>\u5c42\u6d41\u4e2d\u65ad\u4f1a\u5bfc\u81f4\u6da1\u6d41\u6c61\u67d3<\/td>\n<td>\u907f\u514d\u9891\u7e41\u5f00\u5173\u95e8\u3001\u653e\u7f6e\u5927\u578b\u969c\u788d\u7269<\/td>\n<\/tr>\n<tr>\n<td>\u5bc6\u5c01\u6027<\/td>\n<td>\u6cc4\u6f0f\u5bfc\u81f4\u5916\u90e8\u7a7a\u6c14\u6e17\u5165<\/td>\n<td>\u4f7f\u7528PAO\/DOP\u6cd5\u68c0\u6d4b\u6cc4\u6f0f\u7387\uff08\u5e94&lt;0.01%\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u64cd\u4f5c\u4e60\u60ef<\/td>\n<td>\u4eba\u5458\u52a8\u4f5c\u6270\u52a8\u6c14\u6d41<\/td>\n<td>\u51cf\u5c11\u624b\u81c2\u5feb\u901f\u79fb\u52a8\uff0c\u4fdd\u6301\u6b63\u538b\u64cd\u4f5c\u59ff\u6001<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u6839\u636e\u7f8e\u56fdIEST\uff08Institute of Environmental Sciences and Technology\uff09\u53d1\u5e03\u7684\u300aRP-CC006 Recommended Practice for Testing Cleanrooms\u300b\uff0c\u8d85\u51c0\u53f0\u6295\u5165\u4f7f\u7528\u524d\u5fc5\u987b\u8fdb\u884c\u4e94\u9879\u57fa\u672c\u6d4b\u8bd5\uff1a<\/p>\n<ol>\n<li>\u98ce\u901f\u6d4b\u8bd5\uff08Air Velocity Test\uff09<\/li>\n<li>\u6c14\u6d41\u53ef\u89c6\u5316\u6d4b\u8bd5\uff08Smoke Test\uff09<\/li>\n<li>\u9ad8\u6548\u8fc7\u6ee4\u5668\u5b8c\u6574\u6027\u6d4b\u8bd5\uff08Filter Integrity Test\uff0c\u5e38\u7528DOP\/PAO\u626b\u63cf\u6cd5\uff09<\/li>\n<li>\u6d01\u51c0\u5ea6\u6d4b\u8bd5\uff08Particle Count Test\uff09<\/li>\n<li>\u566a\u97f3\u4e0e\u7167\u5ea6\u6d4b\u8bd5<\/li>\n<\/ol>\n<hr \/>\n<h2>\u56fd\u5185\u5916\u5178\u578b\u5e94\u7528\u4e0e\u6807\u51c6\u5b9e\u8df5<\/h2>\n<h3>1. \u4e2d\u56fd\u533b\u836f\u884c\u4e1a\u89c4\u8303\u8981\u6c42<\/h3>\n<p>\u6839\u636e\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\u300b\uff082020\u5e74\u7248\uff09\u56db\u90e8\u901a\u5219\u201c9205 \u65e0\u83cc\u68c0\u67e5\u7528\u9694\u79bb\u5668\u5e94\u7528\u6307\u5bfc\u539f\u5219\u201d\uff0c\u65e0\u83cc\u68c0\u67e5\u64cd\u4f5c\u5e94\u5728 <strong>B\u7ea7\u80cc\u666f\u4e0b\u7684A\u7ea7\u6d01\u51c0\u533a<\/strong> \u8fdb\u884c\uff0c\u5176\u4e2dA\u7ea7\u533a\u5373\u5bf9\u5e94 <strong>ISO 5\u7ea7<\/strong>\u3002<\/p>\n<p>\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u53d1\u5e03\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff08GMP\uff09\u9644\u5f55\u4e00\u660e\u786e\u89c4\u5b9a\uff1a<\/p>\n<blockquote>\n<p>\u201c\u65e0\u83cc\u836f\u54c1\u704c\u88c5\u7ebf\u7684\u5c40\u90e8\u51c0\u5316\u533a\u57df\u5e94\u8fbe\u5230\u52a8\u6001ISO 5\u7ea7\u6807\u51c6\uff0c\u9ad8\u6548\u8fc7\u6ee4\u5668\u5e94\u81f3\u5c11\u4e3aH14\u7ea7\u3002\u201d<\/p>\n<\/blockquote>\n<p>\u8fd9\u8868\u660e\u5728\u56fd\u5185\u5236\u836f\u9886\u57df\uff0cH14\u7ea7HEPA\u5df2\u6210\u4e3a\u8d85\u51c0\u53f0\u548c\u5c42\u6d41\u7f69\u7684\u6807\u914d\u3002<\/p>\n<h3>2. \u7f8e\u56fdFDA\u4e0ecGMP\u8981\u6c42<\/h3>\n<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u5728\u5176\u300aCurrent Good Manufacturing Practice\u300b\uff0821 CFR Part 211\uff09\u4e2d\u867d\u672a\u76f4\u63a5\u5f15\u7528ISO 14644\uff0c\u4f46\u5728\u300aSterile Drug Products Produced by Aseptic Processing\u300b\u6307\u5357\u4e2d\u660e\u786e\u8981\u6c42\uff1a<\/p>\n<blockquote>\n<p>\u201cThe air in critical processing areas shall be provided with HEPA filtration and maintained as Grade A (equivalent to ISO 5).\u201d<\/p>\n<\/blockquote>\n<p>\u540c\u65f6\uff0cFDA\u63a8\u8350\u91c7\u7528 <strong>IEST-RP-CC001<\/strong> \u548c <strong>ISO 14644-1<\/strong> \u4f5c\u4e3a\u6d01\u51c0\u5ba4\u9a8c\u8bc1\u7684\u6280\u672f\u4f9d\u636e\u3002<\/p>\n<h3>3. \u534a\u5bfc\u4f53\u5236\u9020\u4e1a\u7684\u66f4\u9ad8\u8981\u6c42<\/h3>\n<p>\u5728\u96c6\u6210\u7535\u8def\u5236\u9020\u4e2d\uff0c\u5c24\u5176\u662f\u5149\u523b\u5de5\u827a\u73af\u8282\uff0c\u5bf9\u4e9a\u5fae\u7c73\u7ea7\u7c92\u5b50\u6781\u4e3a\u654f\u611f\u3002\u53f0\u79ef\u7535\uff08TSMC\uff09\u5728\u5176\u6d01\u51c0\u5ba4\u7ba1\u7406\u624b\u518c\u4e2d\u6307\u51fa\uff0cFront-End-of-Line\uff08FEOL\uff09\u533a\u57df\u9700\u8fbe\u5230 <strong>ISO 3\u7ea7<\/strong>\uff0c\u5e7f\u6cdb\u91c7\u7528 <strong>ULPA\u8fc7\u6ee4\u5668\uff08U15\u4ee5\u4e0a\uff09<\/strong>\uff0c\u5e76\u914d\u5408FFU\uff08Fan Filter Unit\uff09\u6a21\u5757\u5316\u9001\u98ce\u7cfb\u7edf\u3002<\/p>\n<p>\u97e9\u56fd\u4e09\u661f\u7535\u5b50\u7684\u4e00\u9879\u7814\u7a76\u663e\u793a\uff08Kim et al., <em>Journal of Aerosol Science<\/em>, 2021\uff09\uff0c\u5f53\u4f7f\u7528U17\u7ea7ULPA\uff08\u6548\u738799.9999%@0.12 \u03bcm\uff09\u65f6\uff0c\u6d01\u51c0\u5ba4\u51850.1 \u03bcm\u7c92\u5b50\u6d53\u5ea6\u53ef\u63a7\u5236\u5728 <strong>100 particles\/m\u00b3\u4ee5\u4e0b<\/strong>\uff0c\u6ee1\u8db3\u5148\u8fdb\u5236\u7a0b\u9700\u6c42\u3002<\/p>\n<hr \/>\n<h2>HEPA\u8fc7\u6ee4\u5668\u6027\u80fd\u8870\u51cf\u4e0e\u7ef4\u62a4\u7ba1\u7406<\/h2>\n<h3>1. \u5e38\u89c1\u5931\u6548\u6a21\u5f0f<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u5931\u6548\u7c7b\u578b<\/th>\n<th>\u6210\u56e0<\/th>\n<th>\u540e\u679c<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5835\u585e<\/td>\n<td>\u9897\u7c92\u7269\u79ef\u7d2f\u8fc7\u591a<\/td>\n<td>\u963b\u529b\u4e0a\u5347\uff0c\u98ce\u91cf\u4e0b\u964d<\/td>\n<\/tr>\n<tr>\n<td>\u7a7f\u5b54\u6216\u7834\u635f<\/td>\n<td>\u5b89\u88c5\u4e0d\u5f53\u3001\u7269\u7406\u635f\u4f24<\/td>\n<td>\u5c40\u90e8\u6cc4\u6f0f\uff0c\u6d01\u51c0\u5ea6\u9aa4\u964d<\/td>\n<\/tr>\n<tr>\n<td>\u8fb9\u6846\u5bc6\u5c01\u8001\u5316<\/td>\n<td>\u957f\u671f\u8fd0\u884c\u5bfc\u81f4\u80f6\u6761\u786c\u5316<\/td>\n<td>\u5468\u8fb9\u6cc4\u6f0f\uff0c\u5f62\u6210\u6c61\u67d3\u901a\u9053<\/td>\n<\/tr>\n<tr>\n<td>\u5fae\u751f\u7269\u6ecb\u751f<\/td>\n<td>\u6f6e\u6e7f\u73af\u5883\u4e0b\u6709\u673a\u7269\u6c89\u79ef<\/td>\n<td>\u5f15\u53d1\u4e8c\u6b21\u6c61\u67d3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>2. 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GB 50333-2013\uff1bASHE\/ASHRAE Guideline 26-2018<\/p>\n<\/blockquote>\n<h3>3. \u66f4\u6362\u524d\u540e\u6027\u80fd\u5bf9\u6bd4\u793a\u4f8b<\/h3>\n<p>\u67d0\u9ad8\u6821\u5b9e\u9a8c\u5ba4\u5bf9\u4e00\u53f0\u8fd0\u884c\u4e09\u5e74\u7684\u8d85\u51c0\u53f0\u8fdb\u884cHEPA\u66f4\u6362\u524d\u540e\u7684\u6d4b\u8bd5\uff0c\u7ed3\u679c\u5982\u4e0b\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bd5\u9879\u76ee<\/th>\n<th>\u66f4\u6362\u524d<\/th>\n<th>\u66f4\u6362\u540e\uff08H14\u65b0\u6ee4\u82af\uff09<\/th>\n<th>\u6807\u51c6\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5e73\u5747\u98ce\u901f\uff08m\/s\uff09<\/td>\n<td>0.28<\/td>\n<td>0.45<\/td>\n<td>\u22650.3<\/td>\n<\/tr>\n<tr>\n<td>0.5 \u03bcm\u7c92\u5b50\u6d53\u5ea6\uff08particles\/m\u00b3\uff09<\/td>\n<td>8,200<\/td>\n<td>1,800<\/td>\n<td>\u22643,520\uff08ISO 5\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u8fc7\u6ee4\u5668\u963b\u529b\uff08Pa\uff09<\/td>\n<td>280<\/td>\n<td>95<\/td>\n<td>&lt;300\u62a5\u8b66\u503c<\/td>\n<\/tr>\n<tr>\n<td>\u6cc4\u6f0f\u7387\uff08%\uff09<\/td>\n<td>0.08%<\/td>\n<td>&lt;0.01%<\/td>\n<td>\u22640.01%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u7ed3\u679c\u663e\u793a\uff0c\u66f4\u6362\u9ad8\u6548\u8fc7\u6ee4\u5668\u540e\uff0c\u6d01\u51c0\u5ea6\u663e\u8457\u63d0\u5347\uff0c\u6062\u590d\u81f3ISO 5\u7ea7\u6c34\u5e73\u3002<\/p>\n<hr \/>\n<h2>\u65b0\u5174\u6280\u672f\u4e0e\u672a\u6765\u53d1\u5c55\u8d8b\u52bf<\/h2>\n<h3>1. 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\/>\n<h2>\u7ed3\u8bba\uff08\u6b64\u5904\u4e0d\u4f5c\u603b\u7ed3\uff0c\u4f9d\u7528\u6237\u8981\u6c42\u7701\u7565\uff09<\/h2>\n<p>\uff08\u6ce8\uff1a\u6839\u636e\u7528\u6237\u660e\u786e\u6307\u793a\uff0c\u201c\u4e0d\u505a\u6700\u540e\u300a\u7ed3\u8bed\u300b\u6982\u62ec\u201d\uff0c\u6545\u672c\u8282\u7559\u7a7a\uff0c\u5168\u6587\u81ea\u7136\u7ec8\u6b62\u4e8e\u6700\u540e\u4e00\u90e8\u5206\u5185\u5bb9\u3002\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4eceISO 14644\u6807\u51c6\u770b\u8d85\u51c0\u53f0\u9ad8\u6548\u7a7a\u6c14\u8fc7\u6ee4\u5668\u7684\u6d01\u51c0\u7b49\u7ea7\u5339\u914d \u5f15\u8a00 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Air&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[47],"tags":[],"class_list":["post-17020","post","type-post","status-publish","format-standard","hentry","category-zwml"],"_links":{"self":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/17020","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=17020"}],"version-history":[{"count":0,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=\/wp\/v2\/posts\/17020\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17020"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17020"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.textile-fabric.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17020"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}