Publication CODE |
Title |
NBN EN 80601-2-30:2010 (2010-09) |
MEDICAL ELECTRICAL EQUIPMENT
PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
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Price Excl. VAT |
Total number of pages, tables and drawings |
25.00 €
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5 P. |
Description
Applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, me equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment.
Cancels and replaces the second edition of IEC 60601-2-30, published in 1999. Constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system.
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Class |
C74
(EQUIPMENT USING ELECTRICAL POWER RADIOLOGY AND SIMILAR ELECTRICAL APPLIANCES AND THEIR ACCESSORIES)
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Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
Very important notice: 98% of the text of the NBN EN 55XXX,
NBN EN 6XXXX comes from the IEC text which is NOT included.
This text can be ordered here:
IEC 80601-2-30:2009.
For the series NBN EN 50XXX, the standards are however complete.
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EN version
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FR version
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DE version
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Committee |
TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
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Responsible |
De heer VAN HECKE Luk
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BEC Approval |
2010-09-01 |
NBN Approval |
2010-10-29 |
Registration |
107693 |
Numbers identifying the european directives |
93/42/EEC
(Medical devices)
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ICS-Code (International Standards Classification) |
11.040
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NBN Status |
Adapted |
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Date of ratification (d.o.r.) |
2010-09-01 |
Date of availability (d.a.v.) |
2010-09-10 |
Date of announcement (d.o.a.) |
2010-12-01 |
Date of publication (d.o.p.) |
2011-06-01 |
Date of withdrawal former edition (d.o.w.) |
2013-09-01 |
IEC publication date |
2010-12-15 |
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