Publication details
| Publication CODE |
Title |
| NBN EN IEC 60601-2-31:2020 (2020-04) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
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| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
|
3. |
Description
IEC 60601-2-31:2020 is available as IEC 60601-2-31:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) The requirement for testing for energy reduction has been removed;
b) The test for exposure to external defibrillation has been completely revised;
c) The exclusion for testing ESD immunity only with respect to air discharges has been removed;
d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117;
e) Additional rationale for all changes.
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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 electronically on our website, but isn't available
via this link. Please contact the BEC if you want to buy this text and we'll
give you the appropriate link.
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DE version
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EN version
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FR version
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Status
Origin
| Committee |
CLC/TC 62
Electrical equipment in medical practice
|
Approval
| BEC Approval |
2020-01-01 |
| NBN Approval |
2020-04-29 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2020-01-01 |
| Date of availability (d.a.v.) |
2020-04-03 |
| Date of announcement (d.o.a.) |
2020-07-03 |
| Date of publication (d.o.p.) |
2020-10-03 |
| Date of withdrawal former edition (d.o.w.) |
2023-04-03 |
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Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN IEC 60601-2-31:2020
|
2020-04-03 |
| is identical to |
IEC 60601-2-31:201X
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|
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Foreign |
ISO 14117 |
|
| Standard |
Belgium |
NBN EN 60601-1-2:2015 |
|
| Standard |
Belgium |
NBN EN 60601-1:2007 |
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|
