IEC 80601-2-58:2014
IEC 80601-2-58:2014
| Title | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| Abstract | IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard. |
| Issue Date | 2014-09-04 |
| Category | MED |
| Included in IECEE System | 2014-10-28 |
| 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.
Group/Country | Reference | Last Modified | Differences | TRF Addendum |
|---|---|---|---|---|
| CAN/CSA C22.2 No. 80601-2-58:15 | 2016-10-18 | Download113 kb |
Laboratory Name | City | Country | Responsible National Certification Body |
|---|---|---|---|
94342 Strasskirchen | Germany | ||
Arnhem | Netherlands | ||
Eurofins Electric & Electronic Product Testing AG, Lab Fehraltorf | Fehraltorf | Switzerland | |
Modiin | Israel | ||
Boxborough, | United States of America | ||
Lake Forest, | United States of America | ||
Carlsbad, | United States of America | ||
Puchheim | Germany | ||
Nürnberg | Germany | ||
Pleasanton, | United States of America | ||
San Diego | United States of America | ||
München | Germany |
Id | Name | City | Country |
|---|---|---|---|
13336 | Toronto, Ontario | Canada | |
13360 | Arnhem | Netherlands | |
13372 | Fehraltorf | Switzerland | |
20269 | Modiin | Israel | |
13424 | IL 60005 | United States of America | |
13334 | BRUSSELS 1070 | Belgium | |
13345 | Nürnberg | Germany | |
13346 | München | Germany |
Id | Name | City | Country |
|---|---|---|---|
13607 | Baltimore, | United States of America | |
13371 | Kista | Sweden | |
13361 | Lysaker | Norway |