ASTM F2172-02(2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers is no longer properly aligned with the most recent 3rd edition of IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT-Part 1: General requirements for basic safety and essential performance, and the more recent Amendment 1, now under development as an FDIS ballot (forecasted for circulation 2012-05-31 to 2012-07-30 and publication 2012-09-15). The 3rd edition of the General Standard included major technical revisions and was significantly restructured. Requirements in the electrical section were aligned with those for information technology equipment covered by IEC 60950-1 and a requirement for including a RISK MANAGEMENT PROCESS was added. The pending Amendment 1 addresses a total of 182 issues that were either not fully addressed in voting process or arose after publication of the 3rd edition. In addition to addressing these 182 issues, the Amendment 1 clarifies how risk management and essential principles are managed in the 3rd edition. The changes in Amendment 1 are detailed in the 380 endnotes to Committee Draft 62A/748/CDV. For this particular standard, new technical requirements will also be added to provide adequate risk controls for newly identified hazards, such as the risks of air embolism and infection. The project will be managed using ASTM Virutal Meetings and the ASTM Collaboration Area. ASTM F29.19 COLLABORATION AREA was developed to allow on-line revisions and commenting. Working draft ASTM F2196 2nd edition is under development Christine Lloyd reorganized the draft to conform to IEC 60601-1 3rd edition. This must now be updated to include Amendment 1. Key areas of improvement will also be updated by ASTM F29.19: oRisk management based review of user needs and potential new hazards oNew requirements to reduce the risks of air embolism o Comprehensive literature review oLink to ASA Equipment and Facilities initiatives.
Draft Under Development