CAN/CSA C22.2 NO. 601.1B-90 (R2006) PDF

This amendment contains a second series of revisions to IEC 601-1 (second edition, 1988): Medical electrical equipment - Part 1: General requirements for safety.

It is intended to facilitate interpretation and application of the General Standard. It also identifies additional aspects of safety which were not previously covered. Significant changes include the following:

- APPLIED PARTS are now identified by requirements covering the possibility of physical contact with the PATIENT during NORMAL USE, without electrical considerations; individual PATIENT CONNECTIONS are then defined by requirements concerning electrical contact with the PATIENT during NORMAL USE;

- classification of the degree of protection against electric shock (TYPES CF/BF/B) is not related any more to the word EQUIPMENT but now clearly relates to individual APPLIED PARTS; it is more logical because the degree of protection is determined in fact by that of the APPLIED PART; this means no extra requirements and tests but more differentiation and clarification of the required actions;

- general requirements are included for EQUIPMENT in which the APPLIED PART is marked as providing protection against the discharge voltage from a defibrillator and for which there is no Particular Standard.

- limits for the d.c. component of PATIENT LEAKAGE CURRENT are included to align with the requirement for PATIENT AUXILIARY CURRENT;

- clarification concerning the degree of protection against ingress of liquids by using IP Code, as detailed in the basic safety publication IEC 529 is an improvement;

- the term "not used", which was introduced in the second edition of IEC 601-1, is replaced, where applicable, by the wording "no general requirement" in order to avoid misunderstanding; this means that a Particular Standard may specify requirements if it is deemed necessary;

- references to existing IEC Collateral Standards 601-1-1, 601-1-2, 601-1-3 and future IEC 601-1-4 (see Appendix L), are included;

- additional requirements are included regarding the information which must be supplied by the manufacturer in order to improve the international acceptance of symbols and units and to provide more information about the intended use of the EQUIPMENT; the latter is becoming necessary due to the relation with performance safety aspects;

- some requirements and test methods have been aligned with other existing IEC standards;

- a number of accidents having being reported due to user error during the use of biopotential connectors (as electrodes having attached leads terminating in 2 mm exposed metal pin connectors), some additional requirements have been introduced to prevent the recurrence of such accidents whatever the type of equipment.