Topics

Standard

Output

Reponsibility

Stability

ISO 23640

EP 25-A

(USFDA required)

WHO TGS-2

(WHO required)

EN 13640

Report

Manufacturer

Usability 

IEC 62366

Report

Manufacturer

Safety Electrical Equipment

IEC 61010-1 และ -2

EN 61326-1 และ -2

Report

Certified body

Software validation

IEC 62304

Certification

Certified body

Classification of environmental conditions -

IEC 60721-3-7

Manufacturer

SI units

ISO 1000

Manufacturer

Biocompatibility test

ISO 10993-5 และ -10

Report

Certified body

Labelling

ISO 18113

Manufacturer

Labelling self test

ISO 18113-4 ข้อ 7

Manufacturer

Symbols 

ISO 15223

Manufacturer

Information supplied by the manufacturer of medical devices

EN 1041

Manufacturer

QMS (Scope of design and development)

ISO 13485

Certification

Certified body

Risk Analysis

ISO 14971

Report

Manufacturer

POCT

POCT 04 / ISO 22870

Manufacturer

Reference materials

ISO 15194

Manufacturer

Reference Measurement

ISO 15193

Manufacturer

COVID-19 NAT

ISO/TS 5798 WHO TSS-20

Eliminate/reduction risk of infection

EN 13641