KS P ISO 11980-2006 Ophthalmic optics-Contact lenses and contact lens care products-Guidance for clinical investigations 《眼科光学 隐形眼镜和隐形眼镜防护产品 临床检测指南》.pdf
《KS P ISO 11980-2006 Ophthalmic optics-Contact lenses and contact lens care products-Guidance for clinical investigations 《眼科光学 隐形眼镜和隐形眼镜防护产品 临床检测指南》.pdf》由会员分享,可在线阅读,更多相关《KS P ISO 11980-2006 Ophthalmic optics-Contact lenses and contact lens care products-Guidance for clinical investigations 《眼科光学 隐形眼镜和隐形眼镜防护产品 临床检测指南》.pdf(20页珍藏版)》请在麦多课文档分享上搜索。
1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS 2006 12 5 http:/www.kats.go.krKS P ISO 11980 KS P ISO 11980: 2006 (2011 )P ISO 11980: 2006 : ( ) ( ) ( ) : (http:/www.standard.go.kr) : :2006 12 5 :2011 12 30 2011-0715 : : ( 02-509-7274) (http:/www.kats.go.kr). 10 5 , . ICS 11.040.70 KS P ISO 11980: 2006(2
2、011 ) Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations 1997 1 ISO 11980 Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations . 1. . 2. . . KS B ISO 14534 ISO 14155 Clinical investigation of medical de
3、vices . . . D . 3. ISO 14155 KS B ISO 14534 . ISO 8320 1 KS B ISO 8320 2 ( D ). 4. ISO 14155 . , (ISO 14155). . . ( , ) P ISO 11980: 2006 2 . 5. 5.1 , , , ISO 14155 . 5.2 . . 1. . . 2. , , . , ( D ). 5.3 . 5.4 . A B . 6. . , , . , , , . . a) , , . . b) c) d) e) f) C P ISO 11980: 2006 3 A() , A.1 . A
4、.2 A.2.1 . A.2.2 . 0 = . 1 = 120 2 = 2150 3 = 51100 4 = 100 . 4 . A.2.3 . 0 = . 1 = 2 = (CCC) . 3 = (CCC) 4 = (CCC) A.3 . 0 = . 1 = 15 2 = 68 3 = 8 4 = A.4 . 0 = 1 = 2 = 3 = 4 = A.5 . 0 = . 1 = 1.00 mm P ISO 11980: 2006 4 2 = 1.00 mm 1.5 mm 3 = 1.5 mm 2.00 mm 4 = 2.0 mm . : a) b) : N T I S C X ( ) A
5、.6 ( 1. 2. ). 0 = . 1 = a) b) 2 = a) b) 3 9 c) 3 = 2 mm a) b) 4 = 2 mm . ( A.1 ). 1. . 2. “ ” . A.1 A.7 . 0 = . 1 = ( ) 1 C 2 S 3 N 4 I 5 T P ISO 11980: 2006 5 2 = ( ) 3 = ( ) 4 = ( ) . 0 = . 1 = 2 = 3 = 4 = / (0 = , 1 = ). A.8 . 0 = 1 = 2 = 1 mm / 3 = a) 1 mm / b) 4 = a) 1 mm / b) 1 4 . 1 = 2 = 3 =
6、 ( ) 4 = P ISO 11980: 2006 6 B() , , B.1 . B.2 . , , . , . LogMAR . LogMAR . LogMAR . B.3 ( ) . B.4 . B.5 B.5.1 . B.5.2 ( ) 3 . 0 = 1 = 2 = B.5.3 . a) b) 2 = 1 = 0 = 1 = 2 = B.6 B.6.1 0 = 1 = 2 = ( ). 3 = P ISO 11980: 2006 7 B.6.2 0 = , 1 = , . 2 = , , 3 = , 4 = , . B.6.3 0 = , 1 = , 3 2 = , 10 3 =
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
下载文档到电脑,查找使用更方便
10000 积分 0人已下载
下载 | 加入VIP,交流精品资源 |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- KSPISO119802006OPHTHALMICOPTICS CONTACTLENSESANDCONTACTLENSCAREPRODUCTS GUIDANCEFORCLINICALINVESTIGATIONS

链接地址:http://www.mydoc123.com/p-820439.html