NMPA Announcement on Issuing 3 Medical Device Industry Standards Including YY 9706.274-2022 “Medical Electrical Equipment Part 2-74: Special Requirements for Basic Safety and Basic Performance of Respiratory Humidification Equipment” (No. 6 of 2022)
Three medical device industry standards including YY 9706.274-2022 Medical Electrical Equipment Part 2-74: Special Requirements for Basic Safety and Basic Performance of Respiratory Humidification Equipment have been approved and are now published. See the attachment for the standard number, name, scope of application and implementation date.
It is hereby announced.
Attachment: Medical Device Industry Standard Information Sheet
NMPA
January 13, 2022
Medical Device Industry Standard Information Sheet
| Serial No. | Standard No. | Standard Name | Formulation / Revision | Alternative Standards | Scope of Application | Implementation Date |
| 1 | YY 9706.274-2022 | Medical Electrical Equipment Part 2-74: Special Requirements for Basic Safety and Basic Performance of Respiratory Humidification Equipment | Revision | YY 0786-2010 | This part specifies the basic safety and basic performance of humidifier and its combination with accessories. This section also applies to those accessories that the manufacturer expects to be used in connection with the humidifier, the characteristics of which may affect the basic safety and essential performance of the humidifier. This part contains the requirements for using the humidification function in different medical applications. This section also includes requirements for active HMEs (heat and moisture exchangers), that is, ME equipment that increases the humidity level of the gas delivered by the HME to the patient by actively heating and humidifying. This section does not apply to passive HME, that is, a device that returns part of the moisture and heat exhaled by the patient to the breathing tube during the inspiratory phase without adding moisture and heat. This section does not specify requirements for cold reflux humidifier or bubble humidifier equipment. This section does not apply to so-called “room humidifiers”, or humidifiers used in heating, ventilation and air conditioning systems, nor does it apply to humidifiers integrated into infant incubators. This section does not apply to nebulizers that deliver medication to patients. | Implemented from May 1, 2025. |
| 2 | YY/T 1805.3-2022 | Tissue Engineering Medical Device Product Collagen Part 3: Collagen content detection based on characteristic peptide determination —— LC-MS | Formulation | / | This document specifies a method for determining the characteristic polypeptide content of different types of collagen by LC-MS . This document is applicable to the determination of the content of polypeptides characteristic of different types of collagen in tissue extracted purified collagen and its collagen like products. | Implemented
on August 1, 2022 |
| 3 | YY/T 1849-2022 | Recombinant
collagen |
Formulation | / | This document specifies the quality control requirements, detection indicators and detection methods of recombinant collagen. This document applies to the quality control of recombinant collagen as a raw material for medical devices. | Implemented
on August 1, 2022 |
