{"id":799,"date":"2022-03-11T13:54:16","date_gmt":"2022-03-11T05:54:16","guid":{"rendered":"https:\/\/www.ah-snchain.cn\/?p=799"},"modified":"2025-08-15T16:54:02","modified_gmt":"2025-08-15T08:54:02","slug":"%e6%bf%80%e5%85%89%e5%ae%89%e5%85%a8%e7%ad%89%e7%ba%a7%e5%88%86%e7%b1%bb%ef%bc%88iec-60825-12014%ef%bc%89","status":"publish","type":"post","link":"https:\/\/www.ah-snchain.cn\/?p=799","title":{"rendered":"\u6fc0\u5149\u5b89\u5168\u7b49\u7ea7\u5206\u7c7b\uff08IEC 60825-1:2014\uff09"},"content":{"rendered":"
\n
\n\t

IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements<\/span>
\nIEC 60825-1:2014 \u6fc0\u5149\u4ea7\u54c1\u7684\u5b89\u5168\u6027 - \u7b2c1\u90e8\u5206\uff1a\u8bbe\u5907\u5206\u7c7b\u548c\u8981\u6c42
\nGB 7247.1-2012 \u6fc0\u5149\u4ea7\u54c1\u7684\u5b89\u5168 \u7b2c1\u90e8\u5206\uff1a\u8bbe\u5907\u5206\u7c7b\u3001\u8981\u6c42<\/span>
\nJIS C6802:2014 \u30ec\u30fc\u30b6\u88fd\u54c1\u306e\u5b89\u5168\u57fa\u6e96<\/span>
\nJIS C6802:2014 \u6fc0\u5149\u4ea7\u54c1\u5b89\u5168\u6807\u51c6<\/p>\n

Class 1 laser product
\nany laser product which during operation does not permit human access to laser radiation (accessible emission, see 3.2) in excess of the AEL of Class 1 for applicable
\nwavelengths and emission durations (see 5.3 and 4.3 e)<\/p>\n

1\u7c7b\u6fc0\u5149\u4ea7\u54c1
\n\u5728\u5de5\u4f5c\u671f\u95f4\uff0c\u5728\u76f8\u5e94\u6ce2\u957f\u548c\u53d1\u5c04\u6301\u7eed\u65f6\u95f4\u5185\uff0c\u4eba\u5458\u63a5\u89e6\u7684\u6fc0\u5149\u8f90\u5c04\uff08\u89c13.2\uff09\u4e0d\u5141\u8bb8\u8d85\u8fc71\u7c7b\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\uff08AEL\uff09\u7684\u6fc0\u5149\u4ea7\u54c1\uff08\u89c15.3\u548c4.3 e\uff09\u3002<\/p>\n

Class 1C laser product
\nany laser product which is designed explicitly for contact application to the skin or non-ocular tissue and that:
\n-during operation ocular hazard is prevented by engineering means , i.e. the accessible emission is stopped or reduced to below the AEL of Class 1 when the laser\/applicator is removed from contact with the skin or non-ocular tissue,
\n-during operation and when in contact with skin or non-ocular tissue, irradiance or radiant exposure levels may exceed the skin MPE as necessary for intended treatment procedure, and
\n-the laser product complies with applicable vertical standards<\/p>\n

1C\u7c7b\u6fc0\u5149\u4ea7\u54c1
\n\u4e13\u95e8\u8bbe\u8ba1\u5e94\u7528\u4e8e\u76ae\u80a4\u6216\u975e\u773c\u7ec4\u7ec7\u63a5\u89e6\u7684\u6fc0\u5149\u4ea7\u54c1\uff0c\u5e76\u4e14\uff1a
\n-\u5728\u5de5\u4f5c\u671f\u95f4\uff0c\u901a\u8fc7\u5de5\u7a0b\u624b\u6bb5\u9632\u6b62\u773c\u90e8\u5371\u9669\uff0c\u4f8b\u5982\u5f53\u6fc0\u5149\/\u8bbe\u5907\u4ece\u76ae\u80a4\u6216\u975e\u773c\u7ec4\u7ec7\u63a5\u89e6\u4e2d\u79fb\u9664\u65f6\uff0c\u53ef\u8fbe\u53d1\u5c04\u505c\u6b62\u6216\u51cf\u5c11\u5230\u4f4e\u4e8e1\u7c7b\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\uff08AEL\uff09
\n-\u5728\u5de5\u4f5c\u671f\u95f4\uff0c\u5f53\u4e0e\u76ae\u80a4\u6216\u975e\u773c\u7ec4\u7ec7\u63a5\u89e6\u65f6\uff0c\u5728\u5fc5\u8981\u7684\u6cbb\u7597\u8fc7\u7a0b\u4e2d\uff0c\u8f90\u7167\u5ea6\u6216\u66b4\u8f90\u503c\u53ef\u80fd\u8d85\u8fc7\u76ae\u80a4\u6700\u5927\u66b4\u8f90\u9650\u503c\uff08MPE\uff09\uff0c\u4ee5\u53ca
\n-\u6fc0\u5149\u4ea7\u54c1\u7b26\u5408\u9002\u7528\u7684\u7b49\u7ea7\u6807\u51c6\u3002<\/p>\n

Class 1M laser product
\nany laser product in the wavelength range from 302,5 nm to 4 000 nm which during operation does not permit human access to laser radiation (accessible emission, see 3.2) in
\nexcess of the AEL of Class 1 for applicable wavelengths and emission durations (see 4.3 e)), where the level of radiation is measured according to 5.3 a)<\/p>\n

1M\u7c7b\u6fc0\u5149\u4ea7\u54c1
\n\u5728302.5 nm-4 000 nm\u6ce2\u957f\u8303\u56f4\u5185\uff0c\u5de5\u4f5c\u671f\u95f4\uff0c\u5728\u76f8\u5e94\u6ce2\u957f\u548c\u53d1\u5c04\u6301\u7eed\u65f6\u95f4\u5185\uff0c\u4eba\u5458\u63a5\u89e6\u53ef\u8fbe\u6fc0\u5149\u8f90\u5c04\uff08\u89c13.2\uff09\u4e0d\u5141\u8bb8\u8d85\u8fc7 1 \u7c7b\u53ef\u8fbe\u53d1\u5c04\u9650\u503c \uff08AEL\uff09\u7684\u6fc0\u5149\u4ea7\u54c1\uff08\u89c1 4.3 e\uff09\uff08\u5176\u4e2d\u8f90\u5c04\u6c34\u5e73\u4f9d\u636e 5.3 a \u6d4b\u91cf\uff09\u3002<\/p>\n

Class 2 laser product
\nany laser product in the wavelength range from 400 nm to 700 nm which during operation does not permit human access to laser radiation (accessible emission, see 3.2) in excess of the AEL of Class 2 for applicable wavelengths and emission durations(see 5.3 c)<\/p>\n

2\u7c7b\u6fc0\u5149\u4ea7\u54c1
\n\u5728400 nm-700 nm\u6ce2\u957f\u8303\u56f4\u5185\uff0c\u5de5\u4f5c\u671f\u95f4\uff0c\u5728\u76f8\u5e94\u6ce2\u957f\u548c\u53d1\u5c04\u6301\u7eed\u65f6\u95f4\u5185\uff0c\u4eba\u5458\u63a5\u89e6\u53ef\u8fbe\u6fc0\u5149\u8f90\u5c04\uff08\u89c13.2\uff09\u4e0d\u5141\u8bb8\u8d85\u8fc72\u7c7b\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\uff08AEL\uff09\u7684\u6fc0\u5149\u4ea7\u54c1\uff08\u89c15.3 c\uff09\u3002<\/p>\n

Class 2M laser product
\nany laser product in the wavelength range from 400 nm to 700 nm which during operation does not permit human access to laser radiation (accessible emission, see 3.2) in excess of the AEL of Class 2 for applicable wavelengths and emission durations(see 4.3 e)), where the level of radiation is measured according to 5.3c)<\/p>\n

2M\u7c7b\u6fc0\u5149\u4ea7\u54c1
\n\u5728400 nm-700 nm\u6ce2\u957f\u8303\u56f4\u5185\uff0c\u5de5\u4f5c\u671f\u95f4\uff0c\u5728\u76f8\u5e94\u6ce2\u957f\u548c\u53d1\u5c04\u6301\u7eed\u65f6\u95f4\u5185\uff0c\u4eba\u5458\u63a5\u89e6\u53ef\u8fbe\u6fc0\u5149\u8f90\u5c04\uff08\u89c13.2\uff09\u4e0d\u5141\u8bb8\u8d85\u8fc72\u7c7b\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\uff08AEL\uff09\u7684\u6fc0\u5149\u4ea7\u54c1\uff08\u5176\u4e2d\u8f90\u5c04\u6c34\u5e73\u4f9d\u636e 5.3 c\u6d4b\u91cf\uff09\u3002<\/p>\n

Class 3R and Class 3B laser products
\nany laser product which during operation permits human access to laser radiation (accessible emission, see 3.2) in excess of the AEL of Class 1 and Class 2, as applicable, but which does not permit human access to laser radiation in excess of the AEL of Classes 3R and 3B (respectively) for any emission duration and wavelength (see 5.3 d) and 5.3 e))<\/p>\n

3R\u548c3B\u7c7b\u6fc0\u5149\u4ea7\u54c1
\n\u5728\u5de5\u4f5c\u671f\u95f4\uff0c\u4eba\u5458\u63a5\u89e6\u53ef\u8fbe\u6fc0\u5149\u8f90\u5c04\uff08\u89c13.2\uff09\u5141\u8bb8\u8d85\u8fc71\u7c7b\u548c2\u7c7b\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\uff08AEL\uff09\uff0c\u4f46\u5728\u4efb\u4f55\u53d1\u5c04\u6301\u7eed\u65f6\u95f4\u548c\u6ce2\u957f\uff0c\u4eba\u5458\u63a5\u89e6\u53ef\u8fbe\u6fc0\u5149\u8f90\u5c04\u4e0d\u5141\u8bb8\u8d85\u8fc73R\u7c7b\u548c3B\u7c7b\u5404\u7c7b\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\uff08AEL\uff09\u7684\u6fc0\u5149\u4ea7\u54c1\uff08\u89c15.3 d\u548c5.3e\uff09\u3002<\/p>\n

Class 4 laser product
\nany laser product which permits human access to laser radiation (accessible emission, see 3.2) in excess of the AEL of Class 3B(see 4.3 f))<\/p>\n

4\u7c7b\u6fc0\u5149\u4ea7\u54c1
\n\u4eba\u5458\u63a5\u89e6\u53ef\u8fbe\u6fc0\u5149\u8f90\u5c04\uff08\u89c13.2\uff09\u5141\u8bb8\u8d85\u8fc73B\u7c7b\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\uff08AEL\uff09\u7684\u6fc0\u5149\u4ea7\u54c1\uff08\u89c14.3 f\uff09\u3002<\/p>\n

FDA(CDRH) CFR 1040.10\/1040.11(Laser Notice 56)<\/span><\/p>\n

Class I laser product means any laser product that does not permit access during the operation to levels of laser radiation in excess of the accessible emission limits contained in table I of paragraph (d) of this section.
\nI\u7c7b\u6fc0\u5149\u4ea7\u54c1\u662f\u6307\u5728\u5de5\u4f5c\u671f\u95f4\u4e0d\u5141\u8bb8\u8fdb\u5165\u8d85\u8fc7\u672c\u8282\uff08d\uff09\u6b3e\u8868I\u6240\u8f7d\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\u7684\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\u7684\u4efb\u4f55\u6fc0\u5149\u4ea7\u54c1\u3002<\/p>\n

Class IIa laser product means any laser product that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits contained in table I, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits contained in table II-A of paragraph (d) of this section.
\nIIa\u7c7b\u6fc0\u5149\u4ea7\u54c1\u662f\u6307\u5141\u8bb8\u4eba\u5728\u5de5\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u8868\u4e00\u6240\u5217\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\u7684\u53ef\u89c1\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\uff0c\u4f46\u4e0d\u5141\u8bb8\u4eba\u5728\u5de5\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u672c\u8282\uff08d\uff09\u6b3e\u8868\u4e8c-A\u6240\u8f7d\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\u7684\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\u7684\u4efb\u4f55\u6fc0\u5149\u4ea7\u54c1\u3002<\/p>\n

Class II laser product means any laser product that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits contained in table II-A, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits contained in table II of paragraph (d) of this section.
\nII\u7c7b\u6fc0\u5149\u4ea7\u54c1\u662f\u6307\u5141\u8bb8\u4eba\u5728\u5de5\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u8868II-A\u6240\u5217\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\u7684\u53ef\u89c1\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\uff0c\u4f46\u4e0d\u5141\u8bb8\u4eba\u5728\u5de5\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u672c\u8282\uff08d\uff09\u6b3e\u8868\u4e8c\u6240\u8f7d\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\u7684\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\u7684\u4efb\u4f55\u6fc0\u5149\u4ea7\u54c1\u3002<\/p>\n

Class IIIa laser product means any laser product that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits contained in table II, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits contained in table III-A of paragraph (d) of this section.
\nIIIa\u7c7b\u6fc0\u5149\u4ea7\u54c1\u662f\u6307\u5141\u8bb8\u4eba\u5728\u64cd\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u8868\u4e8c\u6240\u5217\u53ef\u63a5\u8fd1\u53d1\u5c04\u9650\u503c\u7684\u53ef\u89c1\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\uff0c\u4f46\u4e0d\u5141\u8bb8\u4eba\u5728\u64cd\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u672c\u8282\uff08d\uff09\u6b3e\u8868III-A\u6240\u8f7d\u53ef\u63a5\u8fd1\u53d1\u5c04\u9650\u503c\u7684\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\u7684\u4efb\u4f55\u6fc0\u5149\u4ea7\u54c1\u3002<\/p>\n

Class IIIb laser product means any laser product that permits human access during operation to levels of laser radiation in excess of the accessible emission limits of table III-A, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits contained in table III-B of paragraph (d) of this section.
\nIIIb\u7c7b\u6fc0\u5149\u4ea7\u54c1\u662f\u6307\u5141\u8bb8\u4eba\u5728\u5de5\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u8868III-A\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\u7684\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\uff0c\u4f46\u4e0d\u5141\u8bb8\u4eba\u5728\u5de5\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u672c\u8282\uff08d\uff09\u6b3e\u8868III-B\u6240\u8f7d\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\u7684\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\u7684\u4efb\u4f55\u6fc0\u5149\u4ea7\u54c1\u3002<\/p>\n

Class III laser product means any Class IIIa or Class IIIb laser product.
\nIII\u7c7b\u6fc0\u5149\u4ea7\u54c1\u662f\u6307\u4efb\u4f55IIIa\u7c7b\u6216IIIb\u7c7b\u6fc0\u5149\u4ea7\u54c1\u3002<\/p>\n

Class IV laser product means any laser that permits human access during operation to levels of laser radiation in excess of the accessible emission limits contained in table III-B of paragraph (d) of this section.
\nIV\u7c7b\u6fc0\u5149\u4ea7\u54c1\u662f\u6307\u5141\u8bb8\u4eba\u7c7b\u5728\u5de5\u4f5c\u671f\u95f4\u63a5\u89e6\u5230\u8d85\u8fc7\u672c\u8282\uff08d\uff09\u6b3e\u8868III-B\u6240\u8f7d\u53ef\u8fbe\u53d1\u5c04\u9650\u503c\u7684\u6fc0\u5149\u8f90\u5c04\u6c34\u5e73\u7684\u4efb\u4f55\u6fc0\u4ea7\u54c1\u3002<\/p>\n

\u6fc0\u5149\u5206\u7c7b\u00a0 \u00a0\u6fc0\u5149\u5206\u7c7b\u8bf4\u660e
\nI\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u6fc0\u5149\u8f90\u5c04\u4e0d\u88ab\u89c6\u4e3a\u5371\u9669\u7684\u6fc0\u5149\u4ea7\u54c1\u3002
\nIIa\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a01,000 \u79d2\u4ee5\u4e0b\u7684\u89c2\u5bdf\u4e0d\u88ab\u89c6\u4e3a\u5371\u9669\uff0c\u4f46\u8d85\u8fc7 1,000 \u79d2\u7684\u6162\u6027\u5149\u675f\u5185\u89c2\u5bdf\u88ab\u89c6\u4e3a\u5371\u9669\u6fc0\u5149\u4ea7\u54c1\u3002
\n\u53ef\u5e94\u7528\u4e8e\u6ce2\u957f\u4e3a400~710nm\u7684\u53ef\u89c1\u5e26\u6fc0\u5149\u5668\u3002
\nII\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u6162\u6027\u5149\u675f\u5185\u89c2\u5bdf\u88ab\u8ba4\u4e3a\u662f\u5371\u9669\u7684\u6fc0\u5149\u4ea7\u54c1\u3002
\n\u53ef\u5e94\u7528\u4e8e\u6ce2\u957f\u4e3a400~710nm\u7684\u53ef\u89c1\u5e26\u6fc0\u5149\u5668\u3002
\nII Ia\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u7531\u4e8e\u8f90\u7167\u5ea6\u7684\u7a0b\u5ea6\uff0c\u6162\u6027\u5149\u675f\u5185\u89c2\u5bdf\u548c\u4e34\u65f6\u5149\u675f\u5185\u89c2\u5bdf\u90fd\u88ab\u89c6\u4e3a\u5371\u9669\u7684\u6fc0\u5149\u4ea7\u54c1\u3002
\n\u6b64\u5916\uff0c\u5728\u5149\u5b66\u4eea\u5668\u4e2d\u76f4\u63a5\u89c2\u5bdf\u5149\u675f\u662f\u5371\u9669\u7684\uff0c\u5373\u4f7f\u5f88\u77ed\u7684\u65f6\u95f4\u3002\u53ef\u5e94\u7528\u4e8e\u6ce2\u957f\u4e3a400~710nm\u7684\u53ef\u89c1\u5e26\u6fc0\u5149\u5668\u3002
\nIIIb\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u5373\u4f7f\u5f88\u77ed\u7684\u65f6\u95f4\uff0c\u76f4\u63a5\u66b4\u9732\u5728\u76ae\u80a4\u548c\u773c\u775b\u88ab\u8ba4\u4e3a\u662f\u5371\u9669\u7684\u6fc0\u5149\u4ea7\u54c1\u3002
\nIV\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u4e0d\u4ec5\u76f4\u63a5\u66b4\u9732\u5728\u76ae\u80a4\u548c\u773c\u775b\u4e0a\uff0c\u800c\u4e14\u77ed\u6682\u66b4\u9732\u4e8e\u6563\u5c04\u5149\u4e2d\u4e5f\u662f\u5371\u9669\u7684\u6fc0\u5149\u4ea7\u54c1\u3002<\/p>\n

\"\"<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

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