標(biāo)題: Titlebook: Medical Device Guidelines and Regulations Handbook; Prakash Srinivasan Timiri Shanmugam,Pugazhenthan T Book 2022 The Editor(s) (if applica [打印本頁(yè)] 作者: 諷刺文章 時(shí)間: 2025-3-21 17:03
書目名稱Medical Device Guidelines and Regulations Handbook影響因子(影響力)
書目名稱Medical Device Guidelines and Regulations Handbook影響因子(影響力)學(xué)科排名
書目名稱Medical Device Guidelines and Regulations Handbook網(wǎng)絡(luò)公開度
書目名稱Medical Device Guidelines and Regulations Handbook網(wǎng)絡(luò)公開度學(xué)科排名
書目名稱Medical Device Guidelines and Regulations Handbook被引頻次
書目名稱Medical Device Guidelines and Regulations Handbook被引頻次學(xué)科排名
書目名稱Medical Device Guidelines and Regulations Handbook年度引用
書目名稱Medical Device Guidelines and Regulations Handbook年度引用學(xué)科排名
書目名稱Medical Device Guidelines and Regulations Handbook讀者反饋
書目名稱Medical Device Guidelines and Regulations Handbook讀者反饋學(xué)科排名
作者: Tinea-Capitis 時(shí)間: 2025-3-21 21:22
,ISO 13485: Medical Devices – Quality Management Systems, Requirements for Regulatory Purposes,the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 13485 highlights the awareness of and compliance to regulatory requirements as a management responsibility. ISO 13485 provides a sketch for a quality management system. When we construct a q作者: ANTI 時(shí)間: 2025-3-22 02:59
ISO 14971 and ISO 24971: Medical Device Risk Management,e faced with the complex task of making a medical device safe for human use. This implies that the device should be safe and effective. Risk management involves the identification, understanding, control and prevention of failures that can result in hazards when people use medical devices. The purpo作者: Spinal-Fusion 時(shí)間: 2025-3-22 07:51
,ISO 19227: Implants for Surgery – Cleanliness of Orthopedic Implants,ich are based on a risk management process during the implants manufacturing. This Chapter does not talks about packaging or sterilization requirements?which are covered by other international standards. This Chapter applies?to in-process cleaning and final cleaning?in a implant manufacturing. This 作者: 淘氣 時(shí)間: 2025-3-22 09:02 作者: kidney 時(shí)間: 2025-3-22 15:25
ISO 22442: Medical Devices Utilizing Animal Tissues and Their Derivatives,ices to provide performance characteristics that have been chosen for advantages over nonanimal-based materials. The range and quantities of materials of animal origin in medical devices vary. These materials can comprise a major part of the device (e.g. bovine/porcine heart valves, bone substitutes作者: 創(chuàng)作 時(shí)間: 2025-3-22 19:42
ISO 11137: An Overview on Radiation for Sterilization of Medical Devices and Healthcare Products,d of sterilization demands its proper use in terms of handling, mode of dose delivery, exposure and most importantly its dosage. Though radiation is a cleaner and apt sterilization technique for use on medical devices, appropriate caution and care have to be ensured for product and personal safety. 作者: 低位的人或事 時(shí)間: 2025-3-22 21:38 作者: 預(yù)防注射 時(shí)間: 2025-3-23 03:54
An Overview on Sterilization of Health Care Products using Moist Heat: ISO 17665,dly. While using moist heat sterilization, the sterilization agent should be well characterized for the microbicidal activity?on the medical device. To determine the effectiveness of sterilization, minimum cycle lethality is to be determined. It should also be taken care that the sterilization proce作者: 自由職業(yè)者 時(shí)間: 2025-3-23 07:39 作者: Champion 時(shí)間: 2025-3-23 11:57 作者: exorbitant 時(shí)間: 2025-3-23 14:54 作者: Biguanides 時(shí)間: 2025-3-23 19:56
,EU 1272/2008 – Classification, Labelling and Packaging of Substances and Mixtures,European Commission (EC) emphasizes the medical devices are safe for the patient as well as efficient, and for this purpose separate sections of regulations apply for different parts and chemical used in the devices. The Regulation (EC) No. 1272/2008 guides on the classification, labelling, and pack作者: 無(wú)表情 時(shí)間: 2025-3-24 00:44
EU 2015/863: Restriction of Hazardous Substances (RoHS) -3, European Commission, an opinion of the European Economic and Social Committee, an opinion of the Committee regions, and in accordance with the legislative procedure, has laid down restrictions on the use of hazardous substances in electrical and electronic equipment (EEE). This enables to prevent t作者: Neutropenia 時(shí)間: 2025-3-24 05:28 作者: 量被毀壞 時(shí)間: 2025-3-24 07:16 作者: 比喻好 時(shí)間: 2025-3-24 11:52
Device Regulations of Other Countries,d prudent use of various medical devices. In this chapter are outlined the regulations from major countries like India, China, Canada, New Zealand, Australia, Japan, Singapore, and the United Kingdom. Countries like India and China rely majorly on importing their medical devices and therefore, have 作者: archaeology 時(shí)間: 2025-3-24 15:59
schungsrelationen (V.-R.) für stetige Raum—Zeit-Funktionen. Energie und Impuls- satz in der Quantendynamik. § 3. Relativistische Invarianz der V.-R. bei invarianter Lagrangefunktion. — II. Aufstellung der Grundgleichungen der Theorie für elektromagnetische Felder und Materiewellen. § 4. Schwierigkei作者: 巧思 時(shí)間: 2025-3-24 22:31
Karnika Singhschungsrelationen (V.-R.) für stetige Raum—Zeit-Funktionen. Energie und Impuls- satz in der Quantendynamik. § 3. Relativistische Invarianz der V.-R. bei invarianter Lagrangefunktion. — II. Aufstellung der Grundgleichungen der Theorie für elektromagnetische Felder und Materiewellen. § 4. Schwierigkei作者: Encephalitis 時(shí)間: 2025-3-25 02:54
B. Karthika,A. R. Vijayakumarschungsrelationen (V.-R.) für stetige Raum—Zeit-Funktionen. Energie und Impuls- satz in der Quantendynamik. § 3. Relativistische Invarianz der V.-R. bei invarianter Lagrangefunktion. — II. Aufstellung der Grundgleichungen der Theorie für elektromagnetische Felder und Materiewellen. § 4. Schwierigkei作者: 鞏固 時(shí)間: 2025-3-25 05:04
Thamizharasan Sampath,Sandhiya Thamizharasan,K. Vijay Kumar Shetty,Prakash Srinivasan Timiri Shanmugschungsrelationen (V.-R.) für stetige Raum—Zeit-Funktionen. Energie und Impuls- satz in der Quantendynamik. § 3. Relativistische Invarianz der V.-R. bei invarianter Lagrangefunktion. — II. Aufstellung der Grundgleichungen der Theorie für elektromagnetische Felder und Materiewellen. § 4. Schwierigkei作者: 侵略 時(shí)間: 2025-3-25 09:03 作者: GULP 時(shí)間: 2025-3-25 14:49
Thamizharasan Sampath,Sandhiya Thamizharasan,Prakash Srinivasan Timiri Shanmugamtall entscheidend beeinflu?t. Zwar spielt diese Absto?ung keine allzu wichtige Rolle für die Elektronen, deren Energie kleiner ist als die Grenzenergie des Fermi-Gases. Aber gerade die Elektronen mit der Grenzenergie, also die relativ wenigen Elektronen, die für die spezifische W?rme ma?gebend sind,作者: 被告 時(shí)間: 2025-3-25 19:35 作者: 諂媚于人 時(shí)間: 2025-3-25 22:17
Thamizharasan Sampath,Sandhiya Thamizharasan,Krithaksha V.,Prakash Srinivasan Timiri Shanmugamtall entscheidend beeinflu?t. Zwar spielt diese Absto?ung keine allzu wichtige Rolle für die Elektronen, deren Energie kleiner ist als die Grenzenergie des Fermi-Gases. Aber gerade die Elektronen mit der Grenzenergie, also die relativ wenigen Elektronen, die für die spezifische W?rme ma?gebend sind,作者: 迅速成長(zhǎng) 時(shí)間: 2025-3-26 04:06
Balu Venugopal,Sunitha Chandran,Amita Ajittall entscheidend beeinflu?t. Zwar spielt diese Absto?ung keine allzu wichtige Rolle für die Elektronen, deren Energie kleiner ist als die Grenzenergie des Fermi-Gases. Aber gerade die Elektronen mit der Grenzenergie, also die relativ wenigen Elektronen, die für die spezifische W?rme ma?gebend sind,作者: cajole 時(shí)間: 2025-3-26 06:41
Indumathy Jagadeeswaran,Sunitha Chandrann, nach dem die zukünftige Theorie der Elementarteilchen m?glicherweise konstruiert ist. Dieses Schema hat die folgenden Eigenschaften: Die Gesamtheit aller Elementarteilchen wird durch ein einziges Spinorfeld dargestellt. Dieses Spinorfeid genügt (in der sogenannten Wechselwirkungsdarstellung) eine作者: Hyaluronic-Acid 時(shí)間: 2025-3-26 12:04
Renjith P. Nair,Sunitha Chandrann, nach dem die zukünftige Theorie der Elementarteilchen m?glicherweise konstruiert ist. Dieses Schema hat die folgenden Eigenschaften: Die Gesamtheit aller Elementarteilchen wird durch ein einziges Spinorfeld dargestellt. Dieses Spinorfeid genügt (in der sogenannten Wechselwirkungsdarstellung) eine作者: Microaneurysm 時(shí)間: 2025-3-26 15:55
Pugazhenthan Thangaraju,Shoban Babu Varthyatall entscheidend beeinflu?t. Zwar spielt diese Absto?ung keine allzu wichtige Rolle für die Elektronen, deren Energie kleiner ist als die Grenzenergie des Fermi-Gases. Aber gerade die Elektronen mit der Grenzenergie, also die relativ wenigen Elektronen, die für die spezifische W?rme ma?gebend sind,作者: CHANT 時(shí)間: 2025-3-26 17:20 作者: Tailor 時(shí)間: 2025-3-26 22:40
Indumathy Jagadeeswaran,Harini Sriram management, a manager has to assess various costs imposed by uncertainty. The economist analyzes the role of incomplete and too often imperfect information structures on the optimal decisions made by a firm. The need for understanding the role of uncertainty in quantitative decision models, both in作者: forthy 時(shí)間: 2025-3-27 03:51
Indumathy Jagadeeswaran,Harini Sriram von dem Schlagwort des Information Center. Da dieser Begriff eine v?llige Umkehrung der traditionellen, batch-orientierten Arbeitsweise der Rechenzentren impliziert, ist eine Auseinandersetzung mit diesem Betriebskonzept zwingend..Es kann gezeigt werden, da? Faktoren wie ‘Anwendungsstau’, die zuneh作者: Notorious 時(shí)間: 2025-3-27 08:35 作者: carotid-bruit 時(shí)間: 2025-3-27 11:17
Thamizharasan Sampath,Sandhiya Thamizharasan,Krithaksha V.,Prakash Srinivasan Timiri Shanmugam von dem Schlagwort des Information Center. Da dieser Begriff eine v?llige Umkehrung der traditionellen, batch-orientierten Arbeitsweise der Rechenzentren impliziert, ist eine Auseinandersetzung mit diesem Betriebskonzept zwingend..Es kann gezeigt werden, da? Faktoren wie ‘Anwendungsstau’, die zuneh作者: muffler 時(shí)間: 2025-3-27 15:53 作者: vibrant 時(shí)間: 2025-3-27 20:51 作者: Fallibility 時(shí)間: 2025-3-27 22:14 作者: Left-Atrium 時(shí)間: 2025-3-28 04:21
85, ISO 21534, REACH, RoHS, CLP, EU MDR.Presents simplified .This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, th作者: Frenetic 時(shí)間: 2025-3-28 07:07 作者: 提升 時(shí)間: 2025-3-28 11:32
ISO 10993: Biological Evaluation of Medical Devices,dented use in human, it has to be carefully tested and evaluated and is found to fit with the standard criteria. This chapter will throw insights in various aspects of biological evaluation of medical devices under each subheadings.作者: Inoperable 時(shí)間: 2025-3-28 15:35
,EU 722/2012 – Animal Tissue Regulations in Effect for Some Medical Devices,and controls to prevent spreading some animal-borne diseases to users of their products. This regulation also requires affected manufacturers to conduct specific risk analysis and management procedures prior to submitting conformity assessment applications.作者: 變色龍 時(shí)間: 2025-3-28 21:18 作者: obtuse 時(shí)間: 2025-3-29 02:51
Book 2022ce code-related requirements. Focusing on the practical application of the regulations, the .Medical Device Guidelines and Regulations Handbook. delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose material作者: 嗎啡 時(shí)間: 2025-3-29 05:28
,ISO 13485: Medical Devices – Quality Management Systems, Requirements for Regulatory Purposes,cesses to identify how they relate to each other, set goals, measure the processes, and make improvements. This chapter concentrates about ISO 13485, quality management systems for medical devices and requirements for regulatory purposes.作者: Anticoagulants 時(shí)間: 2025-3-29 11:17 作者: stratum-corneum 時(shí)間: 2025-3-29 14:26 作者: Encoding 時(shí)間: 2025-3-29 17:24 作者: 變白 時(shí)間: 2025-3-29 20:08
,EU 2017/746 – In Vitro Diagnostic Medical Devices,on 5 May 2017 and entered into force on 26 May 2017. The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). The IVDR is the new regulatory basis for placing on the market and making available and putting into service in vitro diagnostic medical devices.作者: 物質(zhì) 時(shí)間: 2025-3-30 00:03 作者: grenade 時(shí)間: 2025-3-30 04:41
http://image.papertrans.cn/m/image/629146.jpg作者: laparoscopy 時(shí)間: 2025-3-30 08:33
https://doi.org/10.1007/978-3-030-91855-2Biomedical Micro Devices; Medical and Health Technologies; Medical device industry; Medical devices; Med作者: faction 時(shí)間: 2025-3-30 12:28
978-3-030-91857-6The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl作者: 膽小鬼 時(shí)間: 2025-3-30 18:41
ISO 14155: Clinical Investigation of Medical Devices for Human Subjects,the guidelines for preparing the CIPs. The title of the study and the reference number are considered the identity of a CIP. The important personnel (sponsor, coordinating investigator, and the principal clinical investigator) are responsible for approving the CIP. The CIP is also required to provid作者: 注意到 時(shí)間: 2025-3-31 00:33
ISO 22442: Medical Devices Utilizing Animal Tissues and Their Derivatives,atives which are non-viable or rendered non-viable. This part of ISO 22442 is intended to cover medical devices including active implantable medical devices such as implantable infusion pumps. ISO 22442 consists of the following parts, under the general title Medical devices utilizing animal tissues作者: 步履蹣跚 時(shí)間: 2025-3-31 02:06 作者: Incommensurate 時(shí)間: 2025-3-31 08:58
,ISO 11135: Sterilization of Health-Care Products—Ethylene Oxide, Requirements for Development, Valiconcentration during the exposure should be constantly monitored. Packaging if any should not prevent EO penetration and at the same time should not modify the physical or chemical properties of the device being sterilized. As EO is toxic and flammable, care has to be taken for any residual EO on th
