{"id":16766,"date":"2022-02-16T10:00:21","date_gmt":"2022-02-16T02:00:21","guid":{"rendered":"https:\/\/www.paiqinano.com\/?p=16766"},"modified":"2024-06-18T16:30:22","modified_gmt":"2024-06-18T08:30:22","slug":"%e4%b8%80%e6%96%87%e5%bc%84%e6%87%82%e7%94%9f%e7%89%a9%e7%9b%b8%e5%ae%b9%e6%80%a7%e6%a0%87%e5%87%86-iso-10993-12018","status":"publish","type":"post","link":"https:\/\/www.paiqinano.com\/?p=16766","title":{"rendered":"\u4e00\u6587\u5f04\u61c2\u751f\u7269\u76f8\u5bb9\u6027\u6807\u51c6 ISO 10993-1:2018"},"content":{"rendered":"

\u65b0\u7248\u672c\u76f8\u6eb6\u6027\u89c4\u8303ISO10993-1:2018\uff0c\u5c24\u5176\u662f\u6211\u4eec\u6240\u719f\u8bc6\u7684\u751f\u7269\u4f53\u76f8\u6eb6\u68c0\u6d4b\u53c2\u7167\u660e\u7ec6\u9644\u5219A\u7684\u603b\u4f53\u5347\u7ea7\uff0c\u53ca\u5176\u9644\u5219B\u751f\u7269\u4f53\u98ce\u9669\u7ba1\u63a7\u603b\u4f53\u5f15\u8fdbISO TR 15499\u7684\u5347\u7ea7\u7b49\uff0c\u5c06\u5bf9\u533b\u7597\u8bbe\u5907\u751f\u4ea7\u5382\u5bb6\u3001\u7533\u8bf7\u6ce8\u518c\u4eba\u53ca\u5404\u68c0\u9a8c\u673a\u6784\u9020\u6210\u7ed3\u6784\u7684\u5371\u5bb3\u3002<\/p>\n

\"1.jpg\"<\/p>\n

ISO10993-1:2018\u66ff\u4ee3\u4e86ISO 10993-1:2009\uff0c\u540e\u8005\u968f\u7740\u65e0\u6548\u3002\u65b0\u7248\u672c\u89c4\u8303\u603b\u517141\u9875\uff0c\u5bf9\u6bd4\u4e0a\u4e00\u7248\u768421\u9875\uff0c\u6587\u672c\u5167\u5bb9\u4e0a\u9762\u6709\u5f88\u5927\u7684\u589e\u957f\u5e45\u5ea6\u3002<\/p>\n

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\u6700\u5148\uff0c\u5927\u5bb6\u6839\u636e\u4e00\u4e2a\u7b80\u8868\u6765\u4f53\u4f1a\u4e0b\u6700\u65b0\u7248\u672c\u7684\u76f8\u6eb6\u6027\u8f6c\u53d8\uff1a<\/p>\n

\"2.jpg\"<\/p>\n

\u56fe1\u00a0 \u76f8\u6eb6\u6027\u6d4b\u8bd5\u62a5\u544a\u7b80\u8868\uff08\u4e00\u90e8\u5206\uff09<\/p>\n

Note\uff1a\u4ee5\u4e0a\u9c9c\u7ea2\u8272\u4e3a\u589e\u52a0\u6d4b\u8bd5\u62a5\u544a\u00a0<\/strong><\/p>\n

\u5bf9\u4e8e\u65b0\u7248\u672c\u89c4\u8303\u63d0\u5347\u6216\u53d8\u52a8\u7684\u4e00\u90e8\u5206\uff0c\u73b0\u4f9d\u636eISO 10993-1:2018\u7684\u6392\u7248\u8bbe\u8ba1\u6b21\u5e8f\uff0c\u4ece\u89c4\u8303\u6587\u7ae0\u6b63\u6587\u5373\u6761\u65874 Generalprinciples\u4e3a\u5927\u4f19\u513f\u524d\u8a00\uff1a<\/p>\n

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4<\/strong><\/section>\n<\/section>\n
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General principles\u00a0<\/section>\n<\/section>\n<\/section>\n
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\u00a04.1\u00a0\u00a0\u00a0\u5f15\u8fdb\u4e86\u00a0physical\/chemical information\uff08\u7269\u7406\u5b66\/\u5316\u5b66\u4fe1\u606f\uff09\u7684\u65b0\u7406\u5ff5\uff0c\u8be5\u9879\u5546\u54c1\u4fe1\u606f\u7684\u83b7\u5f97\u4f18\u5148\u9009\u62e9\u5ea6\u6392\u5728\u5168\u90e8\u76f8\u6eb6\u6027\u68c0\u6d4b\u7684\u524d\u8fb9\uff0c\u662f\u65b0\u7248\u672c\u5206\u5b50\u751f\u7269\u5b66\u70b9\u8bc4\u7684\u7b2c\u4e00\u6b65\uff0c\u5e76\u4e3a\u4e4b\u540e\u7684\u5176\u4ed6\u76f8\u6eb6\u6027\u68c0\u6d4b\u7ed9\u4e88\u4e86\u5546\u54c1\u4fe1\u606f\u6839\u636e\u3002<\/p>\n

\u65b0\u6807\u51c6 Figure 1 \u5206\u5b50\u751f\u7269\u5b66\u98ce\u9669\u6027\u7ba1\u7406\u5de5\u4f5c\u8ba1\u5212\u4e2d\u4e5f\u5347\u7ea7 physical\/chemical\u00a0\u00a0information\uff0c\u5e76\u5728\u6d41\u7a0b\u8868\u7b2c\u4e00\u6392\u4e2d\u63d0\u9ad8\u4e86\u4e00\u4e2a\u65b0\u7684\u68f1\u5f62\u683c\u00a0geometry and physical\u00a0properties\uff08\u6784\u9020\u548c\u5316\u5b66\u6027\u8d28\uff09\u3002\u4e0e\u6b64\u540c\u65f6\uff0c\u6d41\u7a0b\u8868\u4e2d\u8fd8\u63d0\u5347\u4e86\u00a0clinical use\u00a0\u505a\u4e3a\u98ce\u9669\u7ba1\u63a7\u7684\u70b9\u8bc4\u65b0\u9879\u76ee\uff0c\u53ef\u53c2\u7167\u56fe 2 \u6240\u663e\u793a\u3002<\/p>\n

\"3.jpg\"<\/p>\n

\u56fe 2 \u8282\u9009\u81ea ISO 10993-1:2018 Figure 1<\/p>\n

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4.3\u00a0\u00a0\u00a0c) packaging materials that directly or indirectly contact the medical device can\u00a0transfer chemicals\u00a0to the medical device and then indirectly to the patient or clinician;<\/p>\n

\u5206\u5b50\u751f\u7269\u5b66\u70b9\u8bc4\u8981\u7d20\u65b0\u63d0\u9ad8\u4e86\u9488\u5bf9\u5305\u88c5\u5236\u54c1\u7684\u8003\u8651\u5230\u3002<\/p>\n

\u4f9d\u636e\u65b0\u7248\u672c\u89c4\u8303\uff0c\u5fc5\u987b\u8003\u8651\u5230\u5305\u88c5\u5236\u54c1\u5728\u8d27\u67b6\u671f\u5185\uff0c\u662f\u4e0d\u662f\u4f1a\u9020\u6210\u6709\u6bd2\u5316\u5408\u7269\u5371\u5bb3\u533b\u7597\u8bbe\u5907\u7684\u5b89\u5168\u7cfb\u6570\u3002\u4f8b\u5982\u751f\u7269\u4f53\u5fc3\u810f\u74e3\u819c\u9700\u6ce1\u6d78\u50a8\u5b58\u5728\u4ee3\u70c3\u9971\u548c\u6eb6\u6db2\u4e2d\uff0c\u800c\u76db\u88c5\u9971\u548c\u6eb6\u6db2\u7684\u50a8\u7f50\u6750\u6599\u901a\u5e38\u4e3a\u6a61\u80f6\u5236\u54c1\uff0c\u8fd9\u5c31\u5fc5\u987b\u8003\u8651\u5230\u5728\u5176\u8d27\u67b6\u671f\u5185\uff0c\u76db\u88c5\u9971\u548c\u6eb6\u6db2\u7684\u50a8\u7f50\u662f\u4e0d\u662f\u6709\u5316\u5408\u7269\u603b\u6df7\uff0c\u4ece\u800c\u5371\u5bb3\u5230\u5fc3\u810f\u74e3\u819c\u7684\u5b89\u5168\u7cfb\u6570\u3002<\/p>\n

4.7\u00a0\u00a0\u00a0The biological safety of a medical device shall be evaluated by the manufacturer\u00a0over\u00a0the whole life-cycle\u00a0of a medical device.<\/p>\n

\u589e\u52a0\u6761\u6587\uff0c\u751f\u4ea7\u5382\u5bb6\u5bf9\u533b\u7597\u8bbe\u5907\u7684\u751f\u7269\u4f53\u5b89\u5168\u6027\u8bc4\u4ef7\u5e94\u906e\u76d6\u533b\u7597\u8bbe\u5907\u9879\u76ee\u751f\u547d\u5468\u671f\u3002<\/p>\n

\u6b64\u6761\u6587\u5f15\u8fdb\u4e86\u9879\u76ee\u751f\u547d\u5468\u671f\u7684\u5206\u5b50\u751f\u7269\u5b66\u70b9\u8bc4\uff0c\u6362\u53e5\u8bdd\u8bf4\u5206\u5b50\u751f\u7269\u5b66\u70b9\u8bc4\u4e0d\u4f1a\u518d\u505c\u6b65\u4e8e\u76f8\u6eb6\u6027\u68c0\u6d4b\uff0c\u63a5\u7740\u4e34\u5e8a\u7814\u7a76\u76f4\u5230\u5546\u54c1\u6682\u505c\u4e0a\u5e02\u73af\u8282\u9020\u6210\u7684\u4efb\u4f55\u6570\u636e\u4fe1\u606f\u90fd\u5c06\u53d8\u6210\u5206\u5b50\u751f\u7269\u5b66\u70b9\u8bc4\u6c47\u62a5\u5347\u7ea7\u7684\u5fc5\u9700\u952e\u5165\u3002<\/p>\n

4.8\u00a0\u00a0\u00a0For\u00a0re-usable\u00a0medical devices, biological safety shall be evaluated for the maximum\u00a0number of validated processing cycles by the manufacturer.<\/p>\n

\u589e\u52a0\u6761\u6587\uff0c\u9488\u5bf9\u53ef\u591a\u6b21\u91cd\u590d\u4f7f\u7528\u533b\u7597\u8bbe\u5907\uff0c\u751f\u4ea7\u5546\u89e3\u51b3\u786e\u5b9a\u8fc7\u8f83\u5927\u89e3\u51b3\u7a0b\u5ea6\u7684\u836f\u7269\u5f00\u5c55\u751f\u7269\u4f53\u5b89\u5168\u6027\u8bc4\u4ef7\u3002<\/p>\n

4.11\u00a0\u00a0\u00a0\u9488\u5bf9\u65b0\u7248\u672c\u89c4\u8303\u57fa\u672c\u4e0a\u89c4\u8303\u7684\u4e00\u4e2a\u8865\u5145\u8bf4\u660e\uff1a<\/p>\n

1\uff09 \u786e\u7acb\u4e86\u65b0\u7248\u672c\u516c\u5e03\u524d\uff0c\u5df2\u70b9\u8bc4\u5b8c\u6bd5\u7684\u533b\u7597\u8bbe\u5907\u4e0d\u7528\u8fdb\u884c\u65b0\u7684\u76f8\u6eb6\u6027\u68c0\u6d4b\uff1b<\/p>\n

2\uff09\u4f9d\u7167\u65b0\u7248\u672c\u89c4\u8303\uff0c\u4e00\u5207\u76f8\u6eb6\u6027\u68c0\u6d4b\u65b0\u9879\u76ee\u7684\u514d\u9664\u90fd\u5fc5\u987b\u7ed9\u4e88\u6709\u6548\u8868\u8ff0\uff1b<\/p>\n

3\uff09\u5386\u53f2\u65f6\u95f4\u4e34\u5e8a\u533b\u5b66\u6750\u6599\u53ef\u505a\u4e3a\u5408\u4e4e\u76f8\u6eb6\u6027\u89c4\u5b9a\u7684\u76f4\u63a5\u8bc1\u636e\u4ee5\u514d\u9664\u68c0\u6d4b\uff1b<\/p>\n

4\uff09\u4e00\u5207\u6d89\u53ca\u5230\u76f8\u6eb6\u6027\u518d\u8bc4\u4f30\u7684\u533b\u7597\u8bbe\u5907\uff0c\u52a1\u5fc5\u4f9d\u7167\u65b0\u7248\u672c\u89c4\u8303\u5f00\u5c55\u518d\u70b9\u8bc4\u3002<\/p>\n

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5<\/strong><\/section>\n<\/section>\n
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Categorization of medical devices\u00a0<\/section>\n<\/section>\n
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5.1\u00a0 General<\/p>\n

\u786e\u7acb\u4e86\u6c14\u7ba1\u7c7b\u533b\u7597\u8bbe\u5907\u7684\u5f52\u7c7b\u53c2\u8003 ISO 18562 \u7cfb\u5217\u4ea7\u54c1\u89c4\u8303\u3002<\/p>\n

5.2.1 Non-contacting medical devices<\/p>\n

\u65b0\u7248\u672c\u89c4\u8303\u906e\u76d6\u4e86\u975e\u89e6\u78b0\u7c7b\u533b\u7597\u8bbe\u5907\uff0c\u786e\u7acb\u4e86\u975e\u89e6\u78b0\u7c7b\u533b\u7597\u8bbe\u5907\u4e0d\u7528\u5f00\u5c55\u76f8\u6eb6\u6027\u68c0\u6d4b\uff0c\u4f8b\u5982\u533b\u836f\u5b66\u786e\u8bcaAPP\uff0c\u8840\u6db2\u5236\u54c1\u673a\u5668\u8bbe\u5907\u53ca\u5176\u91c7\u8840\u7ba1\u7b49\u3002<\/p>\n

5.2.2 Surface-contacting medical devices<\/p>\n

a) Skin<\/p>\n

\u65b0\u7248\u672c\u89c4\u8303\u63d0\u9ad8\u4e86 NOTE \u8868\u8ff0\uff0c\u786e\u7acb\u4e86\u9009\u7528\u57fa\u672c\u539f\u6599\u7684\u808c\u80a4\u89e6\u78b0\u5668\u6750\u4e0d\u7528\u592a\u591a\u7684\u5206\u5b50\u751f\u7269\u5b66\u70b9\u8bc4\u3002\u5305\u542b\u65e0\u80f6\u624b\u5957\u89e6\u78b0\u5668\u6750\uff08\u5982\u7535\u8111\u952e\u76d8\u3001\u6309\u952e\u3001\u89e6\u6478\u663e\u793a\u5c4f\u3001SD \u5361\u3001U \u76d8\u7b49\uff09\u548c\u80f6\u624b\u5957\u89e6\u78b0\u5668\u6750\uff08\u5982\u8f6f\u7ba1\u7684\u6447\u6746\uff09\u3002<\/p>\n

5.2.3 Externally communicating medical devices<\/p>\n

b) Tissue\/bone\/dentin<\/p>\n

Medical devices or components that do not necessarily directly contact tissue or\u00a0bone but serve as\u00a0conduits to delivery fluids\u00a0to the tissue or bone.<\/p>\n

\u7528\u4ee5\u5411\u673a\u6784\u6216\u9aa8\u8fd0\u8f93\u6db2\u6001\u7684\u8f6f\u7ba1\u7c7b\u5668\u6750\uff0c\u65b0\u7248\u672c\u89c4\u8303\u533a\u5212\u4e3a\u5916\u754c\u8fde\u63a5\u5668\u6750\u3002<\/p>\n

5.3 Categorization by duration of contact<\/p>\n

5.3.1 Contact duration categories<\/p>\n

c)\u00a0Long-term\u00a0exposure (C) \u2013 medical devices whose cumulative sum of single, multiple\u00a0or repeated contact time exceeds 30 d.<\/p>\n

\u65b0\u7248\u672c\u89c4\u8303\u4e2d\uff0c\u89e6\u78b0\u8d85\u51fa 30 \u5929\u7684\u533b\u7597\u8bbe\u5907\u9009\u7528 long-term \u66f4\u6362\u4e86 permanent\uff0c\u4ece\u63cf\u8ff0\u4e0a\u66f4\u4e3a\u7684\u8ba4\u771f\u7ec6\u81f4\u3002\u4f8b\u5982\u5fc3\u8840\u7ba1\u652f\u67b6\u4e3a\u957f\u671f\u6027\u5d4c\u5165\u7c7b\u533b\u7597\u8bbe\u5907\uff0c\u4f46\u56e0\u4e3a\u53d7\u5236\u4e8e\u7535\u6c60\u7535\u91cf\uff0c\u5373\u4f7f\u5355\u8154\u8d77\u535a\u5668\u4e5f\u53ea\u6709\u4fdd\u6301 7~8 \u5e74\uff0c\u5e76\u4e0d\u53ef\u4ee5\u7b97\u662f\u6c38\u4e45\u6027\u5d4c\u5165\u3002<\/p>\n

5.3.2 Transitory-contacting medical devices<\/p>\n

\u63d0\u5347\u4e86\u77ed\u6682\u6027\u89e6\u78b0\u533b\u7597\u8bbe\u5907\u7684\u754c\u5b9a\uff0c\u8981\u6c42\u89e6\u78b0\u6642\u95f4\u4f4e\u4e8e\u00a01 \u5206\u9418\u7684\u5668\u6750\u5212\u5165\u4e3a\u77ed\u6682\u6027\u89e6\u78b0\u7c7b\uff0c\u4f8b\u5982\u67f3\u53f6\u5200\u6742\u5fd7\u3001\u76ae\u5185\u6ce8\u5c04\u9488\u3001\u6bdb\u7ec6\u8840\u7ba1\u7b49\u3002\u00a0\u77ed\u6682\u6027\u89e6\u78b0\u533b\u7597\u8bbe\u5907\u901a\u5e38\u4e0d\u7528\u5f00\u5c55\u76f8\u6eb6\u6027\u68c0\u6d4b\uff0c\u4e5f\u672a\u5f52\u5165\u9644\u5219 A\uff0c\u4f46\u8be5\u7c7b\u5668\u6750\u82e5\u6d89\u53ca\u5230\u79ef\u7d2f\u5e94\u7528\uff08cumulative use\uff09\uff0c\u5fc5\u987b\u6b64\u5916\u70b9\u8bc4\u3002<\/p>\n

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6<\/strong><\/section>\n<\/section>\n
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Biological evaluation process\u00a0<\/section>\n<\/section>\n
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6.1 Physical and chemical information<\/p>\n

\u589e\u52a0\u6761\u6587\uff0cphysical and chemical information \u4e3a\u76f8\u6eb6\u6027\u70b9\u8bc4\u5173\u952e\u7684\u7b2c\u4e00\u6b65\uff0c\u843d\u5b9e\u63aa\u65bd\u53ef\u53c2\u7167\u00a0ISO 10993-18\uff0c\u9488\u5bf9\u7eb3\u7c73\u590d\u5408\u6750\u6599\u53ef\u53c2\u7167 2017 \u5e74\u65b0\u4e0a\u5e02\u7684\u76f8\u6eb6\u6027\u89c4\u8303\u00a0ISO\/TR 10993-22.<\/p>\n

6.2 Gap analysis and selection of biological endpoints<\/p>\n

\u589e\u52a0\u6761\u6587\uff0c\u8981\u6c42\u4e86\u5dee\u522b\u5256\u6790\u7684\u6267\u884c\u6b65\u9aa4\uff0c\u5e94\u53c2\u7167\u9644\u5219 A \u7684\u6839\u57fa\u4e0a\uff0c\u878d\u5408\u9644\u5219\u00a0CLiterature review\uff08\u53c2\u8003\u6587\u732e\uff09\u5f00\u5c55\u5224\u65ad\u3002\u00a0\u6839\u636e\u5dee\u522b\u5256\u6790\u7684\u7d50\u679c\uff0c\u5224\u65ad\u5b58\u6709\u7684\u4e0d\u786e\u5b9a\u6027\u98ce\u9669\u6027\uff0c\u4ee5\u51b3\u7b56\u5fc5\u987b\u6311\u9009\u7684\u76f8\u6eb6\u6027\u68c0\u6d4b\u65b0\u9879\u76ee\u3002<\/p>\n

6.3 Biological testing<\/p>\n

\u672c\u6b21\u65b0\u7248\u672c\u89c4\u8303\u589e\u52a0\u7684\u6d4b\u8bd5\u62a5\u544a\u5173\u952e\u53c2\u7167\u4e86 FDA \u6709\u5173 ISO 10993-1 \u64cd\u4f5c\u6307\u5357 2016\u7248\u914d\u4ef6 A \u7684\u5167\u5bb9\uff0c\u8fd9\u5c31\u4ee3\u8868\u7740\u76f8\u6eb6\u6027\u68c0\u6d4b\u7684 ISO \u89c4\u8303\u603b\u4f53\u5411 FDA \u6328\u8fd1\uff0c\u9488\u5bf9\u53c2\u7167 ISO 10993-1 \u9644\u5219 A \u7684\u533b\u7597\u8bbe\u5907\u751f\u4ea7\u5382\u5bb6\u800c\u8a00\u662f\u4e00\u4e2a\u5f88\u5927\u7684\u8bd5\u70bc\uff0c\u5c24\u5176\u662f\u4f8b\u5982\u6162\u6bd2\u3001\u81f4\u764c\u7269\u8d28\u7b49\u957f\u671f\u6027\u6d4b\u8bd5\u62a5\u544a\u7684\u6dfb\u52a0\u3002<\/p>\n

ISO 10993-1 \u9644\u5219 A \u5347\u7ea7\u540e\uff0c\u5982\u4e0b\u56fe\u6240\u793a\uff1a<\/p>\n

\"4.jpg\"\u56fe 3 \u6458\u9009\u81ea ISO 10993-1:18 \u9644\u5219 A<\/p>\n

1\uff09 \u5e94\u7528\u6807\u8bb0 E \u66ff\u4ee3\u4e0a\u4e00\u7248\u7684 X \u4ee5\u6807\u5fd7\u751f\u7269\u4f53\u76f8\u5bb9\u6027\u8bd5\u9a8c\u7ec8\u70b9\u7ad9\uff1b<\/p>\n

2\uff09 \u65b0\u7248\u672c\u89c4\u8303\u6807\u8bb0 X \u8868\u660e\u5206\u5b50\u751f\u7269\u5b66\u98ce\u9669\u8bc4\u4ef7\u5fc5\u987b\u7684\u5916\u7f6e\u4fe1\u606f\u5185\u5bb9\uff0c\u5982Physical and\u00a0chemical information\uff1b<\/p>\n

3\uff09 \u63d0\u5347\u4e86\u65b0\u7684\u751f\u7269\u4f53\u76f8\u5bb9\u6027\u8bd5\u9a8c\u65b0\u9879\u76ee\uff08\u5982\u4e0b\u56fe 3 \u6807\u9ec4\u6240\u663e\u793a\uff09\uff1a\u539f\u6750\u6599\u53d7\u4f53\u70ed\u539f\u3001\u6162\u6bd2\u3001\u81f4\u764c\u7269\u8d28\u3001\u751f\u6b96\u7cfb\u7edf\u6bd2\u548c\u751f\u7269\u964d\u89e3\u3002<\/p>\n

6.3.2.5 Material-mediated pyrogenicity<\/p>\n

\u9644\u5219 A \u589e\u52a0\u6d4b\u8bd5\u62a5\u544a\uff0c\u539f\u6750\u6599\u53d7\u4f53\u70ed\u539f\u3002\u70ed\u539f\u5206\u6210\u7c7b\u6bd2\u7d20\u53d7\u4f53\u70ed\u539f\u548c\u539f\u6750\u6599\u53d7\u4f53\u70ed\u539f\uff0c\u5c3d\u7ba1\u539f\u6750\u6599\u53d7\u4f53\u70ed\u539f\u5728\u4e00\u822c\u533b\u7597\u8bbe\u5907\u8f83\u4e3a\u7f55\u89c1\uff0c\u5e38\u89c1\u4e8e\u751f\u7269\u4f53\u7814\u7a76\u539f\u6750\u6599\u7684\u5668\u6750\uff0c\u5b9e\u9a8c\u65b9\u5f0f\u591a\u89c1\u65b0\u897f\u5170\u5154\u6cd5\u3002<\/p>\n

6.3.2.8 Chronic toxicity<\/p>\n

\u9644\u5219 A \u589e\u52a0\u6d4b\u8bd5\u62a5\u544a\uff0c\u6f2b\u6027\u6bd2\u526f\u4f5c\u7528\u3002\u5bf9\u6bd4\u4e9a\u6162\u6bd2\u526f\u4f5c\u7528\uff0c\u6f2b\u6027\u6bd2\u526f\u4f5c\u7528\u7684\u68c0\u67e5\u5468\u671f\u65f6\u95f4\u4f1a\u66f4\u957f\uff0c\u4f8b\u5982 3 \u4e2a\u6708\u7684\u5c0f\u767d\u9f20\u4e9a\u6162\uff0c\u5fc5\u987b\u957f\u8fbe 6 \u4e2a\u6708\u7684\u5c0f\u767d\u9f20\u6162\u6bd2\u3002\u68c0\u6d4b\u671f\u9650\u7684\u5ef6\u957f\u9488\u5bf9\u533b\u7597\u8bbe\u5907\u8fc5\u901f\u53d1\u552e\u7684\u8282\u594f\u611f\u4e5f\u4f1a\u662f\u4e00\u4e2a\u5f88\u5927\u7684\u8bd5\u70bc\uff0c\u5c24\u5176\u662f\u4f17\u591a\u6f5c\u5728\u6027\u7684\u5408\u89c4\u98ce\u9669\u6027\u3002<\/p>\n

6.3.2.9 Implantation effects<\/p>\n

\u9488\u5bf9\u5d4c\u5165\u5b9e\u9a8c\uff0c\u65b0\u7248\u672c\u89c4\u8303\u62e5\u6709\u91cd\u8981\u5347\u7ea7\uff0c\u63d0\u8bae\u5d4c\u5165\u8bd5\u9a8c\u65b9\u6848\u53ef\u53d1\u5c55\u4e3a\u4e0e\u6b64\u540c\u65f6\u70b9\u8bc4\u90e8\u5206\u53cd\u6620\u548c\u5168\u8eab\u4e0a\u4e0b\u6bd2\u526f\u4f5c\u7528\uff0c\u4ee5\u8fbe\u5230\u4e9a\u6025\u6027\u3001\u4e9a\u6025\u3001\u4e9a\u6162\u548c\u6162\u6bd2\u68c0\u6d4b\u7684\u8981\u6c42\u3002\u5047\u5982\u5f88\u6709\u53ef\u80fd\uff0c\u8840\u591c\u76f8\u6eb6\u6027\u70b9\u8bc4\u8fd8\u53ef\u4ee5\u5305\u62ec\u5728\u5176\u4e2d\u3002<\/p>\n

6.3.2.11 Carcinogenicity<\/p>\n

\u9644\u5219 A \u589e\u52a0\u6d4b\u8bd5\u62a5\u544a\uff0c\u81f4\u764c\u7269\u8d28\u3002\u9488\u5bf9\u4e00\u822c\u533b\u7597\u8bbe\u5907\uff0c\u81f4\u764c\u7269\u8d28\u5b9e\u9a8c\u975e\u5e38\u5c11\u6d89\u53ca\u5230\uff0c\u4f46\u9488\u5bf9\u89e6\u78b0\u6642\u95f4\u8d85\u51fa 30 \u5929\u7684\u533b\u7597\u8bbe\u5907\u5fc5\u987b\u8003\u8651\u5230\u3002\u65b0\u7248\u672c\u89c4\u8303\u63d0\u8bae\uff0c\u81f4\u764c\u7269\u8d28\u53ef\u4ee5\u5408\u62fc\u6f2b\u6027\u6bd2\u5b9e\u9a8c\u5f00\u5c55\uff0c\u5b9e\u9645\u53ef\u53c2\u7167\u00a0OECD Guideline 453.<\/p>\n

6.3.2.12 Reproductive and developmental toxicity<\/p>\n

\u9644\u5219 A \u589e\u52a0\u6d4b\u8bd5\u62a5\u544a\uff0c\u751f\u6b96\u7cfb\u7edf\u6bd2\u526f\u4f5c\u7528\u3002\u9488\u5bf9\u4e00\u822c\u533b\u7597\u8bbe\u5907\uff0c\u751f\u6b96\u7cfb\u7edf\u6bd2\u526f\u4f5c\u7528\u5b9e\u9a8c\u975e\u5e38\u5c11\u6d89\u53ca\u5230\uff0c\u4f46\u9488\u5bf9\u9884\u4f30\u5e94\u7528\u7fa4\u4f53\u4e3a\u5b55\u5988\u5988\u7684\u533b\u7597\u8bbe\u5907\u5fc5\u987b\u8003\u8651\u5230\u3002<\/p>\n

6.3.2.13 Degradation<\/p>\n

\u9644\u5219 A \u589e\u52a0\u6d4b\u8bd5\u62a5\u544a\uff0c\u751f\u7269\u964d\u89e3\u6027\u3002\u9488\u5bf9\u751f\u7269\u964d\u89e3\u533b\u7597\u8bbe\u5907\uff0c\u5e94\u7528\u8eab\u4f53\u4e4b\u5916\u6cd5\u4eff\u771f\u6a21\u62df\u4e34\u5e8a\u533b\u5b66\u5e94\u7528\u5f00\u5c55\u68c0\u6d4b\uff0c\u5f53\u8eab\u4f53\u4e4b\u5916\u68c0\u6d4b\u6ca1\u6cd5\u83b7\u5f97\u5145\u8db3\u7684\u6570\u636e\u4fe1\u606f\u4ee5\u8bc1\u5b9e\u5176\u76f8\u6eb6\u6027\u65f6\uff0c\u5fc5\u987b\u8003\u8651\u5230\u8eab\u4f53\u5185\u6eb6\u89e3\u5b9e\u9a8c\u3002\u6eb6\u89e3\u5b9e\u9a8c\u53ef\u53c2\u7167\u7684\u89c4\u8303\u4e3a ISO 10993-9\uff0cISO 10993-13\uff0cISO\u00a010993-14\uff0cISO 10993-15.<\/p>\n

 <\/p>\n

\u3010\u6c47\u603b\u3011\u00a0<\/strong><\/p>\n

ISO 10993-1:2009 \u968f\u7740\u7740\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u5feb\u901f\u767c\u5c55\u7684\u65f6\u4ee3\uff0c\u4ece\u4e1a\u5fae\u6ce2\u611f\u5e94\u5668\u533b\u7597\u8bbe\u5907\u7684\u540c\u884c\u4e1a\u90fd\u5e76\u4e0d\u4f1a\u751f\u758f\uff0c\u800c\u672c\u6b21\u9614\u522b\u4e5d\u5e74\u7684\u5347\u7ea7\u91cd\u505a\uff0c\u4e5f\u4ece\u4e00\u4e2a\u4fa7\u8fb9\u8868\u660e\u4e86\u65e0\u6e90\u533b\u7597\u8bbe\u5907\u5373\u5c06\u5f00\u59cb\u66f4\u65b0\u6362\u4ee3\uff0c\u800c\u76d1\u7ba1\u90e8\u95e8\u9488\u5bf9\u76f8\u6eb6\u6027\u7684\u68c0\u6d4b\u89c4\u5b9a\u4e00\u6837\u4e5f\u5df2\u9010\u6e10\u63d0\u5347\u3002<\/p>\n

 <\/p>\n

\u3010\u9644\u3011\u00a0\u8be6\u7ec6\u7684\u201c\u76f8\u6eb6\u6027\u6d4b\u8bd5\u62a5\u544a\u76ee\u5f55\u201d<\/strong><\/p>\n

\"5.jpg\"<\/p>\n

 <\/p>\n

\n

\u6d3e\u65d7\u7eb3\u7c73\u5b98\u7f51\uff1ahttps:\/\/paiqinano.com<\/p>\n

\u5927\u91cf\u7535\u5b50\u7eb3\u7c73\u9632\u62a4\u6d82\u5c42\u5242\u3001\u914d\u5957\u55b7\u9540\u8bbe\u5907\u3001OEM\u4ee3\u5de5\u670d\u52a1\u7b49\u8bf7\u5173\u5fc3\u201c\u6d3e\u65d7\u7eb3\u7c73\u201d\u5fae\u4fe1\u516c\u4f17\u53f7<\/p>\n

\u7eb3\u7c73\u6d82\u5c42\u5242\u7406\u5316\u6027\u80fd\u8be6\u7ec6\u53c2\u6570\u76f4\u63a5\u70b9\u51fb\uff1a\u7eb3\u7c73\u7535\u5b50\u9632\u62a4\u6d82\u5c42\u5242\u53c2\u6570<\/a><\/p>\n

\u6280\u672f\u54a8\u8be2\uff1a\u8d75\u5148\u751f\uff1a130 4896 4893<\/p>\n

 <\/p>\n

\"\"<\/p>\n

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