IEC 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.

Body: IEC
Number: IEC 60601-1
Editions: 2012、2020
FDA recognition no.: 19-49

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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