ISO 10993-10

Biological evaluation of medical devices - Part 10: Tests for skin sensitization

Body: ISO
Number: ISO 10993-10
Editions: 2010、2021
FDA recognition no.: 2-296

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 4 General principles - Step-wise approach Annex C

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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