5 Rules to Group Medical Oxygen Tubing in 2021
18 October 21
What are the requirements for importing medical oxygen tubing?
When conducting import and classification activities for medical oxygen tubing, the first step to get started is that the product is the medical device. However, there are some customers who do not know how machines and tubing are identified as medical tubing? In this article, we will cite legal bases for customers to better understand medical tubing.
1 What is a medical device?
2 Grouping of medical tubing in service of circulation
2.1 Single-type medical tubing
2.2 Family of medical tubing
2.3 Medical tubing system
What is medical oxygen tubing?
Currently, the concept of medical tubing comes under certain guidelines and standards Medical tubing means all kinds of tubing, instruments, materials, implants, reagents and in vitro calibrators, and software that simultaneously satisfy the following requirements. The following requirements are important:
Common individually or in combination with each other as specified by the owner of the medical oxygen tubing to serve humans for one or more of the following purposes:
- Diagnosis, prevention , monitoring, treatment and alleviation of illness or compensation for injury, injury;
- examine, replace, correct or support anatomy and physiological processes;
- Support or sustain life;
- Control of conception;
- Provide information for diagnosis, monitoring and treatment through testing of specimens originating from the human body.
Grouping of medical oxygen tubing in service of circulation
The registration for circulation of class A or B, C, D for medical oxygen tubing is easy to register among several types of medical tubing. Usually will group into one of the following three groups:
Single medical tubing
We classify medical tubing by type of single tubing if the name and purpose of such medical tubing has been identified by the owner. Specific device supplies as a separate package, or the medical device does not meet the criteria for classification by medical device family, IVD test kit, and medical device system, tubing cluster IVD medical tubing or other medical oxygen tubing assemblies.
For example: Condoms with packing specifications 3, 12 and 14 is easy to combine and registered as a Single medical device. Moreover, a company that produces a software program that can be common with certain CT-Scanners. Similarly, these can be software program considers medical device and is easy to use on different scanners.
Rules for grouping registration numbers of medical tubing
They have medical tubing. What are they medical devices? How is the identification of medical tubing family regulated by law? Furthermore, identify the family of medical tubing for circulation records. Furthermore, their medical oxygen tubing and their medical tubing is a set of medical tubing that every page of medical tubing in general they have the following information:
- General a product owner;
- Moreover, same type of risk classification;
- Have the same purpose of use;
- Similarly, have the same design and manufacturing process;
Medical tubing system
A medical device system consists of a number of medical devices as medical oxygen tubing and accessories or accessories combined together into a system, the components of which meet the following requirements:
- From one owner ownership;
- Intended to be common in combination to achieve a common purpose;
- Similarly, compatible when common as a system;
- The components that make up a system have their own names.
- Moreover, devices registered as part of a system shall be provided for use with that system only.
- Furthermore, where a device may provide for use by more than one system.
- The device must register with each system separately or is easy to register individually.
Mutual sharing of devices
The owner of the system can incorporate medical oxygen tubing and accessories from other owners that become part of the system to achieve the intended use of the system. Example: Owner A’s patient monitoring system intends for use with Owner B’s vitals sensors and probes.
These accessories are common in combination to achieve standard general purpose use by Owner A, and can be registered with the patient monitoring system in a single file.
What is a line of system?
If several systems meet the following conditions to group as a family, those systems may register as a line of Systems:
- Systems supplied from same product owner;
- Systems that fall under the same risk classification;
- Moreover, systems with the same intended use;
- Systems with the same design and manufacturing process;
- Similarly, important components of systems with changes within the allowable range.
What do you mean by medical oxygen tubing?
Medical oxygen tubing means devices, instruments, materials, implants, reagents and in vitro calibrators, and software that simultaneously satisfy the following requirements:
- Common individually or in combination with each other as specified by the owner of the medical device
- Moreover, diagnose, prevent, monitor, treat and alleviate illness or compensate for injury or illness
- Furthermore, examines, replaces, corrects, or supports anatomical and physiological processes
- Support or sustain life
- Controlling conception
- Similarly, disinfect medical tubing, including chemicals common in testing procedures
- In addition, provide information for diagnosis, monitoring, and treatment through testing of specimens
- Similarly, Do not use pharmacological, immunological or metabolic mechanisms in or on the human body
- They are only supportive to achieve the purposes specified in point of this clause.
- Moreover, support or sustain life;
- Controlling conception;
- Disinfect medical tubing, including chemicals common in testing procedures
Summary medical oxygen tubing
The presence of medical oxygen tubing completely excludes in medical tubes. This is due to the ability of these components to wash out into biologically or chemically aggressive liquid media, contaminating them. At the same time, silicone hoses do not lose flexibility in contact with solutions of various compositions and temperatures.
- Sterilization of medical pump hoses can be carried out:
- by means of temperature steam treatment;
- using ethylene oxide;
- by various chemical methods.
The principle of operation of the medical oxygen tubing
A medical oxygen tubing apparatus takes air from the environment and separates oxygen molecules. For this, the device has something similar to a “molecular sieve”. It retains nitrogen, but oxygen passes into the storage compartment.
At the outlet, the device gives out a concentrated oxygen compound. Concentrator users inhale oxygen through a mask or nasal cannula. That’s what an oxygen concentrator is for.