GB/T 16886.16-2013: Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables

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Scope

This part of GB/T 16886 gives the principles for designing and implementing toxicokinetic studies for medical devices. Appendix A describes the medical device
Mechanical biology evaluates the issues that should be considered in the study of toxicokinetics.

Basic Data

Standard ID	GB/T 16886.16-2013 (GB/T16886.16-2013)
Description (Translated English)	Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100
Word Count Estimation	15,190
Older Standard (superseded by this standard)	GB/T 16886.16-2003
Quoted Standard	ISO 10993-1; ISO 10993-2; ISO 10993-12; ISO 10993-17; ISO 10993-18; ISO 14971
Adopted Standard	ISO 10993-16-2010, IDT
Regulation (derived from)	National Standards Bulletin No. 25 of 2013
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies the design and implementation of the principles of kinetic studies of medical devices poison generations. Appendix A describes the problem Biological evaluation of medical devices pharmacokinetic study of poisoning should be consid