ISO 11737-1:2018 Standard|Sterilization of Medical Device Product| What is ISO 11737-1 Standard?L-2!

Подробнее о видео

ISO 11737-1:2018 Standard|Sterilization of Medical Device Product| What is ISO 11737-1 Standard?L-2!IVD@ivdmanufacturing7208





What is Sterilization?
The purpose of sterilization is to inactivate the microbiological contaminants in order to transform the devices from non-sterilized to sterilized

Method of Sterilization
It can be achieved by high-pressure steam (autoclave), dry heat (oven), chemical sterilants (glutaraldehydes or formaldehyde solutions) or physical agents (radiation).

Types of Sterilization Process
Steam Sterilization
Flash Sterilization
Low-Temperature Sterilization Technologies
Ethylene Oxide “Gas” Sterilization
Hydrogen Peroxide Gas Plasma
Peracetic Acid Sterilization
Microbicidal Activity of Low-Temperature Sterilization Technologies
Bioburden of Surgical Devices
Effect of Cleaning on Sterilization Efficacy
Other Sterilization Methods
Sterilizing Practices



Sterile Medical Device
A sterile medical device is one that is free from viable microorganisms. Medical devices produced under standard manufacturing conditions in accordance with the requirements for Quality Management Systems (QMS) may have microorganisms present on and/or within them prior to sterilization (non-sterile products). Sterile Stainless Steel Blood Lancet, Sterile Stainless Steel Scalpel.

Standards involve in Sterilization-
ISO 11737 consists of the following parts, under the general title Sterilization of medical devices —
Microbiological methods: — Part 1: Determination of a population of microorganisms on products. —
ISO 11737-1:2018
Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.ISO 11737-2 :2009


Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process you should follow for your devices because this will lead to the question of which material you should use to build your device.


List of Queries -
What is ISO 11737-1 Standard
What is ISO 11737-2 Standard
What is Sterilization Process
What is Sterilization Process of Medical Device
ISO Standard for Sterilization of Medical Device
Sterilization of health care products
How to do Sterilization of Medical Device
How to do of health care products
Medical Device sterilize kaise kare
Medical Device sterilize kaise hota hai
Disinfectant of Medical Device
In Vitro Medical Device Sterilization Process
Tips for Sterilization of health care products
Sterilization of Surgical Instruments
Sterilization of Bandages
AutoClave Sterilization
What is the best sterilization method?
How to choose your Sterilization method for Medical Devices?
See how hospitals clean medical devices
How to sterilize hospital operation theatre
Medical Device Sterilization Validation ISO § 7.5.6, 7.5.7, & 820.75
ISO 13485:2016
Packaging and Sterilisation for Medical Devices




✨ Subscribe and hit the bell icon to see the latest videos....

Follow Amar on your favorite Social Media Channels:

👉🏻 Facebook:

👉🏻 Instagram:

👉🏻

👉🏻 YouTube:

👉🏻 Whats App:

LETS LEARN TOGETHER AND GROW TOGETHER !!!!!!