This Japanese Industrial Standard specifies the basic requirement for a washer
sterilizer that washes and sterilizes a used medical device (matters to be sterilized)
polluted by organic matters, such as blood and necrotic cells, using the saturated va-
pour (that is directly available from the water in the chamber, or that is generated by a
built-in steam generator, or that is available from an external steam source) in order to
safely implement washing and post-processing of sterilization of a medical device for
re-use. The washing methods include a hot-water immersion method, an ultrasonic Jr"
radiation method, a jet stream spray method, etc.
In addition, some sterilizers only sterilize a medical device (matters to be sterilized),
using the saturated vapour, for the purpose of the secondary sterilization for re-use
without washing a medical device.
A washer sterilizer covered in this Standard shall have a vessel21 corresponding to
the national pressure vessel structure standard . However, this Standard excludes a
washer sterilizer for biohazard and other types of sterilizers.
Notes 1) It refers to the Safety Standard related to Construction Code for First
Class Pressure Vessels specified by Industrial Safety and Health Law.
2) It refers to First Class Pressure Vessel specified by Industrial Safety and
Health Law, Enforcement Order, Article 1, Item 5.