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Medical Device Classification

This document provides a table for determining the classification of medical devices based on their intended use, risks, and patterns of use. The table separates devices into body-contacting and non-body-contacting, and assigns a risk class of I, II, or III based on factors like degree of invasiveness, duration of use, impact, and whether the device is active or non-active. For example, liquid transportation devices that contact blood and body fluids are usually class III if for long-term or central circulation use. Implantable devices are generally class III. The notes clarify that class I, II, and III refer to the established risk-based classification categories for medical devices

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HARESH NIRMAL
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177 views

Medical Device Classification

This document provides a table for determining the classification of medical devices based on their intended use, risks, and patterns of use. The table separates devices into body-contacting and non-body-contacting, and assigns a risk class of I, II, or III based on factors like degree of invasiveness, duration of use, impact, and whether the device is active or non-active. For example, liquid transportation devices that contact blood and body fluids are usually class III if for long-term or central circulation use. Implantable devices are generally class III. The notes clarify that class I, II, and III refer to the established risk-based classification categories for medical devices

Uploaded by

HARESH NIRMAL
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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Annex

Table for Determination of Medical Device Classification

Body-contacting device

Temporary use Short-term use Long-term use


Status of Skin Blood Skin Blood Blood
use Trauma Trauma Skin/Orifice Trauma
/Orifice circulation /Orifice circulation circulation
Patterns of use /Tissue /Tissue (openings) /Tissue
(openings) /Central (openings) / Central / Central

Liquid transportation
1 Ⅱ Ⅱ Ⅲ Ⅱ Ⅱ Ⅲ Ⅱ Ⅲ Ⅲ
device
Blood and other body
2 － － Ⅲ － － Ⅲ － － Ⅲ
fluids alternation device
3 Medical dressing Ⅰ Ⅱ Ⅱ Ⅰ Ⅱ Ⅱ － Ⅲ Ⅲ
Non-active
device 4 Invasive device Ⅰ Ⅱ Ⅲ Ⅱ Ⅱ Ⅲ － － －
Reusable surgical
5 Ⅰ Ⅰ Ⅱ － － － － － －
device
6 Implantable device － － － － － － Ⅲ Ⅲ Ⅲ
Contraceptive and
family planning device
7 Ⅱ Ⅱ Ⅲ Ⅱ Ⅲ Ⅲ Ⅲ Ⅲ Ⅲ
(excluding reusable
surgical device)
Other non-active
8 Ⅰ Ⅱ Ⅲ Ⅱ Ⅱ Ⅲ Ⅱ Ⅲ Ⅲ
devices

Status of

use Minor injury Moderate injury Serious injury

Patterns of use
Energy treatment
1 Ⅱ Ⅱ Ⅲ
device
Active Diagnostic and
2 Ⅱ Ⅱ Ⅲ
device monitoring device
Liquid transportation
3 Ⅱ Ⅱ Ⅲ
device
Ionizing radiation
4 Ⅱ Ⅱ Ⅲ
device
5 Implantable device Ⅲ Ⅲ Ⅲ
6 Other active devices Ⅱ Ⅱ Ⅲ

1
Non-body-contacting device

Status of use
little impact Minor impact Significant impact
Patterns of use

Non-active 1 Nursing device Ⅰ Ⅱ －


device
Device for medical device
2 － Ⅱ Ⅲ
sterilization and cleaning

3 Other non-active devices Ⅰ Ⅱ Ⅲ

Status of use
little impact Minor impact Significant impact
Patterns of use

Clinical laboratory
1 Ⅰ Ⅱ Ⅲ
instruments
Active
device 2 Stand alone software － Ⅱ Ⅲ

Instruments for medical


3 devices disinfection and － Ⅱ Ⅲ
sterilization

4 Other active devices Ⅰ Ⅱ Ⅲ

Notes: 1. “I”, “II” and “III” herein respectively refer to class I, II and III medical
devices.
2. “-” herein means the situation is inapplicable to any class of medical
devices.

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