Types of Standards: Collateral & Particular

Let's consider IEC 60601 Medical electrical equipment. It has collateral standards (Part 1) and particular standards (Part 2) associated with it.

Collateral standards (sometimes called horizontal standards) "supplement the core requirements by providing technology-related safety requirements." Link to source Links to an external site.

For IEC 60601, these are listed in Part 1. Each collateral standard in Part 1 defines the safety and performance requirements for a specific characteristic of all medical electrical equipment. The Part 1 general standard is IEC 60601-1 Medical electrical equipment - General requirements for basic safety and essential performance Links to an external site.. An example of a collateral standard in Part 1 is IEC 60601-1-3 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment. Links to an external site.

 

Particular standards (sometimes called vertical standards) "supplement the core requirements by providing device-specific safety and performance requirements." Link to source Links to an external site. 

For IEC 60601, these are listed in Part 2. Each particular standard in Part 2 defines the safety and performance requirements for a specific sub-group of medical electrical equipment. An example is IEC 60601-2-21 Medical electrical equipment - Particular requirements for the basic safety and essential performance of infant radiant warmers. Links to an external site.

Both collateral and particular standards have the same standard identification number as the general standard plus additional numbers after a hyphen. 

That means if you're developing a new hospital bed with an alarm system, you'll need to look at multiple IEC 60601 standards: 

• General standard for safety and performance of medical electrical equipment: IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Links to an external site.
• Collateral standard for safety and performance of alarm systems: IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Links to an external site.
• Particular standard for safety and performance of medical beds: IEC 60601-2-52 Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds Links to an external site.