IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD1:2012
| Title | Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| Abstract | IEC TR 62348:2012 provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012, and to trace requirements between the third edition and the amended second edition. |
| Issue Date | 2012-07-13 |
| Category | MED |
| Included in IECEE System | 2012-08-14 |
| 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 |
|---|---|---|---|---|
| CAN/CSA-C22.2 No. 60601-1:14 | 2019-11-15 | Download149 kb | |
| CAN/CSA C22.2 No. 60601-1:14 | 2017-03-17 | Download142 kb | |
| Canadian National standard: CAN/CSA-C22.2 No. 60601-1:08, CAN/CSA-C22.2 No. 60601-1:14 (including amendment 1) and Amendment 2:2022 (MOD) to CAN/CSA-C22.2 No. 60601-1:14 | 2022-08-12 | Download262 kb | |
| CAN/CSA C22.2 No. 60601-1:08 and CAN/CSA-C22.2 No. 60601-1:14 (including amendment1) | 2022-08-26 | Download157 kb | |
| CAN/CSA-C22.2 No. 60601-1:14 | 2019-06-18 | Download149 kb | |
| CAN/CSA-C22.2 No. 60601-1:14 | 2019-10-04 | Download149 kb | |
| CAN/CSA-C22.2 No. 60601-1:14 | 2019-09-17 | Download149 kb | |
| GB 9706.1-2020 | 2024-07-22 | Download50 kb | |
| SI 60601 Part 1 (2018-06) | 2018-09-26 | Download909 kb | |
| National standard JIS T 0601-1:2017 (IEC 60601-1:2005 + A1:2012(MOD)) | 2019-09-17 | Download160 kb | |
| National standard JIS T 0601-1:2017 (IEC 60601-1:2005 + A1:2012(MOD)) | 2019-11-15 | Download159 kb | |
| National standard JIS T 0601-1:2017 (IEC 60601-1:2005 + A1:2012(MOD)) | 2019-05-02 | Download158 kb | |
| National standard JIS T 0601-1:2017 (IEC 60601-1:2005 + A1:2012(MOD)) | 2021-03-15 | Download159 kb | |
| National standard JIS T 0601-1:2017 (IEC 60601-1:2005 + A1:2012(MOD)) | 2019-10-04 | Download159 kb | |
| Notification of MFDS No. 2020-12, Annex 1 | 2020-05-12 | Download48 kb | |
| Notification of MFDS No. 2020-12, Annex 1 | 2021-03-15 | Download68 kb | |
| Notification of MFDS No. 2020-12, Annex 1 | 2020-05-12 | Download68 kb | |
| BS EN 60601:2006 A1 | 2012-08-15 | Download2 Mb | |
| AAMI/IEC 60601-1:2005+AMD1:2012 | 2019-07-10 | Download108 kb | |
| National standard AAMI/IEC 60601-1:2005 + AMD 1:2012 | 2019-09-17 | Download110 kb | |
| National standard AAMI/IEC 60601-1:2005 + AMD 1:2012 | 2019-11-15 | Download110 kb | |
| National standard AAMI/IEC 60601-1:2005 + AMD 1:2012 | 2019-09-02 | Download110 kb | |
| National standard AAMI ES60601-1:2005, AAMI ES60601-1:2005/AMD1:2012, AAMI ES60601-1:2005/AMD2:2021 | 2024-05-17 | Download100 kb | |
| National standard AAMI/IEC 60601-1:2005 + AMD 1:2012 | 2019-10-04 | Download110 kb | |
| National standard AAMI ES60601-1:2005, AAMI ES60601-1:2005/AMD1:2012 | 2024-05-17 | Download102 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
Suwon-si | Korea, Republic of | ||
Loughborough | United Kingdom | ||
Anyang-si | Korea, Republic of | ||
Türkheim | Germany | ||
Bureau Veritas Consumer Products Services (Hong Kong) Limited, Taoyuan Branch | Taoyuan City, Taiwan | Chinese Taipei | |
Littleton 01460 | United States of America | ||
CCIC-CSA International Certification Co. Ltd. Shanghai Branch | Shanghai | China | |
Wismar | Germany | ||
94447 Plattling | Germany | ||
Tokyo | Japan | ||
Seoul | Korea, Republic of | ||
Pointe Claire | Canada | ||
Toronto | Canada | ||
Taoyuan City 333, | Chinese Taipei | ||
Irvine | United States of America | ||
Bangalore | India | ||
Shenzhen, Guangdong | China | ||
Co Meath | Ireland | ||
Matsusaka-shi | Japan | ||
Arnhem | Netherlands | ||
Shanghai 200436 | China | ||
DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou branch | Guangzhou | China | |
Suzhou | China | ||
Dresden | Germany | ||
Stuttgart | Germany | ||
Campanillas | Spain | ||
DongGuan City | China | ||
Yongin-si | Korea, Republic of | ||
Calenzano (FI) | Italy | ||
Regensdorf | Switzerland | ||
Chassieu | France | ||
Shenzhen | China | ||
182 00 Praha 8 – Troja | Czech Republic | ||
Hull | United Kingdom | ||
West Yorkshire, WF10 5PY | United Kingdom | ||
New Taipei City | Chinese Taipei | ||
Eurofins Electric & Electronic Product Testing AG, Lab Fehraltorf | Fehraltorf | Switzerland | |
Shanghai | 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 | |
Gyeonggi-do | Korea, Republic of | ||
Reichenwalde b. Berlin | Germany | ||
Hørsholm 2970 | Denmark | ||
Dongguan, Guangdong | China | ||
Guangdong | China | ||
Gyeonggi-Do | Korea, Republic of | ||
Binyamina | Israel | ||
Modiin | Israel | ||
Gimpo-si | Korea, Republic of | ||
Milano | Italy | ||
Boxborough, | 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 | ||
Plano, | United States of America | ||
Kista | Sweden | ||
United Kingdom | |||
Shanghai | China | ||
Kowloon | Hong Kong | ||
Guangzhou, Guangdong | China | ||
Taipei City | Chinese Taipei | ||
Gyeonggi-do | Korea, Republic of | ||
Japan Quality Assurance Organization, Kita-Kansai Testing Center - JQA Kita Kansai | Osaka | Japan | |
Japan Quality Assurance Organization, Safety & EMC Center - JQA Tokyo | Tokyo | Japan | |
Gyeonggi-do, 15809 | Korea, Republic of | ||
Padova | Italy | ||
Kaufbeuren | Germany | ||
Gyeonggi-do | Korea, Republic of | ||
Seoul 08389 | Korea, Republic of | ||
Fontenay-Aux-Roses | France | ||
Moirans | France | ||
TRAPPES | France | ||
Oak Creek | United States of America | ||
Ottawa | Canada | ||
Biassono (MB) | Italy | ||
Neihu, Taipei | Chinese Taipei | ||
Carlsbad, | United States of America | ||
Pfinztal | Germany | ||
Gyeonggi-do | Korea, Republic of | ||
Lysaker | Norway | ||
Shenzhen, Guangdong | China | ||
Gyeonggi-do 12735 | Korea, Republic of | ||
New Taipei City 24450, Taiwan | Chinese Taipei | ||
Rancho Cucamonga | United States of America | ||
Toronto | Canada | ||
Brussels | Belgium | ||
Tampere | Finland | ||
Helsinki | Finland | ||
Puchheim | Germany | ||
Yokohama | Japan | ||
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 | |
SGS-CSTC Standards Technical Services Co., Ltd. Wuhan Branch | Wuhan | China | |
Ljubljana | Slovenia | ||
Hartmannsdorf | Germany | ||
Genas | France | ||
Dongguan | China | ||
Gyeonggi-do | Korea, Republic of | ||
Hsin-Tien | Chinese Taipei | ||
Bangalore – 560 100 | India | ||
Taoyuan City | Chinese Taipei | ||
Tel-Aviv | Israel | ||
Shanghai | China | ||
Nanshan District | China | ||
Budapest | Hungary | ||
Pogliano Milanese | Italy | ||
Osaka 537-0002, | Japan | ||
Yokohama, | Japan | ||
Seoul, 07298 | Korea, Republic of | ||
Berlin | Germany | ||
Nürnberg | Germany | ||
Taoyuan City 333 | Chinese Taipei | ||
Boxborough, MA 01719 | United States of America | ||
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 | ||
Taiwan | Chinese Taipei | ||
GORMLEY L0H 1G0 | Canada | ||
Jiangsu | China | ||
TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch | Guangzhou | China | |
TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch | Shenzhen, Guangdong | China | |
Tokyo | Japan | ||
Singapore 609937 | Singapore | ||
Hannover | Germany | ||
München | Germany | ||
Whitefield | India | ||
Ballerup | Denmark | ||
Neu-Isenburg (Zeppelinheim) | Germany | ||
20061 Carugate (MI) | Italy | ||
Warszawa | Poland | ||
Singapore | Singapore | ||
Mie 516-0021 | Japan | ||
Uiwang-si | Korea, Republic of | ||
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 | ||
Huangpu District, Guangzhou | China | ||
Kyiv | Ukraine | ||
Taipei City | Chinese Taipei | ||
Offenbach / Main | Germany | ||
New Taipei City | Chinese Taipei | ||
Falconara Marittima (AN) | Italy | ||
Saarbrücken | Germany |
Id | Name | City | Country |
|---|---|---|---|
13864 | COURBEVOIE | France | |
13422 | Milton Keynes | United Kingdom | |
13336 | Toronto, Ontario | Canada | |
13833 | Singapore | Singapore | |
27722 | Mie 515-1104 | Japan | |
13360 | Arnhem | Netherlands | |
26080 | Beaucouzé | France | |
13339 | Troja, 182 00 Praha 8 | Czech Republic | |
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 | Modiin | 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 | |
13749 | NL - 7327 AC Apeldoorn | Netherlands | |
13359 | Gyeonggi-do | Korea, Republic of | |
13356 | Gyeongsangnam-do | 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 | |
13347 | Hartmannsdorf | Germany | |
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 | BELLIS Testing and Certification of Home Appliances and Industrial Products JSC | Minsk | Belarus |
22917 | Getafe | Spain | |
13338 | Beijing 100070 | China | |
13843 | Hamburg | Germany | |
25918 | Tai Po, | China |