ANSI AAMI IEC TIR62348 pdf free download

ANSI AAMI IEC TIR62348 pdf free 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.
5 Changes impacting many users of the standard
5.1 Updated normative references (Clause 2) [Moderate impact]
A number of the standards that are referenced in the 3rd edition have been revised or have been withdrawn and replaced by different documents (e.g., ISO 14971-1:2000 has been replaced by ISO 14971 :2007). These normative references have been updated to reflect current editions.
5.2 Definition and rationale for EXPECTED SERVICE LIFE (Definition 3.28 and rationale for 4.4) [Moderate impact]
The application of the term EXPECTED SERVICE LIFE has led to a misunderstanding in some quarters. To address the misunderstanding, the definition and the rationale have been expanded.
5.3 Restructuring of RISK MANAGEMENT (Subclause 4.2) [Significant impact]
Subclause 4.2 and its rationale have been significantly modified and expanded. The subclause describes in greater detail the RISK MANAGEMENT PROCESS to be employed in complying with IEC 60601-1.
Subclause 4.2.1 introduces the concepts and the purposes of RISK MANAGEMENT within the framework of a TYPE TEST or design assurance standard. The subclause includes a reminder that, “verification of compliance with the RISK MANAGEMENT requirements of this standard can be accomplished by examination of the RECORDS and other documentation required by this standard and assessment of the processes cited in this standard and does not require auditing of the RISK MANAGEMENT PROCESS.”
Subclause 4.2.2 is the heart of the subclause and sets out the basic PROCESS requirements, which remain in compliance with ISO 14971 except for the requirements related to product and post- production monitoring and periodic reviews of the suitability of the RISK MANAGEMENT PROCESS.
Subclause 4.2.3 details how the requirements of this standard are to be applied when evaluating RISK. There are four scenarios described. They are:
a) where IEC 6060 1-1 or its collateral or particular standards specify requirements addressing particular HAZARDS or HAZARDOUS SITUATIONS, together with specific acceptance criteria;
b) where IEC 60601-1 or its collateral or particular standards specify requirements addressing particular HAZARDS or HAZARDOUS SITUATIONS but do not provide specific acceptance criteria;
c) where IEC 60601-1 or its collateral or particular standards identify particular HAZARDS or HAZARDOUS SITUATIONS that have to be investigated without providing specific technical requirements; and
d) where HAZARDS or HAZARDOUS SITUATIONS are identified for the particular ME EQUIPMENT or ME SYSTEM but are not specifically addressed in this IEC 60601-1 or its collateral or particular standards.
5.4 Application of ESSENTIAL PERFORMANCE (Subclause 4.3) [Significant impact] The definition of ESSENTIAL PERFORMANCE has been modified from:
performance necessary to achieve freedom from unacceptable risk
in the 3rd edition to:
performance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK 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.ANSI AAMI IEC TIR62348 pdf download.