Taiyaku ISO 14971 : 2019 <JIS T 14971 : 2020> Iryo Kiki Niokeru Risk Management No Kokusai Kikaku TR T 24971 : 2020 <JIS T 14971 Tekiyo Shishin> Shuroku (Management System ISO SERIES)
Nippon Iryo Kiki Sangyo Rengo Kai / Kanshu ISOTC 210 Kokunai Taisaku in Kai / Kanshu
| Points You Earn | 1% (130p) |
|---|---|
| Release Date | January 2021 |
| Availability | In Stock at Supplier:Usually ships in 2-4 days |
Product Details
| Catalog No. | NEOBK-2577365 |
|---|---|
| JAN/ISBN | 9784542402898 |
| Product Type | BOOK |
| Pages | 312 |
|---|
Books are basically written in Japanese except for bilingual books or ones indicated as not written only in Japanese.
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Translate Description
Description in Japanese
対訳ISO 14971:2019〈JIS T 14971:2020〉医療機器におけるリスクマネジメントの国際規格 TR T 24971:2020〈JIS T 14971適用指針〉収録 (Management System ISO SERIES) / 日本医療機器産業連合会/監修 ISOTC210国内対策委員会/監修
Related Offer & Feature
Tracklisting
| 1 |
1 適用範囲
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| 2 |
2 引用規格
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| 3 |
3 用語及び定義
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| 4 |
4 リスクマネジメントシステムの一般要求事項
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| 5 |
5 リスク分析
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| 6 |
6 リスク評価
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| 7 |
7 リスクコントロール
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| 8 |
8 全体的な残留リスクの評価
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| 9 |
9 リスクマネジメントのレビュー
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| 10 |
10 製造及び製造後の活動
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| 11 |
附属書A(参考)要求事項の根拠
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| 12 |
附属書B(参考)医療機器のリスクマネジメントプロセス
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| 13 |
附属書C(参考)リスクの基礎的な概念
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