Cytotoxicity Screening

Introduction 

Cytotoxicity screening is one of the most important biological assessments used to evaluate the safety of materials intended for human contact. The test determines whether a material or its extracts release substances that can cause damage to living cells, providing an early indication of potential health risks. 

Cytotoxicity screening is widely used in the medical device industry under the ISO 10993 series and may also support the evaluation of drinking water contact materials under BS 69202.5. Although these standards serve different industries, both are designed to protect human health by assessing the biological effects of substances that may migrate from materials during use. 

At METS Lab, we provide cytotoxicity screening services to support manufacturers in demonstrating product safety, regulatory compliance, and market readiness. 

What is Cytotoxicity Screening? 

Cytotoxicity screening is an in vitro assessment that evaluates the effect of a material, product, or extract on cultured mammalian cells. The purpose of the test is to identify whether substances released from a material adversely affect cell viability, growth, or normal cellular function. 

As an early-stage biological evaluation tool, cytotoxicity screening helps manufacturers identify potential hazards before products are introduced to patients, consumers, or public water systems. 

Cytotoxicity Screening Under ISO 10993-1 

ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, provides the framework for assessing the biological safety of medical devices. 

Cytotoxicity is one of the primary biological endpoints considered during a biocompatibility assessment and is often the first biological test performed as part of a medical device evaluation program. The detailed test procedures are described in ISO 10993-5, which outlines methods for assessing the cytotoxic potential of medical device materials and their extracts. 

The objective of cytotoxicity screening under the ISO 10993 series is to determine whether device materials release substances that may cause adverse cellular responses and compromise patient safety. 

Cytotoxicity Screening in BS 6920-2.5 Assessments 

BS 6920 is a British Standard used to evaluate non-metallic products intended for contact with drinking water. The standard assesses whether materials adversely affect water quality or release substances that may present a risk to public health. 

BS 6920-2.5 focuses on the extraction of substances that may be of concern to human health. Materials are exposed to controlled water extraction conditions, and the resulting extracts are assessed to determine whether potentially harmful substances migrate into drinking water. 

Cytotoxicity screening may be used as part of the toxicological evaluation of these extracts to support the overall assessment of material safety. 

Products commonly assessed under BS 6920 include: 

• Water storage tanks 
• Pipes and fittings 
• Seals and gaskets 
• Protective coatings and linings 
• Water treatment system components 
• Plumbing materials 

The objective is to ensure that products used in contact with potable water do not introduce contaminants that could adversely affect consumers. 

The primary difference is that cytotoxicity screening is a fundamental biocompatibility requirement for many medical devices under ISO 10993, whereas under BS 6920-2.5 it serves as supporting evidence within a broader public health evaluation of drinking water contact materials. 

Benefits of Cytotoxicity Screening 

Cytotoxicity screening provides several advantages: 

• Early identification of potentially harmful materials 
• Support for product development and material selection 
• Improved patient and consumer safety 
• Reduced regulatory risk 
• Enhanced confidence in product performance 
• Faster assessment of biological safety 

By identifying potential biological hazards early, manufacturers can make informed decisions and reduce the risk of costly redesigns or compliance issues. 

Why Choose METS Lab? 

METS Lab offers comprehensive cytotoxicity screening services for medical devices, healthcare products, and drinking water contact materials. Our experienced team provides reliable testing solutions in accordance with internationally recognized standards to support product safety and regulatory compliance. 

Our services include: 

• Cytotoxicity screening in accordance with ISO 10993-5 for medical device biocompatibility assessments 
• Cytotoxicity evaluation supporting ISO 10993-1 biological evaluation programs 
• Cytotoxicity assessment of materials and extracts for BS 6920-2.5 compliance 
• Testing support for products intended for contact with potable water 
• Technical guidance for ISO 10993 and BS 6920 compliance requirements 

With experienced scientists, validated methodologies, and a commitment to quality, METS Lab helps manufacturers confidently assess material safety and meet regulatory expectations.