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General Specification

Standards

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DPET:Design Constraints / Applicable Standards
DPET:Design Constraints / Applicable Standards
nameT2102-applicable-standards

Standard

Name

Class

DIN EN 60825-1:2022-07

Safety of laser products

2

ANSI/ASA S3.45-2009 (R2019)

Procedures for Testing Vestibular Function

DIN EN 10993

Biological evaluation of medical devices - Parts 1, 5 & 10

DIN EN 60529

Degrees of protection provided by enclosures (IP Code)

IPX0

DIN EN 60601-1

General requirements for basic safety and essential performance

B

DIN EN 60601-1-2

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