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YY 0677-2008 English PDF

YY 0677-2008 English PDF

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YY 0677-2008: [YY/T 0677-2008] Liquid nitrogen cryosurgical equipment

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Scope

This Standard specifies the scope, terms and definitions, requirements, test methods,
inspection rules, marking, labelling and packaging of liquid nitrogen cryosurgical
equipment.
This Standard is applicable to cryosurgical treatment equipment which uses liquid
nitrogen as the refrigerant and utilizes the latent heat of vaporization phase change for
refrigeration, and with the capacity of liquid nitrogen storage greater than 1 L
(hereinafter referred to as cryosurgical equipment). The cryosurgical equipment mainly
generates low temperature to the target tissue, which is used for cryo-necrosis, cryo-
block, inflammatory reaction and cryo-adhesion.

Basic Data

Standard ID YY 0677-2008 (YY0677-2008)
Description (Translated English) [YY/T 0677-2008] Liquid nitrogen cryosurgical equipment
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C37
Classification of International Standard 11.040.60
Word Count Estimation 9,929
Date of Issue 2008-10-17
Date of Implementation 2010-06-01
Quoted Standard GB 9706.1; GB/T 14710-1993; GB/T 16886.1; YY 0466-2003; YY 0678
Regulation (derived from) SFDA [2008] No. 605
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the liquid nitrogen cryosurgery therapy equipment scope, definitions and terminology, requirements, test methods, inspection rules and signs, labels, and packaging requirements. This standard applies to refrigerant liquid nitrogen, using its latent heat of vaporization of refrigerant, and the memory capacity of more than 1L of liquid nitrogen cryosurgery therapy equipment (hereinafter referred to as therapy equipment). Therapy equipment mainly produce cryogenic target tissue for freezing necrosis, frozen block, inflammatory response and frozen with adhesions.


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