YY/T 0615.2-2007 (English Version) PDF

Scope: This part of YY/T 0615 specifies the requirements for sterile processed medical devices labeled "sterile". Note: Medical devices can be labeled "sterile" only if a confirmed sterilization process is used. YY/T 0567 specifies the confirmation and routine control of aseptic processing.

YY/T 0615.2-2007 Referenced Document

GB 18278 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
GB 18279 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization*， 2023-09-08 Update
GB 18280 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
GB/T 19974-2005 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices
ISO 14160:1998 Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilants
ISO 14937:2000 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
YY/T 0287 Medical devices.Quality management systems.Requirements for regulatory purposes*， 2017-01-19 Update

2007 YY/T 0615.2-2007 Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices