ANSI/AAMI/IEC TIR62348:2012 pdf download – Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1 :2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition.
Subclause 4.3 has been revised and extended to discuss the process the MANUFACTURER can use to determine the ESSENTIAL PERFORMANCE of ME EQUIPMENT or an ME SYSTEM. The fundamental goal was not to change the intent of the concept but make it easier to understand and apply. The definition and the process in 4.3 have been changed to focus on clinical functions and to try an exclude “performance” related to BASIC SAFETY, e.g., the performance of insulation. However, remember, regardless of whether we are speaking of BASIC SAFETY or ESSENTIAL PERFORMANCE, both must be managed.
The rationale for Subclause 4.3 has also been updated.
5.5 Revision to the concept of equivalent safety (Subclause 4.5) [Significant impact]
Recognizing that demonstrating “equivalent safety” can be difficult because many of the requirements in IEC 60601-1 do not provide sufficient detail regarding the level of RESIDUAL RISK, this subclause has been modified to allow alternative RISK CONTROL measures or test methods when it can be demonstrated that that the RESIDUAL RISK resulting from application of the alternative RISK CONTROL measure or test method remains acceptable and is comparable to the RESIDUAL RISK that results from applying the requirements of this standard. The RESIDUAL RISK must satisfy the MANUFACIURERS RISK acceptance criteria and must be comparable to that remaining after applying the requirements of the standard. The MANUFACTURER can demonstrate this by applying:
— scientific data,
— clinical opinion,
— comparative studies, or
— a combination of all three methods.
5.6 Requirements for parts that contact the PATIENT (Subclause 4.6) [Significant impact]
The requirement for such parts was moved from 8.3 d). The RISK MANAGEMENT PROCESS is still required to assess the parts that fall outside of the definition of APPLIED PARTS that need to be subject to the requirements for APPLIED PARTS. However, the revision to 4.6 clarifies that applicable requirements of the collateral standards also apply to these parts.
5.7 Steady-state measurement of Input of the ME EQUIPMENT or ME SYSTEM (Subclause 4.11) [Moderate impact]
The provision in the IEC 60601-1:2005 that allowed a supplier certification to be used in place of the power input measurements required by 4.11 has been replaced by a note that supplier information can be used to supplement those measurements.
5.8 SImultaneous fault testing (Subclause 5.1) [Moderate impact]
Subclause 5.1 was modified to clarify the requirement that the combination of simultaneous independent faults that could result in a HAZARDOUS SITUATION be documented in the RISK MANAGEMENT FILE. The original text of IEC 60601-1:2005 required that the results of the RISK ANALYSIS be used to determine which combination(s) of simultaneous faults were to be tested. Since the RISK ANALYSIS is documented in the RISK MANAGEMENT FILE, this is not a new requirement. When testing is necessary to demonstrate that BASIC SAFETY and ESSENTIAL PERFORMANCE are maintained under such simultaneous independent faults, the related testing may be limited to worst case situations. Because of the potential for additional documentation, this was judged to be of moderate impact.
5.11 Actuating mechanisms (Subclause 5.9.2.3) [Moderate impact] The reference to RISK MANAGEMENT was removed. Any conductive parts of actuating mechanisms are not to be considered ACCESSIBLE PARTS if removal of the handles， knobs, etc. requires the use of a TOOL. 5.12 Legibility of markings (Subclause 7.1.2) [Moderate impact] The test procedure for legibility of markings has been modified so the test is run from the intended OPERATOR position, or, if that is not specified, a distance of 1 m. Also, the description of the visual acuity of the observer is extended to include a near-vision specification. 5.13 Identification of ME EQUIPMENT, parts and ACCESSORIES (Subclauses 7.2.1 and 7.2.4) [Significant impact] The requirements for ldentification of ME EQUIPMENT and ACCESSORIES have been expanded to include several new items. These include: – contact information of the MANUFACTURER (for example, this could be a mailing address, a web site, or a telephone number); a serial number or lot or batch identifier; and the date of manufacture or use by date, if applicable. The serial number, lot or batch identifier, and the date of manufacture may be provided in a human readable code or through automatic identification technology such as barcodes or RFID.