Question

There are THREE common ISO certificates for surgical masks. What are they? Explain.

Answer 1

1. ISO 22609:2004 - (Clothing for protection against Infectious Agents)

This standard describes test methods to measure the resistance of medical face masks to penetration by the impact of synthetic blood. It includes factors such as design, construction , interfaces etc. and the agents which may affect the overall protection offered by the mask. It also tests the clothing such as surgical masks for the infiltration of mixture of airborne particles. It makes sure about the ability of the equipment to protect from the penetration of body fluids deposited on the face mask.

2. ISO 10993-1:2018 -

Biological Evaluation of Medical devices - Evaluation and testing within a risk management process

Assessment of biological safety of the medical device or equipment is standardized. This ISO standard evaluates the medical devices such as masks, gloves, Aprons etc. which are in direct or indirect contact with the patient's body and the user's body. It also includes the electronic devices which are used during the medical processes.

3. ISO 17510 : 2015 -

Medical Devices - Masks and application accessories -

Nasal masks, exhaust ports and headgear are the devices which are included in this ISO standards. These are majorly standardized for breathing therapy equipment.