DOCUMENTS
From brochures and articles to extensive case stories, feel free to take a look at our various materials – all available as downloads.
SECTION:
Stories from the users, created by Axlab.
ARTICLES:
CERTIFICATeS:
CE and IVD certification
FDA cleared
| AS-410M | |
| Japan (PMDA) | REGISTERED |
| Europe (EUDAMED) | REGISTERED |
| UK (MHRA) | REGISTERED |
| Switzerland (SWISSDAMED) | REGISTERED |
| USA (FDA) | REGISTERED |
| Canada (MDEL) | REGISTERED |
| Australia (TGA) | REGISTERED |
| Israel (AMAR) | REGISTERED |
Regulations and Directives
In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746
Ensures the safety, performance, and reliability of in-vitro diagnostic (IVD) medical devices in the EU.
RoHS Directive 2015/863/EU
Restricts the use of hazardous substances (e.g., lead, mercury) in electrical and electronic products.
Safety Standards
IEC61010-1:2010/AMD1:2016
General electrical safety for laboratory equipment.
EN61010-2-101:2018
Safety for IVD (in-vitro diagnostic) equipment specifically.
EN61010-2-010:2019
Safety for lab equipment that heats materials (e.g., ovens, incubators).
Electromagnetic Compatibility (EMC) Standards
EN61326-1:2013
EMC requirements for lab and measurement equipment — ensures resistance to and control of electromagnetic interference.
EN61000-4 Series
EMC immunity test standards:
-2:2009: Electrostatic discharge (ESD)
-3:2006+A1:2008+A2:2010: RF field immunity
-4:2012: Fast electrical transients
-5:2014+A1:2017: Surge immunity (e.g., lightning)
-6:2014: Conducted RF disturbances
-8:2010: Power frequency magnetic fields
-11:2004+A1:2017: Voltage dips and interruptions
Environmental Compliance
EN50581:2012
Defines documentation requirements to show RoHS compliance for electrical/electronic products.
Medical Device Quality & Risk Management
EN ISO14971:2019
Risk management process for medical devices — identifies and controls safety risks.
EN ISO15223-1:2016
Standardized symbols used in medical device labeling and instructions.
EN ISO18113-1:2011 & EN ISO18113-3:2011
Labeling and information requirements for IVD devices, especially those used by professionals.
Classification & Certification
Class A, Rule 5 (Annex VIII of IVDR)
Classification of the device as low risk (Class A), with Rule 5 relating to lab equipment.
Annex II and III (IVDR)
Refers to general safety, performance, and documentation requirements.
Certified in EN ISO9001:2015
Quality management system certification for consistent production and customer satisfaction.
Conformed to EN ISO13485:2016
Quality system specific to medical devices — ensures regulatory and customer requirements are met.