临床检验装备大全(第1卷) 标准与法规 刘毅、安娟娟、郭健

Brand: 科学出版社    Sold By: EM China
临床检验装备大全(第1卷) 标准与法规 刘毅、安娟娟、郭健
临床检验装备大全(第1卷) 标准与法规 刘毅、安娟娟、郭健
临床检验装备大全(第1卷) 标准与法规 刘毅、安娟娟、郭健
临床检验装备大全(第1卷) 标准与法规 刘毅、安娟娟、郭健

临床检验装备大全(第1卷) 标准与法规 刘毅、安娟娟、郭健

Brand: 科学出版社    Sold By: EM China
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临床检验装备大全(第1卷) 标准与法规 刘毅、安娟娟、郭健

临床检验装备大全(第1卷) 标准与法规 刘毅、安娟娟、郭健

$58.04

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编辑推荐
《临床检验装备大全(第卷) 标准与法规》系《临床检验装备大全》之第卷,《临床检验装备大全(第卷) 标准与法规》共分4章。章为体外诊断产品管理情况概述 第二章介绍了中国、美国、欧盟、日本对体外诊断产业的监管体系概况 第三章介绍了上述国家和地区体外诊断产品的相关法规 第四章介绍了体外诊断产品标准体系概况,重点对中国相关标准化管理机构及其标准体系、国际标准化组织、欧盟标准化组织、临床实验室标准协会、国际检验医学溯源联合委员会等国际标准化组织的标准进行了概述。《临床检验装备大全(第卷) 标准与法规》编写理念新颖,内容全面、实用性强,可供IVD产业研发、市场和管理人员,医学实验室技术和管理人员,医疗机构领导和工程技术人员,国家IVD产业领导和监管人员参考。 
作者简介
刘毅,工程师,上海复星医药(集团)股份有限公司医疗器械事业部首席技术官(CTO)。曾先后就职于国家食品药品监督管理总局医疗器械司、市场监督司、北京市医疗器械检验所,有较为丰富的医疗器械行业产业发展研究、监管法规与技术标准研究经验。任职北京市医疗器械检验所所长期间,填补了国内医疗器械检验领域的空白。发起成立“北京医疗器械产业技术创新联盟”,搭建“医疗器械研发测试技术服务平台”,充分发挥检验技术资源和服务能力,支持医疗器械产业技术发展。安娟娟,经济师,北京大学光华管理学院工商管理硕士,现任国家食品药品监督管理总局医疗器械技术审评中心审评三处处长,全国医用临床检验实验室和体外诊断系统标准化技术委员会(SACITC36)委员。郭健,医学硕士,研究员。988年起就职于北京医院,曾任临床检验中心副主任、检验科主任,现任老年医学研究所副所长,北京医院临床生物样本管理中心主任,北京市医学检验质量和改进中心主任。主要从事临床化学研究、医学实验室管理和生物样本库管理工作。学术兼职 历任中华医学会检验医学分会常委、学术秘书、副主任委员 北京医学会检验专业委员会副主任委员、主任委员 北京医院协会临床实验室管理专业委员会主任委员 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SACITC36)副主任委员 中国合格评定国家认可委员会(CNAS)医学专业委员会副主任委员 中国医学装备协会临床检验装备技术专业委员会副主任委员 《中华检验医学杂志》副总编辑,《标记免疫分析与临床》副主编。
目  录
章 -体外诊断产品管理概况
节 -产品的概述
第二节 -产品管理关注的重点技术环节
第三节 -产品使用关注的重点技术环节
第四节 -计量检定关注的重点技术环节

第二章 -体外诊断产品相关监管体系概况
节 -中国监管体系概况
第二节 -美国监管体系概况
第三节 -欧盟监管体系概况
第四节 -日本药事相关法规概况

第三章 -体外诊断产品法规体系概况
节 -中国体外诊断法规体系概况
商品详情

 基本详情信息

 书名:临床检验装备大全(第1卷)-标准与法规

 ISBN:9787030480323

 定价:268.00

 作者:刘毅、安娟娟、郭健

 出版社:科学出版社

 出版时间:2016-06

 其他信息

 纸张:胶版纸

 页数:632

 尺寸:16开

 版次:1

 正文语种:简体中文...

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom and Germany to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

mx当当栏目.jpg

编辑推荐
《临床检验装备大全(第卷) 标准与法规》系《临床检验装备大全》之第卷,《临床检验装备大全(第卷) 标准与法规》共分4章。章为体外诊断产品管理情况概述 第二章介绍了中国、美国、欧盟、日本对体外诊断产业的监管体系概况 第三章介绍了上述国家和地区体外诊断产品的相关法规 第四章介绍了体外诊断产品标准体系概况,重点对中国相关标准化管理机构及其标准体系、国际标准化组织、欧盟标准化组织、临床实验室标准协会、国际检验医学溯源联合委员会等国际标准化组织的标准进行了概述。《临床检验装备大全(第卷) 标准与法规》编写理念新颖,内容全面、实用性强,可供IVD产业研发、市场和管理人员,医学实验室技术和管理人员,医疗机构领导和工程技术人员,国家IVD产业领导和监管人员参考。 
作者简介
刘毅,工程师,上海复星医药(集团)股份有限公司医疗器械事业部首席技术官(CTO)。曾先后就职于国家食品药品监督管理总局医疗器械司、市场监督司、北京市医疗器械检验所,有较为丰富的医疗器械行业产业发展研究、监管法规与技术标准研究经验。任职北京市医疗器械检验所所长期间,填补了国内医疗器械检验领域的空白。发起成立“北京医疗器械产业技术创新联盟”,搭建“医疗器械研发测试技术服务平台”,充分发挥检验技术资源和服务能力,支持医疗器械产业技术发展。安娟娟,经济师,北京大学光华管理学院工商管理硕士,现任国家食品药品监督管理总局医疗器械技术审评中心审评三处处长,全国医用临床检验实验室和体外诊断系统标准化技术委员会(SACITC36)委员。郭健,医学硕士,研究员。988年起就职于北京医院,曾任临床检验中心副主任、检验科主任,现任老年医学研究所副所长,北京医院临床生物样本管理中心主任,北京市医学检验质量和改进中心主任。主要从事临床化学研究、医学实验室管理和生物样本库管理工作。学术兼职 历任中华医学会检验医学分会常委、学术秘书、副主任委员 北京医学会检验专业委员会副主任委员、主任委员 北京医院协会临床实验室管理专业委员会主任委员 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SACITC36)副主任委员 中国合格评定国家认可委员会(CNAS)医学专业委员会副主任委员 中国医学装备协会临床检验装备技术专业委员会副主任委员 《中华检验医学杂志》副总编辑,《标记免疫分析与临床》副主编。
目  录
章 -体外诊断产品管理概况
节 -产品的概述
第二节 -产品管理关注的重点技术环节
第三节 -产品使用关注的重点技术环节
第四节 -计量检定关注的重点技术环节

第二章 -体外诊断产品相关监管体系概况
节 -中国监管体系概况
第二节 -美国监管体系概况
第三节 -欧盟监管体系概况
第四节 -日本药事相关法规概况

第三章 -体外诊断产品法规体系概况
节 -中国体外诊断法规体系概况
商品详情

 基本详情信息

 书名:临床检验装备大全(第1卷)-标准与法规

 ISBN:9787030480323

 定价:268.00

 作者:刘毅、安娟娟、郭健

 出版社:科学出版社

 出版时间:2016-06

 其他信息

 纸张:胶版纸

 页数:632

 尺寸:16开

 版次:1

 正文语种:简体中文...

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom and Germany to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

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