Appendix B: Approvals - Verathon Aperture User Manual

Appendix B: Approvals

Appendix B: Approvals
Standards complied with:
ISO 13485, Certifi cate No 9235
ISO 594/1:1986 - conical fi ttings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 1: General Requirements
ISO 594-2:1998 - Conical fi ttings with a 6% (Luer) taper for syringes, needles and
certain other medical equipment - Part 2: Lock fi ttings
ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation and
testing and FDA requirements of G95
ISO 11137-1, 2, 3:2006 - Sterilization of healthcare products - Radiation
CE Requirements met for Class I and for Class IIa (Stat)
IEC EN 60601-1-1:2000 Safety Requirements for Medical System
IEC EN 60601-1:1988 + A1 + A2: Medical Electrical equipment - Part 1: General
Requirements for safety
IEC EN 60601-2-18 + A1 2000 - Specifi c requirements for safety: Section 2.18
Specifi cations for endoscopic equipment
IEC EN 60601-1-2:2001 + A1 General Requirements for Safety Collateral
Standard Electromagnetic Compatibility Requirements and Tests
Package Impact Testing and ASTM D4169, Schedule E - Vehicle Vibration testing
U.S. UL 60601-1:Medical Electrical Equipment Part 1, General requirements for
Safety
ANSI/IEC 60529-2004: Degree of Protection provided by Enclosure (IP Code)
CAN/CSA C22.2 No. 60601-1 Series Part 1: General Requirements for Safety
AU, CA, DK, IL, and US National Differences, as per CB Bulletin 107a
Licenses/Listings:
FDA Listed Class 1 Device E226090
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