scope:

Replacement:

This standard applies to AUTOCLAVES, including those with an automatic loading and unloading system, which incorporate a PRESSURE VESSEL using steam within the absolute pressure range from 0 to 500 kPa, and intended for the treatment of medical materials and for laboratory processes, for example for sterilization.

NOTES

1 National and other regulations or codes apply for the safety of automatic loading and unloading systems.

2 All pressures are specified in absolute terms. Atmospheric pressure (1 bar) = 100 kPa.

Where an AUTOCLAVE incorporates a steam generator having its own PRESSURE VESSEL within the same enclosure, the applicable safety requirements for the AUTOCLAVE PRESSURE VESSEL apply also to the steam generator (see 14.105).

Equipment excluded from the scope

Addition:

Add the following new dash:

- pressurized environmental cabinets.

NOTES

1 Since all AUTOCLAVES covered by this part 2 use steam, other types using dry heat, toxic gas or radiation are not included.

2 This standard does not deal with special requirements for protection against chemical and high-risk micro-biological hazards associated with the AUTOCLAVE LOAD, nor with requirements for the design of the PRESSURE VESSEL itself.