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在iec 62304這個產品中，有1篇Facebook貼文，粉絲數超過2萬的網紅COMPOTECHAsia電子與電腦 - 陸克文化，也在其Facebook貼文中提到， #嵌入式系統 #微控制器MCU #數位訊號控制器DSC #功能安全 #ISO26262 #IEC61508 #IEC60730 #IEC62304 【不可不知：功能安全】 最終產品的堅固性、可靠性和安全性變得越來越重要。在某些應用領域中，這些要求是形式化和強制性的；而在另一些應用領...

iec 62304 在 COMPOTECHAsia電子與電腦 - 陸克文化 Facebook 的精選貼文

COMPOTECHAsia電子與電腦 - 陸克文化 By COMPOTECHAsia電子與電腦 - 陸克文化

2020-12-18 14:30:01 有 83 人按讚
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#嵌入式系統 #微控制器MCU #數位訊號控制器DSC #功能安全 #ISO26262 #IEC61508 #IEC60730 #IEC62304

【不可不知：功能安全】

最終產品的堅固性、可靠性和安全性變得越來越重要。在某些應用領域中，這些要求是形式化和強制性的；而在另一些應用領域中，則透過這些要求來區分產品的優劣度。

「功能安全」標準取決於目標市場。許多標準支援多種級別的嚴格性，具體程度取決於危害的可能性和嚴重性，範圍包括單一故障、嵌入式系統的安全狀態到完全冗餘，不僅應檢測故障，還應校正故障以防服務中斷或降級。

延伸閱讀：
《Functional Safety for ISO 26262, IEC 61508, IEC 60730 and IEC 62304》
https://www.microchip.com/design-centers/functional-safety?utm_source=compotechasia.com&utm_medium=LeaderboardAd&utm_content=Corp_860x80&utm_campaign=FunctionalSafety

#微芯科技Microchip #AVR #PIC24 #dsPIC #SAM #PIC32

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COMPOTECHAsia電子與電腦 - 陸克文化

About author
2002年，憑藉獨特敏銳度察覺到電子業界需求，《COMPOTECHAsia電子與電腦》於中國大陸取得《COMPOTECHChina》月刊發行權，為初到海外發展及當地讀者出具最具前瞻性且中肯的觀察，具有相當影響力，也成為一流國際大廠競相展示研發心血的首選。 2006年，有鑑於網路環境日趨成熟，《COMPOTECHAsia電子與電腦》再度領先同業，首創線上視頻平台CTOV (COMPOTECH Online Video)。自此，成為整合紙本、網站、電子報及線上視頻的全方位媒體。 2016年，為貫徹市場應用及開發技術的連結並擴大群眾基礎，陸續展開 Facebook、Twitter、LinkedIn 等社群平台經營。 「就市論勢、就勢論市」是我們的信念。我們將於每週一、三、五下午在 FB 分享生活中隨處可見的科普知識，以平易近人的方式，用不一樣的角度觀察市場趨勢和技術走向，並不定時穿插轉載網路精彩佳作或趣聞。記得設為「搶先看」哦！ “COMPOTECHAsia/ China” issue on 8th monthly. It is the dependent media which focuses on electronic industry situation, end user market, and technology trend. The monthly magazine has become the main channel to get professional information for engineers, purchaser, R&D employees and decision-making management. We perceived the demand of electronic industry and strive to get the distribution rights of “China Edition” in Mainland China in 2002. It gives a lot of prospective and proper observation for the overseas workers and local readers. Gradually, COMPOTECH is getting to be the powerful. Nowadays, COMPOTECH is the first-choice platform for the first-class firms to display their R&D results. Furthermore, in 2006, we were ahead of our competitors to build the CTOV platform (COMPOTECH Online Video) due to the mature internet environment. Since then, COMPOTECH has become the integrated media. For having a thorough knowledge of market applications and technology migration, as well as expanding the base of the masses, we begin to manage the Facebook, Twitter and LinkedIn etc. in 2016.
智能系統設計／應用工程師、產品／專案開發主管、元器件／零組件／準系統採購者的交流園地，於每週一、三、五下午分享【科技應用取向】的趨勢議題。
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iec 62304 在 工研院課程｜IEC 62304醫療器材軟體確效系列二部曲(共12小時) 的推薦與評價

2022/02/18 (五) SW-01【IEC 62304醫療器材軟體確效介紹及實作】 2022/03/04 (五) SW-02【醫療器材軟體風險分析工具之應用】. 課程詳情請上工研院產業學院官網 ... ... <看更多>

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#1. IEC 62304 醫療器材軟體| TÜV SÜD

根據IEC 62304合格標準規定，醫療器材驗證範圍涵蓋獨立軟體和醫療器材嵌入軟體兩大方面。IEC 62304, Medical Device Software, medical device functional safety ...

#2. IEC 62304:2015 醫療軟體確效法規與實務

IEC 62304 – medical device – software life cycle processes. • IEC 60335-1 Annex R, IEC 60730-1 Annex H. Master of Automation and Control. Qualifications.

#3. IEC 62304:2006+AMD1:2015 CSV Consolidated version

IEC 62304 :2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks ...

#4. IEC 62304 - Wikipedia

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the ...

#5. 置頂淺談醫療器材軟體IEC 62304標準 - M.D.'s Blogger

醫療器材國際標準IEC 62304主要是針對醫療器材軟體所做的生命週期流程管理，適用範圍包括了純醫療軟體及嵌入或整合於醫療器材上的軟體。

#6. IEC 62304醫療器材軟體確效系列二部曲

IEC 62304 :2006/Amd 1:2015 Medical device software life cycle processes; US FDA Guidance for ... 醫療器材軟體安全等級 (IEC 62304 software safety class vs.

#7. IEC 62304:2006 - Medical device software - ISO

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common ...

#8. IEC 62304醫材軟體生命週期管理之防疫實際運用探討 - FIND

由國際電工委員會（International Electrotechnical Commission, IEC）制定的IEC 62304醫材軟體生命週期標準，由於醫材軟體生命週期攸關病人健康和醫 ...

#9. What Is IEC 62304? Medical Device Software Compliance Tips

IEC 62304 is a functional safety standard that covers safe design and maintenance of software. It provides processes, activities, and tasks to ...

#10. IEC 62304 | Greenlight Guru

IEC 62304 is an international standard medical device software that defines an agreed upon framework for processes that occur throughout the product lifecycle.

#11. 工研院課程｜IEC 62304醫療器材軟體確效系列二部曲(共12小時)

2022/02/18 (五) SW-01【IEC 62304醫療器材軟體確效介紹及實作】 2022/03/04 (五) SW-02【醫療器材軟體風險分析工具之應用】. 課程詳情請上工研院產業學院官網 ...

#12. Medical Device Software & IEC 62304 - Johner-Institut

Medical device software has to be developed according to the FDA and IEC 62304 requirements. Find out how to fulfill these requirements efficiently and ...

#13. IEC 62304 standard for medical device software development

IEC 62304 is an international standard published by the International Electrotechnical Commission (IEC) that defines the requirements of the software ...

#14. What Is IEC 62304 & How Is It Used in Medical Device ...

Created by the International Organization for Standardization (ISO), IEC 62304 is the standard that specifies the process and needed objectives ...

#15. IEC 62304 | FDA Software Validation Compliance - QA Systems

IEC 62304 :2006 (Medical Device Software- Software Life-cycle Processes) is a functional safety standard. A system to which IEC 62304 is applicable often has ...

#16. IEC 62304 ed. 2 – what happened? - LinkedIn

ISO 14971 is therefore a normative reference for risk management in IEC 62304. However, with the scope extension to health software, there was ...

#17. 醫療器材軟體應用、驗證及確效

IEC 62304 :2006/Amd. 1:2015. Class A：. 軟體系統可能會導致危. 害情況，不會導致不可. 接受的風險。 Class B：. 軟體系統可能導致危害情況，. 可能產生危害是非嚴重傷害 ...

#18. IEC 62304:2021 Committee Draft Version: Groundhog Day

That's a déjà-vu. The second version of IEC 62304 is still in draft. It has been in this state for five years, since the publication of the ...

#19. Applying IEC 62304 From a Medical Device Perspective | UL

IEC 62304 is a functional safety standard that defines the life cycle requirements for medical device software providing processes, activities ...

#20. IEC 62304: Medical Device Software LifeCycle Processes

IEC 62304 is the international standard for medical device software development and other medical device software life cycle processes. Every ...

#21. IEC 62304 - 视觉解决方案

IEC 62304 标准为软件开发生命周期流程提供了一个框架，其中包含医疗设备软件安全设计和维护所需的活动和任务。 与此标准的一致性满足21CFR820 和医疗器械 ...

#22. IEC/EN 62304 Medical Device - Software Life Cycle Processes

The standard EN 62304:2006 defines requirements for the life cycle of the development of medical software and for software within medical ...

#23. Standard IEC 62304 - Medical Device Software - ResearchGate

IEC 62304 :2006 – Medical device software – Software life cycle processes [9] , provides specific guidance on the processes to be performed for the development ...

#24. ANSI/AAMI/IEC 62304:2006 and A1:2016

ANSI/AAMI/IEC 62304:2006 and A1:2016. CONSOLIDATED TEXT - Medical device software - Software life cycle processes. Includes Amendment 1.

#25. IEC 62304 & ISO 13485 Relationship - I3CGLOBAL

IEC 62304 must be applied in conjunction with ISO 13485 standard which offers a framework for the lifecycle processes necessary for the safe design & risk.

#26. What is IEC 62304? | KO2 Recruitment

IEC 62304 offers guidance on how to identify potential hazards that could be the result of medical software failures or defects, and therefore outlines how to ...

#27. Articles Tagged 'iec 62304' - Knowledge Base - Infle - Inflectra ...

This page displays a list of KB articles containing the tag 'iec 62304' ... ISO 13485 Medical devices -- Quality management systems -- Requirements for ...

#28. IEC 62304 - Elucidating Medical Device Software Guidelines ...

IEC 62304 is a functional safety standard similar to IEC 61508. You can learn the fundamentals of IEC 62304 through this article and much ...

#29. What is IEC 62304 -standard? | Kasve Ltd

IEC 62304 defines the set of processes for life-cycle management of medical device software.

#30. IEC 62304 | Auriga

IEC 62304 case studies and software development and testing projects by Auriga Inc.

#31. IEC 62304 Hazard Analysis Demystified - Promenade Software

Indeed, safety of the software is the point of the standard. But the IEC 62304 Risk Management Process lists different requirements than ISO 14971 hazard ...

#32. Implementing IEC 62304 for Safe and Effective Medical ...

In response to that, the functional safety standard IEC 62304, “Medical device software – Software life cycle processes,” has emerged as an ...

#33. EN/IEC 62304 軟件需求測試

醫療器械行業使用的IEC 62304 標準為醫療器械軟件的安全設計和維護以及軟件生命週期過程所需的活動和任務提供了框架。

#34. Achieving ISO 13485 & IEC 62304 Medical Device ... - Tuleap

Achieving ISO 13485 & IEC 62304 Medical Device Compliance SleepInnov Technology Story. Sleepinnov Technology is a hi-tech company that develops ...

#35. IEC 62304 standard and software safety classifications

If you are developing medical device software, then you will be working closely with the IEC 62304 standard. The number of activities you ...

#36. IEC 62304 Ed. 2: Software Life Cycle Standard for ... - PubMed

The quality of software is high in medical devices due to the strict regulatory requirements and their implementation in the software ...

#37. Doing a Software Release in Compliance With IEC 62304

IEC 62034 Requirements for Software Release. The requirements in IEC 62304 regarding software release can be summarized as “don't be stupid, ...

#38. Medical Devices & Applications testing- standards compliance ...

IEC 62304 is applicable to all software for medical devices and applications and covers the processes and activities around the production of embedded and ...

#39. IEC 62304 A Complete Guide - 2020 Edition - 博客來

書名：IEC 62304 A Complete Guide - 2020 Edition，語言：英文，ISBN：9780655931119，頁數：314，作者：Blokdyk, Gerardus，出版日期：2019/09/29，類別：商業財經.

#40. IEC 62304 Ed. 1.0 b:2006, Medical device software - Amazon ...

IEC 62304 Ed. 1.0 b:2006, Medical device software - Software life cycle processes [IEC TC/SC 62A] on Amazon.com. *FREE* shipping on qualifying offers.

#41. IEC 62304 Medical Device Software Development - Pro4People

Developing IEC 62304 compliant software for medical devices, in line with its intended use and compliant with ISO 13485, ISO 14971, and IEC 62304 standards.

#42. 什麼是IEC 62304？如何用它滿足醫療器械安全合規性？ - 資訊咖

IEC 62304 是醫療設備的安全標準，遵守該標準對軟體開發商至關重要。無論是醫生、專家還是護士，醫療保健提供者都依賴醫療設備來治療他們的病人。

#43. Achieve Fast Compliance with IEC 62304 - Polarion - Software

IEC 62304 Solution Benefits: Prove the implementation of processes, actions and approvals; Track all actions at a forensic level throughout the entire ...

#44. IEC 62304 | Vector

VectorCAST products help satisfy FDA - IEC 62304 software testing requirements.

#45. Are You IEC 63204 Compliant? - The RND Group

Any software included in a medical device should be IEC 62304 compliant. This is where The RND Group comes in. We are a team of people who ...

#46. IEC 62304:2006/AMD1:2015 - Amendment 1 - iTeh Standards

IEC 62304 :2006/AMD1:2015 - Amendment 1 - Medical device software - Software life cycle processes.

#47. IEC 62304 | SYSGO

Software Certification for Medical Devices. Sophisticated medical devices have to be certified according to IEC 62304, the standard for functional Safety in the ...

#48. IEC 62304 - Recognized Consensus Standards - US Food ...

IEC 62304 :2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, ...

#49. Medical Device Software, Risk Management & IEC 62304 |

The international standard IEC 62304 Medical Device software – software life-cycle processes is the main framework for requirements for the ...

#50. IEC 62304 - Wind River Blog

The Wind River Blog Network is made up of a variety of voices: executives, technologists and industry enthusiasts. We hope to foster conversations and encourage ...

#51. Medical Device Software - Standard IEC 62304 - IEEE Xplore

IEC 62304, if accepted, requires what reputable medical device manufacturers are already doing. The author therefore expect them to welcome it.

#52. UNE-EN IEC 62304 - medical device software - Oqotech

UNE-EN IEC 62304 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard ...

#53. IEC 62304 - VDE Medical Devices and Software

IEC 62304 “Medical device software – Software life cycle processes” defines the life cycle requirements for medical device software. The set of processes, ...

#54. IEC 62304 Compliance Software - ALM Software Tool - Orcanos

IEC 62304 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard ...

#55. IEC 62304 Consultancy & Training Course

IEC 62304 Health Software ✓software lifecycle ✓embedded ✓standalone ✓consultancy ✓support ✓training courses. Lorit Consultancy – your partner for ...

#56. 醫療裝置軟體國際標準IEC 62304認證案例_旋極科技

為了符合IEC 62304標準對嵌入式軟體單元測試框架的要求，FastFocus提出了一套嚴格的工具需求。他們需要一個值得信賴的供應商，可以提供高效的技術 ...

#57. 醫療器材軟體確效實務

器材軟體生命週期過程之必要元素，並以實務方式說明軟體確效之內容，同時介紹美國FDA 對軟體及行動裝置. 醫用APP 之要求。最末將介紹IEC 62304 之改版方向及醫療器材網 ...

#58. IEC-62304対応 イーコンプライアンス

IEC -62304とは ... IEC62304（Medical device software - software Life Cycle Processes）は、 医療機器ソフトウェアの安全性の向上を目的として、ソフトウェア開発及び保守 ...

#59. Is Google Unit Test compatible with IEC 62304? - Stack Overflow

IEC 62304 is a software life cycle process, it has nothing to say about whether you can or cannot use a particular tool, only the steps ...

#60. Which OS for IEC 62304 Medical Systems? - BlackBerry QNX

It lists requirements identified by standards such as IEC 62304, ISO 14971 and IEC 61508, and offers comparative estimates of the effort required to meet ...

#61. Rhapsody Kit for ISO 26262, IEC 61508, IEC 62304, and ... - IBM

BTC Embedded Systems AG provided the following documentation for the Rhapsody Kit for ISO 26262, IEC 61508, IEC 62304, and EN 50128.

#62. IEC/ISO 62304:2015 - BrightInsight

The international standard IEC/ISO 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for ...

#63. MSZ EN 62304:2006 - Magyar Szabványügyi Testület

Hivatkozási szám, MSZ EN 62304:2006. Cím, Gyógyászatikészülék-szoftver. Szoftveréletciklus-folyamatok (IEC 62304:2006). Angol cím, Medical device software.

#64. IEC 62304 - LI-MED

The IEC 62304 is an international standard outlining product life cycle processes pertaining to the development of software used with medical devices.

#65. IEC 62304 - Compliance steps - Elsmar Cove

62304 clause 4.1 requires a quality system to be in place and suggests that ISO/IEC 90003 provides guidance of how to apply quality systems to ...

#66. IEC 62304:2015 | Medical Device Software Standards

This is an evidence product checklist for the IEC standard 62304:2015, dealing with Medical Device Software Life Cycle Processes.

#67. Meeting IEC 62304:2006 Requirements with GitLab

IEC 62304 :2006 defines requirements for the lifecycle of medical device software. It prescribe processes, activities, and tasks to improve the safety and ...

#68. IEC 62304 | ArrowFast MedTech Glossary

IEC 62304 is a standard that defines the life cycle requirements for software that is used in a medical device.

#69. IEC 62304 Software Development

− The IEC 62304 is a process standard, it defines requirements to the development but not the product itself. − Evidence of the correct ...

#70. IEC 62304 General - MEDTEQ

Significant experience has also been obtained testing high risk medical devices such as infusion pumps, dialysis machines, surgical lasers for functional safety ...

#71. 行业认证标准：IEC 62304-医疗设备软件安全分类标准 - CSDN ...

什么是IEC 62304？IEC 62304标准在医疗设备行业中使用，它是一种软件安全分类，它为软件生命周期过程提供了一个框架，其中包含为安全设计和维护医疗 ...

#72. Developing Medical Device Software According to IEC 62304

... the requirements of IEC 62304. The course covers the relationship of IEC 62304 with related standards such as ISO 13485, ISO 14971 and IEC 60601.

#73. IEC 62304 Pitfalls: Software Development Life Cycle - AssurX

IEC 62304, the international standard that defines software development lifecycle requirements for medical device software.

#74. Medical Device Software Development Lifecycle Standard ...

IEC 62304 is a companion standard to the base medical device safety standard, IEC 60601-1, specifically Clause 14 (PEMS). The main differences ...

#75. How we organise around IEC 62304 | In The Pocket

IEC 62304 is inevitable when developing medical devices. How do we bring agility into the process?

#76. IEC 62304

The international standard IEC 62304 – medical device software – software life cycle processes[1] is a standard which specifies life cycle requirements for ...

#77. 5 Major IEC 62304 Compliance Mistakes Medical Software ...

The international standard IEC 62304 is a standard that specifies life cycle requirements for the development of medical software.

#78. IEC 62304 - for safety class A, class B and class C | Axivion

IEC 62304 describes the Software life cycle processes containing the Development and Maintenance Process, Risk Management (incorporating ISO 14971 and the ...

#79. LDRA Medical software application | IEC 62304 | FDA

LDRA's tool suite is a software verification and validation solution for the development of medical device software that meets FDA and IEC 62304 standards.

#80. Best Practices: IEC 62304 Compliant Medical Device Software

If you are developing a new product, learn more about Best Practices for Medical Device Software Developed under IEC 62304.

#81. A Roadmap for Implementing IEC 62304 in Organizations ...

tions in the implementation of IEC 62304. Keywords: Medical device software, medical device standards, regulatory compliance, software roadmap, Software ...

#82. Medical Device software development, IEC 62304 & asking ...

For IEC 62304, it is also important to consider software safety as part of the overall device risk management. In many cases, the software will ...

#83. IEC 62304:2006 - software life cycle processes explained

These areas are regulated by three standards: ISO 14971 that we've already covered in this article, ISO 13485 that we'll focus on next time, and IEC 62304, ...

#84. IEC 62304 2015 - impact on Class A software - Matrix ...

You need to do the following if you choose to use IEC 62304: there must be tests cases for the software requirements; you need to manage issues ...

#85. How to validate a build toolchain according to IEC 61508, ISO ...

How to validate a build toolchain according to IEC 61508, ISO 26262, EN 50128 and IEC 62304. We offer certified versions of the build chain in IAR Embedded ...

#86. K.5890 經皮神經電刺激器肌肉刺激器安全性及功能性試驗服務

PMC擁有TAF ISO 17025認證實驗室，符合法規設計輔導：IEC 60601-1 電氣安全設計輔導與諮詢、衛福 ... IEC 60601-1-4 IEC 62304 EN 62304 軟體確效輔導

#87. IEC 62304:2006 – Medical Device Software - QualityMedDev

IEC 62304 :2006 is an internationally recognised medical device standard which provides a framework for the development, ...

#88. IEC 62304: medical device software - Semantic Scholar

This paper presents a directive to prepare the small entity in planning to apply ISO/IEC 62304 before further testing and certification, and states that the ...

#89. Software & IEC 62304 - Johner-Institut

Die IEC 62304 ist eine in Europa harmonisierte Norm für „Medizingeräte-Software“. Sie stellt Mindestanforderungen an die wichtigsten Software-Lebenszyklus- ...

#90. 程式安全性認證：軟體確效的實行 - 有勁的基因資訊

ISO13485是ISO國際組織針對醫療器材的安全與功效所制定的規則。 ... IEC62304在軟體生命週期管理部分有多個項目與ISO13485軟體確效的流程相關，以下 ...

#91. Software in the MedTech industry (IEC 62304) - konplan

Web, Desktop, and Mobile Applications; Software Concept, Architecture, and Design; Software as a medical product (IEC 62304) ...

#92. Applying ISO/IEC 29110 to ISO/IEC 62304 for Medical Device ...

Moreover, IEC60601 are referring to ISO/IEC 62304 on MDS development. The burden of small entities is an unawareness of the initiation point ...

#93. Development in accordance with IEC 62304/IEC 82304-1 - nsf ...

We support you in the implementation of a software-lifecycle process in accordance with IEC 62304:2006+A1:2015 and IEC 82304-1:2016 to fulfill regulatory ...

#94. Building a Rule-Based Goal-Model from the IEC 62304 ...

IEC 62304 is a standard for the medical device software lifecycle. Developers must develop software that complies with all specifications in ...

#95. Creation of an IEC 62304 compliant software development plan

One such standard IEC 62304, Medical Device Software—Software Life Cycle Processes, defines the processes that are required in order to ...