Author: Steli Loznen
Publisher: Artech House
ISBN: 1630818399
Category : Technology & Engineering
Languages : en
Pages : 350
Book Description
Electrical Product Compliance and Safety Engineering, Volume 2
Author: Steli Loznen
Publisher: Artech House
ISBN: 1630818399
Category : Technology & Engineering
Languages : en
Pages : 350
Book Description
Publisher: Artech House
ISBN: 1630818399
Category : Technology & Engineering
Languages : en
Pages : 350
Book Description
Federal Register
Author:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 426
Book Description
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 426
Book Description
GB, GB/T, GBT - Product Catalog. Translated English of Chinese Standard (All national standards GB, GB/T, GBT, GBZ)
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Social Science
Languages : en
Pages : 2809
Book Description
This document provides the comprehensive list of Chinese National Standards - Category: GB; GB/T, GBT.
Publisher: https://www.chinesestandard.net
ISBN:
Category : Social Science
Languages : en
Pages : 2809
Book Description
This document provides the comprehensive list of Chinese National Standards - Category: GB; GB/T, GBT.
Chinese Standard. GB; GB/T; GBT; JB; JB/T; YY; HJ; NB; HG; QC; SL; SN; SH; JJF; JJG; CJ; TB; YD; YS; NY; FZ; JG; QB; SJ; SY; DL; AQ; CB; GY; JC; JR; JT
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Law
Languages : en
Pages : 7263
Book Description
This document provides the comprehensive list of Chinese National Standards and Industry Standards (Total 17,000 standards).
Publisher: https://www.chinesestandard.net
ISBN:
Category : Law
Languages : en
Pages : 7263
Book Description
This document provides the comprehensive list of Chinese National Standards and Industry Standards (Total 17,000 standards).
GB/T-2020, GB-2020 -- Chinese National Standard PDF-English, Catalog (year 2020)
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Social Science
Languages : en
Pages : 220
Book Description
This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2020.
Publisher: https://www.chinesestandard.net
ISBN:
Category : Social Science
Languages : en
Pages : 220
Book Description
This document provides the comprehensive list of Chinese National Standards - Category: GB, GB/T Series of year 2020.
GB - Chinese National Standard PDF Translated English; Product Catalog (National standard GB Series)
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Social Science
Languages : en
Pages : 552
Book Description
This document provides the comprehensive list of Chinese National Standards - Category: GB Series.
Publisher: https://www.chinesestandard.net
ISBN:
Category : Social Science
Languages : en
Pages : 552
Book Description
This document provides the comprehensive list of Chinese National Standards - Category: GB Series.
Medical Device
Author: Rommel Garcia
Publisher: Xlibris Corporation
ISBN: 1524589209
Category : Medical
Languages : en
Pages : 403
Book Description
This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.
Publisher: Xlibris Corporation
ISBN: 1524589209
Category : Medical
Languages : en
Pages : 403
Book Description
This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.
CE MARKING BOOK -OF ELECTRICAL AND ELECTRONIC PRODUCTS
Author: CHETAN KATHALAY
Publisher: CHETAN KATHALAY
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 157
Book Description
Buy CE marking book in India.This book gives a step-by-step approach to CE marking of electrical and electronic equipment including risk assessment. It covers, in detail, five important directives viz. low voltage directive (LVD), electromagnetic compatibility (EMC) directive, medical devices directive (MDD), radio equipment directive (RED) and the RoHS directive. It provides insights into product design and test methodologies especially EMC and product SAFETY so that the product meets the technical requirements of the applicable standards. It also seeks to clarify the many doubts and misconceptions about CE marking. The book begins with a chapter that introduces the reader to the nuances of the CE marking process, the conformity assessment modules and to compile supporting documents that illustrate the process. This is followed by the chapter on product safety which describes the principles of safety as found in the international IEC and European harmonized safety standards. It provides ways and means to improve product design so as to ensure reasonable compliance when a product is subject to safety evaluation by a test laboratory. Then, there are two chapters dedicated to EMC. One explains the EMC fundamentals, standards and the test methodology while the other deals with EMC design. The design chapter contains ways and means to incorporate EMC measures like line filters, shielding, grounding and cable routing at the design stage so that the product can comply with the EMC tests with a minimum of iterations. The design means discussed are very practical in nature and are given in such a way that the design engineer can immediately incorporate them without worrying too much about theory. All the directives now-a-days require a detailed risk assessment to be carried out in addition to testing as per standards. Thereafter the risk assessment needs to be documented so as to demonstrate how the risks have been reduced/eliminated. The book deals with the risk assessment in detail for all the directives under consideration. And last but not the least, the CE marking procedure is not complete unless the entire process is documented through the so-called technical file or technical documentation. The last chapter explains the compilation of technical documentation as required by the directives and the European surveillance authorities.
Publisher: CHETAN KATHALAY
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 157
Book Description
Buy CE marking book in India.This book gives a step-by-step approach to CE marking of electrical and electronic equipment including risk assessment. It covers, in detail, five important directives viz. low voltage directive (LVD), electromagnetic compatibility (EMC) directive, medical devices directive (MDD), radio equipment directive (RED) and the RoHS directive. It provides insights into product design and test methodologies especially EMC and product SAFETY so that the product meets the technical requirements of the applicable standards. It also seeks to clarify the many doubts and misconceptions about CE marking. The book begins with a chapter that introduces the reader to the nuances of the CE marking process, the conformity assessment modules and to compile supporting documents that illustrate the process. This is followed by the chapter on product safety which describes the principles of safety as found in the international IEC and European harmonized safety standards. It provides ways and means to improve product design so as to ensure reasonable compliance when a product is subject to safety evaluation by a test laboratory. Then, there are two chapters dedicated to EMC. One explains the EMC fundamentals, standards and the test methodology while the other deals with EMC design. The design chapter contains ways and means to incorporate EMC measures like line filters, shielding, grounding and cable routing at the design stage so that the product can comply with the EMC tests with a minimum of iterations. The design means discussed are very practical in nature and are given in such a way that the design engineer can immediately incorporate them without worrying too much about theory. All the directives now-a-days require a detailed risk assessment to be carried out in addition to testing as per standards. Thereafter the risk assessment needs to be documented so as to demonstrate how the risks have been reduced/eliminated. The book deals with the risk assessment in detail for all the directives under consideration. And last but not the least, the CE marking procedure is not complete unless the entire process is documented through the so-called technical file or technical documentation. The last chapter explains the compilation of technical documentation as required by the directives and the European surveillance authorities.
Technical specifications of radiotherapy equipment for cancer treatment
Author:
Publisher: World Health Organization
ISBN: 9240019987
Category : Medical
Languages : en
Pages : 160
Book Description
Publisher: World Health Organization
ISBN: 9240019987
Category : Medical
Languages : en
Pages : 160
Book Description
GB/T 13797-2023 Translated English of Chinese Standard (GB/T 13797-2023, GBT13797-2023)
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 22
Book Description
This document defines the terms and definitions of medical X-ray tubes, and specifies the requirements and test methods for medical X-ray tubes. This document applies to medical X-ray tubes. Note: This product, used as the ray source of medical X-ray equipment, is assembled in the sleeve (X-ray tube assembly) that uses oil as the insulating and cooling medium; it is used for supporting medical X-ray equipment.
Publisher: https://www.chinesestandard.net
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 22
Book Description
This document defines the terms and definitions of medical X-ray tubes, and specifies the requirements and test methods for medical X-ray tubes. This document applies to medical X-ray tubes. Note: This product, used as the ray source of medical X-ray equipment, is assembled in the sleeve (X-ray tube assembly) that uses oil as the insulating and cooling medium; it is used for supporting medical X-ray equipment.