MDR技术文档风险管理计划(中文)

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3.0 冒牌货 2026-01-14 3 2.05MB 15 页 120质量币
侵权投诉
󷿏󷵪󶊢󵬇󷊢󳤓
󾘉󳚞󴩯 EN ISO 14971:2019󾘊
󳖨󳯂󳬎󶃱󾘛
󳺌󳫸󾘛
󴲈󳗷󶘗󳫸󾘛
󵥉󴸭󾘛
󴳦󴸠󾘛
󴳦󴸠󾘛
󴳦󴸠󾘛 󶘗󷋒󶜆󾘛
󴊢󷴆󳖻󾘛
󴪉󴹄󴲺󾘛
󵷯󴙖
0. 󳛯󷊣󳪇󳫳󷊱󴙖 ...........................................................................................................................................................................................................................3
1. 󶨄󳷵󳔏󴘖󷄁 ................................................................................................................................................................................................................... 3
1.1 󶨄󳷵 ....................................................................................................................................................................................................................3
1.2 󶊁󳗌 .............................................................................................................................................................................................3
2. 󴊛󳕊 ................................................................................................................................................................................................................................ 3
3. 󳫃󶜄󴼈󳣇󳮍󳫃󶜄󴲈󵨯 ................................................................................................................................................................................................3
3.1 󴘖󵰩󴼈󳣇 ............................................................................................................................................................................................................3
3.2 󳫃󵡨󵥪 󴲈󳗷 ............................................................................................................................................................................................ 5
4. 󷿏󷵪󶊢󵬇 󴱀󶉗󳔏󷿏󷵪󶊢󵬇 󵑂󶄌 ..................................................................................................6
4.1 󷿏󷵪󶊢󵬇 󶉗󵱦󱜃6
4.2 󷿏󷵪󶊢󵬇 󷛈󶄌.......................................................................................................................................................................6
5. 󷿏󷵪󶊢󵬇 󷊢󳤓8
5.1 󷊢󳤓󶨄󳷵 .......................................................................................................................................................................................................... 8
5.2 󳖨󳯂 󳛢󴝰 ..............................................................................................................................................................................................8
5.3 󸆍󷋂 .....................................................................................................................................................................................10 󷊢󳤓
5.4 󳘛󳭙 󳮍󷐤󳗼 .................................................................................................................................................... 11
5.5 󷋅󴊢󴜼󶗔 󵐼󳦩 .................................................................................................................................................................11
5.6 󷿏󷵪󷋅󳘱󳔏󷿏󷵪󴪦󳫘 󴼈󳣇 ........................................................................................................... 13
6 󷿏󷵪󳤇󴺑󳔏󴪨󳤷 ........................................................................................................................................................................................................ 615
6.1. 󷋇󳤬 󳩲󷵪󳷡󶐡󵶅󵔆󳩖 .........................................................................................................................................................15
6.2 󴸁󳤞 󳩲󷵪 󳤇󴺑󾘍󷿏󷵪󷋅󳘱 , 󷿏󷵪󴪨󳤷 󴪫󴲾 󳮍 󵊌󵱚󵶅 󷿏󷵪󷋅󳘱 󳔻
15 m
6.3 󴪨󳤷󶗔󷊻 󴪫󴲾..............................................................................................................................................................17
6.4 󷿏󷵪/󴰷󵷋󳤇󴺑󳔏󴊢󴻦 󴜼󵊌󴓯󵶅 󷿏󷵪󳫰󴪦󳫘󴜨 ..........................................................17
6.5 󳔎󶥰󳖌󳗷󴦦󳭋 󳛢󴝰 ............................................................................................................................................................17
6.6 󵰠󳖨 󳗦󳫋󳬏󴸠󳤷󳙝 󳛢󴝰 .............................................................................................................17
7. 󵰲󰜧󰜧󴘖󷑸󵶅󷿏󷵪 󷿏󷵪󴪨󳤷 󴪫󴲾 ......................................................................................................................................................17
8. 󷿏󷵪󴪨󳤷󵶅󴊍󴱵󴜨 ......................................................................................................................................................................................................17
8.1 󳥪󳙚󷿏󷵪󷋅󳘱 ....................................................................................................................................................................17
8.2 󴜼󳙔󳥪󳙚󷿏󷵪󷋅󳘱 ..........................................................................................................................................................................................17
8.3 󳥪󳙚󷿏󷵪󳛢󴝰 󴦬󷸳 ..................................................................................................................................................... 17
9. 󴱵󳙔󳥪󳙚󷿏󷵪󷋅󳘱 󳫰󴪦󳫘󴜨 ..............................................................................................................................................17
10. 󵰠󳖨 󳗦󳫋󳬏󴸠󳤷󳙝 󵐼󳦩 .........................................................................................................................17
11. 󶗔󷊻 .............................................................................................................................................................................................................................17
0.󳛯󷊣󳪇󳫳
󳬧󱜃 󵦷󴜂
󴥺󳣇󳖻 󴫐󷛱 󵰠󴱉󴳦󴸠
1.󶨄󳷵󳔏󳗌󶗎
1.1 󶨄󳷵󾘛
1.2 󶊁󳗌󾘛
2.󴊛󳕊
o 󴩠󴊴󾘛󷖬󳙔󳫘󳘥󳮍/󴤗󳝦󴖸󴤗󷐣󳖨󳫘󴩠󱜃
o 󳩲󷵪󾘛󵙝󳸩󵶅󳘥󴊴󵖑
󷿏󷵪󾘛󳩲󴊴󳫒󵰠󴕷󷜡󴤑󴩠󴊴󵶅󳫰󶟾󷾒󵪈󳗦󳫋󴩠󴊴󵶅󳔦󷣎󶄌󴖧
o 󷿏󷵪󳤇󴺑󾘛󴋺󵪱󴸊󳛢󴝰󷛜󶽍󷌄󴻦󾘍󳗦󷋇󳤬󳩲󷵪󴕷󷋅󳘱󷿏󷵪󱜃o 󴊊󳡩󾘛󳡎󳫘󳔎󳫰󴪦󳫘󵶅󳘥󴊴󷿏
󷵪󱜃
3.󳫃󶜄󴼈󳣇󳮍󴲈󵨯󷑅󴲚
3.1 󳫃󶜄󴼈󳣇
󳬧 󴲈󴽤󴼈󷾙󷋂󳗷󳫸󵼂
摘要:

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作者:冒牌货 分类:专业资料 价格:120质量币 属性:15 页 大小:2.05MB 格式:PDF 时间:2026-01-14
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