T/HSIPA 012-2022 The application specifications of this herb aerosol preparation

Scope

Scope: This document specifies the terms and definitions, basic requirements, testing indicators and requirements, nebulizer requirements, clinical application management, and precautions related to herbal nebulizer preparations. This document is applicable to standardized use in all levels and types of medical institutions. The herbal nebulizer preparations recommended in this document should be used under the guidance of professional physicians. Main technical content: 1. Scope: This document specifies the terms and definitions, basic requirements, testing indicators and requirements, nebulizer requirements, clinical application management, and precautions related to herbal nebulizer preparations. This document is applicable to standardized use in all levels and types of medical institutions. The herbal nebulizer preparations recommended in this document should be used under the guidance of professional physicians. 2. Normative reference documents: The contents of the following documents are essential provisions of this document through normative reference in the text. GB 9701.1–2007 Medical electrical equipment – Part 1: General safety requirements GB 4706.1 Safety of household and similar electrical appliances – Part 1: General requirements GB/T 14710 Environmental requirements and test methods for medical electrical equipment GB/T 14881 Quality control guidelines for food products GB/T 25163 Requirements and test methods for child-resistant packaging that can be resealed GB 7718–2011 National food safety standard – General principles for the labeling of prepackaged foods YY 0109–2013 Medical ultrasonic nebulizers T/SHPPA 008–2020 General norms for the production of traditional Chinese medicine formula granules The Pharmacopoeia of the People's Republic of China (2020 Edition) Expert consensus on the application of inhalation therapy in respiratory diseases (2019 Edition) Chinese Medical Association Respiratory Disease Branch 3. T

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