|
IEC 60068-2-27:2008
|
Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
|
IEC 60601-1:2005+AMD1:2012 CSV
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
|
ISO 14253-1:2017
|
Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications |
|
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
|
IEC 60721-3-7:1995+AMD1:1996 CSV
|
Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
|
IEC 60601-1-8:2006+AMD1:2012 CSV
|
Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
|
IEC 60068-2-64:2008
|
Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
|
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
|
IEC 60601-1-2:2014
|
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
|
ISO 16269-6:2014
|
Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals |
|
ISO 15378:2017
|
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
|
IEC 61000-4-2:2008
|
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
|
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV
|
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
|
ISO 9001:2015
|
Quality management systems — Requirements |
|
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
|
ISO 11137:1995
|
Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
|
IEC 60601-1-4:1996+AMD1:1999 CSV
|
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
|
ISO 27427:2013
|
Anaesthetic and respiratory equipment — Nebulizing systems and components |
|
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
|
IEC 60068-2-30:2005
|
Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) |