Breas Medical AB

Address(es)
  • Företagsvägen 1
    SE-SE-435 33 Mölnlycke
    Sweden

Website https://www.breas.com/
Status

MEMBER

Acceptance date 2019-10-08

Further information

Stage

Country

Name

2

Norway

Nemko Group AS

LEGEND: Scope Limitations
  • RA : Audio amplifiers with audio power > 0,5 Watts excluded
  • RC : Apparatus with connection(s) to a cable distribution system excluded
  • RSH : Shredders excluded
  • RT : Apparatus with connection(s) to a telecommunication network excluded
  • RV : CRT (cathode ray tubes)/ picture tubes, plasma/LCD or other video apparatus excluded
  • ROUT : Equipment intended for installation outdoors excluded
  • RWPT : Wireless power transmitter excluded

Category

Name

Tests/Clauses

Acceptance Date

Responsible National Certification Body

MED

IEC 60601-1-8:2006/AMD2:2020

Accepted clauses: 6.3.3.2
 2023-08-29

Nemko Group AS

MED

ISO 80601-2-12:2020

Accepted clauses: 201.9.6.2.1.101, 201.11.1.2.2, 201.11.8.101 k-o), 201.12, 201.102.7, 201.103
 2023-08-29

Nemko Group AS

MED

ISO 80601-2-61:2017

Accepted clauses: 201.11.8.101, 201.13.101, 201.103, 208.6.1.2.101, 208.6.5.4.101, 208.6.8.5.101
 2023-08-29

Nemko Group AS

MED

ISO 80601-2-74:2021

Accepted clauses: 201.9.6.2.1.101, 201.12
 2023-08-29

Nemko Group AS

MED

ISO 80601-2-79:2018

Accepted clauses: 201.9.6.2.1.101, 201.11.8, 201.12, 201.107
 2019-10-08

Nemko Group AS

MED

ISO 80601-2-80:2018

Accepted clauses: 201.9.6.2.1.101, 201.11.8, 201.12, 201.103
 2019-10-08

Nemko Group AS