I.S. EN 61010-2-101:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
Hardcopy , PDF
06-05-2024
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
FOREWORD
1 Scope and object
2 Normative references
3 Terms and definitions
4 Tests
5 Marking and documentation
6 Protection against electric shock
7 Protection against mechanical HAZARDS
8 Resistance to mechanical stresses
9 Protection against the spread of fire
10 Equipment temperature limits and resistance to heat
11 Protection against HAZARDS from fluids
12 Protection against radiation, including laser sources,
and against sonic and ultrasonic pressure
13 Protection against liberated gases and substances,
explosion and implosion
14 Components and subassemblies
15 Protection by interlocks
16 HAZARDS resulting from application
17 RISK assessment
Annexes
Annex L (informative) - Index of defined terms
Bibliography
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Relationship between this
European Standard and the essential
requirements of Directive 98/79/EC
[OJ L 331] aimed to be covered
Pertains to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
54
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN 61010-2-101:2004 | Identical |
| BS EN 61010-2-101:2017 | Identical |
| NBN EN 61010-2-101 : 2003 | Identical |
| DIN EN 61010-2-101 : 2017 | Identical |
| EN 61010-2-101:2017 | Identical |
| ASTM D 4169 : 2016 : REDLINE | Standard Practice for Performance Testing of Shipping Containers and Systems |
| EN ISO 13857:2008 | Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008) |
| ISO 13857:2008 | Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 18113-5:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
| EN ISO 18113-5:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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