Testing of Medical Devices

Medical devices that come into contact with the human body are required by the regulatory authorities to be tested on possible interactions and potential unwanted side effects. Therefore, medical devices are assigned to different categories dependent on the kind of contact and the contact time to the human body.

vivo Science offers various tests according to ISO 10993 for your medical device of either class I, class IIa/IIb or class III in full compliance with the principles of Good Laboratory Practice (GLP). Together with our partner laboratories, we´ll also provide the risk assessment of your product needed for market authorization.

• ISO 10993-1:     Evaluation and testing within a risk management process
• ISO 10993-2:     Animal welfare requirements
• ISO 10993-3:     Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-4:     Selection of tests for interactions with blood
• ISO 10993-5:     Tests for in vitro cytotoxicity
• ISO 10993-6:     Tests for local effects after implantation
• ISO 10993-10:   Tests for skin sensitization
• ISO 10993-11:   Tests for systemic toxicity
• ISO 10993-12:   Sample preparation and reference materials
• ISO 10993-20:   Principles and methods for immunotoxicology testing of medical devices
• ISO 10993-23:   Tests for irritation

The different categories are shown in the table below. Thereby, you can decide in which category your medical device may be classified and identify the corresponding tests on biocompatibility to be performed for market authorization.

Tests to consider
(ISO 10993-1: Biological Evaluation of Medical Devices Part 1, Attachment A, 2013)

Nature of body contact	Contact duration *	Cytotoxicity	Sensitization	Irritation or i.c. reactivity	Systemic toxicity (acute)	Subchronic (subacute) toxicity	Genotoxicity	Implantation	Haemocompatibility
Surface device
Intact skin	A	x	x	x
	B	x	x	x
	C	x	x	x
Mucosal membrane	A	x	x	x
	B	x	x	x	o	o		o
	C	x	x	x	o	x	x	o
Breached or compromised surface	A	x	x	x	o
	B	x	x	x	o	o		o
	C	x	x	x	o	x	x	o
External communicating device
Blood path, indirected	A	x	x	x	x				x
	B	x	x	x	x	o			x
	C	x	x	o	x	x	x	o	x
Tissue/bone/dentin +	A	x	x	x	o
	B	x	x	x	x	x	x	x
	C	x	x	x	x	x	x	x
Circulating blood	A	x	x	x	x		o		x
	B	x	x	x	x	x	x	x	x
	C	x	x	x	x	x	x	x	x
Implant device
Tissue/bone	A	x	x	x	o
	B	x	x	x	x	x	x	x
	C	x	x	x	x	x	x	x
Blood	A	x	x	x	x	x		x	x
	B	x	x	x	x	x	x	x	x
	C	x	x	x	x	x	x	x	x

*Contact duration:
A-limited (≤ 24 h)
B-prolonged (> 24 h to 30 d)
C-permanent (> 30 d)
X = ISO Evaluation Tests for Consideration
O = Additional Tests which may be applicable
Note * For all devices used in extracorporeal circuits

Remark concerning ISO/IEC 17025 compliance for studies performed under GLP at vivo Science:

A position paper regarding the relationship between the OECD Principles of GLP and ISO/IEC 17025, published in Sept. 2016 by the OECD, qualifies GLP laboratories to perform non-clinical health and environmental safety studies that should be accepted as (at least) coequal to the quality standards of ISO/IEC 17025. Therefore, GLP should be recognized as regulatory valid for tests performed according to ISO 10993.