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YY/T 0297-1997 English PDF

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YY/T 0297-1997: Clinical investigation of medical devices
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YY/T 0297-1997English489 Add to Cart 3 days [Need to translate] Clinical investigation of medical devices   YY/T 0297-1997

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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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