EngLib USM > @i* Standard >

MS ISO 11135-1:2010 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135-1:2007, IDT)

MS ISO 11135-1:2010 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135-1:2007, IDT)

Description Printed version of this standard is available at Library. To request, please e-mail to adminpk@usm.my and include a copy of this record in your e-mail. Abstract This Malaysian Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. Sterilization processes validated and controlled in accordance with the requirements of this standard are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Primary Item Type: Malaysian Standard Identifiers: Standard Number MS ISO 11135-1:2010 ICS 11.080.01 ISC ISC R - Medical Devices and Facilities for Healthcare Language: English Subject Keywords: Medical device; Sterilization; Ethylene oxide First presented to the public: 7/30/2018 Original Publication Date: 12/16/2010 Previously Published By: Department of Standards Malaysia Place Of Publication: Cyberjaya, Selangor Citation: Extents: Number of Pages - 48 License Grantor / Date Granted:   / ( View License ) Date Deposited 2018-07-30 13:46:49.029 Date Last Updated 2019-01-07 11:24:16.6254 Submitter: Mohamed Yunus Yusof

All Versions

• Help | 
• About | 
• Privacy Policy