Braun Welch Allyn Thermoscan PRO 6000 Gebrauchsanweisung Seite 31

Standards and compliance
This device conforms to the following Safety and Performance Standards:
This infrared thermometer meets requirements established in ASTM Standard E 1965–98 (for the
thermometer system [thermometer with probe cover]). Full responsibility for the conformance of
the product to the standard is assumed by Kaz USA, Inc., 250 Turnpike Road, Southborough,
MA 01772, USA.
ASTM laboratory accuracy requirements in the display range of 37 °C to 39 °C (98 °F to 102 °F)
for infrared thermometers is ± 0.2 °C (± 0.4 °F), whereas for mercury‑in‑glass and electronic
thermometers, the requirement per ASTM Standards E 667‑86 and E 1112‑86 is ± 0.1 °C (± 0.2 °F).
This product conforms to the provisions of the EC directive 93/42/EEC (Medical Device Directive).
A clinical summary is available upon request.
ANSI/AAMI STD ES60601‑1, UL STD 60601‑1, CAN/CSA STD C22.2 No. 60601‑1,
IEC 60601‑1:1988 + A1:1991 + A2:1995, IEC 60601‑1:2005, EN 60601‑1:2006,
Medical electrical equipment—
Part 1: General requirements for basic safety and essential performance
EN 12470‑5:2003 Clinical thermometers—Part 5: Performance of infra‑red ear thermometers
(with maximum device)
Meets CB Scheme
EN 60601‑1‑2:2007, IEC 60601‑1‑2:2007 General requirements for basic safety and essential
performance—Collateral Standard: Electromagnetic Compatibility–Requirement & Tests Medical
electrical equipment—Part 1–2: General requirements for basic safety and essential performance—
Collateral standard: Electromagnetic compatibility—Requirements and test
IEC 62304:2006 Medical device software—Software life cycle processes
IEC 62366:2007 (IEC 60601‑1‑6:2010) Medical devices—Application of usability engineering to
medical devices
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 14971:2007 Medical devices—Application of risk management to medical devices
ISO 80601‑2‑56:2009 Medical electrical equipment—Part 2–56: Particular requirements for basic
safety and essential performance of clinical thermometers for body temperature measurement
ISO 10993‑1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (includes
US FDA Blue book memo G95‑1‑100 Title)
GBT 21417.1:2008
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed
description of EMC requirements please contact an authorized local Service Centre.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
EQUIPMENT
Internally powered ME equipment.
Continuous operation.
Not protected against ingress of water.
IPX0
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