CAN/CSA-C22.2 No.61010-2-043-98 (R2003)

This National Standard of Canada is equivalent to International Standard CEI/IEC 61010-2-043: 1997. 1. Scope and Object This clause of part 1 is applicable except as follows: 1.1 Scope Replacement: This standard applies to STERILIZERS, including those having an automatic loading and unloading system, with one or more C HAMBERS operating at approximately atmospheric pressure and using hot air or hot inert gas intended for the treatment of medical materials, and for laboratory processes. NOTES 1 Regulations and codes, national or other, may apply for the safety of automatic loading and unloading systems. 2 It is generally recommended that automatic control is provided for equipment using high temperatures because a manual control system could present serious hazards to the OPERATOR. 1.1.2 Equipment excluded from scope Addition: Add two new dashes and the note as follows: - laboratory equipment for the heating of materials, other than for sterilization (see IEC 61010-2-010); - environmental cabinets. NOTE - This standard does not specify requirements for protection against high-risk microbiological hazards associated with the LOAD, or requirements for the design of the CHAMBER itself. 1.4 Environmental conditions Replacement: Replace the first dash by the following: - indoor use, and outdoor use if specified by the manufacturer (see 11.6 of IEC 61010-1).