Standards Update, September 2010
This article was originally published in RAJ Devices
International Electrotechnical Commission (IEC)
Number | Title |
IEC 60601-2-52 ed 1.0 | Corrigendum 1 – Medical electrical equipment – Part 2-52: Particular requirements for the basic safety and essential performance of medical beds |
Number | Title | Comments due |
Project IEC 60601-2-46 ed 2.0 | Medical electrical equipment – Part 2-46: Particular requirements for the basic safety and essential performance of operating tables | 26 November 2010 |
International Organization for Standardization (ISO)
Number | Title |
ISO 8536-4:2010 | Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed |
ISO 10873:2010 | Dentistry – Denture adhesives |
Number | Title | Comments due |
ISO/IEC DGuide 63 | Guide to the development and inclusion of safety aspects in International Standards for medical devices | Not available |
European Standards (CENELEC)
Number | Title |
EN 80601-2-30:2010 | Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
US
Association for the Advancement of Medical Instrumentation (AAMI)/American National Standards Institute (ANSI)/American Dental Association (ADA)
Number | Title | Status |
ANSI/AAMI/ISO 10993-10:2010 | Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity | Identical national adoption and revision of ANSI/AAMI BE78-2002 (R2008) and ANSI/AAMI BE78-2002/A1-2006 (R2008). Effective 10 September 2010 |
Number | Title | Status |
BSR/AAMI ST67-201x | Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labelled "sterile" | Revision of ANSI/AAMI ST67-2003 (R2008). Submit comments by 1 November 2010 |