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Publication details

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
 
Price Excl. VAT Total number of pages, tables and drawings
25.00 € 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.
Class  C74  (EQUIPMENT USING ELECTRICAL POWER RADIOLOGY AND SIMILAR ELECTRICAL APPLIANCES AND THEIR ACCESSORIES)
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.

EN version
FR version
DE version
Status
Status Registered trilingual Belgian standard EN or FR or DE
Situation Withdrawn
Replaced by  NBN EN IEC 80601-2-30:2019
Replaces  NBN EN 60601-2-30:2000
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2010-09-01
NBN Approval 2010-10-29
Registration 107693
Numbers identifying the european directives 93/42/EEC  (Medical devices)
ICS-Code (International Standards Classification) 11.040
NBN Status Adapted
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
Correspondences with international standards
Relation International standard Date
is identical to EN 80601-2-30:2010 2010-09-10
is identical to IEC 80601-2-30:2009/ed. 1.0 2009-01-28
is identical to IEC 80601-2-30:2009/COR1:2010/ed. 1.0 2010-01-01
Relations to belgian/foreign publications
Type Origin Code Date
Standard Foreign ISO 594-1
Standard Foreign ISO 594-2
Standard Foreign ISO 81060-2
Standard Belgium NBN EN 60068-2-27
Standard Belgium NBN EN 60068-2-31
Standard Belgium NBN EN 60068-2-64
Standard Belgium NBN EN 60601-1-2
Standard Belgium NBN EN 60601-2-2