ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]

Body: ISO
Number: ISO 10993-7
Editions: 2008、2026
FDA recognition no.: 2-275

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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