BS EN 61010-2-101:2017 - Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment

BS EN 61010-2-101:2017

Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment

Status : Current, Under review   Published : March 2017

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IEC 61010-2-101:2015 is available as

IEC 61010-2-101:2015 RLV

which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.



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.



This publication is to be read in conjunction with

IEC 61010-1:2010

.




Standard NumberBS EN 61010-2-101:2017
TitleSafety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment
StatusCurrent, Under review
Publication Date31 March 2017
Normative References(Required to achieve compliance to this standard)EN ISO 14971, ISO 18113-5, EN ISO 18113-5, EN ISO 13857, ISO 14971, ISO 13857
Informative References(Provided for Information)98/79/EC, ASTM D4169, ISO 15223-1, EN 980:2008
ReplacesBS EN 61010-2-101:2002
International RelationshipsEN 61010-2-101:2017,IEC 61010-2-101:2015
Draft Superseded By12/30269739 DC
DescriptorsElectronic equipment and components, Safety measures, Clinical investigation instruments, Electrical medical equipment, Medical equipment, Electrical equipment, Electrical safety, Electrical components
ICS11.040.55
19.080
71.040.10
Title in FrenchRègles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire. Exigences particulières pour les appareils médicaux de diagnostic in vitro (DIV)
Title in GermanSicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte. Besondere Anforderungen an In-vitro-Diagnostik (IVD)-Medizingeräte
CommitteeEPL/66
ISBN978 0 580 80361 1
PublisherBSI
FormatA4
DeliveryYes
Pages28
File Size826 KB
Price£182.00


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