The normative references in WST 649-2019 Hygienic Requirements for Medical Low-Temperature Steam Formaldehyde Sterilizers indicate:
The following documents are essential to the application of this document. Where cited documents are dated, only the dated version applies to this document. Where a referenced document is not dated, the latest version (including all change orders) applies to this document.
GB/T 191 Graphic symbols for packaging, storage and transport
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements
GB/T 19633 Packaging of terminally sterilized medical devices
GBZ 2.1 Limits of occupational exposure to hazardous factors in the workplace Part 1: Chemical hazards
GBZ 2.2 Occupational Exposure Limits for Hazardous Factors in the Workplace Part 1: Physical Factors
GBZ/T 159 Specification for Collection of Hazardous Substances in the Air in the Workplace
GBZ/T 189.8 Measurement of Physical Factors in the Workplace Part 8: Noise
GBZ/T 300.99 Determination of Toxic Substances in the Air at the Workplace Part 99: Formaldehyde Determination of substances Part 99: Formaldehyde, acetaldehyde and butyraldehyde
IS0 11138-5 Sterilization of healthcare products. Biological indicators. Part 5: Bioindicators for low-temperature steam formaldehyde sterilization processes EN 14180 Medical sterilization sterilizers Low-temperature steam formaldehyde sterilizers Requirements and testing
EN 867-5 Specification for indicator systems and handling equipment to be used in the performance tests for non-biological systems for sterilizers, small sterilizers of categories B and S
EN 60584-2 Thermocouples, Part 2: Tolerances
EN 60751 Sensors for industrial platinum resistance thermometers
Code of practice for the management of labeling instructions for disinfection products (2005) Ministry of Health (Health Supervision and Inspection Department [2005] No. 426)