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.
This technical report provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012.
This technical report also provides a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended.
This report is intended to be used by:
- those who must align standards based on the second edition of IEC 60601-1 with the third edition as amended;
- manufacturers of medical electrical equipment or medical electrical systems;
- health care regulatory authorities， test houses and other organizations responsible for implementing standards for medical electrical equipment and medical electrical systems.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Amendment 1:2012
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 + A1:2012 apply.
4 Assessment of the changes in Amendment 1:2012
Amendment 1 contains 496 separate changes. During the development of the amendment, each change was assessed by the experts involved for its potential impact on users of the standard.
Most of the changes are editorial corrections or clarifications and were assessed and having minimal or no impact on the application of the standard.
However, 83 of the changes were assessed as having a moderate to significant impact on the users of the standard. This assessment is based on the likelihood that some alterations to the design documentation, testing, the product itself or its accompanying documents will be required because of the change to a requirement in the amendment.
The changes have been divided into two groups:
- those assessed as having a significant impact (Table 1), and
- those assessed as having a moderate impact (Table 2).
Because any assessment is somewhat subjective, users of the standard are encouraged to review the contents of the amendment and determine its impact on the sections that are relevant to their products.
The following clauses break down the changes into two groups based on the breadth of their anticipated impact.
- The first group are those changes that are anticipated to impact many, if not most, of the users of IEC 60601-1 (Clause 5). An example would be the change to the requirements for humidity preconditions testing to align with the IEC Certified Testing Laboratories (CTL) decision to harmonize basic environmental testing conditions for electrical products. Because of the impact on existing test protocols, the impact was assessed as significant.
- The second group are those changes that should impact only some of the users of IEC 60601-1 depending on the nature of the equipment to which they are applying the standard (Clause 6). Examples are the requirements that are applied only to sterile ME EQUIPMENT or ME EQUIPMENT parts or to MOBILE ME EQUIPMENT.ANSI/AAMI/IEC TIR62348 pdf download.