In Vitro Diagnostic Equipment Safety Testing to IEC 61010-2-101
IEC 61010-2-101 specifies safety requirements for in vitro diagnostic (IVD) medical equipment. Compatible Electronics is FDA ASCA recognized (TL-82) for IEC 61010-2-101 testing, providing streamlined regulatory acceptance for your IVD devices.
What is IEC 61010-2-101?
IEC 61010-2-101 is a particular standard within the IEC 61010 series, specifically addressing safety requirements for in vitro diagnostic medical equipment used to examine specimens derived from the human body. It supplements IEC 61010-1 general requirements.
Products Covered
Clinical Analyzers
- Clinical chemistry analyzers
- Hematology analyzers
- Immunoassay systems
- Coagulation analyzers
Diagnostic Systems
- Molecular diagnostic equipment
- Urinalysis systems
- Blood gas analyzers
- Point-of-care devices
Sample Preparation
- Specimen preparation equipment
- Centrifuges
- Mixers and shakers
- Incubators
FDA ASCA TL-82
- Recognized laboratory
- Streamlined 510(k) review
- Regulatory certainty
Key Safety Tests
- Protection against biohazardous materials
- Protection from chemical hazards
- Mechanical hazards from moving parts
- Thermal hazards from heating elements
- Electrical safety requirements
- Radiation safety (where applicable)
- Ergonomic considerations
- Emergency stop provisions
FDA ASCA Recognition (TL-82)
Streamlined FDA Review
Our TL-82 recognition means FDA accepts our IEC 61010-2-101 test reports without additional technical review. This significantly reduces your 510(k) review time for IVD devices and provides regulatory certainty.
ASCA recognition accelerates market clearance for your IVD products
Standards We Test To
International
- IEC 61010-2-101 Ed. 2.0
- IEC 61010-2-101 Ed. 2.1
- IEC 61010-1 Ed. 3.0/3.1
European
- EN 61010-2-101 (European harmonized)
- IVD Directive 98/79/EC
- IVDR 2017/746 compliance
North America
- UL 61010-2-101
- CSA C22.2 No. 61010-2-101
- FDA ASCA TL-82 recognized
Related Standards
- IEC 61326-2-6 (IVD EMC)
- ISO 15189 (medical laboratory quality)
- ISO 14971 (risk management)
Contact Us for IVD Equipment Safety Testing
Get FDA ASCA recognized testing for your IVD devices.
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