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Glossary Term
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ISO 7153 (Surgical Instruments – Metallic Materials)

Definition

ISO 7153 is an international standard that defines the types of metallic materials suitable for surgical instruments, providing guidelines for material composition, mechanical properties, and corrosion resistance. The standard ensures that instruments made from these materials can withstand repeated use, cleaning, and sterilization without compromising performance or safety.

Relevance to the MedTech Industry

ISO 7153 ensures that surgical instruments are made from materials that meet the demanding conditions of clinical use. By specifying materials with proven durability and biocompatibility, the standard supports patient safety and the reliable performance of surgical tools.

Additional Information & Related Terms

Key Components of ISO 7153

  1. Material Specifications

    • Lists acceptable metallic materials, including stainless steels, cobalt-based alloys, and titanium alloys.

  2. Corrosion Resistance

    • Emphasizes resistance to corrosion from exposure to blood, bodily fluids, and sterilization processes.

  3. Mechanical Properties

    • Ensures that materials have the necessary hardness, strength, and ductility for surgical applications.

  4. Sterilization Compatibility

    • Confirms that materials can withstand repeated sterilization cycles, such as autoclaving, without degradation.


Examples of Applications

  • Scalpels and Surgical Scissors: Made from stainless steels specified in ISO 7153 for sharpness and durability.

  • Forceps and Needle Holders: Designed with materials that resist corrosion and maintain tensile strength.

  • Orthopedic Instruments: Constructed from high-strength alloys to handle mechanical stresses during procedures.

  • Reusable Instruments: Materials must withstand repeated cleaning and sterilization cycles without degradation.

Related Terms

  • Corrosion Resistance Testing: A critical aspect of ensuring materials meet ISO 7153 requirements.

  • Biocompatibility Testing (ISO 10993): Ensures that materials used in surgical instruments are safe for patient contact.

  • Sterilization Compatibility: Materials must withstand processes like autoclaving or chemical sterilization without compromising integrity.

  • ISO 13485: Quality management systems for medical devices, which often integrate material compliance standards like ISO 7153.

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