ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]

Body: ISO
Number: ISO 11135
Editions: 2014
FDA recognition no.: 14-529

Scope

Complete standard

Scope source: FDA 认可共识标准库

Laboratories covering this standard

Body	Location	Accreditations
SUNGO Lab (Shanghai SUNGO Medical Technology Co., Ltd.)	上海	CNAS accreditation、CMA (China Inspection Body and Laboratory Mandatory Approval)、IAS accreditation (USA)、ILAC-MRA

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