IEC 61010-2-101:2015

Title
Abstract

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.

Issue Date

2015-01-23

Category

MEAS

Included in IECEE System

2015-02-03

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DISCLAIMER: National differences

The National differences and Group differences, National Deviations and Special National conditions (SNC), are based solely on information provided to the Secretariat by the IECEE Member Bodies and/or NCBs and other sources. The IEC/IECEE is not responsible for, nor will it take any position related to, the accuracy or validity of the information provided. To verify the current status of this type of information, we recommend contacting the Member Body (MB) or National Certification Body (NCB) of the relevant country.

Group Differences are applicable for CENELEC member countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Group/Country

Reference

Last Modified

Differences

TRF Addendum

CanadaCanada

2023-05-05

Download66 kb

CanadaCanada

2023-03-21

Download52 kb

Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Scandicci (FI)

Italy

Littleton, MA

United States of America

Shanghai

China

Wismar

Germany

94342 Strasskirchen

Germany

Tokyo

Japan

Pointe Claire

Canada

Richmond

Canada

Toronto

Canada

Irvine

United States of America

Arnhem

Netherlands

Shanghai 200436

China

Campanillas

Spain

Osnago (LC)

Italy

Yongin-si

Korea, Republic of

Regensdorf

Switzerland

Montigny le Bretonneux

France

Vendargues

France

Hitchin

United Kingdom

Hull

United Kingdom

Fehraltorf

Switzerland

Shanghai

China

Austin

United States of America

Baltimore, MD 21230-3432

United States of America

West Yorkshire, WF10 5PY

United Kingdom

Reichenwalde b. Berlin

Germany

Hørsholm 2970

Denmark

Lod

Israel

Milano

Italy

Boxborough,

United States of America

Columbus,

United States of America

Kaufbeuren

Germany

Duluth,

United States of America

Campoformido (UD)

Italy

Tokyo

Japan

Lake Forest,

United States of America

Menlo Park,

United States of America

Fridley, MN

United States of America

Kista

Sweden

United Kingdom

Guangzhou, Guangdong

China

Taipei City

Chinese Taipei

Osaka

Japan

Tokyo

Japan

Seoul 08389

Korea, Republic of

Fontenay-Aux-Roses

France

Moirans

France

TRAPPES

France

Oak Creek

United States of America

Nänikon

Switzerland

Ottawa

Canada

Biassono (MB)

Italy

Carlsbad,

United States of America

Pfinztal

Germany

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Shenzhen, Guangdong

China

Round Rock, Texas

United States of America

Gyeonggi-do 12735

Korea, Republic of

Borås

Sweden

Helsinki

Finland

Munich

Germany

Yokohama

Japan

Gunpo-si

Korea, Republic of

Suwanee

United States of America

Taiwan 248

Chinese Taipei

Madrid

Spain

Shanghai

China

Guangzhou

China

Ljubljana

Slovenia

Genas

France

Dongguan

China

Bangalore – 560 100

India

Littleton, MA 01460

United States of America

Fareham, Hampshire

United Kingdom

Tel-Aviv

Israel

Volpiano (TO)

Italy

Beijing 100176

China

Shanghai

China

Nanshan District

China

Budapest

Hungary

Pogliano Milanese

Italy

Osaka 537-0002,

Japan

Yokohama,

Japan

Seoul, 07298

Korea, Republic of

Berlin

Germany

Köln

Germany

Leek

Netherlands

Taoyuan City 333

Chinese Taipei

Pleasanton,

United States of America

Peabody

United States of America

New Brighton

United States of America

San Diego

United States of America

Tampa,

United States of America

GORMLEY

Canada

Jiangsu

China

Guangzhou 510656

China

Tokyo 160-0023

Japan

Seoul, 07326

Korea, Republic of

Singapore 609937

Singapore

Frankfurt

Germany

Hannover

Germany

München

Germany

Ballerup

Denmark

Neu-Isenburg (Zeppelinheim)

Germany

20061 Carugate (MI)

Italy

Singapore

Singapore

Mie 516-0021

Japan

Uiwang-si

Korea, Republic of

Brea,

United States of America

Fremont,

United States of America

Melville

United States of America

Mounds View

United States of America

Northbrook, IL 60062

United States of America

Research Triangle Park

United States of America

Basingstoke

United Kingdom

Suzhou

China

Kyiv

Ukraine

Taipei City

Chinese Taipei

Offenbach / Main

Germany

Saarbrücken

Germany

Id

Name

City

Country

13864

COURBEVOIE

France

13336

Toronto, Ontario

Canada

13360

Arnhem

Netherlands

26080

Beaucouzé

France

13478

Skelmersdale

United Kingdom

13372

Fehraltorf

Switzerland

13607

Baltimore,

United States of America

13348

Reichenwalde b. Berlin

Germany

21077

Broendby

Denmark

20269

Lod

Israel

13351

Milano

Italy

13371

Kista

Sweden

13375

Surrey

United Kingdom

13365

Singapore

Singapore

13424

IL 60005

United States of America

13353

Tokyo

Japan

13358

Gunpo-si,Gyeonggi-do, 15809

Korea, Republic of

13356

Seoul

Korea, Republic of

13343

Fontenay-Aux-Roses

France

13641

Paris Cedex 15

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

13367

Ljubljana

Slovenia

13349

Budapest

Hungary

13354

Yokohama

Japan

13345

Nürnberg

Germany

13427

Singapore 609937

Singapore

13346

München

Germany

13340

Ballerup

Denmark

13423

Northbrook

United States of America

13374

Kyiv

Ukraine

13344

Offenbach / Main

Germany

Id

Name

City

Country

13721

Minsk

Belarus

13749

NL - 7327 AC Apeldoorn

Netherlands

13469

Toronto,

Canada