IEC 61010-2-101:2018
IEC 61010-2-101:2018
| Title | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
| Abstract | IEC 61010-2-101:2018 is also available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 61010-2-101:2018 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 publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: |
| Issue Date | 2018-10-05 |
| Category | MEAS |
| Included in IECEE System | 2018-12-21 |
| Purchase | webstore |
| Test Report Form | |
| Testing Equipment List |
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 |
|---|---|---|---|---|
| 2021-05-03 | Download52 kb | ||
| CSA C22.2 No. 61010-2-101:19 | 2023-08-22 | Download68 kb | |
| 2019-09-02 | |||
| EN IEC 61010-2-101:2022/A11:2022 used in conjunction with EN 61010-1:2010 + A1:2019 | 2023-08-04 | Download334 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
Suwon-si | Korea, Republic of | ||
Scandicci (FI) | Italy | ||
Littleton, MA | United States of America | ||
CCIC-CSA International Certification Co. Ltd. Shanghai Branch | Shanghai | China | |
Wismar | Germany | ||
94342 Strasskirchen | Germany | ||
Tokyo | Japan | ||
Pointe Claire | Canada | ||
Toronto | Canada | ||
Irvine | United States of America | ||
Getafe | Spain | ||
Arnhem | Netherlands | ||
Shanghai 200436 | China | ||
DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou branch | Guangzhou | China | |
Suzhou | China | ||
Hsinchu County 31061 | Chinese Taipei | ||
Campanillas | Spain | ||
Osnago (LC) | Italy | ||
Yongin-si | Korea, Republic of | ||
Regensdorf | Switzerland | ||
Vendargues | France | ||
Hitchin | United Kingdom | ||
Irvine | United States of America | ||
New Taipei City | Chinese Taipei | ||
Eurofins Electric & Electronic Product Testing AG, Lab Fehraltorf | Fehraltorf | Switzerland | |
Shanghai | China | ||
Shenzhen | China | ||
Aix en Provence | France | ||
Eurofins Electrical and Electronic Testing NA, Inc. (Austin) | Austin | United States of America | |
Eurofins Electrical and Electronic Testing NA, Inc. (Baltimore) | Baltimore, MD 21230-3432 | United States of America | |
Eurofins Electrical and Electronic Testing NA, Inc. (Union City) | Union City | United States of America | |
West Yorkshire, WF10 5PY | United Kingdom | ||
Reichenwalde b. Berlin | Germany | ||
Hørsholm 2970 | Denmark | ||
Binyamina | Israel | ||
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 | |||
Shanghai | China | ||
Guangzhou, Guangdong | China | ||
Taipei City | Chinese Taipei | ||
Japan Quality Assurance Organization, Kita-Kansai Testing Center - JQA Kita Kansai | Osaka | Japan | |
Japan Quality Assurance Organization, Safety & EMC Center - JQA Tokyo | Tokyo | Japan | |
Kaufbeuren | Germany | ||
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 | ||
Toronto | Canada | ||
Brussels | Belgium | ||
Helsinki | Finland | ||
Munich | Germany | ||
Gunpo-si | Korea, Republic of | ||
Suwanee | United States of America | ||
Taiwan 248 | Chinese Taipei | ||
Madrid | Spain | ||
Shanghai | China | ||
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch | Guangzhou | China | |
SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch | Shenzhen | China | |
Ljubljana | Slovenia | ||
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 | ||
TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch | 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 | ||
Taipei City | Chinese Taipei | ||
Offenbach / Main | Germany | ||
Saarbrücken | Germany |
Id | Name | City | Country |
|---|---|---|---|
13336 | Toronto, Ontario | Canada | |
22917 | Getafe | Spain | |
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 | |
21201 | Binyamina | Israel | |
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 | |
21547 | Kaufbeuren | Germany | |
13356 | Seoul | Korea, Republic of | |
13343 | Fontenay-Aux-Roses | France | |
13641 | Paris Cedex 15 | France | |
13361 | Lysaker | Norway | |
13469 | Toronto, | Canada | |
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 | |
13344 | Offenbach / Main | Germany |
Id | Name | City | Country |
|---|---|---|---|
13864 | COURBEVOIE | France | |
13721 | BELLIS Testing and Certification of Home Appliances and Industrial Products JSC | Minsk | Belarus |
25774 | Sunnyvale, | United States of America | |
13749 | NL - 7327 AC Apeldoorn | Netherlands | |
25918 | Tai Po, | China |