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However, at least the following changes have been found: Note: it seems that HF surgery got mentioned twice in item 6) and 12), possibly as a result of combining two standards (IEC 6 and IEC 6)ĭue to the size of the clause, it is difficult to fully detect all changes.
Accurate 4 standard edition manual#
Requirements for the operation manual have been substantially modified in the new standard (see standard for details). The ECG applied part must now by Type CF (previously there was no restriction).ĭetachable lead wires must be marked at both ends (identifier and/or colour) However, manufacturers of patient monitors with 12 lead ECG options, with measurements of amplitudes, durations and intervals or automated interpretations might find it difficult to justify a claim of not being for diagnostic purpose.įor test circuits, resistors are now required to be ☑% (previously 2%) This would then depend on the intended purpose statement (and contraindications) associated with the patient monitor. However, the correct interpretation has always been that if the patient monitor provides an ECG record intended for diagnostic purposes, then diagnostic standard should also be applied.
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There has been a common mistake that IEC 6/IEC 6 should not be applied to patient monitors, and a similar mistake can also expected for this edition. The scope statement has been reworded, so for unusual cases it should be checked carefully. Table: List of changes, corrections and problems in IEC 6:2011 There is no explanation for this, however the change is of interest for the CB scheme since it is now possible to objectively test compliance with all performance tests. One major change worth noting is that requirements for ECG interpretation (the old clause 50.102 in IEC 6) have been completely removed from the standard. This table was compiled during the real tests against new standard. The table below provides an overview of corrections, changes and problems found to date in the new standard.
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Experience also indicates that historical data for existing equipment is often of limited quality, so it may anyhow be an excellent opportunity to do a full re-test against the new standard.ĭespite the updated tests, it seems that significant errors still persist, which is to be expected given the number of complexity of the tests.
Accurate 4 standard edition update#
However, compared to the update of IEC 6, the changes are far more extensive making it difficult to apply the new standard in a gap analysis approach.
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Also, similar to IEC 6, the opportunity has been taken to correct some of the errors in requirements and test methods for performance tests that existed in the previous edition. The standard has of course been updated to fit with IEC 60601-1:2005 (the 3rd edition). For the second edition of this standard, IEC 6 and IEC 6 were combined and re-published as IEC 6:2011 (Edition 2.0).