Certainly, here is the translation of the provided text:
1. **Essence of the Law:** Order of the Ministry of Health of Ukraine No. 1212 dated July 31, 2025, “On the Organization of Reprocessing of Medical Devices” establishes new state sanitary norms and rules regarding the reprocessing (reuse) of medical devices in healthcare facilities and by individual entrepreneurs who are licensed to practice medicine. This order defines the requirements for all stages of reprocessing, including initial treatment, cleaning, disinfection, sterilization, storage, and transportation of medical devices. The aim is to ensure infectious and toxicological safety for patients and medical personnel. The order also repeals the previous order No. 552 of 2014, which regulated disinfection, pre-sterilization cleaning, and sterilization of medical devices.
2. **Structure and Main Provisions:**
* The Law consists of State Sanitary Norms and Rules “Reprocessing of Medical Devices” and amendments to certain regulatory legal acts of the Ministry of Health of Ukraine.
* It defines the requirements for reprocessing limited (multiple-use) medical devices, including requirements for premises, equipment, and personnel.
* Establishes clear requirements for each stage of reprocessing, from initial treatment to sterilization and storage.
* Implements a quality management system (QMS) in accordance with the standard DSTU EN ISO 13485:2018.
* Contains appendices detailing requirements for disinfection, water quality, selection of sterilization methods, etc.
3. **Key Provisions for Use:**
* Requirements for reprocessing various types of medical devices (critical, semi-critical, non-critical) and the selection of appropriate sterilization or disinfection methods.
* The need to implement a QMS and validate reprocessing processes.
* Requirements for documenting each stage of reprocessing and record-keeping.
* Requirements for premises, equipment, and training of personnel involved in reprocessing.
* **** The order comes into force two years after the cessation or cancellation of martial law in Ukraine, which is important to consider when planning and organizing reprocessing processes.
