YY/T 0297-1997 English PDF

US$489.00 · In stock
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YY/T 0297-1997: Clinical investigation of medical devices

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0297-1997	489	Add to Cart	3 days	Clinical investigation of medical devices

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Basic data

Standard ID: YY/T 0297-1997 (YY/T0297-1997)
Description (Translated English): Clinical investigation of medical devices
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Word Count Estimation: 14,157
Date of Issue: 8/27/1997
Date of Implementation: 1/1/1998
Adopted Standard: ISO 14155-96, IDT
Issuing agency(ies): State Administration of Medicine
Summary: This standard applies to the body as an object, on the need to evaluate the clinical performance of medical devices for clinical investigation; b) specifies whether the clinical investigation of medical devices organizers expected performance (safety and efficacy) carried out and documented requirements, determine under normal conditions of use undesirable side effects, and to make them acceptable risk assessment instrument based on the expected performance; c) provides clinical investigation of the organization, design, effective data collection, documentation and implementation issue detailed written procedures framework.

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