ISO 15223 is an international standard that specifies the symbols that are used to convey data of medical devices.
ISO 15223 ensures that the medical device symbols are clear and understandable regardless of language and region.
It mainly focuses on the symbols used in the labeling of products to communicate important information about the products’ safety and use. It also helps to ensure patient safety.
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This certification specifies the symbols that are use on medical devices. It specifies the requirements for various symbols of medical devices. The main purpose of ISO 15223 ensure that the medical device symbols are understandable by the common person.
Why ISO 15223 is important
ISO 15223 is important for several reasons, it ensures that the labels of medical devices are standardized with international regulations. It increases patient safety.
Also it helps to reduce the risk for medical devices. It establishes the manufacturer’s commitment to quality and safety. It helps to enhance market access.
Who can apply for ISO 15223?
Manufacturers of medical devices
Distributors and importers of medical devices
Design and packaging companies
Healthcare providers and hospitals
Software developers for medical device labeling
Benefits of The 15223 ISO Certification?
Improves patient safety
International recognition
Market access
Reduce risk
Regulatory compliance
Enhanced user experience
Cost efficiency
Improves brand reputation
Adaptability to technological advancement
Environment benefits
Key elements of ISO 15223
Symbols of key information include-
Manufacturer’s information- Symbols that tell the name and address of the manufacturer.
Expiry date- symbols that represent the expiry date of the device.
Reusability- it tells whether the device is reused or disposable.
Handling and storage- symbols that show how the device is stored and handled.
Warning and caution- symbols that highlight the safety information.
Sterilization status- symbols that show whether the device is sterile or not.
Global recognition- symbols that are designed in a way that each religion can understand the information of the symbol, that particularly helps in global markets.
Regulatory Alignment- it helps the manufacturers to meet the regulatory requirements og various markets.
Requirements of ISO 15223
Reduce translation burden
Requirements for symbols
Color and contrast
Symbol development and usage
Labeling requirement
Size and scaling
Regulatory and legal compliance
Documentation and instructions
Symbol maintenance
Interpretability and clarity
International applicability
How to apply for ISO 15223
Understanding- understand the requirements of ISO 15223.
Choose a certification body- choose a certification to apply for your ISO 15223 certificate.
Gap analysis- check for the areas that need improvement according to the ISO 15223.
Prepare a plan- prepare a plan to fulfill the requirements according to the ISO 15223.
Apply- apply for the ISO certification with required documents.,
Implement the plan- execute the plan as decided.
Internal audit- An internal audit will be conducted by the certification body to check the requirements of the ISO 15223 in the organization.
Re-audit- Re-audit will be conducted to verify the requirements again and to decide whether to issue the ISO 15223 certificate or not.
Certificate issues- if audits are successful, the certificate issues.
Documents required for ISO 15223 certificate
PAN card
GST registration
Scope of work
Adhar Card
MSME
Company’s letterhead
Company’s Visiting card
Udyog Aadhaar registration certificate
Business registration proof
Sales & purchase bill copies
Cost of ISO 15223?
The cost of ISO 15223 includes-
Standard fees
Certification body
Size and complexity of the organization
Implementation fees
Processing time for ISO 15223?
If you are applying your ISO 15223 certificate with A Star Legal Associates, you will get the certificate within 24 hours.
Validity of ISO 15223
3 years
Symbols used in ISO 15223 for Medical devices
ISO 15223 Certification Consultants
If you also want ISO 15223, A Star Legal associates provide ISO 15223 in India. We will provide complete information about ISO 15223 and also will give you the best services. So consult with us today for information about ISO 15223.
ISO 15223 mainly focuses on the symbols used in the labeling of products to communicate important information about the products’ safety and use. The symbols are use to give information about medical devices. Labeling medical devices gives us the best information about the medical device. It tells us how we can use it and for what purpose it is use.
FAQ
What is the main purpose of ISO 15223?
The main purpose of ISO 15223 is to signify the requirements of symbols that are use in medical devices.
Do not use if the package is damaged. What does this mean?
If the medical device package is opened or damaged, then it is instructed not to open and use the device.
What does the ⏳ symbol identify
This symbol signifies that the hourglass is not done.
Latest version of ISO 15223
The current version of ISO 15223 is ISO 15223-1:2021.
