This standard specifies terms and definitions that apply to medical devices intended for use by only one specific patient or for use by only one specific physician. This standard is intended to identify and describe the various categories of such products, and to define certain terms relevant to the definition of these types of products. This International Standard is not intended to guide clinical decisions regarding the use of personalized medical devices.
GOST R 59771-2021 history
2021GOST R 59771-2021 Personalized medical devices. Key terms and definitions