IEC 60601-2-16:2008
IEC 60601-2-16:2008
Title | Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
Abstract | IEC 60601-2-16:2008 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2008 does not take into consideration the dialysing fluid control system of Haemodialysis equipment using regeneration of dialysing fluid and central delivery systems. It does however take into consideration the specific safety requirements of such Haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2008 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2008 includes all medical electrical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This third edition cancels and replaces the second edition of IEC 60601-2-16, published in 1998. This edition constitutes a technical revision. Changes since the previous edition include, among others, a summary of additional essential performance requirements, revision of terms and definitions, classification of applied parts and limits as numbers for protection against hazardous outputs, in the annex. The contents of the corrigendum of October 2008 have been included in this copy. |
Issue Date | 2008-04-25 |
Category | MED |
Included in IECEE System | 2008-05-13 |
Purchase | webstore |
Test Report Form | |
Testing Equipment List | No information declared |
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 |
---|---|---|---|
Pointe Claire | Canada | ||
Arnhem | Netherlands | ||
Milano | Italy | ||
Boxborough, | United States of America | ||
Kista | Sweden | ||
Japan Quality Assurance Organization, Safety & EMC Center - JQA Tokyo | Tokyo | Japan | |
Oak Creek | United States of America | ||
Carlsbad, | United States of America | ||
Lysaker | Norway | ||
Budapest | Hungary | ||
Yokohama, | Japan | ||
Tokyo | Japan | ||
München | Germany | ||
Fremont, | United States of America | ||
Northbrook, IL 60062 | United States of America | ||
Research Triangle Park | United States of America |
Id | Name | City | Country |
---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13360 | Arnhem | Netherlands | |
13351 | Milano | Italy | |
13371 | Kista | Sweden | |
13424 | IL 60005 | United States of America | |
13353 | Tokyo | Japan | |
13361 | Lysaker | Norway | |
13349 | Budapest | Hungary | |
13354 | Yokohama | Japan | |
13345 | Nürnberg | Germany | |
13427 | Singapore 609937 | Singapore | |
13346 | München | Germany | |
13423 | Northbrook | United States of America |
Id | Name | City | Country |
---|---|---|---|
13607 | Baltimore, | United States of America |