GB 18279-2000 English Version, GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization (English Version)

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Position: Chinese Standard in English/GB 18279-2000

GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization (English Version)
Standard No.:	GB 18279-2000	Status:	superseded remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	12000 words	Translation Price(USD):	360.0 remind me the price change Email:
Implemented on:	2001-5-1	Delivery:	via email in 1~3 business day

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Standard No.:	GB 18279-2000
English Name:	Medical devices--Validation and routine control of ethylene oxide sterilization
Chinese Name:	医疗器械环氧乙烷灭菌确认和常规控制
Chinese Classification:	C47 Public medical equipment
Professional Classification:	GB National Standard
Source Content Issued by:	State Quality and Technology Supervision Bureau
Issued on:	2000-01-02
Implemented on:	2001-5-1
Status:	superseded
Superseded by:	GB 18279.1-2015 Sterilization of health care products―Ethylene oxide―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB/T 18279.2-2015 Sterilization of health care products―Part 2:Guidance on the application of GB 18279.1
Superseded on:	2017-1-1
Superseding:	GB/T 18279.2-2015 Sterilization of health care products―Part 2:Guidance on the application of GB 18279.1
Target Language:	English
File Format:	PDF
Word Count:	12000 words
Translation Price(USD):	360.0
Delivery:	via email in 1~3 business day

GB 18279-2000 is referred in:

* YY/T 0821-2010 Dispensing syringe for single use
*YY 0502-2016 Joint replacement implants―Knee joint prostheses
*YY 0118-2016 Joint replacement implants - Hip joint prostheses
*YY/T 1553-2017 Cardiovascular implants-Cardiac occluder
*GB 19335-2003 Blood flow products for single use—General specification
*GB 8369.2-2020 Transfusion sets for single use—Part 2: With pressure infusion apparatus use
*YY/T 0148-2006 Medical adhesive bandages-General requirements
*YY/T 0148-2006/XG1-2020 Medical adhesive bandages-General requirements
*YY/T 0595-2006 Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003

Standard

GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization (English Version)
Standard No.	GB 18279-2000
Status	superseded
Language	English
File Format	PDF
Word Count	12000 words
Price(USD)	360.0
Implemented on	2001-5-1
Delivery	via email in 1~3 business day

Detail of GB 18279-2000

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Introduction of GB 18279-2000

本标准规定了医疗器械环氧乙烷(EO)灭菌过程的确认与常规控制的要求和指南。需特别注意有关安全性、质量和有效性的具体试验。对某一具体产品可能会超出4.2条的范围。本标准不包括质量保证体系，该体系必须控制所有生产阶段，包括灭菌过程。本标准不涉及操作者的安全问题(进一步的信息见IEC1010-2)。EO是有毒的易燃易爆气体。应注意我国有关EO管理及使用的安全要求法规，还应注意我国有关医疗器械及各种产品EO残留限量的法规。本标准不包括运用直接注射EO或其混合气体到单件产品包装中的技术进行灭菌，也不包括无间断灭菌。本标准不包括用于测定EO和(或)其反应产物残留量水平的分析方法(见ISO10993-7)。本标准不包括EO或在灭菌过程中产生的其他EO残留物会对其造成不良影响的产品。

Contents of GB 18279-2000

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Keywords:
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