Publication details
| Publication CODE |
Title |
| NBN EN 61010-2-101:2017 (2017-02) |
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR in VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
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| Price Excl. VAT |
Total number of pages, tables and drawings |
|
25.00 €
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6 P.. |
Description
IEC 61010-2-101:2015 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes:
- excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment;
- updated Biohazard and Lot symbols in Table 1 in Clause 5;
- added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5;
- added requirement for gas or liquid markings and ratings to Clause 5;
- added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5;
- added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5;
- added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5;
- added requirement for OPERATOR maintenance instructions to Clause 7;
- added requirements for sample zones and loading zones to Clause 7;
- excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8;
- added requirement for biohazard marking to Clause 13;
- added requirement for interlock systems containing electric/electronic or programmable components to Clause 15;
- added informative reference to Usability standard IEC 62366 to Clause 16;
- replaced Clause 17 with requirements of ISO 14971 for RISK assessment.
- Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5.
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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 61010-2-101:2015.
For the series NBN EN 50XXX, the standards are however complete.
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EN version
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DE version
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FR version
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Status
Origin
| Committee |
TC 66
SAFETY OF MEASURING, CONTROL, AND LABORATORY EQUIPMENT
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2015-02-27 |
| NBN Approval |
2017-03-22 |
| Registration |
175922 |
| Numbers identifying the european directives |
98/79/EC
(In vitro diagnostic medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.55
, 19.080
|
| NBN Status |
New |
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| Date of ratification (d.o.r.) |
2015-02-27 |
| Date of availability (d.a.v.) |
2017-02-24 |
| Date of announcement (d.o.a.) |
2017-05-24 |
| Date of publication (d.o.p.) |
2017-08-24 |
| Date of withdrawal former edition (d.o.w.) |
2020-02-24 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 61010-2-101:2017
|
2017-02-24 |
| is identical to |
IEC 61010-2-101:2015/ed. 1.0
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2015-01-23 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Standard |
Belgium |
NBN EN ISO 13857 |
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| Standard |
Belgium |
NBN EN ISO 14971 |
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| Standard |
Belgium |
NBN EN ISO 18113-5 |
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|
