Publication details
| Publication CODE |
Title |
| NBN EN IEC 80601-2-30:2019 (2019-05) |
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 €
|
4. |
Description
NEW!IEC 80601-2-30:2018 is available as IEC 80601-2-30:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-30:2018 applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as ME equipment, which by means of an inflatable cuff, are used for non continuous indirect estimation of the blood pressure without arterial puncture. This document specifies requirements for the basic safety and essential performance for this ME equipment and its accessories, including the requirements for the accuracy of a determination. This document covers automatic electrically-powered ME equipment used for the intermittent, indirect estimation of the blood pressure without arterial puncture, including blood pressure monitors for the home healthcare environment. Requirements for indirect estimation of the blood pressure without arterial puncture ME equipment with an electrically-powered pressure transducer and/or displays used in conjunction with a stethoscope or other manual methods for determining blood pressure (non-automated sphygmomanometers) are specified in document ISO 81060-1. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. This second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015;
b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12;
c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series;
d) added additional requirements for public self-use sphygmomanometers;
e) added a list of primary operating functions.
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| Class |
C
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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 80601-2-30:2018.
For the series NBN EN 50XXX, the standards are however complete.
|
FR version
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EN version
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DE version
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Status
Origin
| Committee |
TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2018-04-26 |
| NBN Approval |
2019-06-26 |
| ICS-Code (International Standards Classification) |
11.040
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2018-04-26 |
| Date of availability (d.a.v.) |
2019-05-24 |
| Date of announcement (d.o.a.) |
2019-08-24 |
| Date of publication (d.o.p.) |
2019-11-24 |
| Date of withdrawal former edition (d.o.w.) |
2022-05-24 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN IEC 80601-2-30:2019
|
2019-05-24 |
| is identical to |
IEC 80601-2-30:2018
|
2018-03-22 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
EN ISO 80369-1:2018 |
|
| Standard |
Belgium |
EN ISO 81060-2:2014 |
|
| Standard |
Foreign |
IEC 60601-1-12:2014 |
|
| Standard |
Foreign |
IEC 80369-5:2016 |
|
| Standard |
Belgium |
NBN EN 60068-2-27:2009 |
|
| Standard |
Belgium |
NBN EN 60068-2-64:2010 |
|
| Standard |
Belgium |
NBN EN 60601-1-10:2008 |
|
| Standard |
Belgium |
NBN EN 60601-1-11:2015 |
|
| Standard |
Belgium |
NBN EN 60601-1-2:2015 |
|
| Standard |
Belgium |
NBN EN 60601-1-6:2010 |
|
| Standard |
Belgium |
NBN EN 60601-1-6:2010/A1:2015 |
|
| Standard |
Belgium |
NBN EN 60601-1:2007 |
|
| Standard |
Belgium |
NBN EN 60601-1:2007/A2:2013 |
|
| Standard |
Belgium |
NBN EN 62366-1:2015 |
|
| Standard |
Belgium |
NBN EN IEC 60601-2-2:2018 |
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