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

Chinese Classification Professional Classification ICS Classification Latest News Value-added Services

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Standard No.:	GB 18279-2000	Status:	superseded remind me the status change Email:
Language:	English	File Format:	PDF
Word Count:	12000 words	Price(USD):	360.0 remind me the price change Email:
Implemented on:	2001-5-1	Delivery:	via email in 1~3 business day

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
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Status:	superseded
Superseded by:	GB 18279.1-2015 Sterilization of health care products―Ethylene oxide―Part 1:Requirements for development,validation and routine control of a sterilization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Superseded on:	2017-1-1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
Language:	English
File Format:	PDF
Word Count:	12000 words
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Status	superseded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

Standard No.

English Name

Chinese Name

Chinese Classification

Professional Classification

ICS Classification

Issued by

Issued on

Implemented on

Status

Superseded by

Superseded on

Abolished on

Superseding

Language

File Format

Word Count

Price(USD)

Keywords

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

Tel: +86-10-8572 5655 \| Fax: +86-10-8581 9515 \| Email: coc@codeofchina.com \| QQ: 672269886
Copyright: TransForyou Co., Ltd. 2008-2040



Keywords:
GB 18279-2000, GB/T 18279-2000, GBT 18279-2000, GB18279-2000, GB 18279, GB18279, GB/T18279-2000, GB/T 18279, GB/T18279, GBT18279-2000, GBT 18279, GBT18279