EN 61010-2-101:2017
Current
The latest, up-to-date edition.
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
24-02-2017
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.
Committee |
CLC/TC 66X
|
DocumentType |
Standard
|
PublisherName |
European Committee for Standards - Electrical
|
Status |
Current
|
Standards | Relationship |
DS EN 61010-2-101 : 2017 | Identical |
I.S. EN 61010-2-101:2017 | Identical |
DIN EN 61010-2-101 : 2017 | Identical |
UNE-EN 61010-2-101:2018 | Identical |
UNE-EN 61010-2-101:2004 | Identical |
BS EN 61010-2-101:2017 | Identical |
VDE 0411-2-101 : 2017 | Identical |
PN EN 61010-2-101 : 2017 | Identical |
SN EN 61010-2-101 : 2017 | Identical |
NEN EN IEC 61010-2-101 : 2017 | Identical |
NF EN 61010 2 101 : 2017 | Identical |
CEI EN 61010-2-101 : 2003 | Identical |
NBN EN 61010-2-101 : 2003 | Identical |
I.S. EN ISO 15197:2015 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
ISO 15197:2013 | In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
UNE-EN ISO 15197:2015 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
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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