IEC 60601-2-37:2007
IEC 60601-2-37:2007
| Title | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
| Abstract | Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the operator to understand the risk of the output of the ultrasonic diagnostic equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. This second edition cancels and replaces the first edition published in 2001 and its Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition and its amendments into a form compatible with the parent IEC 60601-1:2005. |
| Issue Date | 2007-08-09 |
| Category | MED |
| Included in IECEE System | 2007-11-30 |
| 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.
No information declared
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
Suwon-si | Korea, Republic of | ||
CCIC-CSA International Certification Co. Ltd. Shanghai Branch | Shanghai | China | |
94447 Plattling | Germany | ||
Seoul | Korea, Republic of | ||
Toronto | Canada | ||
Irvine | United States of America | ||
Arnhem | Netherlands | ||
DEKRA Testing and Certification (Shanghai) Ltd., Guangzhou branch | Guangzhou | China | |
Yongin-si | Korea, Republic of | ||
New Taipei City | Chinese Taipei | ||
Shanghai | China | ||
Aix en Provence | France | ||
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 | ||
Binyamina | Israel | ||
Modiin | Israel | ||
Milano | Italy | ||
Boxborough, | United States of America | ||
Duluth, | United States of America | ||
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 | ||
United Kingdom | |||
Shanghai | China | ||
Guangzhou, Guangdong | China | ||
Japan Quality Assurance Organization, Safety & EMC Center - JQA Tokyo | Tokyo | Japan | |
Gyeonggi-do | Korea, Republic of | ||
Seoul 08389 | Korea, Republic of | ||
Fontenay-Aux-Roses | France | ||
TRAPPES | France | ||
Oak Creek | United States of America | ||
Carlsbad, | United States of America | ||
Gyeonggi-do | Korea, Republic of | ||
Lysaker | Norway | ||
Puchheim | Germany | ||
Yokohama | Japan | ||
Suwanee | United States of America | ||
Taiwan 248 | Chinese Taipei | ||
Shanghai | China | ||
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch | Guangzhou | China | |
Bangalore – 560 100 | India | ||
Tel-Aviv | Israel | ||
Shanghai | China | ||
Nanshan District | China | ||
Budapest | Hungary | ||
Osaka 537-0002, | Japan | ||
Yokohama, | Japan | ||
Seoul, 07298 | Korea, Republic of | ||
Taoyuan City 333 | Chinese Taipei | ||
Boxborough, MA 01719 | United States of America | ||
Pleasanton, | United States of America | ||
GORMLEY L0H 1G0 | Canada | ||
TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch | Guangzhou | China | |
Tokyo | Japan | ||
Singapore 609937 | Singapore | ||
München | Germany | ||
Ballerup | Denmark | ||
Mie 516-0021 | Japan | ||
Uiwang-si | Korea, Republic of | ||
Fremont, | United States of America | ||
Melville | United States of America | ||
Northbrook, IL 60062 | United States of America | ||
Research Triangle Park | United States of America | ||
Huangpu District, Guangzhou | China | ||
Kyiv | Ukraine | ||
Taipei City | Chinese Taipei | ||
Offenbach / Main | Germany |
Id | Name | City | Country |
|---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13360 | Arnhem | Netherlands | |
13607 | Baltimore, | United States of America | |
13348 | Reichenwalde b. Berlin | Germany | |
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 | |
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 | |
13334 | BRUSSELS 1070 | Belgium | |
13342 | Helsinki | Finland | |
13597 | Tel-Aviv | Israel | |
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 |
|---|---|---|---|
26080 | Beaucouzé | France | |
13347 | Hartmannsdorf | Germany |