CEI EN 61010-2-101 : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
19-06-2023
English - Italian
01-01-2003
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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.
| Committee |
CT 85/66
|
| DevelopmentNote |
Classificazione CEI 66-19 (12/2003) 1ED 2003 Edition is valid until 24-02-2020; and only available in combined English/Italian. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 61010-2-101:2017 | Identical |
| 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) |
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