CAN/CSA-C22.2 No.61010-2-042-98 (R2003)

This National Standard of Canada is equivalent to International Standard CEI/IEC 61010-2-042: 1997. 1 Scope and object This clause of part 1 is applicable except as follows: 1.1 Scope Replacement: This standard applies to AUTOCLAVES and STERILIZERS, including those with an automatic loading and unloading system, which incorporate a CHAMBER using toxic gas 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 In general it is considered that automatic control of the sterilization cycle is essential for the safe operation of equipment using toxic gases because a manual control system might present serious hazards (see 1.2) to the OPERATOR. 3 The principal sterilant gases in use are ethylene oxide and formaldehyde. 4 For some applications, the CHAMBER may be operated at a pressure above or below atmospheric pressure. 5 All pressures are specified in absolute terms. Atmospheric pressure (1 bar) =>100 kPa. 6 The word AUTOCLAVES includes STERILIZERS unless specifically stated otherwise. Where an AUTOCLAVE incorporates a steam generator having its own PRESSURe VESSEL within the same enclosure for the purpose of humidifying the LOAD, the applicable safety requirements specified in this standard apply also to the steam generator. 1.1.2 Equipment excluded from the scope Modification: Add the following text at the end of the last dash: except for an atmosphere created by the AUTOCLAVE itself (see 13.2.103.1). Addition: Add the following new dash and notes: - environmental cabinets. NOTEs 1 Since all AUTOCLAVES covered by this part 2 use toxic gas, other types using only steam or dry heat for sterilization are not included. 2 This standard does not deal with special requirements for washer disinfectors, nor with protection against high-risk microbiological hazards associated with the LOAD, nor with requirements for the design of the PRESSURe VESSEL itself. 1.2 Objet Modification: Insert in the sixth dash after the word "gases" the following text: (including the non-intentional escape of toxic gas) 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 or part 1).