CSA C22.2 No. 61010.2.101 : 2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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
28-08-2019
English
01-01-2015
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
Pertains to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
DocumentType |
Standard
|
Pages |
63
|
PublisherName |
Canadian Standards Association
|
Status |
Withdrawn
|
ASTM D 4169 : 2016 : REDLINE | Standard Practice for Performance Testing of Shipping Containers and Systems |
ISO 13857:2008 | Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs |
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 |
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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