استانداردهای برچسب‌گذاری و شناسایی تجهیزات پزشکی

بررسی بندهای مهم استانداردهای مربوط به برچسب‌گذاری و شناسایی تجهیزات پزشکی

برای بررسی دقیق‌تر بندهای کلیدی هر استاندارد در رابطه با برچسب‌گذاری و شناسایی تجهیزات پزشکی، در ادامه بخش‌های مهم به زبان انگلیسی ذکر شده است:

1. ISO 13485:2016 – Medical Devices Quality Management System

• Clause 7.5.3.2.1: Identification
  Medical devices must be uniquely identified and traceable through labeling that includes batch or serial numbers.

• Clause 7.5.3: Product Identification
  The labeling must meet regulatory requirements, ensuring devices are properly identified for safety and tracking.

• Clause 7.2: Customer Requirements
  Labeling must include all relevant information required by the user, such as instructions for use (IFU) and safety information.

2. ISO 15223-1:2021 – Symbols to be used with Medical Device Labels

• Clause 5.1: General Symbols
  Standardized symbols for device features (e.g., CE mark, manufacturer’s name, lot number, serial number) that are internationally recognized.

• Clause 5.4: Symbols for Safe Use
  Symbols for indicating device limitations (e.g., single use only, expiration date) and safety warnings.

• Clause 5.7: Sterilization Symbols
  Symbols related to sterilization methods and status, helping the user understand the device’s sterility conditions.

3. ISO 60601-1:2012 – Medical Electrical Equipment

• Clause 7.2: Marking on the Outside of Equipment
  Marking includes electrical ratings (voltage, current type) and any necessary warnings or precautions regarding use.

• Clause 7.9: Warnings and Cautions
  Labels must contain relevant warnings, including hazards associated with the electrical aspects of the device.

• Clause 7.5: Durability of Markings
  Markings and labels must be durable and remain legible during the entire life cycle of the device.

4. IEC 61326-1:2012 – EMC Compliance for Electrical Equipment

• Clause 5.2.1: Electromagnetic Compatibility (EMC)
  Devices must be labeled with warnings or restrictions regarding use in certain electromagnetic environments.

• Clause 7: Documentation and Labeling
  Instructions for ensuring device functionality and compatibility in the presence of electromagnetic fields must be clear on labels.

5. 21 CFR Part 801 (FDA) – Labeling of Medical Devices

• Section 801.1: General Labeling
  Devices must bear labels with the name, address, and contact information of the manufacturer, as well as the intended use.

• Section 801.15: Misbranding
  A device is misbranded if the labeling is false or misleading in any particular way or does not follow prescribed labeling requirements.

• Section 801.109: Prescription Devices
  Prescription medical devices require labeling that provides adequate directions for use by a licensed practitioner.

6. EN 1041:2008 – Information supplied by the manufacturer with medical devices

• Clause 4.2: Content of Information
  Information on labels must include product name, manufacturer’s details, batch or serial numbers, and specific device usage.

• Clause 4.7: Instructions for Use
  Devices must include adequate instructions for proper use and any warnings necessary for safe handling.

• Clause 4.5: Language Requirements
  Labels must be provided in the language(s) of the country where the product is marketed to ensure comprehension by the end user.

7. ASTM F2503-13 – Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

• Clause 5: Marking Requirements
  Devices used near MRI systems must be labeled as MR-safe, MR-conditional, or MR-unsafe to indicate compatibility with MRI equipment.

• Clause 6: Symbol Use
  Symbols indicating MRI safety status must be used consistently to convey the device’s compatibility with magnetic fields.

8. ISO 14971:2019 – Medical Devices Risk Management

• Clause 7.5: Information for Safety
  Risk analysis must inform the labeling, ensuring all risks and necessary warnings are clearly identified on the product’s label.

• Clause 6.2: Risk Control Measures
  Labeling must include controls, warnings, and instructions that mitigate identified risks, ensuring safe device usage.

• Clause 7.4: Communication of Residual Risks
  Labels should communicate residual risks (after control measures) clearly to users, helping avoid unintended harm.

These sections emphasize the role of labeling in ensuring safety, traceability, and regulatory compliance in medical devices. Each standard provides specific guidelines on how information should be presented on devices to promote proper usage, reduce risks, and meet legal requirements.